2013 News Briefs - International Neuromodulation Society
Earlier News:
Later News:
January - December 2013
December 2013 - The BROADEN (BROdmann Area 25 DEep brain Neuromodulation) Study has been closed, reportedly after a futility analysis did not support continuing St. Jude Medical's clinical investigation of the intervention in treatment-resistant major depressive disorder, following an FDA-approved expansion in 2011 of up to 20 sites and 231 patients. (Neurotech Business Report) (Neurotech Reports)
Dec. 25, 2013 - In a presentation in western Montana, a neurological surgeon describes deep brain stimulation for movement disorder, saying the quality-of-life benefits in appropriate patients at the right window of time are tremendous, such as being able to go to a restaurant, write a letter, or pay bills. (Daily Inter Lake)
Dec. 24, 2013 - A Colorado Springs woman with Parkinson's disease had her new deep brain stimulation system programmed for the first time the week of Christmas. The formerly athletic mother of four had had Parkinson's disease for more than a decade, and said she considers the treatment a new beginning. (9news.com)
Dec. 23, 2013 - The large regional private insurer Medical Mutual has written a positive coverage policy for percutaneous tibial nerve stimulation delivered via Uroplasty Inc.'s Urgent PC Neuromodulation system for treatment of overactive bladder. The insurer covers 2.7 million people, primarily in Ohio, as well as Georgia, Indiana, Michigan, Pennsylvania, South Carolina and West Virginia. This decision brings to 148 million the number of people in the U.S. with access to coverage for the therapy. (Wall Street Journal)
Dec. 22, 2013 - A pain specialist in Malaysia compares and contrasts percutaneous electrical nerve stimulation (PENS) for pain with acupuncture and transcutaneous electrical nerve stimulation, saying the National Institute of Clinical Excellence issued a guideline in the spring on the use of PENS in pain. (The Star)
Dec. 20, 2013 - Although it has been reported that young patients who receive deep brain stimulation (DBS) to the globus pallidus after a relatively short period of dystonia are able to sustain benefits after stimulation is switched off, a small randomized, controlled, double-blind crossover study of adult (mean age 52) who had dystonia for a mean time of 11 years did not exhibit this sustained effect. Although initially stimulation takes longer to exert symptom control than in other conditions, the 12 patients in the study had resumed symptom relief within a few minutes of restarting stimulation following a shutoff of less than two days. The authors conclude, "This phenomenon and the underlying neurobiology should be studied in greater detail in the future, aiming at the possibility of early DBS treatment of dystonia for sustained changes in maladaptive neuronal plasticity." (Movement Disorders)
Dec. 19, 2013 - A psychiatrist who teaches bioethics at Columbia University presents emerging clinical experience involving deep brain stimulation in addiction and other behavioral conditions. (Scientific American)
Dec. 19, 2013 - Greatbatch has filed for pre-market approval of its spinal cord stimulation system that was designed by its subsidiary, QiG Group. Offering a complete medical system is part of a strategy to increase growth and profitability, the company said. (Mass Device)
Dec. 19, 2013 - A study of patients before and after deep brain stimulation for Parkinson's disease indicates that any effect on difficulty recognizing facial expressions such as sadness following surgery may be transitory dues to microlesions that are largely reabsorbed after a few months. While patients before and after stimulation therapy had trouble recognizing the facial expression for disgust, verbal expressions of emotion did not elicit any difficulty in either group. (Medical Xpress)
Dec. 6, 2013 - A study in Obesity Surgery of five morbidly obese patients who received cervical spinal cord stimulation and occipital nerve stimulation during the day for eight weeks led to a steady and sustained loss of body fat, probably through activation of the autonomic nervous system. (F1000Prime)
Dec. 18, 2013 - A study of simulated driving with 65 subjects, some of whom had Parkinson's disease and a third of whom controlled motor symptoms through deep brain stimulation showed that stimulation resulted in more driving accuracy. In fact that group did not perform significantly worse than the controls in any category of error and even performed better in making fewer slight errors. The study, published in Neurology, was conducted at the University Medical Center Hamburg-Eppendorf in Germany. (EurekAlert)
January 2014 - A review article summarizes how, over the past 25 years, technology for deep brain stimulation has evolved so that stimulation can be more precisely targeted and feedback incorporated that may allow therapy to monitor disease states and apply stimulation on demand. (Parkinsonism & Related Disorders)
Dec. 18, 2013 - International Neuromodulation Society members Robert Foreman, PhD and Jiande Chen, PhD report with colleagues that in diabetic rats, spinal cord stimulation quickened gastric emptying, probably by inhibiting activity of the sympathetic nervous system, and it may have utility for treating gastrointestinal motility disorders. (Neurogastroenterology & Motility)
Dec. 16, 2013 - A stroke patient in Scotland who is participating in a clinical trial to see if vagus nerve stimulation enhances rehabilitation for arm weakness describes his recovery. (Mail Online)
Dec. 16, 2013 - Saying depression is a disorder of brain circuits, neurologist Helen Mayberg, MD of Emory University has been producing probabilistic tract maps with colleagues to better position deep brain stimulation electrodes for delivering electrical stimulation that flows from the brain target Area 25 to the frontal cortex via white tracts -- which appears be key to providing relief. Moving a left-side electrode 2 mm deeper in one instance helped a patient go from a reduction in symptoms of just 30% to remission, Mayberg said at the Society for Neuroscience annual meeting. (Dana Foundation)
Dec. 16, 2013 - The rhythmical current of vagus nerve stimulation raises the seizure threshold in epilepsy, a neurologist explains in a profile of a woman who has been seizure-free in the four years since receiving her implant. She said she is more alert now she is not trying combinations of drugs to control the symptoms. (Duluth News Tribune)
Dec. 14, 2013 - A woman underwent deep brain stimulation in a clinical trial of the procedure in depression in 2009 had the leads moved to a more ideal position a year later during a second surgery in which she was kept partially awake to gauge her reaction. The brain target was Area 25, which neurologist Helen Mayberg, MD said, in an interview about the research, is targeted to try to turn negative mood and psychic pain off. (Pittsburgh Post-Gazatte)
Dec. 14, 2013 - Stimulation to the prefrontal area of the brain, in four volunteers with epilepsy, apparently enhanced a braking function required to complete a task by slowing action -- indicating potential to enhance self-control by increasing function of this circuit, as reported in the Journal of Neuroscience. (Psych Central)
Dec. 14, 2013 - A small early trial of 11 patients with treatment-resistant depression who received external trigeminal nerve stimulation overnight led to mood improvement within two weeks of the eight-week trial, according to details in a news feature about the work. Co-inventor Ian Cook, MD, a professor of psychiatry at the University of California, Los Angeles and member of the International Neuromodulation Society, said in an interview that the trigeminal nerve projects to a lot of important areas in the brain, sending sensory information from the environment that may be useful to survival. Due to that, the ability to stimulate this nerve externally permits an influence to be extended to deeper brain circuits that are involved in behavior. (Pittsburgh Post-Gazatte)
Dec. 13, 2013 - Optogenetics influenced the visual decision-making of two primates in research reported in Current Biology, with a similar rate as electrical stimulation to the lateral intraparietal area, although the speed of reaction time was slower with electrical stimulation, possibly due to its relative imprecision in the cells it reached. (R&D Magazine)
Dec. 12, 2013 - In a survey by the Parkinson Alliance of 334 people with Parkinson's disease who underwent deep brain stimulation (DBS) therapy and 819 individuals who did not, there was 2.52 more risk of falls in the respondents who had DBS, according to the results. The organization recommends discussing fall prevention at each visit for patients who have DBS. (PR Newswire)
Dec. 9, 2013 - A joint teletherapy program offers language training conducted remotely for children under the age of 3 who have received cochlear implants. Toddlers from Salinas, CA to the Oregon border participate in the program, Baby Talk, regardless of ability to pay. A 1-year-old girl who is among the 17 youngsters enrolled is featured in a news column describing her home-therapy sessions. (Stanford University)
Dec. 11, 2013 - In remarks at an event, the founder and CEO of visual prosthetics inventor Second Sight Medical, whose Argus II retinal implant was approved by the FDA earlier this year, discusses the 22-year, $200 million development of the "bionic eye" for improving visual perception in patients with retinitis pigmentosa. He said the next challenge would be to bypass the optic nerve and stimulate the visual cortex, a goal that may lead to a device to test in the next two years. (Mass Device)
Dec. 11, 2013 - Michigan-based Spectrum Health, whose medical group chief of neurology is the immediate past chair of the National Epilepsy Foundation, will be among the first health systems in the U.S. to offer the NeuroPace® Responsive Neurostimulation (RNS®) System for patients with medically refractory epilepsy that has no more than two origin points. NeuroPace, Inc. estimates that approximately 400,000 people in the U.S. meet criteria for the device and may benefit from treatment. (Phys.org)
Dec. 11, 2013 - A newspaper columnist writes about two friends who will undergo deep brain stimulation surgery similar to the operation he had nearly three years ago to manage symptoms of his Parkinson's disease. (Fountain Hills Times)
December 2013 - One of 25 expected locations for the U.S. ACCURATE pivotal clinical study of Spinal Modulation, Inc.'s Axium™ Neurostimulator System for patients with chronic lower limb pain is Holy Cross Hospital in Fort Lauderdale, FL. The neurostimulator targets the dorsal root ganglion to interrupt pain signals traveling to the brain. (Holy Cross Hospital)
Dec. 10, 2013 - At the American Epilepsy Society annual meeting, Cyberonics, Inc. presented results from 14 European centers in which 31 patients received the company's investigational AspireSR generator, which provides normal-mode vagus nerve stimulation augmented by seizure response stimulation. The performance and safety study met its endpoint; the IntelliSense cardiac-based seizure detection system detected more than 80% of seizures accompanied by a heart-rate increase that often occurs near or before the seizure onset. (Pharmabiz.com)
Dec. 9, 2013 - International Neuromodulation Society member Alexander Green, MD, and colleagues report that deep brain stimulation for chronic neuropathic pain significantly improved mood, anxiety, and aspects of quality of life in a six-month follow-up compared to baseline. However, improvements in pain severity from stimulation of the periventricular/periaqueductal grey area and sensory thalamus were associated with less improvement, and even deterioration, on measures of executive cognitive functioning. (The Journal of Pain)
Dec. 9, 2013 - Highland Instruments, Inc. announced its ESStim™ technology, noninvasive brain stimulation that combines independently controlled electromagnetic and ultrasonic fields, was presented during the 5th International Symposium on Neuromodulation in September in Brazil. A preliminary analysis of 18 patients with osteoarthritis of the knee showed significant pain reduction lasting up to four weeks post-stimulation. (PR Newswire)
Dec. 9, 2013 - A reporter for National Public Radio's Morning Edition profiles the experiences of a man being evaluated for epilepsy in the hospital, centering on how selective brain stimulation during these procedures can reveal more about the roles of different brain regions, such as the recently reported association between a particular brain center and perseverance. (WBUR)
Dec. 8, 2013 - Results of the 250-patient pivotal clinical trial for the NeuroPace responsive neurostimulation device approved by the FDA last month were presented at the American Epilepsy Society's annual meeting. Responder rates increased steadily over the first two to three years after implant, with seizure frequency dropping about 55%, a level that was sustained for up to 80 months. (MedPage Today)
Dec. 5, 2013 - International Neuromodulation Society members Adnan Al-Kaisy, MD; J.P. Van Buyten, MD; Iris Smet, MD; Stefano Palmisani, MD; and Thomas Smith, MD were among authors reporting two-year follow-up results in a prospective, multi-center study of high-frequency spinal cord stimulation in patients with chronic pain of the low back and legs. Of the 64 patients assessed after 24 months, clinically significant improvements in pain reduction, reduced opioid use, function, and satisfaction were observed. (Pain Medicine)
Dec. 5, 2013 - A study in Neuron http://www.cell.com/neuron/retrieve/pii/S0896627313010301 indicates the importance of the anterior cingulate cortex in perseverance to overcome challenges. The study involved two epileptics who had electrodes implanted in their anterior midcingulate cortex to learn about their seizures. Stimulation of this region, the authors report, "elicits autonomic changes and the expectation of an imminent challenge coupled with a determined attitude to overcome it." (Medical Daily)
Dec. 5, 2013 - International Neuromodulation Society member Jaimie Henderson, MD, implanted the first deep brain stimulation device in the U.S. that is capable of sensing and storing electrical activity in the brain. Stanford University, where he is a professor of neurosurgery at the medical school, will receive 10 of these next-generation symptoms as part of a clinical study, according to the Stanford Center for Clinical and Translational Research and Education. Henderson said the device provides "a unique window on brain function and dysfunction in Parkinson's disease." (Stanford School of Medicine)
Dec. 6, 2013 - At the 17th annual meeting of the North American chapter of the International Neuromodulation Society (INS), Boston Scientific Corporation presented a retrospective study of up to three months follow-up with its Precision Spectra™ spinal cord stimulation system (SCS). INS member Salim Hayek, MD, PhD, chief, Division of Pain Medicine at University Hospitals of Cleveland commented on the effectiveness of pain-reduction shown in up to 213 consecutive patients at 13 centers with the SCS system. It uses 32 contacts and an anatomy-driven computer model for programming stimulation. Among initial results were a 94% trial success rate; pain reduction from 7.8 out of 10 to 3.2 in the 113 patients who were three months post-implant; and a lower-back-pain reduction from an initial 7.0 to 2.9 out of 10 in 32 lower-back-pain patients who reached a three-month follow-up. Early results indicated improved function, and reduced opioid use and disability. (Yahoo! Finance)
Dec. 5, 2013 - Medtronic, Inc. announced that the first U.S. patients have received implants of the company's Activa PC+S deep brain stimulation system (DBS) that senses and records brain activity. The system could be subject to research at up to 20 centers, and the brain-mapping data will be made available to physicians worldwide for clinical studies. The system is investigational in the U.S., and received CE Mark in January in the European Union. The first U.S. patients were treated at Stanford Movement Disorders Center and the University of California San Francisco’s Bachmann-Strauss Dystonia and Parkinson Foundation Center of Excellence. (Star Tribune)
Dec. 5, 2013 - Product developer Sangentia announced it will work on a programming interface with SetPoint Medical to develop an iPad App and advise on radio frequency and Bluetooth Low Energy interfaces for SetPoint's bioelectronics platform. The platform is being developed to treat inflammation-mediated autoimmune diseases as a lower-risk, lower-cost alternative to immunosuppressive drugs for chronic inflammatory diseases. (Business Wire)
Dec. 5, 2013 - Amol Sarva, PhD, writes in Wired Magazine he is building a team to target using neurostimulation to treat brain damage, with a 12-person controlled trial complete and a 100-person trial anticipated. The co-founder of Virgin Mobile USA, he calls neurostimulation a mind-expanding idea that might be commercialized to improve cognitive function. Sarva pursued a doctorate in cognitive science at Stanford University and previously created two communications startup companies. (Wired)
Dec. 4, 2013 - St. Jude Medical, Inc. announced the first patient has been enrolled in a randomized controlled clinical study that compares spinal cord stimulation (SCS) alone against SCS with peripheral nerve field stimulation (PfNS) for managing chronic low back and leg pain. The patient was enrolled by International Neuromodulation Society (INS) member Thomas Yearwood, MD, PhD. A maximum of 450 patients who have failed back surgery syndrome will be enrolled at up to 35 sites in the U.S. in the trial, led by principal investigator and INS member Porter McRoberts, MD. The SENSE™ Subcutaneous and Epidural Neuromodulation System Evaluation study will examine safety and efficacy of combined SCS and PfNS, as well as pain reduction, quality of life, changes in disability measures, and cost-effectiveness data to support reimbursement coverage. (Business Wire)
Dec. 4, 2013 - Minnesota-based Uroplasty, Inc. expects to end calendar year 2013 with an increasing number of patients receiving insurance reimbursement for its percutaneous tibial nerve stimulation system, Urgent® PC, for overactive bladder and relate symptoms. This includes approximately 40 million Medicare recipients, an increase from 37 million a year ago, and approximately 106 million patients with private insurance, up from 87 million a year ago. The Health Care Service Corporation (HCSC), the largest customer-owned health insurance company in the United States, recently announced that in Illinois, Montana, New Mexico, Oklahoma and Texas, as of Dec. 15, 2013, coverage will be extended for up to three years for patients showing continued improvement after the first year of treatment.
(Benzinga)
Dec. 4, 2013 - Deep brain stimulation pioneer Alim Benabid, MD, PhD, was among speakers at a two-day Brain Forum in Jeddah designed to place Saudi Arabia on the "roadmap of the human brain frontier," according to the organizer of this first-ever event. (Saudi Gazette)
Dec. 3, 2013 - EnteroMedics said its vagus nerve stimulation implant, the Maestro Rechargeable system, showed in the first 18 months of a pivotal five-year study that 117 patients in the active treatment group achieved 25% loss of excess weight compared to 12% weight loss in the 42 patients in the sham treatment group. With the news, shares rose 81 cents Tuesday to $2.24. (TwinCities.com)
Dec. 3, 2013 - International Neuromodulation Society member John Honeycutt, MD, led the first two surgeries in which children with dystonia received deep brain stimulation implants while "asleep" through the use of real time image guidance and visualization. The surgeries using MRI Interventions' ClearPoint® Neuro Intervention System and an IMRIS VISIUS® Surgical Theatre took place at the Cook Children's Medical Center Department of Neurosurgery in Fort Worth, Texas in November. (MarketWatch)
Dec. 3, 2013 - St. Jude Medical, Inc. has initiated a U.S. clinical trial of spinal cord stimulation with its Prodigy™ neurostimulator that uses a proprietary burst mode of stimulation. Up to 442 chronic pain patients will be enrolled at up to 50 sites in the safety and efficacy trial, SUNBURST™ (Success Using Neuromodulation with BURST). The new investigational device has an expected 10-year battery life and requires recharging approximately once a week. It is designed to deliver both tonic and burst stimulation. International Neuromodulation Society President Elect Tim Deer, MD commented that the comprehensive approach may help manage pain in patients whose pain is not adequately managed by tonic spinal cord stimulation alone, or who lose therapeutic benefit over time. Also, the prospect of burst stimulation providing paresthesia-free pain relief means it could suit patients who cannot tolerate traditional stimulation. (Mass Device)
Dec. 2, 2013 - Soterix Medical Inc. of New York, N.Y., Rogue Resolutions Ltd of Cardiff, UK, and neuroConn GmbH of Ilmenau, Germany announced a transcranial direct current stimulation (tDCS) platform with a headgear designed for clinical trial or home use. The MOBILE neuromodulation device kits are designed to deliver Limited Total Energy (LTE) tDCS, using a proprietary technology developed at The City College of New York. The kits include cloud-based compliance monitoring and are explicated to enter clinical trials in 2014. (PR Newswire)
Dec. 2, 2013 - A woman who had chronic pain more than 20 years after two back surgeries and finally regained more daily functioning after receiving a spinal cord stimulator (SCS) implant says she hopes others with such a condition will seek help and get relief after reading about a woman with degenerative disc pain who was able to run a half-marathon after using SCS. (Monterey County Herald)
Dec. 1, 2013 - A 4-year-old boy who has had epileptic seizures since infancy received a vagus nerve stimulation system, benefitting from that stimulation since treatment began one month ago. (Las Cruces Sun)
Nov. 30, 2013 - When involuntary movements are continuous, life-threatening and refractory to intensive care procedures, a prospective study of seven critical care patients indicates that neurostimulation could represent a valuable choice. In the study by International Neuromodulation Society member Angelo Franzini, MD, and co-authors, five patients with status dystonicus received bilateral deep brain stimulation (DBS) to the globus pallidus internus, resolving those symptoms from between 1 week to 3 months. A patient with post-stroke severe hemiballismus received unilateral DBS to the unilateral ventralis oralis anterior and posterior nucleus of the thalamus. That patient's symptoms were controlled in 10 hours and the patient was discharged in two days. Another patient with hemiballismus who was also treated with unilateral DBS was transferred to the neurosurgery ward after 13 days. (Journal of Neural Transmission)
Nov. 30, 2013 - A news feature explores the experiences of a Parkinson's disease patient who chose to have deep brain stimulation surgery (DBS) early in his disease at the recommendation of his neurologist, and has begun a support group for people who have had, or are considering, DBS. (Las Vegas Review-Journal)
Nov. 29, 2013 - Two possible mechanisms of action are proposed for the therapeutic effect of sphenopalatine ganglion (SPG) stimulation in migraine. Parasympathetic activity of the SPG may contribute to the pain of migraine as well as tearing, nasal stuffiness, and other symptoms of the autonomic nervous system. Possible mechanisms of SPG stimulation are either interrupting parasympathetic outflow that triggers those symptoms, or modulating sensory processing in the trigeminal nucleus caudalis. (Cephalalgia)
Nov. 29, 2013 - An article describes how early studies indicate that deep brain stimulation may be promising in treating such eating disorders as obesity or anorexia. (dailyrx.com)
Nov. 27, 2013 - A U.S. military publication explains how the Defense Advanced Research Projects Agency's Systems-Based Neurotechnology for Emerging Therapies (SUBNETS) program is aimed at evaluating how the central nervous system represents traumatic brain injury, addiction, and fibromyalgia/chronic pain. If successful, the program manager said, the research would "advance neuropsychiatry beyond the realm of dialogue-driven observations and resultant trial and error . . . to produce major improvements in quality of life for service members and veterans who have very few options with existing therapies. These are patients for whom current medical understanding of diseases like chronic pain or fatigue, unmanageable depression or severe post-traumatic stress disorder can’t provide meaningful relief.” (Armed With Science)
Nov. 26, 2013 - In a paper describing possible therapeutic mechanisms of neuromodulation in migraine using such interventions as sphenopalatine ganglion stimulation or transcranial magnetic and electrical stimulation, computational scientists describe how conceivably a dynamical network biomarker might provide an early-warning system for episodic bouts of chronic conditions. They say that quantitative modeling at cellular and tissue scales might have predictive properties and help to optimize treatment protocols as well as develop a unified theory of control. Experimental data, such as imaging of neural connectivity, would aid this endeavor. (Translational Neuroscience)
Nov. 25, 2013 - International Neuromodulation Society member Ryder Gwinn, MD, explains how the new NeuroPace responsive neurostimulation system for epilepsy provides a window into brain activity, building therapy around a patient's seizure fingerprint and permitting programming of stimulation to be refined through closed-loop feedback. (KOMO News)
Nov. 24, 2013 - A team at the University of British Columbia performed studies on rats that showed inactivating the lateral habenula, as may occur in deep brain stimulation, led to the research subjects displaying indifference about choosing between rewards with different subjective costs and benefits. The work suggests that rather than serve as an aversion center, conveying an anti-reward signal as previously thought, the region may act as a preference center for expressing subjective decision biases. (University of British Columbia)
Nov. 19, 2013 - In what is called the first prospective study of its kind, 27 patients received spinal cord stimulation of the conus medullaris for refractory pudendal neuralgia; 20 patients were considered responders after a trial phase and went on to permanent implantation. All the implanted responders continued to benefit at a mean follow-up of 15 months. The authors conclude that routine use of this technique should be validated in a larger study in this type of patient. (Neurology and Urodynamics)
Nov. 25, 2013 - A retrospective analysis of 217 patients with lower urinary tract dysfunction showed that in a median follow-up of almost four years, the benefits of sacral neuromodulation persisted with less need for repositioning in patients treated by more recent percutaneous self-anchoring leads. (medwireNews)
Nov. 22, 2013 - The Australian Therapeutic Goods Administration has approved use of SPR Therapeutics' Smartpatch percutaneous peripheral nerve stimulation system for shoulder pain. The device is manufactured by NDI Medical of Cleveland, Ohio. International Neuromodulation Society Secretary Marc Russo, MBBS, commented that the minimally invasive system fills a gap in the pain treatment continuum, between narcotics or more invasive surgery. (Digital Journal)
Nov. 22, 2013 - The Defense Projects Research Agency has issued a request for proposals about using brain stimulation to help treat post-traumatic stress disorder, traumatic brain injury, and other brain maladies through closed-loop neural recording and stimulation. (FEDweek)
Oct. 30, 2013 - St. Louis-based EndoStim announced it has received approval in Argentina for sale of its neurostimulation system to treat gastroesophageal reflux disease, GERD. The Lower Esophageal Sphincter Stimulation System strengthens the muscle that prevents stomach acid from rising into the esophagus, which lacks a protective lining to protect against tissue damage. The system uses bipolar leads that are implanted laparoscopically and powered by an impulse pulse generator. (PR Newswire via EndoStim)
Nov. 22, 2013 - Cyberonics Inc. of Houston, TX announced second-quarter 2013 gains with net income up to $13.8 million from $13.5 million during the same quarter one year ago. Sales of its vagus nerve stimulation system grew internationally by almost 10% and overall sales were at a record high. Product development includes submission of the vagus nerve stimulation generator AspireSR for approval in Europe for use in epileptics in whom the device could automatically deliver stimulation in response to a change in heart rhythm. (Fierce Medical Devices)
Nov. 21, 2013 - International Neuromodulation Society member Dirk De Ridder, MD, PhD, and colleagues published an early view case series in Neuromodulation: Technology at the Neural Interface describing how medication-free patients with chronic tinnitus who received 20 daily sessions pairing a brief electrical stimulation of the vagus nerve and tones other than the tinnitus-matched frequency experienced improvement in symptoms that was stable for two months after therapy. This case series was an attempt to translate into humans findings from animal research indicating it may be possible to drive neural plasticity in a controlled way to limit symptoms of the disorder. (University of Texas at Dallas)
Nov. 21, 2013 - The founder of Second Sight Medical, creator of the Argus II visual prosthetic that is due to be marketed in the U.S. in 2014, described its development as a means to bypass a gap in the sensory nervous system pathway, and what future treatments may be in store. (Mass Device)
Nov. 21, 2013 - Oberlin, Ohio-based Synpase Biomedical received Health Canada approval for its diaphragm pacing system, NeuRx. The system electrically stimulates the muscles to allow spinal cord injury patients to breathe longer without the need of a mechanical ventilator forcing air into the lungs. (Today's Medical Developments)
Nov. 19, 2013 - Medtronic Inc.'s former vice president and general manager of neuromodulation, Karl Schweitzer, was appointed to the board of EBS Technologies GmbH, an emerging device company developing a noninvasive electrical brain stimulation platform to expand the visual field in patients whose vision is impaired following stroke or other nerve damage. The NEXT WAVE(TM) platform stimulates firing along optic pathways. (Market Watch)
Nov. 19, 2013 - Boston Scientific Corporation received CE mark approval for European use of its deep brain stimulation (DBS) system Vercise™ in intractable primary and secondary dystonia. The system has separate controls for each electrical contact to allow adjustment of stimulation fields and tailor treatment in order to manage or reduce symptoms of the condition. The system is investigational in the U.S. although the FDA permits use of deep brain stimulation in dystonia through a Humanitarian Device Exemption. (PR Newswire)
Nov. 18, 2013 - A professor at the University of Kentucky has already enrolled five of an expected six patients to undergo both deep brain stimulation and an autologous transplant of peripheral nerve into the brain in a Phase I safety and feasibility trial in Parkinson's disease. The tissue graft is intended to stimulate repair of brain regions that progressively degrade in Parkinson's disease. Since some peripheral nerves can regenerate, the procedure involves taking about an inch of peripheral nerve from above the ankle, and grafting the tissue into the patient's substantia nigra during the deep brain stimulation surgery, where the tissue may release nerve growth factors. Early results showed the five patients were able to stop taking Parkinson's disease medication one month after surgery. (University of Kentucky)
November 2013 - International Neuromodulation Society member Youichi Saitoh, MD, PhD and colleagues report a randomized, double-blind cross-over trial of 21 Parkinson's disease patients that compared sham stimulation with high-frequency repetitive transcranial magnetic stimulation (HF rTMS). In the clinical trial, they found HF rTMS over the primary motor foot area significantly improved motor symptoms. The authors report no adverse effects and found daily repeated stimulation was not significantly more effective than a single session, but may maintain motor symptom improvement.
Nov. 14, 2013 - NeuroPace, Inc. of Mt. View, Calif. received premarket approval from the FDA for the first closed-loop responsive brain stimulation system, an adjunctive treatment for adults with partial onset seizures not controlled by two or more epileptic drugs. The RNS® System is designed to detect certain types of pre-seizure electrical activity in the brain and deliver small bursts of electrical stimulation intended to reduce the frequency of seizures. (U.S. News and World Report)
Nov. 7, 2013 - A review intended to expand knowledge among non-surgically skilled providers who deal with patients who have fecal incontinence describes neuromodulation as an effective, minimally invasive procedure with a low rate of adverse events and an apparently favorable cost-efficacy profile. (World Journal of Gastroenterology)
Nov. 14, 2013 - In animal studies, physicians investigated what might be a safe lead-tip temperature for induced neurostimulation lead heating, finding 43 degrees C for 30 minutes appeared, in tissue examination seven days after recovery, to not cause clinically evident thermal damage. (Neurosurgery)
Nov. 13, 2013 - A physician who pioneered a deep brain stimulation (DBS) program at Penn State Hershey said none of his more than 300 patients have chosen to reverse the procedure, and adds he thinks "we're just scratching the surface of what DBS can do." (Pennsylvania State University)
Nov. 13, 2013 - For the past 12 months, Rosellini Scientific, LLC of Dallas, Texas has been collaborating with NanoWattICs SRL of Montevideo, Uruguay to develop a suite of implantable, wireless and non-invasive neurostimulation technologies for applications including migraines and neuropathic pain. Montevideo, Uruguay- based NanoWattICs received a grant to partially fund this work from the Agencia Nacional de Investigación e Innovación in Uruguay. The company focuses on custom circuits that maximize battery life in portable applications. (PR Web)
Nov. 13, 2013 - New organic materials that also conduct electricity might become part of a plastic brain implant embedded with nerve-growth factors or other biologically active proteins to make it a biologically active device, in a technology under development in Australia through a $675,000 National Health and Medical Research Council grant. Led by the ARC Centre of Excellence for Electromaterials Science, which includes the University of Wollongong, St. Vincent's Hospital, and La Trobe, Monash and Deakin universities, the project involves electrodes produced by 3D printers that will be implanted in the frontal area of brains of animals who have genes for susceptibility to schizophrenia. (Herald Sun)
Nov. 13, 2013 - In research presented at the Society for Neuroscience annual meeting in San Diego, 20 patients suffering from anorexia or bulimia received 20 sessions of repetitive transcranial magnetic stimulation over 4-6 weeks. Almost half of patients had a 50% drop in binging and purging; another third had an 80% improvement, and some patients eliminated the behavior altogether. The study targeted an area of the brain involved in executive control of thoughts, emotions, and behavior. Responders showed less connectivity to this regulatory center in brain scans, while non-responders had more, suggesting the latter group might respond to stimulation designed to inhibit rather than excite that region. (Philly.com)
Nov. 13, 2013 - Bryan Howell, a PhD candidate in the department of biomedical engineering at Duke University, presented a poster at the 6th International IEEE EMBS Neural Engineering Conference in San Diego, about modeling electrodes for deep brain stimulation that provide more efficient battery use and precise stimulation. (International Science Grid This Week)
Nov. 13, 2013 - In a sham-controlled study of smoking cessation in 115 smokers, high-frequency repetitive transcranial magnetic stimulation combined with an advance cue led to a quit rate of 44%. The same stimulation without the cue led to a 25% quit rate, and sham or low-frequency stimulation resulted in only 13% of subjects quitting. The treatment, presented at the Society for Neuroscience annual meeting in San Diego, targeted the prefrontal cortex and insula. (MedPage Today)
Nov. 12, 2013 - International Neuromodulation Society member Kendall Lee, MD, PhD reported at the Society for Neuroscience’s annual meeting in San Diego on preclinical development of a new deep-brain stimulation device, Harmoni, that monitors both electrical activity and neurotransmitter release -- chemical activity -- in response to deep brain stimulation. The system could potentially become a closed-loop device that wirelessly transmits recordings and adjusts stimulation based on the readings. Harmoni's chemical sensing is accomplished through a localized cyclic voltage change that transiently drives electrons off certain neurotransmitters.That induces a measurable current, enabling detection of the unique electrical signature of the neurotransmitter. So far, the developers have been using functional magnetic resonance imaging to watch areas in the brains of rats or pigs that respond to an implant stimulus. Sensors are then placed in these sometimes-distant brain regions. In an observation that might guide development of a device for conditions such as Parkinson's disease, the team was able to show activity in the caudate nucleus following stimulation of the subthalamic nucleus, for instance. (Nature)
Nov. 11, 2013 - Emory University is creating a new center for clinicians, researchers, and engineers working on deep brain stimulation. The Emory Neuromodulation and Technology Innovation Center, ENTICe, will provide technology transfer and commercialization expertise to collaborators from the departments of Neurosurgery, Neurology, Psychiatry, Rehabilitation, Biomedical Engineering, Neuroscience, and Psychology as well as the Yerkes Primate Center and Georgia Tech. (Emory University)
Nov. 12, 2013 - The University of South Florida and Tampa General Hospital celebrate 20 years of deep brain stimulation for movement disorder. A woman who gave up work due to her worsening symptoms of essential tremor, and whose family had been considering assisted living for her, wondered how it took her 17 years to learn of the option, and has now recovered her independence. (ABC Action News)
Nov. 11, 2013 - A 74-year-old man who received active vagus nerve stimulation starting five months ago as a participant in the Inovate-HF (Increase of Vagal Tone in Heart Failure) clinical trial said his last checkup showed one leaky heart valve had started to heal by itself and he feels as if his heart has received rest and recuperation and he has a new lease on life. His physician adds that the stimulator appears to act therapeutically in a way no drugs have been shown to do. (Mail Online)
November 2013 - A 33-year-old veteran who found back pain relief in a clinical trial of spinal cord stimulation at Fort Bragg in North Carolina has become an advocate for medical devices and chronic pain sufferers, saying that being able to test-drive a device was incredibly appealing to him after years of opiate dependence. (AdvaMed)
November 2013 - "In all cases of chronic non-cancer pain, neurostimulation should be given some consideration, and if appropriate trialed for possible long-term use," writes International Neuromodulation Society President-Elect Timothy Deer, MD, in an editorial on digital drugs reducing or eliminating the need for opioids in the treatment of chronic pain. (Expert Review of Medical Devices)
Efforts Advance to Develop Neural Prosthetics for Spinal Cord Injury
Nov. 6, 2013 - A blog post describes how personalized neuroprosthetics may be enabled by early clinical and pre-clinical research on spinal cord-injured subjects in labs around the world, which are gaining attention through presentations and articles lately. (TED Blog)
Nov. 5, 2013 - Neuromodulation is one of four areas to receive investment from the state of Minnesota through the MnDRIVE initiative funded by the legislature at the University of Minnesota (leading to new faculty openings http://www.nature.com/naturejobs/science/jobs/351465-mndrive-neuromodulation-scholars). The other areas in the two-year, $35.6 million innovation investment are food production, robotics, and water quality. (University of Minnesota)
November 2013 - In a Neurosurgical Focus article, authors from Columbia University Medical Center and Keck Hospital of the University of Southern California discuss use of deep brain stimulation in motor disorder and psychiatric or emerging indications, and its proposed mechanisms, such as activation and inhibition of neural circuits or reseting of rhythmic activity. They also consider possible future refinements as understanding evolves about the brain's interconnected "oscillations and burst firing patterns that we are just beginning to decode." (Journal of Neurosurgery)
November 2014 - International Neuromodulation Society member Richard North, MD, presented preliminary findings at the 2013 International Congress on Neuropathic Pain showing that in 42 failed back surgery syndrome (FBSS) patients followed for a mean of just over 3 years, “SCS was more effective and, given the high failure rate in the reoperation group, incrementally less expensive than reoperation in selected FBSS patients.” (Pain Medicine News)
Nov. 1, 2013 - A randomized, double-blinded clinical trial of 28 adults with high-functioning autism or Asperger's syndrome, aimed at using sessions of repetitive transcranial magnetic stimulation to stimulate the dorsomedial prefrontal cortex, showed a significant improvement one month later in social skills and reduced anxiety. The region stimulated had been shown to be underactive in people with autism and is an area linked with understanding others' thoughts, beliefs and intentions. (New Scientist)
Nov. 1, 2013 - Science magazine presents a news focus on deep brain stimulation and depression -- the research and its implications for developing more precise treatment -- in a special issue on neuroscience. The staff writer of the news focus was interviewed in an 8-minute podcast available for listening to on the publication's website. (Science)
Nov. 1, 2013 - A review of deep brain stimulation for Parkinson's disease, Tourette syndrome, depression and obsessive compulsive disorder by psychiatrist Nolan R. Williams, MD and neurologist Michael S. Okun, MD, examines optimizing stimulation for each, its potential positive and negative effects, and likely future innovations involving electrical modulation of neural networks. (Journal of Clinical Investigation)
November 2013 - Using Medicare physician fee schedules and published studies, an analysis of the cost-effectiveness of various test-phase strategies for sacral neuromodulation indicates that unilateral and bilateral Stage I implantation were the most cost-effective in terms of quality-adjusted life years, with bilateral preferred for greater treatment effectiveness. (Female Pelvic Medicine & Reconstructive Surgery)
Oct. 31, 2013 - International Neuromodulation Society member John Stamatos, MD, is described in a press release as having been the first physician in New York state to implant a Medtronic SureScan MRI neurostimulator. The device was implanted in August in a 43-year-old woman who had chronic back pain. He commented it is important for patients who have had previous back surgeries or chronic illness to have an MRI-compatible device due to the likelihood of needing scans performed in the future. (Market Watch)
Podcast Addresses Spinal Cord Stimulation Innovations
Oct. 31, 2013 - International Neuromodulation Society member Giancarlo Barolat, MD, is interviewed on a web-radio installment about chronic pain regarding innovations in spinal cord stimulation (SCS), following an account by a patient who uses SCS. Dr. Barolat commented that devices will decrease in size, become less prone to breakage or movement, and may operate wirelessly. The interview briefly mentions recent products by Medtronic, Inc., Boston Scientific Corporation, St. Jude Medical and Nevro Corp. (Aches and Gains)
Studies Suggest Predictors of Improvement After Deep Brain Stimulation for Parkinson's Disease
October 2013 - An analysis of three randomized clinical trials to assess health-related quality of life after deep brain stimulation therapy in Parkinson's disease indicates several predictors of quality-of-life improvement after this treatment, including including good levodopa response, young age and good cognitive function. (Touch Neurology)
Oct. 31, 2013 - International Neuromodulation Society member Brian H. Kopell, MD, director of the Center for Neuromodulation at Mount Sinai Hospital in New York City, and colleagues have begun enrolling heart failure patients as part of the international randomized clinical trial of vagus nerve stimulation, INOVATE-HF (INcrease Of VAgal TonE in chronic Heart Failure). Active stimulation of the right vagus nerve is intended to slow heart rate by restoring balance between the sympathetic and parasympathetic nervous systems. The trial compares stimulation and optimum medical therapy to optimum medical therapy alone on a 3:2 basis in patients with moderate symptoms of left ventricular systolic dysfunction. The CardioFit® system under investigation, by Israel-based BioControl Medical, includes a sensor in the right ventricle of the heart to monitor heart activity and adjust stimulation accordingly. International experience in the study is said to indicate that weeks or months of gradually increased stimulation can lead to an improvement in symptoms. (EurekAlert)
Oct. 30, 2013 - International Neuromodulation Society member John Donoghue, PhD, and his fellow Brown University professor Arto Nurmikko received the $1 million Moshe Mirilashvili Memorial Fund Breakthrough Research and Innovation in Neurotechnology (B.R.A.I.N.) Prize from Israeli President Shimon Peres at a technology conference in Tel Aviv for their years of work on the BrainGate brain-computer interface with collaborators from the Providence Department of Veterans Affairs, Massachusetts General Hospital, Stanford University and Case Western Reserve University. (Brown Daily Herald)
Oct. 29, 2013 - Soterix Medical Inc. of New York City plans a Phase III clinical trial in Brazil comparing transcranial direct current stimulation against antidepressant medication, using its low-voltage tDCS - Limited Total Energy device and the antidepressant Escitalopram oxalate (Lexapro®). With a target enrollment of 240 patients who have major depressive disorder, the trial at the University of Sao Paulo is designed to see if the stimulation is as effective as the medication, but with fewer side effects. The double-blinded trial will have one arm with sham stimulation plus placebo medication, another with sham stimulation and active medication, and a third with active stimulation and placebo medication. (PR Newswire)
Oct. 29, 2013 - Humana, Inc. -- the sixth-largest private health insurer in the U.S. and administrator of Tricare South and several Medicare Advantage plans -- will begin covering treatment with percutaneous tibial nerve stimulation of overactive bladder and associated symptoms, announced Uroplasty, Inc., manufacturer of the Urgent PC Neuromodulation System. (Wall Street Journal)
Oct. 29, 2013 - While shares of Boston Scientific have risen 120% in the past year and exceeded expectations, its adjusted earnings per share growth is less than competitors St. Jude Medical and Medtronic, notes a financial columnist, who adds that the company announced changes ahead with resignation of its CFO, new approvals in China and Europe, and layoffs for 2014. The columnist says moves to stabilize costs and margins would be positive catalysts and, since the stock is trading at a premium (based on its forward profit/earnings ratio) compared to its competitors, the price could be impacted more than its peers during a market pullback. (Motley Fool)
Patient With Interstitial Cystitis Receives Pudendal Nerve Stimulator
Oct. 29, 2013 - A teen-ager who had interstitial cystitis and plans to enter the pharmacy field received pudendal nerve stimulation in a procedure at Beaumont Health System’s Women’s Urology Center in Detroit. The treatment is described as potentially helping women or men who have pelvic floor pain and may not respond to sacral neuromodulation (the pudendal nerve branches to the second, third and fourth sacral nerves). Having recently received her permanent implant, she is currently taking university classes online. (Great Falls Tribune)
Advanced Materials May Improve Depth and Focus of Transcranial Magnetic Stimulation
Oct. 29, 2013 - Researchers at the University of Michigan are using metamaterials, which offer specific properties such as focusing electromagnetic radiation to a point smaller than its wavelength, to create next-generation transcranial magnetic stimulation systems. The goal is to penetrate the brain farther and stimulate structures important in treating depression without excessively stimulating nearby regions. Computer simulation indicates the system should be able to induce an electrical field about half a centimeter or more farther than conventional systems while focusing more narrowly. That precision resulted in 2.6 times less brain volume receiving unwanted side-stimulation. (EurekAlert)
Research Into Brain Stimulation Mechanisms Receives Australian Recognition
Oct. 29, 2013 - The Australian Institute of Policy and Science gave Kate Hoy, a clinical neuropsychologist from Monash University, a Young Tall Poppy Science Award for her research into brain stimulation, such as exploring why transcranial direct current stimulation helps improve schizophrenia-associated deficits in working memory. Award recipients must be high achievers under the age of 35. (Melbourne Leader)
Vagus Nerve Stimulation Improves Quality of Life for Man Diagnosed with Epilepsy in His Teens
Oct. 27, 2013 - A young man whose epilepsy was diagnosed seven years ago, at the age of 15, was able to improve memory, attention, and struggle less in school after turning to vagus nerve stimulation at the age of 16. He had not known he had been having seizures daily, and had been misdiagnosed at first with attention deficit disorder. Now he has been seizure-free for several months, he can seek a driver's license for the first time at age 23. (Sandy Journal)
Possible Biomarker for Effectiveness of Sacral Neuromodulation Explored
Oct. 18, 2013 - The level of inflammatory-response chemokines appears to correlate to the effectiveness of treatment with sacral neuromodulation for interstitial cystitis or painful bladder syndrome, and may be a biomarker of treatment response, according to a 24-week follow-up with seven of an initial 16 patients who were treated at the Oakland University William Beaumont School of Medicine. The study data were presented at the American Urological Association annual meeting in San Diego. (Urology Times)
Oct. 28, 2013 - International Neuromodulation Society member James North, MD is quoted in a television segment about the importance of patient selection in the success of spinal cord stimulation for chronic pain, and how reliance on opiates to relieve pain is decreasing after a "huge swing" toward their use in the early and mid-1990s. (WWLTV)
"Asleep" Deep Brain Stimulation Clinical Experience Presented at Neurological Surgeons' Meeting
Oct. 28, 2013 - Deep brain stimulation surgery while patients are "asleep", guided by MRI imaging using the ClearPoint Neuro Intervention System by MRI Interventions, Inc,. was presented at the annual meeting of the Congress of Neurological Surgeons in San Francisco, CA, USA. A prospective study of 60 patients showed that 98% of electrodes were correctly placed with a single pass into the brain; the average accuracy was 0.6 mm; and surgical times averaged from 3 hours to about 2.5 hours for bilateral and unilateral cases, respectively. One presenter commented that a number of her patients would not have agreed to undergo awake surgery, so she feels being able to use this real-time guidance system has benefitted them in providing a way to manage their movement disorder symptoms. (Market Watch)
Oct. 27, 2013 - A Star Tribune analysis of data from the U.S. Department of Health and Human Services indicates that there were more than 19,000 neurostimulation implants in the U.S. in 2010, with most of the implants being performed on patients younger than 65 years of age for pain and other indications, such as movement disorder or bladder dysfunction. The total number of neurostimulation implants in 2010 is 80% more than the number performed in the year 2000. The article includes comments from patients industry leaders and states that, according to Transparency Market Research of Albany, N.Y., the global market for neuromodulation devices is expected to grow to more than $6 billion by 2018, at a rate of 14% a year. (Minneapolis Star Tribune)
Oct. 25, 2013 - Patient selection for referral to deep brain stimulation treatment for Parkinson's disease or essential tremor is the subject of a literature review intended to aid primary care physicians in their understanding in order to identify potential candidates. (Gerontology)
Oct. 25, 2013 - From the perspective of payers in the United Kingdom, deep brain stimulation (DBS) combined with best medical treatment was compared for cost-effectiveness with best medical treatment alone. Statistical analysis of data from a six-month randomized controlled clinical trial suggests DBS is cost-effective for patients with advanced Parkinson's disease and provides good value for payers. (Journal of Neurology)
Oct. 24, 2013 - Uroplasty, Inc. announced a 5% increase in revenues the second fiscal quarter of 2014 compared to the same quarter a year ago. The Minneapolis, MN-based maker of devices to treat voiding dysfunctions took in $6 million in the quarter ended Sept. 30, with $4.5 million of that from U.S. sales. The company booked a one-time expense of $1.2 million due to changes in executive management and internal reviews, and overall had an operating loss of $1.9 million. (PR Newswire)
Agency Devotes Research Funding to Improving Deep Brain Stimulation Sensing and Control
Oct. 24, 2013 - The U.S. Defense Advanced Research Projects Agency (DARPA) announced it will spend more than $70 million over five years to enhance real-time detection of signatures of brain-based illnesses and injuries through the Systems-Based Neurotechnology and Understanding for the Treatment of Neuropsychological Illnesses program. Part of the BRAIN initiative announced earlier this year, which also involves the NSF and NIH, DARPA's particular research program focuses on improving deep brain stimulation technology. (New York Times)
Functional Electrical Stimulation Research Adapts Spinal Cord Stimulation to a New Purpose
Oct. 24, 2013 - Functional electrical stimulation research at the University of Louisville on spinal-cord injury patients aims to reawaken sensory feedback to the spinal cord in an attempt to allow such functions as independent standing. A news feature explains how new hardware and software is being developed at collaborating academic centers to suit this application of spinal cord stimulation better than leads and pulse generators created to address chronic pain. (IEEE Spectrum)
Oct. 24, 2013 - Boston Scientific Corporation announced revenue growth in neuromodulation of 32% compared to one year ago, with $115 million in sales in neuromodulation in the third quarter of 2013. The company announced restructuring in 2014 should increase operational efficiencies by reducing headcount between 1,100 - 1,300 worldwide through attrition and reductions in force. Overall the company generated $1.735 billion in sales and adjusted earnings per share of $0.17 in the quarter ending Sept. 30, 2013, and reported a GAAP loss of $5 million. After neuromodulation, the next highest area of revenue growth was in MedSurg, which was up 9% (12% on a constant currency basis). Interventional cardiology, meanwhile, had the most depressed earnings, down 4% or 2% on a constant currency basis. (Yahoo Finance!)
Epilepsy Patients in Ireland Get New Vagal Nerve Stimulation Clinic
Oct. 24, 2013 - A Vagal Nerve Stimulation Clinic opened Sept. 20 at the University Hospital Galway, allowing epilepsy patients in the region to receive full care there rather than have to travel to Dublin. (Galway Advertiser)
Oct. 23, 2013 - A 3-year-old boy who received an auditory brainstem implant five months ago is beginning to use and recognize single words, according to a television report. He was born without a cochlear nerve so would not have been a candidate for a cochlear implant. (CBS Evening News)
Researchers Use Deep Brain Stimulation to Trigger Limb Movements in Injured Rats
Oct. 23, 2013 - Swiss researchers report in Science Translational Medicine that walking and swimming motions were improved in spinal-cord-injured rats when a midbrain area, the mesencephalic locomotor region, received electrical stimulation. Previously investigated to treat disorders such as Parkinson's disease, stimulation to this brain area might also help people with spinal cord injuries, the research suggests. (IEEE Spectrum)
Occipital Nerve Stimulation Shows Success in the Case of a Migraineur
Oct. 22, 2013 - International Neuromodulation Society member Brian Snyder, MD, described a patient's success at reducing her migraines from approximately twice a day to once every two weeks through the use of occipital nerve stimulation. He explained that it takes experience to recognize which patients just need a change in medication or further therapy, and which are appropriate to consider for this treatment that can yield different degrees of response in different patients. (WWSB)
Oct. 21, 2013 - Saying further controlled studies of neurostimulation are warranted, the European Headache Federation published a consensus document saying neurostimulation should only be used in patients with intractable headache, carried out at a tertiary care center either as part of a valid study or with such evidence of effectiveness and acceptable side effects. (The Journal of Headache and Pain)
Oct. 21, 2013 - A Parkinson's disease patient who received a deep brain stimulation implant during the first such operation using Mazor Robotics Renaissance Guidance System was interviewed on a Florida television news broadcast. Her operation in August at Florida Hospital Celebration Health was the first such of three that month. (Orlando.com)
October 2013 - Disability decreased and quality of life increased with spinal cord stimulation (SCS) in a two-year Italian study of 80 patients with failed back surgery syndrome that compared costs associated with conventional medical management alone, and SCS plus medical management. The study, presented at the International Society for Pharmacoeconomics and Outcomes Research, found that the combined SCS and medical management approach was economical and effective. International Neuromodulation Society President-Elect Tim Deer commented in a news article about the work that the study adds to recent data showing SCS makes the care of chronic pain less expensive through reducing use of opioids and other pharmaceuticals. (Pain Medicine News)
Oct. 17, 2013 - A two-year study of 100 pain patients who received sessions of either anodal or cathodal transcutaneous direct current stimulation (tDCS) showed that more than half experienced at least a 50% pain reduction that was either transient or lasted up to 12 weeks. An article describing the study, which was presented at the 2013 annual meeting of the American Pain Society, concludes that further research may be warranted since tDCS causes minimal harm, is relatively inexpensive, and seems like a feasible approach, although reimbursement may be an issue. (Pain Medicine News)
Oct. 16, 2013 - The Cleveland Clinic announced Second Sight's Argus II retinal prosthesis, which won FDA approval in February was the first in the list of its top 10 medical innovations for 2013, and NeuroPace Inc.'s responsive neurostimulation system to detect seizure onset and reduce the intensity and frequency of epileptic seizures was third on the list. The news, along with explanatory videos, was also covered by Mass Device. (Cleveland.com)
Oct. 15, 2013 - During FierceMedical's second annual selection of the top 15 device and diagnostic companies of the year, SetPoint Medical was named one of the most promising private med-tech companies. Companies on the list are evaluated based on factors including technology strength, partnerships, venture backers and a competitive market position. SetPoint is developing vagus nerve stimulation of the autonomic nervous system to combat inflammation in autoimmune disease. (EON)
Functional Electrical Stimulation Research Concerns Adding the Sense of Touch to Prostheses
Oct. 15, 2013 - Researchers at the University of Chicago are working with rhesus monkeys to map the somatosensory cortex response to touch, pressure and grasping in order to learn how sensations might be added to functional electrical prosthetic limbs. (Wired.co.uk)
Oct. 10, 2013 - A reporter with essential tremor reports on one patient who relieved her symptoms arising from the same condition through opting for a deep brain stimulation implant. (WFLA)
Decision Tools Urged for Urologists Assessing Potential Referral to Sacral Neuromodulation
Oct. 11, 2013 - International Neuromodulation Society member Thomas Kessler, MD and co-authors report on factors influencing urologists' referral to sacral neuromodulation that were found in a survey of 108 urologists at two national urological meetings. Factors that influenced the decision to refrain from referral included absolute contraindications, followed by cardiac pacemaker and diabetes mellitus. An important factor for referral, on the other hand, was fecal incontinence. The authors conclude that decision tools should be broadly disseminated to help urologists identify appropriate potential treatment candidates. (Neurology and Urodynamics)
Oct. 13, 2013 - Peripheral nerve stimulation reduced frequency and intensity of chronic headache in 46 patients who received either occipital or supraorbital nerve stimulation between 2005 - 2012, according to a study presented at the American Society of Anesthesiologists annual meeting. (Newswise)
Oct. 11, 2013 - Researchers in Germany propose in an opinion piece that deep brain stimulation may ameliorate memory dysfunction by enhancing normal electrophysiological patterns underlying long-term memory processes within the temporal lobe. (Trends in Cognitive Sciences)
Oct. 10, 2013 - With Investigational Device Exemption from the FDA for its Altius™ System to deliver high-frequency stimulation to sensory nerves in the peripheral nervous system to block chronic pain, Neuros Medical, Inc. can start its pivotal clinical trial of the high-frequency nerve block for management of intractable limb pain in amputees, the company said in a press release. Neuros Medical plans to enroll 130 patients at 15 U.S. institutions for a prospective, randomized controlled clinical trial to evaluate the system's safety and efficacy. (Business Wire)
Review Discusses Neurostimulation Methods and Mood Disorder Treatment
Oct. 9, 2013 - International Neuromodulation Society member Thomas Schlaepfer, MD, dean of medical education at the University of Bonn and a professor of psychiatry at the University of Bonn Hospital, writes with colleagues about 15 years of advances in research studies and clinical use of repetitive transcranial magnetic stimulation, vagus nerve stimulation (VNS), and deep brain stimulation for psychiatric disorders. The review article maintains that there is compelling and new evidence that Medicare and private insurance should cover VNS therapy for treatment-resistant depression. (Psychiatric Times)
Psychiatrist Discusses Deep Brain Stimulation for Treatment-Resistant Depression at European Meeting
Oct. 9, 2013 - The results of worldwide experience with approximately 60 patients who have received deep brain stimulation for treatment-resistant depression suggest that one of the better target locations is the nucleus accumbens, said Dr. Bruno Millet, professor of psychiatry at the University of Rennes, France, at a meeting of the European College of Neuropsychopharmacology in Barcelona. He is expanding a clinical trial of this target, with sites in 12 centers in France and Geneva. (Clinical Psychiatry News)
Oct. 9, 2013 - Transcranial magnetic stimulation (TMS) could potentially be used to treat chronic dizziness, according to TMS research with healthy subjects into the temporal parietal junction of the right cerebral hemisphere, an area that is implicated in the perception of being upright, based on studies in stroke victims with balance problems. (redOrbit)
Oct. 9, 2013 - The company electroCore has entered a deal with waveCore -- a company owned by the founding shareholders of electroCore -- to develop a system to wirelessly power and control an implanted vagus nerve stimulator. New Jersey-based electroCore has developed external vagus nerve stimulation (VNS) to address symptoms of headache and potentially other disorders, such as bronchoconstriction, epilepsy, gastric motility disorders, depression and anxiety. The implanted VNS system would include a receiver that is powered by a transmitter worn on the body or placed up to four feet away at night. With the deal, waveCore will pay electroCore $2 million to fund the first-in-man pilot study, with additional milestone payments of $12 million during the U.S. regulatory process. (Enhanced Online News)
Pudendal Nerve Stimulation Draws Patients Seeking Relief of Pelvic Pain, Urinary Condtions
Oct. 9, 2013 - An emerging treatment, pudendal nerve neuromodulation for pelvic floor dysfunction – including debilitating pelvic pain and/or urinary frequency and urgency -- is drawing patients to the Beaumont Health System's Women's Urology Center in Royal Oak, MI, where five women from five states all returned recently for permanent pulse-generator implants and had their picture taken with a pioneer of the technique, urologist Kenneth Peters, MD. (PRWeb)
Parkinson's Disease Patient Recovers Some Motor Functions After Deep Brain Stimulation Therapy
Oct. 8, 2013 - An early-onset Parkinson's disease patient who likened available medicines to a "hailstorm" of pills joked that he might have gotten deep brain stimulation surgery sooner if it were named something like Parkinson's repair, and has recovered much of his motor abilities again through the therapy. (Lancaster Online)
Authors Report Experience with New Deep Brain Stimulation Target for Neuropathic Pain
Oct. 4, 2013 - International Neuromodulation Society members Tipu Aziz, MD, PhD, Alex Green, MD, Liz Moir, RN and colleagues report on bilateral deep brain stimulation to the anterior cingulate cortex significantly reducing neuropathic pain through two years of follow-up in a 49-year-old patient. (Neuroreport)
Oct. 7, 2013 - A man who has been using the Argus II visual prosthesis that will soon be marketed in the U.S. by Second Sight describes in an interview how it aids his coping with retinitis pigmentosa. The eyeglass-mounted device contributes to quality of life, says ophthalmology professor Jacque Duncan of the University of California, San Francisco, because its video camera link to a retinal implant allows users to distinguish edges and moving objects through enhancing their perception of light and dark. (CBS News)
Oct. 6, 2013 - Deep Transcranial Magnetic Stimulation (TMS) system manufacturer Brainsway Ltd. of Jerusalem, Israel has raised NIS 24 million on the Tel Aviv Stock Exchange, and also received $1 million over the weekend in the first of two payments from the distributor Century Medical, Inc. of the Japanese ITOCHU Group for exclusive distribution rights in Japan. The company uses technology licensed from the National Institutes of Health to penetrate TMS stimulation to structures deep within the brain. The therapy has initially been focused on major depressive disorder, with other indications under investigation. (Globes)
Oct. 3, 2013 - International Neuromodulation Society member Thomas Schlaepfer, MD, dean of medical education at the University of Bonn and a professor of psychiatry at the University of Bonn Hospital, describes how three different targets investigated for deep brain stimulation (DBS) in treatment-resistant depression -- the subcallosal cingulate cortex, the anterior limb of the capsula interna and the nucleus accumbens -- are either close to, or overlap, fibers of the medial forebrain bundle, viewed as a key input structure of the reward system. In a pilot study of patients with treatment-resistant depression, neuromodulation close to the medial forebrain bundle, the ventral tegmental area, led to a rapid response at lower stimulation levels in six responders. He believes DBS may be a transitional technology leading to less invasive treatments based on greater understanding of neural circuits and emerging techniques, such as optogenetics. (Scientific American)
Oct. 2, 2013 - A chronic migraineur who received combined occipital and supraorbital neurostimulation for her condition discusses her treatment in a T.V. interview. (WCSH Portland)
Oct. 2, 2013 - The National Institutes of Health has awarded $1.8 million over four years to a research project at Case Western Reserve University that is designed to investigate ways to limit inflammatory response to brain-machine interfaces that can cause neurons near the interface to die and lead to failure of the implant. A candidate drug identified in animal research inhibits a gene cluster, CD14, involved in coordinating cell recognition and binding of serum proteins to damaged cells. (Phys.org)
Oct. 2, 2013 - A 26-year-old carpenter from Australia who had treatment-resistant depression for six years received deep brain stimulation surgery in India Sept. 25 for his condition -- becoming the 67th person to have the surgery for this condition, his surgeon told the Mumbai Mirror. The patient learned of the investigational treatment through the Internet and eventually found a practitioner in India. (Times of India)
Oct. 1, 2013 - Researchers in Ontario, Canada have demonstrated the feasibility of using small biopsies taken near the surface of the brain with consent from Parkinson's disease patients during deep brain stimulation surgery and storing and culturing the cells, which expressed nerve growth factors. The work, reported in The FASEB Journal, shows the feasibility of creating an autologous supply of cell substrate that may have therapeutic application in neurologic disease. (London Free Press)
Funding Aims to Develop Real Time Navigational Guidance for Deep Brain Stimulation Surgery
Oct. 1, 2013 - The National Science Foundation has given a biomedical engineering assistant professor, Nuri Ince of the University of Houston, $330,000 for a three-year-project to develop signal-processing of electrode recordings from probes during deep brain stimulation surgery to aid navigation to targets such as the subthalamic nucleus, which sits almost three inches beneath the scalp and measures roughly 6 by 4 mm. (Phys.org)
Focal Repetitive Transcranial Magnetic Stimulation Trialed in Stroke Rehabilitation
Sept. 30, 2013 - Alexander Chervyakov, PhD, of the Russian Academy of Medical Sciences presented results of a randomized, blind, sham-controlled study of 22 patients who had suffered an ischemic stroke and were undergoing motor recovery. The patients received either sham treatment, MRI-navigated repetitive transcranial magnetic stimulation (nTMS) at low frequency to the primary motor cortex (M1) of the unaffected hemisphere, or nTMS of high frequency to M1 of the affected hemisphere, or a combination of the nTMS treatments. Patients who received a combination of stimulation had the best outcome, according to an abstract of the paper presented at the XXI World Congress of Neurology in Vienna on Sept. 25, 2013. Stimulating both hemispheres had the greatest effect on spasticity, the authors concluded, while low-frequency stimulation was best for motor recovery, and high frequency stimulation was effective at pain relief but carried the greatest risk of seizure. (MedPage Today)
October 2013 - International Neuromodulation Society member Charles Knowles, BChir, PhD, FRCS and co-authors report that, according to a meta-analysis of 61 studies, median success rates for sacral nerve stimulation (SNS) for fecal incontinence was 63, 58, and 54 percent in the short, medium, and long terms, respectively. The success rate of percutaneous tibial nerve stimulation (PTNS) was 59 percent at the longest reported follow-up of 12 months. In four reported studies, transcutaneous tibial nerve stimulation resulted in improved quality of life. The authors conclude PTNS may be a useful treatment before SNS, and outcome measures should be standardized so further reports can be meaningfully compared. (British Journal of Surgery)
Oct. 1, 2013 - Recognizing the literature on spinal cord stimulation (SCS) comprises approximately 1,500 publications and is growing at an ever-increasing rate, the Neuromodulation Foundation, Inc. has launched a beta version of its Wikistim website at www.wikistim.org for users to gather and share published SCS data; tabulate and compare details about methods and results; and participate in on-line discussions. The site has been launched with 22 randomly selected articles about SCS. Participants are encouraged to submit more, as well as to offer feedback and suggestions. The intent is to expand the site to include other forms of neuromodulation as well. (Wikistim)
Final Patient Receives Implant in Obstructive Sleep Apnea Multi-Center Trial
Sept. 29, 2013 - The final patient has been implanted in a safety and efficacy trial of ImThera Medical, Inc.'s hypoglossal nerve stimulation system, aura6000™, for treating moderate to severe obstructive sleep apnea. The study enrolled 57 subjects at nine medical centers in five countries. (ImThera Medical)
October 2013 - Authors from the Danish Headache Center review progress on several neurostimulation strategies that are being investigated for chronic cluster headache, including stimulation of the hypothalamus, occipital nerves and sphenopalatine ganglion. Development of neural plasticity over weeks or months may be a factor, since only stimulation of the sphenopalatine ganglion has demonstrated a rapid effect. (Cepalalgia)
Authors Weigh Benefits of Early Deep Brain Stimulation in Parkinson's Disease
October 2013 - Since it reduces fluctuations and delaying levodopa-sensitive complications, early deep brain stimulation in Parkinson's disease can be considered to alter the course of the disease, say two authors in an article about the risks and benefits of subthalamic neurostimulation for the disease. (Lancet Neurology)
Sept. 27, 2013 - In research published in the journal Science, a graduate student at the University of North Carolina and collaborators report using optogenetics to confirm neurocircuitry within the lateral hypothalamus that when activated in mice drove eating even when energy needs were met. The study targeted an outcropping of the amygdala, the bed nucleus of the stria terminalis, and GABA neurons there, whose nerve fibers have branched synapses that innervate the lateral hypothalamus. Inhibition of this circuit suppressed feeding. (Medical Xpress)
Sept. 25, 2013 - Among the 24 new fellows announced by the MacArthur Foundation -- who will receive an unrestricted $625,000 to support their work -- is one who is marrying optogenetics with signal processing to vastly improve retinal prostheses. Sheila Nirenberg, PhD, associate professor of computational biomedicine and physiology and biophysics at Weill Cornell Medical College, has demonstrated in mice the ability to detect the interplay of how healthy light-detecting retinal cells encode visual data that is relayed to basal ganglia, and apply that understanding to improve signaling in retinal prostheses to enable challenging tasks that were essentially beyond the scope of existing devices, such as facial recognition. Applications to other senses or machine vision might also be possible, she said. She will describe her work Oct. 3 at a computing conference in Minneapolis, MN, and plans to apply the funding to pursue eventual clinical trials. (MacArthur Foundation)
September 2013 - International Neuromodulation Society President-Elect Tim Deer is quoted in an article introducing the formation of neurostimulation guidelines, which have been developed by the Neuromodulation Appropriateness Consensus Committee. (Anesthesiology News)
Sept. 23, 2013 - Several startup companies will be presenting at the 2013 Neurotech Leaders Forum in San Francisco, CA, USA from Oct. 14 - 15, where serial entrepreneur Danny Sachs, M.D., will be the keynote speaker. The second day will focus on developments in noninvasive stimulation, neurosensing and diagnostics, consumer neurotech applications, and advances in brain-computer interfaces. (Massachusetts Newswire)
Sept. 23, 2013 - Vagus nerve stimulation (VNS) will be trialled at the Western Infirmary in Glasgow for three weeks on up to 10 stroke-recovery patients who have little or no movement in one arm. Another 10 patients will only undergo rehabilitation exercises. All will receive six weeks total rehabilitation exercise therapy; the VNS group will undergo the last half of the six-week period with their stimulators switched on. (Mail Online)
Sept. 20, 2013 - A review of 60 studies found that repetitive transcranial magnetic stimulation and deep brain stimulation both yielded evidence of reduced symptoms in anorexia nervosa and bulimia nervosa. The authors at the Section of Eating Disorders, Institute of Psychiatry, King's College London conclude that drawing from such findings and emerging neural models of eating disorder, treatment approaches "are highly unlikely to remain 'brainless' ". (European Eating Disorders Review)
Sept. 22, 2013 - Researchers at the University of Bristol are looking at a number of brain targets for potentially addressing treatment-resistant depression with deep brain stimulation. (The Telegraph)
Sept. 17, 2013 - The first U.S. Tourette's syndrome patient to be treated by deep brain stimulation (DBS) speaks at a community college about how receiving DBS resolved his lifelong, debilitating tics. (YouTube)
Sept. 19, 2013 - Based on an assessment of 216 scientific articles from 1996 - early 2012, the 1999 guideline on vagus nerve stimulation (VNS) by the American Academy of Neurology has been updated. The review found that VNS efficacy in reducing epileptic seizures as an adjunctive treatment may improve over time, and also that VNS may benefit a broader group of children than those over the age of 12 who have partial-onset seizures. (Neurology Today)
Sept. 20, 2013 - MicroTransponder, Inc. of Dalla, TX has raised $3.4 million to carry out clinical trials of vagus nerve stimulation -- two trials that would use the company's Vivistim System to restore functionality in the upper limbs of stroke patients, and one using its Serenity System that is designed to "rewire" the auditory cortex of tinnitus patients. The company intends to secure a CE mark for both systems next year, and then raise more funds to support a clinical trial for a pre-market approval in the U.S. (BioNews Texas)
Sept. 17, 2013 - Alim Louis Benabid, MD, PhD, a developer of deep brain stimulation (DBS) for Parkinson's disease, will receive the Jay Van Andel Award for Outstanding Achievement in Parkinson's Disease Research from the Van Andel Institute during its second annual symposium on Grand Challenges in Parkinson's Disease in Grand Rapids, MI tomorrow. His work is credited with helping more than 140,000 Parkinson's disease patients who have undergone DBS treatment. (MLive)
Sept. 16, 2013 - Neuros Medical, Inc. has received an FDA investigational device exemption approval for its Altius, an implantable high-frequency generator for Electrical Nerve Block™ treatment of chronic pain, such as chronic amputation pain. The Cleveland, OH company had previously demonstrated pain reduction of 50% or greater for up to 12 months in seven out of nine study subjects using an external high-frequency stimulation device. The study subjects will now be able to use the implantable generator. (Business Wire)
Sept. 16, 2013 - Neuronetics, Inc. of Malvern, PA reported that its transcranial magnetic stimulation (TMS) NeuroStar therapy for major depressive disorder (MDD) was subject to an observational study, "Transcranial Magnetic Stimulation (TMS) for Major Depression: A Multisite, Naturalistic, Observational Study of Quality of Life Outcome Measures in Clinical Practice", which was published in CNS Spectrums in July. The study concluded TMS is effective in treating acute MDD and is associated with improved quality of life and functional status. The authors assessed 307 outpatients from 42 clinical TMS practice sites in the United States who had a primary diagnosis of MDD and had not benefitted from antidepressant medication. (PR Newswire)
Sept. 15, 2013 - International Neuromodulation Society member Ashwini Sharan, MD, performs deep brain stimulation surgery on a Parkinson's disease patient while the process is documented in a news feature. (Philadelphia Inquirer)
Sept. 13, 2013 - New Jersey-based GammaCore's handheld external vagus nerve stimulation device to minimize effects of chronic migraine is expected to be submitted for FDA approval early next year, after completion of clinical studies, according to a business profile. The prescription device has received approval in Europe, India, Brazil, Canada and Australia, but has not launched commercially. (NJ.com)
Sept. 12, 2013 - An MRI center in South Bend, IN announced it performed the first MRI in the U.S. on a patient who had a neurostimulator that was recently approved for conditional use in full-body MRI scans. (Market Watch)
Sept. 12, 2013 - At the 86th congress of the German Society of Neurology in Dresden from Sept. 18 - 21, cerbomed GmbH, of Erlangen, Germany, will present transcutaneous vagus nerve stimulation (t-VNS) for the treatment of epilepsies, depression and pain, for which their non-invasive system has received CE mark approval. Two clinical studies are in process regarding the effectiveness of t-VNS in patients with drug-resistant epilepsy and chronic migraine. Last year the company entered into a strategic partnership with Cyberonics, Inc., a market leader in vagus nerve stimulation. (openPR)
Sept. 12, 2013 - Rohan J. Hoare, Ph.D., previously president of St. Jude Neuromodulation Division, has been named senior vice president of strategic planning at Cyberonics, Inc. With core expertise in neuromodulation, Cyberonics developed and markets an implanted vagus nerve stimulation system that is FDA-approved for the treatment of refractory epilepsy and treatment-resistant depression. (Market Watch)
Sept. 11, 2013 - In a six-month study of patients with refractory overactive bladder, 51 of whom received sacral neuromodulation and 77 who received standard medical treatment, the neuromodulation was significantly better than an additional trial of standard medical treatment, according to results presented at the 43rd Annual Meeting of the International Continence Society in Barcelona by researchers from Kansas City. (Renal & Urology News)
Sept. 11, 2013 - Brad Carter, a CSI actor and musician who was videotaped playing guitar during his deep brain stimulation surgery for benign essential tremor, is raising funds to produce an album and anticipating a second surgery now that his left hand is also starting to shake. (CBS Los Angeles)
September 2013 - In Europe and in U.S. trials, auditory brainstem implants (ABI) have been tried in pediatric patients who have auditory pathway problems other than tumors, with some support for the concept that this population may have a greater capacity to develop some post-implant speech perception. Researchers in the U.S. and Switzerland are collaborating to develop a flexible electrode array that better conforms to this brain target and also to develop ABI electrodes that deliver blue light to excite photosensitized cochlear nucleus neurons through optogenetics. ABI bypasses damaged or absent cochlea and auditory nerves, delivering electrical impulses to the cochlear nucleus in the brainstem, which is the first brain rely center for processing of sound information. (The Hearing Journal)
Sept. 9, 2013 - Repetitive transcranial magnetic stimulation, deep brain stimulation, and other current or investigational interventions for treatment-resistant depression are described in an overview. The article says subsets of depression may respond to different therapies based on different levels of activity in certain brain regions revealed in brain scanning. (Reuters)
Sept. 6, 2013 - Cognitive psychology researchers at Leiden University in the Netherlands review the development of optogenetics as a potentially useful tool for cognitive neuroscience studies into the neural underpinnings of conditions that are believed to be affected by temporal and spatial phenomena in brain circuits, such as an excitation-inhibition imbalance in nerve firing or synchronized oscillations of nerve activity. (Frontiers in Psychology)
Sept. 5, 2013 - Researchers at the University of California, Riverside recast biocompatible dental cement into a formulation with a transparent crystal structure. The implant material has potential application for creating a "window through the skull" to enable light-based medical purposes such as optogenetic neuromodulation therapy or laser-based diagnostics. Their paper, "Transparent Nanocrystalline Yttria-Stabilized-Zirconia Calvarium Prosthesis," was published online Aug. 21, 2013 in Nanomedicine: Nanotechnology, Biology and Medicine. (Extreme Tech)
Sept. 5, 2013 - BioPharm Insight reviews the status of research into various deep brain stimulation (DBS) targets for treatment-resistant depression, saying DBS is being pioneered for a range of central nervous system conditions. (FT.com)
Sept. 1, 2013 - Addressing the issue of the inherent challenges involved in surgically accessing the vagus nerve to implant cuff electrodes prior to a lengthy recovery period, ElectroCore Medical of Bernards Township, New Jersey is developing non-invasive vagus nerve stimulation therapies. The devices are being developed to treat or prevent symptoms of serious headache conditions, including migraines and cluster headaches, and bronchoconstriction including asthma and chronic obstructive pulmonary disorder. (Implantable Devices)
Sept. 3, 2013 - In a companion to a recent guideline on the use of vagus nerve stimulation for treating epilepsy, the American Academy of Neurology has published guidance and background to reduce obstacles for coverage, especially where uncertainties exist and levels of evidence are lower. (Neurology)
Aug. 28, 2013 - International Neuromodulation Society Expert Panel moderator Tipu Aziz, MD, a professor of neurosurgery at the University of Oxford, describes deep brain stimulation (DBS) as a concatenation of biological effects due to stimulating nerves in the target area as well as fibers of more distal nerves in an interview with BBC radio in which a chronic pain patient's DBS surgery is followed. The patient remarks afterward that his pain level and functioning improved. Parkinson's disease and depression are also mentioned in the 30-minute segment. (BBC Radio)
Aug. 28, 2013 - A columnist notes that after more than 100,000 people have received deep brain stimulation systems, they are becoming a standard of care, and reports on the closed-loop sensing-and-stimulation capability of Medtronic, Inc.'s Activa PC+S deep brain stimulation system. (Forbes)
Aug. 28, 2013 - Medtronic, Inc. is noted as being worthy of consideration for income investors due to its stable history of dividend increases and diversification into such divisions as neuromodulation, which has future growth potential. (Motley Fool via Daily Finance)
Aug. 27, 2013 - Calling chronic post-surgical pain a major unaddressed need, International Neuromodulation Society President-Elect Timothy Deer, MD, was quoted along with INS member Eric Grigsby, MD, in an announcement about the first patient enrollment in a clinical trial of spinal cord stimulation targeting the dorsal root ganglion. The approach could potentially expand treatment options for underserved patients who have chronic pain following such procedures as hernia surgery or amputation, Deer said. The ACCURATE Study will evaluate the safety and efficacy of Spinal Modulation’s Axium Neurostimulator System for the treatment of chronic pain affecting the lower limbs, and is expected to enroll 152 patients in up to 25 medical centers in the U.S. (Business Wire)
August 2013 - International Neuromodulation Society members Paul Lynch, MD and Tory McJunkin, MD, and colleagues write in a column on interventional pain medicine about treatment of post-amputation pain with neuromodulation. The authors state that peripheral nerve stimulation and spinal cord stimulation may be viable options for patients in whom alternative treatment methods have failed, adding that promising results in a study of the effects of transcutaneous electrical stimulation merit additional research. (Pain Medicine News)
Aug. 26, 2013 - The FDA-approved clinical trial of auditory brainstem implant (ABI) on 10 children aged 2 - 5, paid for with a grant by the National Institutes of Health, will be the first time the procedure will be studied in a clinical trial in the U.S. on people who have never had the ability to hear. ABI was developed in 1979 at the nonprofit House Research Institute, and approved for use in people aged 12 or older who had lost the ability to hear due to damage of the cochlear nerve. About 10 years ago, research in Italy on young children provided data in that patient group. It is estimated about half of otherwise healthy young children receiving ABI may go on to develop speech. (Southern California Public Radio KPCC)
Aug. 24, 2013 - Fourteen months after receiving an auditory brainstem implant, a 2-year-old boy in the UK who was one of the youngest people to get the implant, uttered his first word, "mam". The boy was diagnosed at birth with auditory neuropathy spectrum disorder. (Medical Daily)
August 2013 - The August issue of Psychiatric Annals is devoted to a review of the latest research in deep brain stimulation, since, as pointed out in an accompanying editorial, it is showing increasingly positive effects in the movement toward resolution of several treatment-resistant psychiatric disorders. (Psychiatric Annals)
Aug. 23, 2013 - A transcranial magnetic stimulation technology developed by NeuroStar for major depressive disorder was approved by the South Korea Ministry of Food and Drug Safety. Neuronetics will work with distribution partner BR Holdings of Seoul for entry into the market, which is considered to represent the world's 15th largest economy. (BioSpectrum Asia)
Aug. 22, 2013 - Net product sales increased 12.4% to $67.4 million in the first fiscal quarter ended July 26 for Cyberonics, Inc. of Houston, TX. Including license revenue, sales were up 14.2% overall, with Europe in particular contributing a strong performance. Diluted earnings per share were adjusted by $0.17 cents due to a litigation settlement. (PR Newswire)
Aug. 22, 2013 - Ohio's neurostimulation industry is described as being "on the brink of a breakout" due to its economic climate, investments, advances and talent. (hiVelocity)
Aug. 22, 2013 - A feature about the potential of electrostimulation to treat immune disease says that although nerve-stimulating devices have been available for years, bioelectronic therapies are beginning to ramp up, (MIT Tech Review)
Aug. 21, 2013 - A young woman who is entering graduate school this month describes the benefits of her vagus nerve stimulation system that controls the epilepsy she developed at age 11. Since receiving the implant in 2005 she has been able to get a driver's license, travel alone for three months to India, and participate in 10-kilometer runs. (Winston-Salem Journal)
Aug. 20, 2013 - Minneapolis-based Respicardia announced the beginning of its pivotal clinical trial of a phrenic nerve stimulator, the Remede System, designed to trigger action of the diaphragm to relieve central sleep apnea that is experienced by many heart failure and atrial fibrillation patients. The first patients were enrolled in Ohio, Missouri, and Nebraska. The trial is expected to eventually include 25 centers in the U.S. and a few in Europe. (Mass Device)
Aug. 20, 2013 - The National Institute on Deafness and Communications Disorders has provided a five-year grant for a clinical trial of auditory brainstem implantation in children who have congenital bilateral deafness resulting from a malformed or non-existent cochlea or hearing nerve. The study is being led by the House Research Institute and Children’s Hospital Los Angeles Children’s Hospital. (Newswise)
Aug. 12, 2013 - International Neuromodulation Society member Andre Machado, MD, PhD, is featured in an article about implanting a deep brain stimulation system in a 17-year-old girl who had lifelong dystonia. She sought treatment at the Cleveland Clinic's Center for Neurological Restoration, which he directs, with the hope of establishing an independent life. (Wall Street Journal)
Article Highlights Ethical Considerations for BRAIN Initiative
Aug. 14, 2013 - A Nature news article features neuroethicists' perspectives on the need for establishing ethical standards in neuroscience, in light of recent advances in brain research and technology that influence cognition, emotion and movement. The article precedes next week's commission on bioethics meeting, where the agencies participating in the BRAIN (Brain Research through Advancing Innovative Neurotechnologies) Initiative and neuroethicists will start developing ethical standards for neuroscience research in human and animal subjects. (Nature)
Aug. 8, 2013 - A year after starting a Bioelectronics R&D division, GlaxoSmithKline launched Action Potential Venture Capital (APVC) Limited in Cambridge, Mass., a $50 million venture capital fund targeting development of bioelectronic medicines and technologies with the potential to normalize signaling between the peripheral nervous system and organs in some chronic disease states. Along with Covidien and Boston Scientific Incorporated, APVC joined existing investors to participate in a $27 million round of financing for neuromodulation start-up SetPoint Medical, a Valencia, CA company creating vagus nerve stimulation devices to treat inflammatory diseases. (Fierce Medical Devices)
Aug. 7, 2013 - Rapid neuromodulation advances prompted development of guidelines by the 60-member Neuromodulation Appropriateness Consensus Committee, International Neuromodulation Society President-Elect Tim Deer, MD, explained in Pain Medicine News. Announced at the International Neuromodulation Society's 11th World Congress, the guidelines are designed to clarify patient selection and reduce complications associated with neurostimulation. The guidance should aid pain physicians overall, commented Ebby Varghese, MD, medical director of the Interventional Pain Medicine Clinic and assistant professor of clinical physical medicine and rehabilitation, University of Missouri-Columbia, saying, "It is important that all physicians, no matter what their background is, understand when neuromodulation should be used." (Pain Medicine News)
Aug. 7, 2013 - In an operation at at Ludwig Maximilians University in Munich, a Parkinson's disease patient was the first to receive a deep brain stimulation implant that senses and records electrical activity in the brain, Medtronic, Inc.'s Activa® PC+S DBS system, which received CE mark in Europe in January. In coming months, the system is expected to undergo investigational use in the U.S. (Thomson Reuters)
Aug. 6, 2013 International Neuromodulation (INS) members Ali Rezai, MD, David Caraway, MD, PhD, Mehul Desai, MD, MPH, are among the first physicians to implant Medtronic, Inc.'s spinal cord stimulation systems that were recently cleared by the FDA as conditionally safe for full-body MRI scans under specific conditions, the RestoreSensor® SureScan® MRI neurostimulation system, the company announced today. In addition, INS member Benjamin Venger, MD, also announced implanting the new system in one of the first patients in the Western U.S. Dr. Rezai, president of the INS North American chapter, directs the Center for Neuromodulation and Functional Neurosurgery at Ohio State's Wexner Medical Center, which also issued an announcement. (Thomson Reuters)
Aug. 6, 2013 - A team of physicians at the Department of Pain Medicine, Hyogo College of Medicine, in Nishinomiya, Japan retrospectively analyzed data from 91 patients who had mixed leg pain from lumbar spinal stenosis, 41 of whom responded to a trial of spinal cord stimulation (SCS) and opted for an implant between 2003 - 2011. After one year of neuromodulation, 95% of the patients had a good response. Although there has been no established view on the usefulness of SCS in managing this type of pain, the authors conclude based on these results that SCS should be actively adopted to treat indicated patients as an intermediate measure between conservative therapy and surgery.
Aug. 6, 2013 - At the recent International Headache Society congress in Boston, researchers reported results showing more than 80% of chronic migraine patients -- adults and adolescents -- benefited from neurostimulation combining subraorbital and occipital nerve stimulation. (PR Web)
July 26, 2013 - Introducing or erasing specific action potentials may be a future therapeutic mode involving microscopic implants with the capacity to both read, and deliver, individual nerve cell impulses, according to a news feature that describes the "electroceuticals" initiative of GlaxoSmithKline. (IEEE Spectrum)
Aug. 1, 2013 - U.S. Army veterans describe finding relief of up to 95% from "excruciating, horrific" pain through treatment with spinal cord stimulation, which is called an emerging technology that has been in use for some three decades. Their provider explains it uses electrical signaling, and can improve blood flow as well as functional recovery -- allowing for reduced reliance on pain medication and later removal if needed. (dcmilitary.com)
Aug. 1, 2013 - Uroplasty, Inc. reported its first sequential growth for three quarters in its quarterly results for the first quarter of fiscal 2014, ended June 30, 2013. Sales of its devices to treat voiding dysfunctions grew 11% from the fourth quarter of fiscal 2013. Overall, the company's global sales increased 5% to $5.8 million in the first quarter of fiscal 2014, compared to $5.6 million in the fiscal first quarter a year ago. (MSNMoney)
July 30, 2013 - Neuronetics, Inc. announced enrollment of the first five patients in an open-label clinical trial to evaluate its transcranial magnetic stimulation system in women with major depressive disorder (MDD) who experience postpartum symptoms. Study sites across the U.S. are enrolling females ages 18-50 who have been diagnosed with MDD with postpartum onset within six months of childbirth. Investigators have established the primary endpoint as safety and efficacy observed following acute treatment (up to eight weeks); the secondary endpoint is safety and efficacy observed in the study population in clinical follow up through 12 months. (PR Newswire)
July 31, 2013 - To facilitate functional rehabilitation from complex regional pain syndrome, spinal cord stimulation should be considered earlier when there is a lack of progress from conservative measures, according to a research analysis in Neuromodulation: Technology at the Neural Interface. The recommendation was recently discussed in an online Expert Panel session by members of the International Neuromodulation Society. (Newswise)
July 28, 2013 - A woman in Colorado with gradually worsening essential tremor received a deep brain stimulation implant from a team at Swedish Medical Center that has been in place for a year, according to a television report about how the implant has minimized her symptoms. (KUSA)
July 29, 2013 - NeuroSigma, Inc. has received conditional FDA approval for a Phase III multi-center trial of its external trigeminal nerve stimulator for the treatment of drug-resistant epilepsy. The company plans a clinical trial at centers in the U.S., Europe and Canada. In Phase I and II trials, more than 40% of patients had a 50% or greater reduction in seizures. (PR Newswire)
July 26, 2013 - International Neuromodulation Society Member Joel Saper, MD, commented about a publicized case of a teen-ager who found migraine relief from neurostimulation to the occipital and/or supraorbital nerves that there remains much to learn about long-term treatment with the technique. (ABC News)
July 17, 2013 - In a retrospective study of 143 epilepsy patients who had received vagus nerve stimulators, researchers in Sweden found in follow-up of 4 - 5 years that the two main complications were infection following the implant procedure (3.5% superficial, 3.5% deep and requiring explant) and vocal cord palsy (5.6%) due to damage to the vagus nerve. (Seizure)
July 8, 2013 - Deep brain stimulation was first introduced in Hong Kong in 2007 and advances in the procedure are offering relief for patients with Parkinson's disease and other neurological conditions. (South China Morning Post)
July 25, 2013 - Of 29 patients with overactive bladder who completed three years of treatment with percutaneous tibial nerve stimulation, some 77% maintained moderate or marked improvement in overactive bladder symptoms, according to research published in the Journal of Urology. (Medical Xpress)
July 25, 2013 - Boston Scientific Corporation's neuromodulation sales in the second quarter of 2013 ending June 30th were up 21% over the same period the previous year, according to quarterly results the company announced Thursday. Overall, analysts noted the device maker showed organic sales growth, from an operational standpoint, for the first time since 2009. This 2% growth on a constant currency basis, excluding divested businesses, was largely due to its neuromodulation and cardiovascular business segments. Neuromodulation sales were $14 million ahead of analysts' consensus forecast, at $111 million for the second quarter of 2013. (Medical Device and Diagnostic Industry)
July 24, 2013 - Second Sight Medical Products is seeking to raise $10.5 million, according to a regulatory filing. The Sylmar, Calif.-based company received FDA approval earlier this year to market its Argus II retinal prosthesis -- already sold in Europe -- in the U.S. to assist patients who have late-stage retinitis pigmentosa. (Medical Device and Diagnostic Industry)
July 22, 2013 - NICTA spin-out Saluda Medical received a $5M grant from an inaugural round of funding from the New South Wales, Australia Government’s Medical Devices Fund. Through the Ministry of Health, the fund is intended to promote innovative new medical technologies that may have a global benefit. NICTA is Australia’s largest publicly-funded information and communications technology research organization. Sydney-based Saluda is developing closed-loop spinal cord stimulation that adjusts stimulation levels based on detecting neural response. (WhaTech)
August 2013 - Laboratory studies in rats suggest that different peripheral and spinal segmental mechanisms may be involved in attenuating mechanical hypersensitivity when using spinal cord stimulation (SCS) at different frequencies and amplitudes than conventional 50 Hz SCS. In a rat model of neuropathic pain, high frequency SCS had an earlier onset of effect and required a lower intensity to block peripheral Aβ fibers, but failed to significantly inhibit excitability in spinal wide-dynamic–range neurons. The authors hypothesize that SCS at different frequencies may induce greater pain inhibition at the higher intensities due to activation of more A-fibers. In addition, because kilohertz-level SCS delivers many more electrical pulses than does 50 Hz SCS of the same stimulus intensity and treatment duration, it may also induce a stronger pain inhibition than 50 Hz SCS. Yet, it is also possible that different frequencies of SCS may have distinct mechanisms of action, as with transcutaneous electrical nerve stimulation and electroacupuncture. (Anesthesiology)
July 23, 2013 - With a three-year, $750,000 grant from the U.S. Department of Defense, researchers at The Miami Project to Cure Paralysis and the Miami VA Healthcare System plan a Phase 1 clinical trial of deep brain stimulation (DBS) to reduce pain and other symptoms in up to 12 spinal cord injury patients. The study is based on preclinical research indicating that stimulating the periaqueductal gray matter for a few weeks after spinal cord injury reduces sensitivity to pain, improves food transit to the stomach and intestines, normalizes insulin levels, reduces development of periods of high blood pressure (autonomic dysreflexia) and enhances movement. DBS has been used in clinical trials to stimulate the periaqueductal gray region of a few hundred patients with treatment-resistant chronic pain. Approximately 40 of those individuals had a spinal cord injury. (University of Miami)
July 22, 2013 - Great Lakes NeuroTechnologies announced the U.S. Patent Office has allowed an expansion of claims in a patent covering timing of neurostimulation to include a system for Parkinson's disease patients to wear a non-invasive transcranial direct current stimulation system at night. The concept is envisioned to treat motor symptoms through stimulation of the motor cortex, which may decrease sleep disturbances and help the patient feel better upon awakening, a time when medication normally has worn off. (MedCity News)
July 19, 2013 - In Springfield, Mo., International Neuromodulation Society member Benjamin Lampert, MD, has treated the first patient to participate in a multi-center, randomized, placebo-controlled clinical trial -- OPTIMISE -- to determine whether occipital nerve stimulation with Boston Scientific Corporation's Precision™ System can safely and effectively treat chronic migraine when used in conjunction with anti-migraine medications. (PR Newswire)
July 18, 2013 - Patients who are dissatisfied with or fail treatment of overactive bladder with intravesical botulinum toxin can respond to sacral neuromodulation (SNM) with a success rate of test stimulation and one-year satisfaction rate that are comparable to the success rate of patients who did not have botulinum toxin treatment, according to an observational study of 20 patients. An explanation is that SNM is thought to have a central nervous system effect through afferent signaling that is important for storage and voiding, while the effect of botulinum toxin injection is local, reducing cell activity through chemical denervation that temporarily inhibits neuromuscular nerve signaling. It is unclear which should come first in the treatment algorithm since both are considered minimally invasive. One advantage of SNM is the long and permanent treatment effect, where botulinum treatment needs repeat sessions more or less annually. (The Journal of Urology)
August 2013 - A team who treated chronic pain in five Parkinson's disease patients with spinal cord stimulation (SCS) noticed a subsequent improvement in gait suggest in a research abstract that brain mechanisms and the synergistic effect of l-dopa administration seen in animal studies of SCS-induced locomotion should be explored to better understand mechanisms underlying the improvement. (Clinical Neurophysiology)
July 15, 2013 - In an abstract presenting data from six pediatric primary dystonia patients, MRI-guided placement of deep brain stimulation leads while the patient was asleep appeared to be straightforward and had an average accuracy of lead placement of less than 1 mm. The data developed at the University of California, San Francisco, were presented at the 2013 International Congress of Parkinson's Disease and Movement Disorders. (MRI Interventions)
July 12, 2013 - Tests on 16 volunteers and 16 fibromyalgia patients indicate that a novel multi-coil repetitive transcranial magnetic stimulation configuration, designed to penetrate deeply enough to reach the dorsal anterior cingulate cortex, may be a safe and effective treatment for acute or chronic pain. The optimum stimulation configuration was determined in the volunteer group through placebo-controlled crossover variations that were evaluated in PET/CT scans. In the study carried out at Stanford University School of Medicine, four weekly stimulation sessions at 10 Hz reduced fibromyalgia pain 43%, and pain inhibition lasted four weeks post-treatment. (ProHealth)
July 9, 2013 - International Neuromodulation Society members Stephanie Washburn, PhD, Roger Catlin, MD, and Bernard Canlas, MD, along with Klee Bethel, MD, report on a randomized, double-blinded crossover study that compared perceptions of constant current and constant voltage spinal cord simulation during a trial period in 30 chronic pain patients. The study showed that 70% of patients preferred constant current stimulation and that it produced a significantly larger decrease in pain scores. (Neuromodulation)
July 8, 2013 - International Neuromodulation Society members Rod S. Taylor, PhD and Philippe Rigoard, MD and colleagues have published a meta-analysis of 63 studies of spinal cord stimulation (SCS) in chronic back and leg pain (CBLP), which supports SCS as an effective pain relieving treatment for CBLP with predominant leg pain with or without a prior history of back surgery. The mean level of pain relief was 58% at an average follow-up of 24 months; however, no predictive factors were identified. (Neuromodulation)
July 12, 2013 - International Neuromodulation Society member Alex Green, PhD, and colleagues at the University of Oxford have published a research article in the Annals of Neurology about a proof-of-concept study of adaptive deep brain stimulation (aDBS) in eight patients with advanced Parkinson's disease. Feedback was obtained by recording and processing local field potentials directly from the stimulating electrodes. In the study, aDBS was applied for 10 minute periods and compared to the effect of no stimulation, constant stimulation (cDBS), and randomized intermittent stimulation. Both blinded and unblinded assessment of motor effect were performed. Motor scores improved by 66% (unblinded) and 50% (blinded) during aDBS, which were 29% (p = 0.03) and 27% (p = 0.005) better than cDBS, respectively. These improvements were achieved with a 56% reduction in stimulation time compared to cDBS, and a corresponding reduction in energy requirements. (University of Oxford)
July 11, 2013 - At study published in Brain Stimulation of deep brain stimulation in 94 patients over a period ranging from six months to five years concludes that impedance stability cannot be taken for granted over the long term. Although the study was not designed to link the fluctuations to clinical outcome, it does indicate the importance of continued followup to monitor and adjust stimulation levels. (Red Orbit)
July 11, 2013 - A neurosurgeon explains that deep brain stimulation for Parkinson's disease tends to smooth out the body's response to medications and helps with motion, stiffness and tremor, in a television segment showing a patient have his device programmed for the first time following surgery. (WNCT)
July 10, 2013 - Researchers at the University of Nottingham say they have shown for the first time that deep brain stimulation (DBS) surgery targeting the subthalamic nucleus in advanced Parkinson's disease provides a survival advantage. The study examined 106 patients who underwent DBS and 41 who declined. The DBS group had significantly longer survival and were less likely to enter residential care than patients whose condition was merely managed medically. The authors suggest the effect may have several reasons, ranging from better functions (such as swallowing) to an as-yet unrecognized benefit from reduction in dopaminergic medication. (Neurology, Neurosurgery & Pyschiatry)
July 11, 2013 - Greatbatch, Inc. is looking for a partner to bring its spinal cord stimulation system Algostim to the end market, and believes the spinal cord stimulation market is $1.4 billion, growing at more than 10% a year, according to an interview in a business column. The company is combining the sales, marketing and operations groups of its Greatbatch Medical and Electrochem Solutions, the article says, in a realignment that is meant to help achieve growth of 5% or more annually. (Dallas Business Journal)
July 9, 2013 - NeuroPace of Mt. View, California reported in a U.S. Securities and Exchange Commission filing that it has raised about $18 million of a planned $50 million round of funding. The 20 investors who provided the new capital were not named. Since its founding in 1997, NeuroPace has raised about $180 million. (Silicon Valley Business Journal)
July 1, 2013 - Enrollment will be beginning in a clinical trial meant to compare the effectiveness of spinal cord stimulation (SCS), peripheral nerve field stimulation (PNfS), or both SCS and PNfS for treating chronic low back pain or low back and leg pain. (Arizona Pain Monthly)
July 11, 2013 - A three-year-old girl born without a cochlear nerve has become the first child to receive an auditory brainstem implant in the United Arab Emirates. (Gulf News)
July 10, 2013 - An anorexia patient describes participating in a clinical trial of deep brain stimulation at Toronto General Hospital, where her neurosurgeons are also interviewed regarding the intervention. (The Windsor Star)
July 10, 2013 - A guitar-playing actor who developed benign essential tremor, Brad Carter, was featured in an online-video news event by the University of California, Los Angeles hospital where he'd received a deep brain stimulation implant to control the tremor. (New York Daily News)
July 10, 2013 - Researchers in the United Kingdom describe a two-center randomized controlled clinical trial design to evaluate a tinnitus therapy under development, acoustic coordinated reset neuromodulation by Adaptive Neuromodulation GmbH of Koln, Germany. The design is intended to estimate efficiency of the therapy compared to placebo, as well as examine physiological effects with respect to the putative mechanism of action, disruption of hyper synchronous neuronal activity. (Trials Journal)
July 5, 2013 - International Neuromodulation Society members Angelo Franzini, MD and Giovanni Broggi, MD, and colleagues present a prospective study of 39 refractory epilepsy patients who received vagus nerve stimulation (VNS) and were followed for a median period of 36 months. The study outcome suggests that younger patient age and focal or multifocal epilepsy are related to better seizure control and cognitive outcome; also, that VNS could be considered in severe conditions, such as drug-refractory cases. (Epilepsy & Behavior)
July 7, 2013 - Through July 21, the International Neuromodulation Society is hosting an online discussion for members regarding neuromodulation and complex regional pain syndrome (CRPS). The discussion is led by Frank Huygen, MD, PhD, FIPP, professor of Pain Medicine and head of the Center for Pain Medicine at Erasmus University Medical Centre in Rotterdam, the Netherlands, and Marc Russo, MBBS DA FANZCA FFPMANZCA, secretary on the INS board, director of the Hunter Pain Clinic in New South Wales and the Inpatient CRPS Management Program at Lindard Private Hospital in Newcastle, Australia. Dr. Russo is leading an investigator-initiated trial of high-frequency spinal cord stimulation in CRPS. Meanwhile, the March/April issue of Neuromodulation: Technology at the Neural Interface carries a review article by several INS members that sets forth a rationale for considering spinal cord stimulation for CRPS earlier than a last-resort therapy. (INS)
July 4, 2013 - The Alpha IMS by Germany's Retina Implant is the second device to receive CE mark for sale in the European Union for patients who have lost vision due to the progressive condition retinitis pigmentosa. The device has no external hardware and requires a 10-hour surgery, providing a visual prosthesis that may help patients distinguish light and dark and possibly some objects, aiding mobility. (MedCity News)
July 1, 2013 - A sham-controlled motor-performance study on 11 participants showed that transcranial direct current stimulation induced behavioral changes in the non-dominant hand as a consequence of mechanisms associated with use-dependent cortical plasticity. Motor function improved significantly with stimulation, compared to sham. The authors conclude the plasticity was independent of the electrode arrangement, whether it was bilateral or unilateral, with either cathodal or anodal stimulation over the dominant motor cortex. (BMC Neuroscience)
July 26, 2013 - Introducing or erasing specific action potentials may be a future therapeutic mode involving microscopic implants with the capacity to both read, and deliver, individual nerve cell impulses, according to a news feature that describes the "electroceuticals" initiative of GlaxoSmithKline. (IEEE Spectrum)
Aug. 1, 2013 - U.S. Army veterans describe finding relief of up to 95% from "excruciating, horrific" pain through treatment with spinal cord stimulation, which is called an emerging technology that has been in use for some three decades. Their provider explains it uses electrical signaling, and can improve blood flow as well as functional recovery -- allowing for reduced reliance on pain medication and later removal if needed. (dcmilitary.com)
Aug. 1, 2013 - Uroplasty, Inc. reported its first sequential growth for three quarters in its quarterly results for the first quarter of fiscal 2014, ended June 30, 2013. Sales of its devices to treat voiding dysfunctions grew 11% from the fourth quarter of fiscal 2013. Overall, the company's global sales increased 5% to $5.8 million in the first quarter of fiscal 2014, compared to $5.6 million in the fiscal first quarter a year ago. (MSNMoney)
July 30, 2013 - Neuronetics, Inc. announced enrollment of the first five patients in an open-label clinical trial to evaluate its transcranial magnetic stimulation system in women with major depressive disorder (MDD) who experience postpartum symptoms. Study sites across the U.S. are enrolling females ages 18-50 who have been diagnosed with MDD with postpartum onset within six months of childbirth. Investigators have established the primary endpoint as safety and efficacy observed following acute treatment (up to eight weeks); the secondary endpoint is safety and efficacy observed in the study population in clinical follow up through 12 months. (PR Newswire)
July 31, 2013 - To facilitate functional rehabilitation from complex regional pain syndrome, spinal cord stimulation should be considered earlier when there is a lack of progress from conservative measures, according to a research analysis in Neuromodulation: Technology at the Neural Interface. The recommendation was recently discussed in an online Expert Panel session by members of the International Neuromodulation Society. (Newswise)
July 28, 2013 - A woman in Colorado with gradually worsening essential tremor received a deep brain stimulation implant from a team at Swedish Medical Center that has been in place for a year, according to a television report about how the implant has minimized her symptoms. (KUSA)
July 29, 2013 - NeuroSigma, Inc. has received conditional FDA approval for a Phase III multi-center trial of its external trigeminal nerve stimulator for the treatment of drug-resistant epilepsy. The company plans a clinical trial at centers in the U.S., Europe and Canada. In Phase I and II trials, more than 40% of patients had a 50% or greater reduction in seizures. (PR Newswire)
July 26, 2013 - International Neuromodulation Society Member Joel Saper, MD, commented about a publicized case of a teen-ager who found migraine relief from neurostimulation to the occipital and/or supraorbital nerves that there remains much to learn about long-term treatment with the technique. (ABC News)
July 17, 2013 - In a retrospective study of 143 epilepsy patients who had received vagus nerve stimulators, researchers in Sweden found in follow-up of 4 - 5 years that the two main complications were infection following the implant procedure (3.5% superficial, 3.5% deep and requiring explant) and vocal cord palsy (5.6%) due to damage to the vagus nerve. (Seizure)
July 8, 2013 - Deep brain stimulation was first introduced in Hong Kong in 2007 and advances in the procedure are offering relief for patients with Parkinson's disease and other neurological conditions. (South China Morning Post)
July 25, 2013 - Of 29 patients with overactive bladder who completed three years of treatment with percutaneous tibial nerve stimulation, some 77% maintained moderate or marked improvement in overactive bladder symptoms, according to research published in the Journal of Urology. (Medical Xpress)
July 25, 2013 - Boston Scientific Corporation's neuromodulation sales in the second quarter of 2013 ending June 30th were up 21% over the same period the previous year, according to quarterly results the company announced Thursday. Overall, analysts noted the device maker showed organic sales growth, from an operational standpoint, for the first time since 2009. This 2% growth on a constant currency basis, excluding divested businesses, was largely due to its neuromodulation and cardiovascular business segments. Neuromodulation sales were $14 million ahead of analysts' consensus forecast, at $111 million for the second quarter of 2013. (Medical Device and Diagnostic Industry)
July 24, 2013 - Second Sight Medical Products is seeking to raise $10.5 million, according to a regulatory filing. The Sylmar, Calif.-based company received FDA approval earlier this year to market its Argus II retinal prosthesis -- already sold in Europe -- in the U.S. to assist patients who have late-stage retinitis pigmentosa. (Medical Device and Diagnostic Industry)
July 22, 2013 - NICTA spin-out Saluda Medical received a $5M grant from an inaugural round of funding from the New South Wales, Australia Government’s Medical Devices Fund. Through the Ministry of Health, the fund is intended to promote innovative new medical technologies that may have a global benefit. NICTA is Australia’s largest publicly-funded information and communications technology research organization. Sydney-based Saluda is developing closed-loop spinal cord stimulation that adjusts stimulation levels based on detecting neural response. (WhaTech)
August 2013 - Laboratory studies in rats suggest that different peripheral and spinal segmental mechanisms may be involved in attenuating mechanical hypersensitivity when using spinal cord stimulation (SCS) at different frequencies and amplitudes than conventional 50 Hz SCS. In a rat model of neuropathic pain, high frequency SCS had an earlier onset of effect and required a lower intensity to block peripheral Aβ fibers, but failed to significantly inhibit excitability in spinal wide-dynamic–range neurons. The authors hypothesize that SCS at different frequencies may induce greater pain inhibition at the higher intensities due to activation of more A-fibers. In addition, because kilohertz-level SCS delivers many more electrical pulses than does 50 Hz SCS of the same stimulus intensity and treatment duration, it may also induce a stronger pain inhibition than 50 Hz SCS. Yet, it is also possible that different frequencies of SCS may have distinct mechanisms of action, as with transcutaneous electrical nerve stimulation and electroacupuncture. (Anesthesiology)
July 23, 2013 - With a three-year, $750,000 grant from the U.S. Department of Defense, researchers at The Miami Project to Cure Paralysis and the Miami VA Healthcare System plan a Phase 1 clinical trial of deep brain stimulation (DBS) to reduce pain and other symptoms in up to 12 spinal cord injury patients. The study is based on preclinical research indicating that stimulating the periaqueductal gray matter for a few weeks after spinal cord injury reduces sensitivity to pain, improves food transit to the stomach and intestines, normalizes insulin levels, reduces development of periods of high blood pressure (autonomic dysreflexia) and enhances movement. DBS has been used in clinical trials to stimulate the periaqueductal gray region of a few hundred patients with treatment-resistant chronic pain. Approximately 40 of those individuals had a spinal cord injury. (University of Miami)
July 22, 2013 - Great Lakes NeuroTechnologies announced the U.S. Patent Office has allowed an expansion of claims in a patent covering timing of neurostimulation to include a system for Parkinson's disease patients to wear a non-invasive transcranial direct current stimulation system at night. The concept is envisioned to treat motor symptoms through stimulation of the motor cortex, which may decrease sleep disturbances and help the patient feel better upon awakening, a time when medication normally has worn off. (MedCity News)
July 19, 2013 - In Springfield, Mo., International Neuromodulation Society member Benjamin Lampert, MD, has treated the first patient to participate in a multi-center, randomized, placebo-controlled clinical trial -- OPTIMISE -- to determine whether occipital nerve stimulation with Boston Scientific Corporation's Precision™ System can safely and effectively treat chronic migraine when used in conjunction with anti-migraine medications. (PR Newswire)
July 18, 2013 - Patients who are dissatisfied with or fail treatment of overactive bladder with intravesical botulinum toxin can respond to sacral neuromodulation (SNM) with a success rate of test stimulation and one-year satisfaction rate that are comparable to the success rate of patients who did not have botulinum toxin treatment, according to an observational study of 20 patients. An explanation is that SNM is thought to have a central nervous system effect through afferent signaling that is important for storage and voiding, while the effect of botulinum toxin injection is local, reducing cell activity through chemical denervation that temporarily inhibits neuromuscular nerve signaling. It is unclear which should come first in the treatment algorithm since both are considered minimally invasive. One advantage of SNM is the long and permanent treatment effect, where botulinum treatment needs repeat sessions more or less annually. (The Journal of Urology)
August 2013 - A team who treated chronic pain in five Parkinson's disease patients with spinal cord stimulation (SCS) noticed a subsequent improvement in gait suggest in a research abstract that brain mechanisms and the synergistic effect of l-dopa administration seen in animal studies of SCS-induced locomotion should be explored to better understand mechanisms underlying the improvement. (Clinical Neurophysiology)
July 15, 2013 - In an abstract presenting data from six pediatric primary dystonia patients, MRI-guided placement of deep brain stimulation leads while the patient was asleep appeared to be straightforward and had an average accuracy of lead placement of less than 1 mm. The data developed at the University of California, San Francisco, were presented at the 2013 International Congress of Parkinson's Disease and Movement Disorders. (MRI Interventions)
July 12, 2013 - Tests on 16 volunteers and 16 fibromyalgia patients indicate that a novel multi-coil repetitive transcranial magnetic stimulation configuration, designed to penetrate deeply enough to reach the dorsal anterior cingulate cortex, may be a safe and effective treatment for acute or chronic pain. The optimum stimulation configuration was determined in the volunteer group through placebo-controlled crossover variations that were evaluated in PET/CT scans. In the study carried out at Stanford University School of Medicine, four weekly stimulation sessions at 10 Hz reduced fibromyalgia pain 43%, and pain inhibition lasted four weeks post-treatment. (ProHealth)
July 9, 2013 - International Neuromodulation Society members Stephanie Washburn, PhD, Roger Catlin, MD, and Bernard Canlas, MD, along with Klee Bethel, MD, report on a randomized, double-blinded crossover study that compared perceptions of constant current and constant voltage spinal cord simulation during a trial period in 30 chronic pain patients. The study showed that 70% of patients preferred constant current stimulation and that it produced a significantly larger decrease in pain scores. (Neuromodulation)
July 8, 2013 - International Neuromodulation Society members Rod S. Taylor, PhD and Philippe Rigoard, MD and colleagues have published a meta-analysis of 63 studies of spinal cord stimulation (SCS) in chronic back and leg pain (CBLP), which supports SCS as an effective pain relieving treatment for CBLP with predominant leg pain with or without a prior history of back surgery. The mean level of pain relief was 58% at an average follow-up of 24 months; however, no predictive factors were identified. (Neuromodulation)
July 12, 2013 - International Neuromodulation Society member Alex Green, PhD, and colleagues at the University of Oxford have published a research article in the Annals of Neurology about a proof-of-concept study of adaptive deep brain stimulation (aDBS) in eight patients with advanced Parkinson's disease. Feedback was obtained by recording and processing local field potentials directly from the stimulating electrodes. In the study, aDBS was applied for 10 minute periods and compared to the effect of no stimulation, constant stimulation (cDBS), and randomized intermittent stimulation. Both blinded and unblinded assessment of motor effect were performed. Motor scores improved by 66% (unblinded) and 50% (blinded) during aDBS, which were 29% (p = 0.03) and 27% (p = 0.005) better than cDBS, respectively. These improvements were achieved with a 56% reduction in stimulation time compared to cDBS, and a corresponding reduction in energy requirements. (University of Oxford)
July 11, 2013 - At study published in Brain Stimulation of deep brain stimulation in 94 patients over a period ranging from six months to five years concludes that impedance stability cannot be taken for granted over the long term. Although the study was not designed to link the fluctuations to clinical outcome, it does indicate the importance of continued followup to monitor and adjust stimulation levels. (Red Orbit)
July 11, 2013 - A neurosurgeon explains that deep brain stimulation for Parkinson's disease tends to smooth out the body's response to medications and helps with motion, stiffness and tremor, in a television segment showing a patient have his device programmed for the first time following surgery. (WNCT)
July 10, 2013 - Researchers at the University of Nottingham say they have shown for the first time that deep brain stimulation (DBS) surgery targeting the subthalamic nucleus in advanced Parkinson's disease provides a survival advantage. The study examined 106 patients who underwent DBS and 41 who declined. The DBS group had significantly longer survival and were less likely to enter residential care than patients whose condition was merely managed medically. The authors suggest the effect may have several reasons, ranging from better functions (such as swallowing) to an as-yet unrecognized benefit from reduction in dopaminergic medication. (Neurology, Neurosurgery & Pyschiatry)
July 11, 2013 - Greatbatch, Inc. is looking for a partner to bring its spinal cord stimulation system Algostim to the end market, and believes the spinal cord stimulation market is $1.4 billion, growing at more than 10% a year, according to an interview in a business column. The company is combining the sales, marketing and operations groups of its Greatbatch Medical and Electrochem Solutions, the article says, in a realignment that is meant to help achieve growth of 5% or more annually. (Dallas Business Journal)
July 9, 2013 - NeuroPace of Mt. View, California reported in a U.S. Securities and Exchange Commission filing that it has raised about $18 million of a planned $50 million round of funding. The 20 investors who provided the new capital were not named. Since its founding in 1997, NeuroPace has raised about $180 million. (Silicon Valley Business Journal)
July 1, 2013 - Enrollment will be beginning in a clinical trial meant to compare the effectiveness of spinal cord stimulation (SCS), peripheral nerve field stimulation (PNfS), or both SCS and PNfS for treating chronic low back pain or low back and leg pain. (Arizona Pain Monthly)
July 11, 2013 - A three-year-old girl born without a cochlear nerve has become the first child to receive an auditory brainstem implant in the United Arab Emirates. (Gulf News)
July 10, 2013 - An anorexia patient describes participating in a clinical trial of deep brain stimulation at Toronto General Hospital, where her neurosurgeons are also interviewed regarding the intervention. (The Windsor Star)
July 10, 2013 - A guitar-playing actor who developed benign essential tremor, Brad Carter, was featured in an online-video news event by the University of California, Los Angeles hospital where he'd received a deep brain stimulation implant to control the tremor. (New York Daily News)
July 10, 2013 - Researchers in the United Kingdom describe a two-center randomized controlled clinical trial design to evaluate a tinnitus therapy under development, acoustic coordinated reset neuromodulation by Adaptive Neuromodulation GmbH of Koln, Germany. The design is intended to estimate efficiency of the therapy compared to placebo, as well as examine physiological effects with respect to the putative mechanism of action, disruption of hyper synchronous neuronal activity. (Trials Journal)
July 5, 2013 - International Neuromodulation Society members Angelo Franzini, MD and Giovanni Broggi, MD, and colleagues present a prospective study of 39 refractory epilepsy patients who received vagus nerve stimulation (VNS) and were followed for a median period of 36 months. The study outcome suggests that younger patient age and focal or multifocal epilepsy are related to better seizure control and cognitive outcome; also, that VNS could be considered in severe conditions, such as drug-refractory cases. (Epilepsy & Behavior)
July 7, 2013 - Through July 21, the International Neuromodulation Society is hosting an online discussion for members regarding neuromodulation and complex regional pain syndrome (CRPS). The discussion is led by Frank Huygen, MD, PhD, FIPP, professor of Pain Medicine and head of the Center for Pain Medicine at Erasmus University Medical Centre in Rotterdam, the Netherlands, and Marc Russo, MBBS DA FANZCA FFPMANZCA, secretary on the INS board, director of the Hunter Pain Clinic in New South Wales and the Inpatient CRPS Management Program at Lindard Private Hospital in Newcastle, Australia. Dr. Russo is leading an investigator-initiated trial of high-frequency spinal cord stimulation in CRPS. Meanwhile, the March/April issue of Neuromodulation: Technology at the Neural Interface carries a review article by several INS members that sets forth a rationale for considering spinal cord stimulation for CRPS earlier than a last-resort therapy. (INS)
July 4, 2013 - The Alpha IMS by Germany's Retina Implant is the second device to receive CE mark for sale in the European Union for patients who have lost vision due to the progressive condition retinitis pigmentosa. The device has no external hardware and requires a 10-hour surgery, providing a visual prosthesis that may help patients distinguish light and dark and possibly some objects, aiding mobility. (MedCity News)
July 1, 2013 - A sham-controlled motor-performance study on 11 participants showed that transcranial direct current stimulation induced behavioral changes in the non-dominant hand as a consequence of mechanisms associated with use-dependent cortical plasticity. Motor function improved significantly with stimulation, compared to sham. The authors conclude the plasticity was independent of the electrode arrangement, whether it was bilateral or unilateral, with either cathodal or anodal stimulation over the dominant motor cortex. (BMC Neuroscience)
June 25, 2013 - Although case series show subcutaneous nerve stimulation (SQS) may provide clinically important levels of pain relief for patients who have failed back surgery syndrome (SBSS), the SubQStim study will be the first randomized controlled clinical trial to investigate the use of SQS for patients with FBSS, compared to optimized medical management (OMM) alone. International Neuromodulation Society members Sam Eldabe, MD, Michael Kern, MD, Rod Taylor, PhD, and colleagues have published their trial protocol that calls for up to 400 patients at approximately 33 centers in Europe and Australia, who will be randomized 1:1 to the SQS or OMM arms. (Trials Journal)
June 17, 2013 - Discussing the impact of business strategy and the FDA regulatory environment on the future of spine surgery at the 11th Annual Spine, Orthopedic & Pain-Management Driven ASC Conference, a pain-management specialist remarked that neuromodulation will be utilized more in coming years for a variety of conditions, from obesity to sleep apnea, with European market approvals generally occurring prior to U.S. approvals. (Becker's ASC Review)
June 2013 - International Neuromodulation Society member Jamil Rzaev, MD, PhD, who organized an INS chapter in formation in Russia, describes learning about neuromodulation in the U.S., his concerted efforts to build a referral base, and eventual success in persuading the state healthcare system to create a budget to help cover costs of neuromodulation devices for chronic pain or movement disorder in Russia, where he currently heads the Federal Neurosurgical Center in Novosibirsk. (AANS Neurosurgeon)
June 27, 2013 - Stroke patients performed two to three times better in 10 daily sessions of speech and language rehabilitation after first receiving transcranial magnetic stimulation (TMS) to the side of the brain unaffected by the stroke, compared to patients who only received sham stimulation, according to a proof-of-concept study in Germany and Canada that was published in Stroke, the journal of the American Heart Association. The stimulation was designed to temporarily decrease activity in the unaffected brain hemisphere, essentially driving the effort in rehabilitation to the side that was healing from injury. A multi center trial of TMS in stroke recovery, Northstar, is set to begin in October. (CTV News)
June 26, 2013 - Minnesota-based EnteroMedics submitted its premarket approval application to the FDA for review of the Maestro VBLOC system that stimulates the vagus nerve to reduce food cravings to treat obesity, metabolic disease and other gastrointestinal disorders. (Mass Device)
June 24, 2013 - Early results of a clinical trial of non-invasive vagus nerve stimulation in cluster headache were reported at the 11th World Congress of the International Neuromodulation Society, electroCore reported in a news release. Data from 21 patients, five with 12 months of experience with the company's gammaCore device, showed benefits in both time to relief from an acute cluster headache, and a decrease in attack frequency. (Business Wire)
June 21, 2013 - Calling his deep brain stimulation implant for Parkinson's disease "life-changing," a blogger has posted a video demonstrating his uncontrolled motor symptoms without treatment and the rapid improvement when the device is switched back on. (Medical Daily)
June 19, 2013 - International Neuromodulation Society past president and journal founder Elliott Krames, MD, was named a Giant of Neuromodulation at the society's 11th World Congress for his energetic devotion to establishing the multidisciplinary field throughout the world during a formative time. The biennial recognition was inaugurated at the 10th World Congress in London, where Canadian neurosurgeon Krishna Kumar, MD -- an active clinical researcher and founding member of the INS Canada chapter -- received the honor. (Newswise)
June 21, 2013 - International Neuromodulation Society member and past president Giancarlo Barolat, MD, is quoted as praising a technique of leaving slack in a spinal cord stimulation lead during trial stimulation to avoid lead migration, presented at the Pain Society of the Carolinas Annual Meeting by Erza Riber, MD. Riber named the technique "Lily's Loop" after his daughter, and in 22 consecutive patients who had the loop on one side and not the other, 73% of non looped leads migrated after three days compared to 22% of looped leads. Dr. Barolat encouraged more prospective studies and said the initial results appear promising although Dr. Riber acknowledged the technique is not perfect and some leads may migrate in a cephalad or upward position, which is rare otherwise. (Pain Medicine News)
June 20, 2013 - Three surveys presented in poster sessions at the annual International Congress on Parkinson's Disease and Movement Disorders indicate that deep brain stimulation can provide long-term relief of movement disorders with few infections or complications, although controlling motor symptoms does not affect the underlying rate of disease progression. (MedPage Today)
June 20, 2013 - A 3-year-old boy who received an auditory brainstem implant three weeks ago as the first participant in a U.S. clinical trial of the technology in children under 12 is likely still adapting to having his brain organize itself to use sound, his mother said in an interview about the development. (CBS News)
June 20, 2013 - International Neuromodulation Society members Tory McJunkin, MD and Paul Lynch, MD and co-authors write in Pain Medicine about studies concerning psychological screening issues and patient selection for spinal cord stimulation. (Pain Medicine)
June 19, 2013 - In a study of generalized dystonia patients whose condition is due to a genetic defect, a pair of physicians report in the Journal of Neuroscience that in 47 consecutive patients treated with deep brain stimulation, the severity of symptoms dropped to less than 20% of baseline within two years of device implantation. Patients were able to discontinue all their dystonia-related medications in 61% of the cases, and 91% were able to discontinue at least one class of drugs for at least one year. The report represents one of the longest follow-up studies of patients with this most common form of hereditary dystonia, who were followed over a span of 10 years, from 2001 to 2011. (Science Codex)
June 19, 2013 - A poster presentation at the international congress of Parkinson’s Disease and Movement Disorders showed that of 48 Parkinson's disease study group centers, 97% of which performed deep brain stimulation surgery and 67% of which serve more than 500 patients a year, only 23% of sites employed a formal battery of tests for impulsive and compulsive behavior and that 7% did not screen for impulse control disorders. The survey, prompted by a concern that patients who become more impulsive after surgery were more likely to be lost to follow up, found that 80% of responding centers used a neuropsychologist to screen for potential behavioral issues but only 32% used a psychiatrist, suggesting a focus on identifying the problem without necessarily having the facilities to manage and treat it. (Clinical Psychiatry News)
June 19, 2013 - An editorial raises concerns regarding incipient interest in at-home transcranial magnetic stimulation systems. (Nature)
June 14, 2013 - Research by International Medical Society member Michael Oh, MD, and colleagues in a FDA-approved clinical trial of three morbidly obese patients who safely received deep brain stimulation implants was featured in a local television news interview with one of his colleagues when Oh presented the work in Berlin at the INS 11th World Congress. (WTAE - Pittsburgh)
June 17, 2013 - Boston Scientific Corporation announced the first U.S. patient has been implanted with the Vercise deep brain stimulation system for the treatment of Parkinson's disease at Cedars-Sinai Medical Center in a prospective, multi-center, double-blinded, randomized, controlled study, INTREPID, to evaluate the safety and effectiveness of motor function and overall quality of life.
June 18, 2013 - The Ohio Third Frontier Commission has awarded a $3 million grant to Case Western Reserve University to commercialize a neurostimulation technology in collaboration with NDI Medical LLC, SPR Therapeutics and Valtronic. Developed over the past decade, the platform is designed to treat indications ranging from pain to muscle paralysis. (Healio)
June 18, 2013 - Six months of data from 40 Parkinson's disease patients were presented at the annual International Congress of Parkinson's Disease and Movement Disorders in Sydney, Australia concerning the Boston Scientific Vercise deep brain stimulation system, with multiple independent current control for fine, selective control of stimulation. The system is approved for sale in Europe, Israel and Australia. The interim data showed the patients from six European centers experienced approximately 60 percent mean improvement in motor function compared to baseline after six months. (Stockhouse)
June 13, 2013 - NeuroTronik of Chapel Hill, N.C. received $13.1 million from a venture capital syndicate led by Hatteras Venture Partners to develop its neuromodulation system to treat heart failure by improving pumping effectiveness. (News & Observer)
June 11, 2013 - The Massachusetts Eye and Ear Infirmary is enrolling deaf children and infants who are not candidates for a cochlear implant in a clinical trial of an auditory brainstem implant, the Nucleus 24 ABI. The ABI stimulates auditory neurons directly at the brainstem. The device is currently FDA-approved for adults and children 12 and older who are diagnosed with neurofibromatosis type 2. The FDA issued an investigational device exemption for the current trial, which is taking place in consultation with international experts on pediatric ABI surgery, (Newswise)
June 13, 2013 - Emerging and potential future advances in neurostimulation for chronic pain are examined in recommendations of the Neuromodulation Appropriateness Consensus Committee that are being submitted for peer review to the journal Neuromodulation: Technology at the Neural Interface. The committee considered such new options as electrical stimulation to the dorsal root ganglion; new frequencies of neurostimulation; and new devices for peripheral nerve stimulation. (Newswise)
June 13, 2013 - A deep brain stimulation trial in treatment-resistant obesity linked a weight loss trend to a metabolism increase programmed in a metabolic chamber, according to a pilot study presented at the International Neuromodulation Society’s 11th World Congress by International Neuromodulation Society member Michael Oh, MD of the Department of Neurosurgery, Allegheny General Hospital, Pittsburgh, Pa. (Newswise)
June 12, 2013 - Six authors of Neuromodulation Appropriateness Consensus Committee guidelines are quoted today in a news release about implantable "digital drugs" for the treatment of head and body pain. The announcement was made in conjunction with the International Neuromodulation Society's 11th World Congress in Berlin. (Newswise)
June 11, 2013 - International Neuromodulation Society member Magdy Hassouna, MD, PhD, professor of surgery (urology) at the University of Toronto, presented results of a prospective study in which 23 women treated with sacral nerve stimulation for bladder disorder showed an improvement in sexual dysfunction averaging 18 percent post-treatment. (Newswise)
June 11, 2013 - At the 11th World Congress of the International Neuromodulation Society, Bridget Southwell, PhD., of the Murdoch Childrens Research Institute of the Royal Childrens Hospital in Melbourne, Australia presented results of a novel use of transcutaneous electrical stimulation, in which home care by parents using transabdominal, noninvasive stimulation improved hardest-to-treat chronic constipation in children. (Newswise)
June 10, 2013 - The Neuromodulation Appropriateness Consensus Committee, an international group of more than 60 leading pain specialists led by the International Neuromodulation Society (INS) President-Elect Tim Deer, MD, announced at the INS 11th World Congress it has created the first consensus guidelines for the use of neurostimulation for chronic pain, which can significantly reduce the need for opioids. The guidance will be submitted for peer review to the journal Neuromodulation: Technology at the Neural Interface. (International Neuromodulation Society)
May 24, 2013 - Costs and effects of spinal cord stimulation (SCS) and conventional medical management alone were modeled over 20 years in a study published by International Neuromodulation Society members Krishna Kumar, MD, and Syed A. Rizvi, MD in Pain Medicine. They found the incremental cost-effectiveness ratio for SCS in failed back surgery syndrome (in Canadian dollars) was $9,293; in complex regional pain syndrome was $11,216; in peripheral arterial disease was $9,319, and in refractory angina pectoris was $9,984. (Pain Medicine)
June 5, 2013 - A team at the University of Minnesota in Minneapolis demonstrated control of a model helicopter in three dimensions by an operator using a noninvasive cap of electrodes to detect changes in the strength and frequency of nerve firing in the motor cortex. The operators imagined making a fist with either or both hands to signal moving left, right, or up. Several hours of training were required in modulating sensorimotor rhythms, first with a computer cursor, then while watching the robotic vessel's progress through a camera mounted on the hull. The demonstration was reported in the Journal of Neural Engineering as a proof-of-concept for brain-computer interfaces. (Nature)
June 4, 2013 - The first pretested integrated lead-interconnect system designed for implantable neurostimulator pulse generator devices will be featured at the International Neuromodulation Society's 11th World Congress in Berlin June 8-13 at the Evergreen Medical Technology booth. The system, Encompass, is versatile and enables rapid product development; it has a port-entry screw-anchor mechanism and three lead strain relief seal options for transition from the header port. A slot is molded into the header for the placement of a radiopaque identifier and a suture hole is included. The header has been designed with a set of two anchors to firmly attach the header to the hermetic enclosure. (Business Wire)
June 4, 2013 - Neuros Medical Inc. announced it will present details of its pilot study of its patented Electrical Nerve Block treatment at the upcoming International Neuromodulation Society’s 11th World Congress in Berlin, Germany, June 8-13. In the pilot study, seven out of nine patients with chronic amputation pain who received on-demand, high-frequency stimulation over the course of a year received significant pain relief, averaging 83% pain reduction. (BioPortfolio)
June 4, 2013 - Berlin-based EBS Technologies GmbH plans to expand a clinical trial of patients with neurological vision deficits after announcing that its repetitive transorbital alternate current stimulation, coupled with EEG feedback, resulted in a mean 24% increase in stimulation of the visual field compared to controls in a clinical trial of 82 patients. The treatment, approved for sale in Europe, involves 40-minute treatments over 10 consecutive days, and is designed to revitalize optical neural pathways damaged by trauma, stroke, or tumor surgery. (Business Wire)
June 3, 2013 - International Neuromodulation Society member John Donoghue, PhD's BrainGate neural interface and nine other research competition finalists are being considered for the Israel Brain Technologies' (IBT) $1 million R&D award, B.R.A.I.N. (Breakthrough Research and Innovation in Neurotechnology). The finalists will be judged in October after presentations in Tel Aviv. IBT is a nonprofit organized to advance Israel's neurotechnology industry and increase collaboration with counterparts around the world. (PR Newswire)
June 3, 2013 - Brainsway is poised to begin shipping its Deep TMS (transcranial magnetic stimulation) system to the U.S. where the company received clearance for marketing it for drug-resistant major depressive disorder. The system is also approved in Europe for addressing neuropathic chronic pain, bipolar disorder, and schizophrenia. Using a special helmet to target specific regions of the brain, treatment is conducted in an outpatient setting during 20-minute sessions over a four week period. (MedGadget)
June 1, 2013 - Researchers comparing the neuroplastic effects of brain stimulation in healthy subjects and untreated depressed subjects found that the ability to form new neural connections was stunted in the brains of depressed people. That may contribute to the lack of ability to think clearly, impacting the ability to adapt and learn, and indicates the condition is more than just a chemical imbalance in the brain. Depression treatments do increase brain plasticity. (Sydney Morning Herald)
May 31, 2013 - For his pioneering contributions to developing strategies such as deep brain stimulation to treat Parkinson's disease, Alim Louis Benabid, MD, PhD, has received the 2013 Robert A. Pritzker Prize for Leadership in Parkinson's Research from the Michael J. Fox Foundation for Parkinson's Research. The prize comes with a $100,000 research grant. (Business Wire)
May 30, 2013 - The European Union's proposed regulation of active implantable devices has clarified definitions; an active device relies on a source of power, which includes standalone software, while an implantable device is one that is intended to remain in place for at least 30 days. Demonstrating equivalence with another device would not generally be considered sufficient without gathering clinical data and clinical trials would be subject to a unified electronic system. (Mondaq)
May 30, 2013 - Minnetonka, Minnesota-based Uroplasty, Inc. announced fourth-quarter and fiscal year performance for the period ended March 31, 2013. For the full year, sales grew $1.9 million to $22.4 million, reflecting an 18% increase in U.S. sales and a 10% decrease in sales outside the U.S. Fiscal fourth quarter 2013 sales in the U.S. increased 2%, driven by an 11% increase in sales of the Urgent® PC Neuromodulation System, compared with fiscal fourth quarter a year ago. The company also announced that as of June 1, 2013, the Medicare administrative contractor Wisconsin Physicians Services (WPS) will begin coverage for posterior tibial nerve stimulation for treatment of overactive bladder and associated symptoms of urinary urgency, urinary frequency and urge incontinence. WPS provides medical and drug benefits to approximately 8.7 million Medicare beneficiaries in Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska and Wisconsin. (PR Newswire)
May 30, 2013 - A man who suffered from chronic pain despite repeat surgery and painkillers found relief through spinal cord stimulation, according to a newspaper account that profiles the patient, a U.S. Navy veteran. His procedure was one of the first in the Dallas-Ft. Worth area with Boston Scientific's 32-contact Precision Spectra™ system. (Star-Telegram)
May 29, 2013 - In an operation at the University of North Carolina in Chapel Hill, a 3-year-old boy born without a cochlear nerve as a result of Charge syndrome became the first child to receive an auditory brainstem implant as part of a clinical trial. He will receive hearing and speech therapy to adjust to and work with his new perception of sound. (WRAL.com)
May 28, 2013 - Getting neural interfaces to access information flowing through the nervous system and immune system is both a computing challenge and an even greater engineering challenge to see how neuroscience, disease biology and circuit design can come together, according to a news feature about GlaxoSmithKline's initiative to create small-scale, precise therapeutic interventions known as electroceuticals. The anatomical aspect of the mapping of neurons is relatively easy, but it's also important to map how electrical signals travel along them and what immune responses they provoke, the article says, referring to the immune system and the nervous system as "the two memory systems of the body". (Wired.co.uk)
May 28, 2013 - Cyberonics, Inc. is developing its sixth-generation VNS device, AspireSR, to monitor heart rate for signs on an impending epileptic seizure, and despite competition, still dominates the market for epilepsy, according to a news feature in Xconomy. (Xconomy)
May 28, 2013 - Medtronic, Inc.'s vice president and general manager of the Gastro/Urology Therapies business for the Neuromodulation Division, Cindy Kent, was named one of eight Women of Distinction by the Girl Scouts of Minnesota and Wisconsin River Valleys. (ABC Newspapers)
May 27, 2013 - Boston Scientific Corporation has received CE Mark approval for use of its deep brain stimulation visualization system, Guide DBS, in Parkinson's disease. The tool allows physicians to visualize the relative position of the lead and model stimulation fields and output. Designed to help reduce programming time and tailor stimulation therapy, the system is the first commercial product resulting from the company's acquisition of Intelect Medical in 2011. (PR Newswire)
May 23, 2013 - A 39-year-old actor who has had essential tremor for seven years became the 500th person at the University of California, Los Angeles Medical Center to undergo deep brain stimulation surgery. International Neuromodulation Society member Nader Pouratian, MD, performed the operation that was publicized in short videos while the patient checked his symptom improvement by playing guitar. (Huffington Post)
May 23, 2013 - Venture and commercialization firm NDI Medical launched a new portfolio company, Deep Brain Innovations, LLC, to commercialize its Temporally Optimized Patterned Stimulation (TOPS™) technology that delivers novel, more efficient, patterns of stimulation, allowing smaller and longer-lasting devices. (Digital Journal)
May 20, 2013 - Twenty children with Attention Deficit Hyperactivity Disorder saw mean improvements of more than 45 percent after eight weeks of external trigeminal nerve stimulation in a clinical trial that was reported Monday at the American Psychiatric Association Meeting in San Francisco. (PR Newswire)
May 16, 2013 - Transcranial random-noise stimulation can induce long-term enhancement of cognitive and brain functions, according to research published in Current Biology that shows students who received the stimulation while practicing math problems remained quicker than a control group at similar problems six months later. (Nature)
May 16, 2013 - The FDA issued draft guidance for comment in the next 90 days about its appeals process for medical device marketing applications. For the first time, the agency clarifies what significant decisions would be eligible for a request for a summary of the rationale underlying the decision. (Mass Device)
May 16, 2013 - In a pilot study of volunteers with chronic pain, researchers found that transcranial ultrasound stimulation improved mood, possibly due to "tuning" microtubules that grow and extend neurons and form and regulate synapses. The researchers who published the results in Brain Stimulation plan to study the effect in traumatic brain injury, Alzheimer's disease and post-traumatic stress disorder. (Medical Xpress)
May 14, 2013 - In an interview in the Daily Express about a patient's success using a rechargeable spinal cord stimulator (SCS), International Neuromodulation Society President Simon Thomson, MD, points out that studies show SCS systems recoup their costs in 1 - 3 years due to due to a reduction in spending on drugs and repeat hospitalization. His patient found relief from SCS for her chronic back pain after relying on medications proved inadequate and risky over the long term. (Daily Express)
May 14, 2013 - International Neuromodulation Society member Liong Liem, MD, PhD, was quoted along with co-author Frank Huygen, MD, PhD about their study published yesterday in Neuromodulation: Technology at the Neural Interface regarding pain relief from neurostimulation of the dorsal root ganglion (DRG). The six-month study of 32 patients suffering from long-term nerve damage following surgery (chronic post surgical pain), complex regional pain syndrome, amputation pain, or failed back surgery syndrome showed that 70% of patients suffering from leg pain and 89% of patients suffering from foot pain reported clinically significant pain relief. The multi-center study examined the Axium spinal cord stimulation system by Spinal Modulation, which is available in Europe and Australia. (Wall Street Journal)
May 14, 2013 - An Italian government move to cut prices for medical devices was invalidated in a court ruling that found the program, which had been scheduled to go into effect in January, was based on faulty use of a national medical device classification system and used inaccurate price sampling. Italian health care authorities must now come up with a different formula for implementing cost controls that recognizes the varied and specialized characteristics of the medtech sector, Clinica reported. (AdvaMed)
May 13, 2013 - Clinica reports that two experts -- Erik Vollebregt of Axon Lawyers and Mika Reinikainen of AbNovo consultants -- believe that the European Parliament's proposal for pre-market authorization for medical devices would most likely be unwieldy if approved, but the politics of the issue are murky and the outcome of the debate unpredictable. Reinikainen believes the EU would do better to improve the current system, and Vollebregt added that the proposal is hostile to innovation by assuming that anything innovative carries more risk. (AdvaMed)
May 10, 2013 -- A study published in the Journal of Urology shows that most overactive bladder patients who responded to 12 weekly percutaneous tibial nerve stimulation treatments safely sustained symptom improvement over three years with an average of one treatment per month. After a 14-week treatment tapering protocol, 29 patients completed the 36-month continuing treatment. (Market Watch)
May 10, 2013 - A health column about emerging uses of deep brain stimulation (DBS) mentions Prof. Tipu Aziz of the University of Oxford, who has been investigating DBS in chronic pain. (Daily Mirror)
May 10, 2013 - A review of neuromodulation (sacral nerve stimulation and percutaneous tibial nerve stimulation) in chronic pelvic pain in men (chronic prostatitis) concludes "at least a subset of patients in most of the published studies and case series derive some benefit in the short term and limited evidence suggests that long-term improvement of symptoms is possible." (Uro Today -- requires free registration)
May 7, 2013 - A woman with essential tremor is featured in a news segment about a new deep brain stimulation service being offered in the Rio Grande Valley region of Texas. (Valley Central - Action 4 News)
May 7, 2013 - PET scanning shows changes in glucose metabolism in areas involved in dopamine production in the brain several weeks or months before symptom improvement in patients with treatment-resistant depression who were treated with vagus nerve stimulation, according to an early online edition of a paper by researchers at Washington University School of Medicine in St. Louis published by the journal Brain Stimulation. (Science Codex)
May 2, 2013 - A television interview includes a physician and his patient who found relief from spinal cord stimulation after being concerned about addiction issues from the painkillers she used following a car accident injury. (WFAA.com)
May 6, 2013 - A woman who was living with stiffness and tremors after an accident received deep bain stimulation (DBS) surgery to try to control her motor symptoms. Her neurologist plans to publish the case describing this use of DBS in Parkinsonism. (CINewsNow)
May 6, 2013 - International Neuromodulation Society North American Chapter President Ali Rezai, MD was quoted in an article about recall of an optional cap for deep brain stimulation leads, ranked Class 1 by the FDA, saying it would be incorrect to interpret the recall as representing a life-threatening concern -- the maximum consequence under that ranking. The article explained that the cap, which he said he does not use and few other neurosurgeons do, is intended to cover the end of the leads before they are connected to a pulse generator, and may cause lead damage if the cap is twisted or its screw is over-tightened. Lead damage would likely be noticed during the connection step, and the likely result of lead damage would be that the patient would not receive the full benefit of therapy to control symptoms, a result that might be life-threatening in a cardiac arrest treated with a defibrillator, but not when controlling tremor and stiffness of Parkinson's disease or other motor disorders. (Mass Device)
May 1, 2013 - In motor disorders such as Parkinson's disease, oscillatory activity at beta frequency is elevated, and is modulated during the generation of movements. Continuous theta burst stimulation using repetitive transcranial magnetic stimulation can inhibit motor activity for up to an hour, but the neuroplastic effects are highly variable between individuals. Brain mapping of 16 healthy research subjects with magnetoencephalography suggests the observed variability may relate to GABAergic mechanisms that govern the presence of oscillatory beta activity in the motor system. (Journal of Neuroscience)
May 1, 2013 - International Neuromodulation Society member William Newton, DO, became the first physician in his state to implant a next-generation, 32-contact spinal cord stimulation (SCS) system for chronic pain of the trunk and/or limbs, according to a news report. He commented that many patients cycle through various therapies before trying SCS since it can be hard to treat, so encourages people living with chronic spine pain to talk to their physician and see if the treatment might be appropriate for them. (WGNS)
May 2, 2013 - Medtronic, Inc. announced it issued an Urgent Medical Device Correction notification in February to inform physicians about the potential for temporary caps sometimes used on deep brain stimulation (DBS) leads to cause twisting damage to the lead. Medtronic received reports of DBS leads being damaged due to twisting of the connector within the lead cap, which is sometimes used to temporarily protect the end of a DBS lead after implantation. The FDA classified the notification a Class 1 Recall. A manufacturing change intended to address the issue is currently under FDA review, and in the meantime Medtronic has issued modified instructions to physicians who may use DBS lead caps. Any malfunctions or adverse events related to a device should be reported to Medtronic Neuromodulation Technical Services at 1-800-707-0933, weekdays from 7 a.m. to 6 p.m. CST, and the FDA's MedWatch Program at http://www.fda.gov/MedWatch. (Wall Street Journal)
April 30, 2013 - A study of a nonmotor impact of deep brain stimulation to the subthalamic nucleus in patients with Parkinson's disease showed on-stimulation decreases endogenous glucose production by 22% compared to off-stimulation or controls, without altering whole body glucose disposal, suggesting that cross-talk between the central nervous system and peripheral tissues may regulate glucose homeostasis. (Journal of Clinical Endocrinology & Metabolism)
First-Hand Account of Deep Brain Stimulation Surgery for Parkinson's Disease
April 29, 2013 - A reporter chronicles his own experience with deep brain stimulation surgery for Parkinson's disease and its benefits to his work and life. (Daytona Beach News-Journal)
East Anglia Patient Interviewed about Receiving New MRI-Compatible Spinal Cord Stimulation Implant
April 27, 2013 - International Neuromodulation Society Member Mike Sidery, BSc, MB BChir, MA, PhD, called a spinal cord stimulation system that provides MRI compatibility reassuring for patients. His patient who received an implant to control her leg pain was interviewed about her new implant. A chronic pain patient since 2010, she said she previously had MRI scans to try to find the cause of her leg pain. She was said to be one of the first patients in Britain to receive this system. (Norfolk Eastern Daily Press)
April 28, 2013 - North America is estimated to account for the maximum share of the neuromodulation market in 2012, followed by Europe, and Asia-Pacific countries like Japan, India, and China, according to a report by Markets and Markets that looks at 2012 - 2017. (Digital Journal)
Neuromodulation Growth Reported in Company Earnings Report
April 25, 2013 - Boston Scientific announced global year-over-year revenue growth of 6 percent in neuromodulation and combined revenue in the countries of Brazil, Russia, India and China 35 percent year-over-year, while taking a write down of $422 million related to the 2006 acquisition of Guidant Corp. for $28 billion. Overall adjusted earnings per share were $0.16 for the first quarter ended March 31, 2013, on revenue of $1.761 billion. (Sacramento Bee)
NICE Issues Guidelines on Use of Occipital Nerve Stimulation for Intractable Chronic Migraine
April 24, 2013 - The National Institute for Health and Care Excellence (NICE) has issued full guidance to the NHS in England, Wales, Scotland and Northern Ireland on occipital nerve stimulation (ONS) for intractable chronic migraine. Selection of patients for treatment using ONS for intractable chronic migraine should be done by a multidisciplinary team, including specialists in headache, pain management and neurosurgery. Clinicians should enter details about all patients undergoing ONS for intractable chronic migraine onto the UK Neuromodulation Register when access to that database is available. NICE encourages publication of further information from comparative studies and from collaborative data collection to guide future use of this procedure and to provide patients with the best possible advice. Publications should include full details of any complications, and of adjunctive or subsequent treatments. Outcomes should include measures of pain, function and quality of life, particularly in the long term. (NICE)
April 23, 2013 - Mice receiving deep brain stimulation to the nucleus accumbens consumed less high-fat food compared to controls according to a paper published in the Journal of Neuroscience. At the same time, similar stimulation to obese mice resulted in less calorie consumption, a loss of body weight, and improved glucose sensitivity -- suggestive of a reversal of type 2 diabetes. (University of Pennsylvania)
April 23, 2013 - During a visit to Houston, pioneering neurologist Dr. Helen Mayberg discussed deep brain stimulation, saying the brain "works as ensembles, like an orchestra, with coordinated interactions among different areas for different functions. Identifying circuits and using electricity to tune them - the brain uses electricity to communicate - is attractive because while it's brain surgery, tuning the brain is not permanent; it's reversible. You can try a setting, and if it doesn't work, you can turn it off. You can remove the electrodes and it doesn't generally damage the brain." (Houston Chronicle)
Study of Spine Surgery Records Finds Low Utilization of Spinal Cord Stimulation
April 2013 - Researchers specializing in spinal cord stimulation (SCS) reviewed records of 16,455 spine surgery patients who had continued chronic pain -- so-called Failed Back Surgery Syndrome -- and found only 2.4% of those underwent SCS implantation from 2000 - 2099, according to a study presented at the 2012 annual meeting of the North American Neuromodulation Society. Surgeons should be more aware that SCS may be superior to repeat surgery in select patients, said study co-author Nandan Lad, MD, PhD, a member of the International Neuromodulation Society and assistant professor of neurosurgery, Duke University School of Medicine. (Anesthesiology News)
April 2013 - Neurotech Reports, the publisher of Neurotech Business Report, will publish the 2013 Directory of Neuromodulation Products later this year. The print directory will be given to each attendee at the 11th World Congress of the International Neuromodulation Society (INS), which takes place June 8-13, in Berlin, Germany, and attracts more than 1,500 clinicians, engineers, researchers and entrepreneurs to hear an internationally renowned faculty address the most comprehensive breadth of all neuromodulation therapies. For more information, contact Neurotech Reports at 415 546 1259 or visit this link. (Neurotech Reports)
April 22 - A U.S. study published in JAMA Otolaryngology - Head & Neck Surgery of 14 patients with tinnitus showed that four weeks of sessions of repetitive transcranial magnetic stimulation improved their chronic ringing in the ears by 10 points, while crossover sham treatment yielded a six-point improvement. (Reuters)
Study: Spinal Cord Stimulation to the Cervical Spine Relieved Pain for Majority of Patients
April 2013 - An observational study, presented by International Neuromodulation Society President-Elect Dr. Tim Deer at the 2012 annual meeting of the North American Neuromodulation Society, supports the use of spinal cord stimulation in the cervical spine for chronic pain. The study, part of an ongoing 40-center registry study supported by a research grant from St. Jude Medical, tracked 38 patients for at least three months and found that most reported their pain relief as being excellent or good. (Pain Medicine)
INS Accepts Record Number of Abstracts for Biennial Congress
April 19, 2013 - The International Neuromodulation has accepted a record number of abstracts for its 11th World Congress June 8 - 13 in Berlin. Diverse highlights are previewed in a news announcement issued today. INS also announced a pre-conference innovation-and-investment summit. (Newswise)
April 18, 2013 - Results of external trigeminal nerve stimulation in children aged 7 - 14 who have attention deficit hyperactivity disorder will be presented on May 20 in San Francisco by Los Angeles-based NeuroSigma, Inc. The open-label Phase I study was prompted by observations in PET scans of the stimulation's effect on attention centers. (San Francisco Business Times)
April 18, 2013 - TechNavio predicts a compound annual growth rate of 15.3 percent from 2012 - 2016 for neuromodulation across the globe, partly due to an increase in neurological disease. (PR Web)
Company Sees First-Quarter Earnings Dip, But Strong Year-Ahead Prospects
April 17, 2013 - St. Jude Medical sales of neuromodulation products were $99 million in the first quarter of 2013, down 4 percent from the prior year. Overall, partly due to unfavorable currency translations, the company reported net sales of $1.338 billion in the first quarter of 2013, a decline of approximately 4 percent compared with the first quarter of 2012. With more than 20 diverse products due to launch in 2013, the company expects full-year 2013 consolidated net earnings to be in the range of $3.68 to $3.73. (Wall Street Journal)
April 17, 2013 - Commenting on a new deep brain stimulation service for Parkinson's disease patients in Bangalore, a neurologist calls the procedure a good option in carefully selected patients. The Columbia Asia Referral Hospital in Yeshwanthpur is one of more than 20 medical facilities in India and Southeast Asia operated by Columbia Asia Group, which entered the country with 100 percent foreign investment. (Moneylife)
Cigarette Craving Temporarily Reduced in Transcranial Magnetic Stimulation Study
April 16, 2013 - A dose of transcranial magnetic stimulation was shown to temporarily reduce nicotine craving in in smokers in a sham-controlled trial by a team at the Medical University of South Carolina, published in Biological Psychiatry. The stimulation focused on the dorsolateral prefrontal cortex, a region linked with cue-related behavior, such as the sight of a cigarette triggering a craving. (Wired.co.uk)
April 15, 2013 - Looking at outcomes of sacral neuromodulation in 332 patients, 71 of whom had a co-morbid neurologic disorder, follow-up over two years showed that patients with neurogenic bladder dysfunction experienced benefits after neuromodulation similar to the benefits experienced by those without coexisting neurologic conditions, according to a study in Urology. (Urology)
April 15, 2013 - Boston Scientific Corporation announced it has acquired and is launching the Fixate Tissue Band for spinal cord stimulator leads and pain pump catheters. Anulex Technologies of Minnetonka, MN developed the device to secure leads to the fascia or inter-spinous/supra-spinous ligament, and received expanded FDA approval last year for the catheter application. International Neuromodulation Society member Richard Bowman, MD, commented that the device permits quick and efficient lead anchoring. (Implantable Medical Devices)
Physicians in Colombia Receive Spinal Cord Stimulation Training
April 15, 2013 - An interview with a chronic pain patient mentions that International Neuromodulation Society member Carlos Viesca, M.D. recently returned from providing spinal cord stimulation training to 200 anesthesiologists and neurosurgeons in three cities in Colombia. (El Paso Times)
April 15, 2013 - Since the ability to walk while dual-tasking has been related to fall risk, researchers examined attention, executive function, and gait in 28 patients with advanced Parkinson's disease with bilateral sub-thalamic nucleus deep brain stimulation on and off, both with and without medication. The stimulation improved motor symptoms, certain features of gait and attention, but not executive function. However, stimulation apparently failed to reduce the negative impact of a dual task on walking abilities. (Journal of Neuroengineering and Rehabilitation)
April 11, 2013 - An international team of researchers report on development of injectable, cellular-scale optoelectronics with applications for wireless optogenetics in Science. (Wired)
Peripheral Nerve Stimulation Trial for Back Pain Begins Enrolling Patients
April 11, 2013 - Patient enrollment has begun in the SubQStim II pivotal clinical trial of peripheral nerve stimulation for chronic back pain. Medtronic, Inc. plans for up to 323 patients at up to 30 U.S. centers in the trial, in which patients will be randomized into control or treatment groups for the first three months, then participate in open-label follow-up for up to five years. (Mass Device)
April 11, 2013 - At the 29th Annual Meeting of the American Academy of Pain Medicine, a case series of three patients was presented in which multiple lead arrays and paddle leads were placed through a percutaneous port and anchored using dissection along the spinous process and placement of a perforating towel clamp, deep in the paraspinal musculature. The clamps created an anchoring point for the leads. Each patient was followed for at least one year. (Medical Xpress)
April 11, 2013 - Researchers at the U.S. Department of Energy's Brookhaven National Laboratory published an online paper in the Journal of Neuroscience that describes combining optogenetic stimulation and PET scans to trace effects of localized stimulation throughout the brain of laboratory rats. The method helps show which downstream neurological pathways are activated or inhibited by stimulation, and how that correlates with behaviors and/or disease conditions. The work could provide fine-scale control such as comparing the role of dopamine D1 or D2 receptors involved in processing reward, and might help refine treating conditions ranging from depression to Parkinson's disease, neurodegenerative disorders and drug addiction, as well as provide treatment monitoring. (Medical Xpress)
April 11, 2013 - The director of chemical and pharmaceutical sciences at the American Council on Science and Health, Josh Bloom, Ph.D., calls promising early reports about investigations of deep brain stimulation for treatment-resistant depression "potentially huge" and able to "help reinforce the idea that depression is a physical disease of the brain." (American Council on Science and Health)
Deep Brain Stimulation for Parkinson's Disease is Called Cost-Effective for the German Healthcare System
April 10, 2013 - In a study supported by the German Ministry of Education and Research, a team of journal co-authors from institutions in Austria and Germany, as well as Harvard Medical School, provide a lifetime statistical analysis of deep brain stimulation (DBS) for Parkinson's disease that supports adopting and reimbursing DBS within the German health care system. They conclude DBS can be considered cost-effective, offering a value-for-money profile comparable to other well-accepted health care technologies. The lifetime incremental cost-utility ratio for deep brain stimulation was €6700 per quality-adjusted life year (QALY) and €9800 and €2500 per United Parkinson's Disease Rating Scale part II (motor experiences of daily living) and part III (motor examination) score point gained, respectively. Deep brain stimulation costs were mainly driven by the cost of surgery and of battery exchange. (Movement Disorders)
April 10, 2013 - Professors at Bonn University Hospital report on seeing improvements within days in major depression symptoms in six of seven patients treated with bilateral deep brain stimulation to a relatively novel target, the supero-lateral branch of the medial forebrain bundle, a structure that runs from the limbic system to the prefrontal cortex. They report that a high proportion of responders needed lower stimulation intensities than seen in previous studies. Their pilot study appeared in Biological Psychiatry online April 5. (Gizmag)
April 10, 2013 - The global pharmaceutical company GlaxoSmithKline (GSK) announced plans to foster development of "electroceuticals" that were compared to a cross between a device and molecular medicine. The investment might initially target using an electric stimulus to regulate cytokine production involved in inflammatory diseases such as rheumatoid arthritis. The unveiling includes a $1 million research prize, and initial funding of work by 40 scientists in 20 labs at such institutions as MIT, the University of Pennsylvania, and Feinstein Institute of Medical Research. Heading the effort, GSK Vice President of Bioelectronics Research and Development Kristoffer Famm was lead co-author of a commentary in Nature. (Fierce Biotech)
Future Growth Will be a Key Topic of the INS 11th World Congress Pre-Conference, Innovations in Neuromodulation
April 10, 2013 - The International Neuromodulation Society expects more than 200 entrepreneurs, thought leaders, innovators and investors at Innovations in Neuromodulation on June 9th in Berlin, a pre-conference of the INS 11th World Congress. The day-long session draws industry strategists and investment managers by focusing on business, technical, and regulatory developments in this rapidly changing field. (Business Wire)
April 10, 2013 - St. Jude Medical, Inc. announced it is the first to receive CE Mark approval for use of deep brain stimulation to manage both primary and secondary dystonia. Dystonia is considered secondary when its cause can be attributed to a toxin, injury, or another disease or condition. In the announcement, International Neuromodulation Society Member Elena Moro, Ph.D., professor of neurology at the University Hospital Center of Grenoble, France noted that the involuntary muscle contraction and spasms of dystonia strike people of all ages. (St. Jude Medical)
April 9, 2013 - In a study in Restorative Neurology and Neuroscience of 17 people with focal hand dystonia, 68% reported that their symptoms improved after 5 daily sessions of low-frequency repetitive transcranial magnetic stimulation and 58% said their symptoms were better 10 days post-treatment. The stimulation was given while patients performed writing movements that did not trigger their dystonic symptoms. Although handwriting was not improved at a 10-day follow up, three patients contacted the investigators for additional treatment, indicating that they felt their symptoms had improved for several months. (Medical Xpress)
April 9, 2013 - Researchers at Imperial College London have received $9 million from the European Research Council to support development of a potential treatment option for obesity. The researchers' investigative device uses a nerve cuff electrode to target the branch of the vagus that ennervates the gut. The controller is intended to read conditions in the stomach and provide signals of satiety to the brain with proper stimulation. (Medical Xpress)
Modeling Shows Major Effect of Slight Changes in Location of Deep Brain Stimulation
April 6, 2013 - In a patient receiving deep brain stimulation of the subcallosal cingulate white matter -- as an investigative treatment for major depressive disorder -- a model of pathways that may mediate the effect predicts stimulation effects, and suggests, based on different simulated activation patterns from four different electoral contacts, that small differences in location can generate substantial differences in the directly activated pathways. The new tool, a tractography-activation model (TAM), combines imaging data, electric field modeling of stimulation parameters, and activation pathway prediction. In part, the TAM predictions are suggested by cable models of different axon states. (Brain Stimulation)
April 4, 2013 - Researchers in New Zealand and Australia report on a model of stroke rehabilitation in which the importance of control exerted by the motor cortex on the opposite side of the body suggests that careful consideration be given to using noninvasive brain stimulation to suppress the motor cortex there. They conclude that neurophysiological, neuroimaging, and clinical assessments can facilitate the best use of noninvasive brain stimulation in a stroke rehabilitation setting. (Frontiers in Neuroscience)
April 4, 2013 - A brief article about the EARLYSTIM trial, reported in the Feb. 14 issue of the New England Journal of Medicine, notes that the randomized trial of 251 patients who were followed over two years in European centers shows an overall benefit in the group that received neurostimulation rather than medical treatment alone, although there were more frequent adverse events in the group that received deep brain stimulation. For instance, major depression occurred more often, although there was an overall improvement in mood by the end of the trial. (Neurology Today)
Louisiana Television Station Features Interview of Parkinson's Disease Patient Who Benefitted from Deep Brain Stimulation
April 5, 2013 - A local television station reports about a man whose Parkinson's disease improved after he received a deep brain stimulation system. Three years after the implant, he is helping to raise awareness in support of fundraising events of the Southwest Louisiana and Southeast Texas chapter of the National Parkinson Foundation. (KPLC)
April 5, 2013 - PROMISE is a prospective randomized clinical trial to compare the outcomes of using optimal medical management for predominant low back pain alone, or with multicolumn implantable lead stimulation. The multi center trial is now enrolling patients at the Singing River Health System Neuroscience Center, one of up to 30 centers in the U.S., Canada and Europe participating in the Medtronic, Inc.-sponsored study. The study seeks participants who have persistent or recurring pain in the back and/or legs following one or more spine surgeries. (Mississippi Press)
Optogenetic Study in Animal Model of Cocaine Addiction Highlights Importance of Activity Level in Prefrontal Cortex
April 4, 2013 - The prelimbic region of the prefrontal cortex plays a central role in compulsive cocaine addiction, according to preclinical optogenetics research in the journal Nature. Researchers at the National Institute on Drug Abuse, the Ernest Gallo Clinic and Research Center and the Johns Hopkins School of Medicine introduced light-sensitive proteins in rat neural cells in that brain region, and introduced light there through fiber optics to increase or inhibit neural activity. Activating the neurons eliminated the compulsive behavior displayed by some of the rats in the study, and inhibiting neural activity in that region triggered compulsive cocaine-seeking behavior in the non-addicted rats. (UCSF)
U.S. BRAIN Initiative Would Create a Dynamic Map of Brain Activity
April 2, 2013 - U.S. President Barrack Obama unveiled a proposed $100 million initiative, Brain Research through Advancing Innovative Neurotechnologies (BRAIN), that is intended to show how individual cells and complex neural circuits interact in both time and space. The National Institutes of Health (NIH) is establishing a high-level working group to help articulate scientific goals and develop a multi-year plan with timetables, milestones, and cost estimates. Input will be sought from the scientific community, patient advocates, and general public. By fall 2013 the working group should have specific recommendations on investments for fiscal year 2014, with a final report due to the NIH director in June 2014. NIH is working closely with other government agencies, including the Defense Advanced Research Projects Agency and the National Science Foundation. Private foundations have expressed interest and support, including the Howard Hughes Medical Institute, the Allen Institute for Brain Science, The Kavli Foundation, and the Salk Institute for Biological Studies. Private industries are also interested in becoming involved. The NIH enterprise-wide Blueprint for Neuroscience Research will lead planning contributions, and published an NIH toolbox for such assessments as pain, cognition, and movement disorder in the March 12, 2013 issue of Neurology. (NIH)
Grant Supports Early Stage Research in Deeply Targeting Transcranial Magnetic Stimulation
April 1, 2013 - The Roy J. Carver Charitable Trust is giving $395,280 to Iowa State University to support research into directing transcranial magnetic stimulation into deep brain areas as a potential non-invasive treatment of such disorders as Parkinson's disease. Engineering and veterinary faculty are teaming to carry out the research in mice. (Iowa State University)
April 1, 2013 - A balanced approach seems best in researching the pros and cons of potentially using technology -- such as transcranial direct current stimulation (tDCS) -- to enhance human performance, a writer concludes after conducting a number of interviews over the course of a two-month series about various potential types of human enhancement. Besides its being explored to treat severe depression or aid rehabilitation from stroke, the article notes, there has been research interest in the potential of tDCS to enhance learning of cognitive tasks or performance in training exercises. (Slate)
Vagus Nerve Stimulation System for Weight Control Would Include a Smart Sensor
April 1, 2013 - Researchers at Imperial College London are developing a "smart" microchip to modulate sensations of appetite through sensing and stimulation at the vagus nerve. Earlier, the team developed a similar device that targets the vagus nerve to reduce epileptic seizures. Existing devices that target the vagus nerve to reduce food consumption are EnteroMedics' VBloc device and the Abiliti device by IntraPace. The latest device may be ready for human trials within three years. (Inland News Today)
March 31, 2013 - Abu Dhabi now has a deep brain stimulation (DBS) service at Sheikh Khalifa Medical City. The new service is unfamiliar to insurance companies, says Maher Mansour, MD, a consultant neurosurgeon at the facility. However, nationals of Abu Dhabi do receive partial coverage from the national medical coverage program. In a related article, the mother of a patient who acquired dystonia following a brain injury expressed gratitude for access to DBS surgery there. (The National)
March 29, 2013 - International Neuromodulation Society member Anthony Berg, MD, was interviewed by a business columnist about using the new 32-contact Precision Spectra spinal cord stimulator by Boston Scientific. In the three cases he has implanted so far, patients have all seen a significant drop in use of pain medication and an improvement in quality of life, he said. (Dallas Business Journal)
News Site Features MRI-Guided Deep Brain Stimulation Surgery
March 28, 2013 - A neurosurgical navigation platform that permits deep brain stimulation surgery under general anesthesia, the ClearPoint® Neuro Intervention System by MRI Interventions, Inc. was featured on the Fox News Health website about MRI-guided brain surgery being easier on Parkinson's patients. (PR Newswire)
March 28, 2013 - Two women have been implanted with deep brain stimulation systems as part of a 10-person study at The Ohio State University to explore whether the stimulation has protective effects in the progression of Alzheimer's disease. The first patient has completed 12 weeks of stimulation. The study will examine the impact of stimulation over time on thinking, focus and alertness. (HealthDay)
Neural Network Model Reflects Frequency-Dependent Response to Deep Brain Stimulation
March 23, 2013 - A team of researchers at INSERM and the Centre Hospitalier Universitaire in Rennes, France report on their model of a brain network that includes the biophysical effects of direct stimulation, based on EEG data from a patient with drug-resistant epilepsy and a focal cortical dysplasia. The dysplasia responds to either high- or low-frequency deep brain stimulation, but not intermediate-frequency. In the model, it appeared the frequency-dependent response could be explained by: a) feed-forward inhibition and synaptic short-term depression of thalamocortical connections at low-frequency stimulation, and b) inhibition of the thalamic output at high-frequency stimulation. (Frontiers in Computational Neuroscience)
FDA Clears Trial of Vagus Nerve Stimulation in Heart Failure
March 26, 2013 - The FDA has approved BioControl Medical's third and largest phase of the clinical trial of its vagus nerve stimulator CardioFit® in heart failure. INOVATE-HF (INcrease Of VAgal TonE in Heart Failure) is a global, multi-center, investigational device exemption (IDE) clinical study of the company’s CardioFit® system for heart failure. The approval, which is based on the FDA’s safety review of the first two successful completed phases, allows unconditional study expansion to full enrollment of 650 patients at 80 centers worldwide. (Business Wire)
March 2013 - Retrograde neuromodulation -- spinal cord stimulation directed toward the sacrum -- appeared effective in patients who had a well-localized pain and clear dermatome distribution, according to a series of 10 patients at the University General Hospital of Valencia in Spain, in which seven of 10 patients had effective stimulation. Retrograde neuromodulation appeared most effective in radiculopathy related to failed back surgery syndrome, and of limited effectiveness in treating perineal pain. (Pain Physician)
March 25, 2013 - Research and Markets calls neuromodulation a high-growth industry for the next decade, and offers the report "Neuromodulation Market - [Spinal Cord Stimulation (SCS), Vagus Nerve Stimulation (VNS), Gastric Electrical Stimulation (GES), Deep Brain Stimulation (DBS), Sacral Nerve Stimulation (SNS), & Transcranial Magnetic Stimulation (TMS)] - Forecasts to 2017". (PR Newswire)
March 25, 2013 - Los Angeles-based NeuroSigma, Inc. will report on the first example of potential clinical utility of its external trigeminal nerve stimulation device, the Monarch™ eTNS™ System, as an adjunctive treatment in refractory status epilepticus at the 4th London-Innsbruck Colloquium on Status Epilepticus and Acute Seizures to be held in Salzburg, Austria from April 4-6, 2013. (PR Newswire)
Lecture to Examine Past, Present and Future of Deep Brain Stimulation
March 18, 2013 - Neuromodulation: Technology at the Neural Interface editorial board member Kim Burchiel, MD, planned to present the past, present and future of deep brain stimulation during a lecture series at the Oregon Health & Science University. In an introductory blog post, he concluded, "the technology poses the bioethical question of whether our ability to modify brain function should be uncritically applied." (Oregon Health & Science University - On the Brain)
March 23, 2013 - Greatbatch Inc.'s ambitious, five-year, $50-million initiative to develop medical devices -- starting with a spinal cord stimulation (SCS) system, Algostim -- may capture a significant share of the $1.4 billion SCS market, according to a news feature in the Buffalo News. The company is growing its intellectual property portfolio, and will retain is business supplying components to makers of neurostimulation and cardiac rhythm management devices. For Algostim, it would design and manufacture the devices but use a marketing partner for commercialization. (Buffalo News)
March 22 - The Atlanta-based startup ConservoCare LLC is developing a high-frequency electrical nerve stimulation system for urinary retention or incontinence. The device is designed to eliminate spasms of the urethral sphincter and allow the bladder to function. Using technology licensed from Case Western Reserve University, the company has been financed by a $125K Phase I Small Business Technology Transfer grant from the National Institutes of Health, and by Case’s Translational Research Partnership with the Wallace H. Coulter Foundation. (MedCity News)
March 20, 2013 - Perspectives articles in Science Translational Medicine address requirements for turning the technology of optogenetics into a therapy, and describe potential new circuit-level targets or biochemical, cellular events for intervention. (Science Translational Medicine)
March 15, 2013 - In a television segment, deep brain stimulation (DBS) for Parkinson's disease is called a little-known procedure that hasn't been reaching all the patients and physicians who could benefit. The segment includes an example of a patient whose tremor and medication dosages were reduced after she received DBS. (Windycitylive.com)
March 14, 2013 - In a radio interview with two neurosurgeons, a radio segment describes being in the operating theater during a deep brain stimulation surgery and inquires about the future for better understanding and treating disorders of neural circuits. (612 ABC Brisbane)
Acute Migraine Treatment Study Using External Vagus Nerve Stimulation to Be Presented at Meeting
March 13, 2013 - ElectroCore®, announced that its study of patients with acute migraine headache treated with its non-invasive, portable vagal nerve stimulation treatment, GammaCore®, will be presented at the American Academy of Neurology Annual Meeting March 16-23 in San Diego. In the study, 27 participants treated an acute migraine with two, 90-second stimulation doses, applied externally at 15-minute intervals and delivered to the right cervical branch of the vagus nerve. Two-thirds of patients treated at mild pain were pain-free at two hours. Treatment-related adverse effects were limited. The company is now enrolling patients in a chronic migraine prevention study at several U.S. centers.
March 12, 2013 - Researchers at the University of Toronto have used repetitive transcranial magnetic stimulation (rTMS) to improve working memory in 27 medicated schizophrenia patients in a double-blind pilot study. After 20 rTMS sessions over four weeks, the improvement was comparable to healthy subjects. Working memory problems can be a functionally disabling component of schizophrenia. (Science Daily)
New Content Posted to INS Website on Spasticity and Rehabilitation Approaches
March 10, 2013 - International Neuromodulation Society member Konstantina Petropoulou MD, PhD, of the National Rehabilitation Center in Athens, Greece, has written an overview for healthcare professionals regarding management of spasticity with a focus on rehabilitation, including the use of intrathecal drug delivery systems. She has also contributed review of a brief description of the condition for non-specialists, posted to the INS website.
March 10, 2013 - Preclinical research indicates that applying electrical stimulation to the rap he nuclei of the brainstem may induce biological control mechanisms that could enhance recovery from traumatic brain injury or spinal cord injury. (Neurotech Zone)
March 7, 2013 - Nevro Corp. has completed a $48 million Series C round of financing led by new investor Novo Ventures, with New Enterprise Associates and Coviden Ventures. Existing investors participating in this financing round included Accuitive Medical Ventures, Bay City Capital, Johnson & Johnson Development Corporation, Mayo Clinic, MPM Capital, and Three Arch Partners. Based in Menlo Park, Calif., Nevro is commercializing the Senza® high-frequency spinal cord stimulation system for chronic pain, such as low back pain, and other conditions. The system is available in Europe and Australia. The funds will be used to sponsor an ongoing U.S. clinical trial, explore new indications, and support commercialization. (Nevro)
March 7, 2013 - Researchers at the U.S. Army Medical Research and Materiel Command, in collaboration with the University of Wisconsin-Madison and NeuroHabilitation Corporation, are working on a battery-operated neurostimulator that is inserted on the tongue for periods of 20 minutes or so during rehabilitation activities. Called the Portable NeuroModulation Stimulator (PoNs), it is designed to provide so-called "cranial nerve non-invasive neuromodulation" to the brainstem. PoNs has been considered for helping improve balance in patients who have multiple sclerosis, or assisting treatment of people suffering from concussion or brain injury. Testing will include a collaborative study with researchers and clinicians at the Blanchfield Army Community Hospital in Fort Campbell, Ky.
(Fort Campbell Courier)
Brain Stimulation in Anorexia Trial Shows Effects Beyond Stimulation Target
March 7, 2013 - A news feature describes a woman who had anorexia nervosa for two decades and has achieved a healthy weight as part of a clinical trial led by Dr. Andres Lozano of Toronto Western Hospital. He said the targeted area of the brain, the subcallosal cingulate, is turned down by the stimulation, likely toning down the anxiety, depression and other moods disorders that are hallmarks of the eating disorder. A surprise was an area of the brain involved with self-perception, or body image, was turned up. He compared the stimulation to a butterfly flapping its wings, since changing the activity of one area of the brain has consequences at other areas that are remote but are connected. (The Canadian Press)
March 6, 2013 - In a Phase I safety trial of six patients with treatment-resistant anorexia nervosa, by nine months after the start of deep brain stimulation to the subcallosal cingulate, half the patients had gained weight, four had improved mood, and two of those completed an inpatient eating disorders program, according to a research report in The Lancet. (Medical Xpress)
March 6, 2013 - Nine years after being diagnosed with Parkinson's disease at age 29, an Arizona man became one of about 1,000 patients so far to undergo a new deep brain stimulation surgery that takes place while the patient is under anesthesia. (ABC News)
Brain Stimulation for Learning Study Shows Tradeoffs in Speed and Concentration
March 5, 2013 - A controlled research study on 19 healthy volunteers at the University of Oxford found that transcranial electrical stimulation during a mathematical training exercise had mixed effects. Subjects whose parietal area was stimulated performed more quickly during the weeklong study, but they were slower to put their new learning to use on a novel task. Meanwhile, volunteers who had the prefrontal area stimulated were slower than controls in learning the new numerical system but quicker to apply it to a new test at the end of the experiment. (Wired)
Deep Brain Stimulation Service in Vancouver Experiences Growing Demand
March 6, 2013 - The province of British Columbia has only one neurosurgeon performing deep brain stimulation surgery at up to about 40 cases annually -- resulting in a waiting list of almost three years. The service is budgeted as a local program of the Vancouver Coastal Authority although most patients live outside that region. So far efforts to find research funding from a charitable group focused on Parkinson's disease have been unsuccessful. (Vancouver Sun)
March 4, 2013 - In a market report that spans 2013 - 2023, Visiongain projects a value of $12.45B for the global neuromodulation devices market in 2023. Among other factors, the report describes expanding disease indications. (PR Newswire)
Temporary Electrodes Track Excessive Brain Synchronization in Motor Disorder and Therapeutic Effect of Deep Brain Stimulation
March 4, 2013 - A method to detect excessive brain synchronization at the surface of the brain in people with Parkinson’s disease is being reported online this week in the Proceedings of the National Academy of Sciences, based on three years of study by researchers at the University of California, San Francisco; University of Cincinnati; Stanford University; and the University of Washington Medical Center. The researchers used flexible electrodes at the surface of the brain to detect activity there during neurosurgery. The study was conducted in 25 patients -- 16 with Parkinson’s disease and nine with cervical dystonia. The researchers compared the brain activity of these patients who had motor disorder to that recorded in patients who were being operated on for epilepsy. The research showed the effect of deep brain stimulation in halting excessive synchronization. Such findings could contribute to future neurostimulation approaches that respond automatically and flexibly to a patient’s needs. (University of California, San Francisco)
Access to Epilepsy Treatment Affected by Limited Information
March 4, 2013 - Despite the existence of interventions for epilepsy that include 26 approved medications in the U.S. and FDA-approved vagus nerve stimulation, access to care and referrals to treatment still fall short, according to a neurologist who contributed to a 2012 Institute of Medicine panel on the issue. Dr. Joseph Sirven, professor of neurology and department chair at the Mayo Clinic Arizona, writes that misinformation and lack of information are one limiting factor. (NBC Latino)
Feb. 28, 2013 - Sorin Group announced a $5 million investment in Israel-based Enopace Biomedical, which is developing an endovascular neurostimulation system for heart failure. Sorin Group, a global medical device company based in Milan, has invested in Enopace in 2011 and anticipates further investments based upon completion of development milestones. (Business Wire)
Small Study of Focused Transcranial Direct Current Stimulation Lowered Pain Perception in Fibromyalgia
Feb. 28, 2013 - A novel noninvasive brain stimulation technique, high-definition transcranial direct current stimulation (HD-tDCS), which uses algorithms to focus and target stimulation, was tested in single, 20-minute sessions on 18 patients who have fibromyalgia in a sham-controlled crossover trial. The stimulation was reported in the Journal of Pain to provide significant reduction in overall perceived pain as compared to sham stimulation, regardless of polarity. (ProHealth.com)
Thought-Controlled Prosthetic Arm Implanted
Feb. 26, 2013 - An amputee in Sweden has received the first permanent implantation of a prosthetic arm that is attached to the bone via a titanium socket, and controlled by electrodes implanted in his nerves and muscles. Designed at Chalmers University with contributions from Sahlgrenska University Hospital, the limb is designed to permit more movements than a simple, externally attached, robotic hand. (Gizmag.com)
Feb. 22, 2013 - Two patients whose primary generalized dystonia was successfully treated in their teens with bilateral pallidal deep brain stimulation (DBS) were reported to retain clinical benefit for at least two months after their devices had inadvertently been switched off. Unusually, the reappearing symptoms were milder than before. It is hypothesized the stimulation induced changes in the abnormal neural connectivity underlying the disease -- possibly due to their young age, short duration of disease and length of time on DBS, as well as their relatively low level of stimulation. Details and commentary were published in Movement Disorders (Medscape Medical News)
Feb. 26, 2013 - Greatbatch, Inc. posted a fourth-quarter 2012 adjusted earnings per share of 53 cents significantly exceeded the year-ago adjusted earnings of 39 cents (up 36% year over year). Within the neuromodulation and cardiac rhythm management area, sales decreased 5% year over year to $73.7 million due to market competition, strong shipments in the prior quarter and tough year-over-year comparables. In this sector, management anticipated short-term headwinds from key original equipment manufacturer customers. (NASDAQ.com)
External Trigeminal Nerve Stimulation Study Author Notes Effects on Seizures, Mood
Feb. 21, 2013 - Both anti-epileptic effect and mood effects appeared in a double-blind, randomized, active-control trial of external trigeminal nerve stimulation that was completed by 42 patients who have medically resistant epilepsy. An interview with lead study author Christopher M. DeGiorgio, MD, professor of neurology at the University of California, Los Angeles, and vice president of NeuroSigma, appeared in Neurology Today, along with a podcast interview. He said response climbed to 40.5 percent of the treatment group by 18 weeks. (Neurology Today)
Feb. 26, 2013 - International Neuromodulation Society members Jean-Pierre Van Buyten, MD, Adnan Al-Kaisy, MD and colleagues report in Neuromodulation results of a trial of high-frequency spinal cord stimulation without parathesia using the Nevro Corp. Senza system. The trial enrolled 83 patients with chronic back pain. Of 72 patients who went on to permanent implant, more than 70% had significant and sustained low back pain and leg pain relief. (NeuroNews)
Using 32 Contacts Allows Neurostimulation to Circle Skull for Chronic Headache "Halo" Treatment
Feb. 25, 2013 - International Neuromodulation Society member Nameer Haider, MD, announced a neurostimulation treatment for chronic headache that circles the skull. The 360-degree Halo procedure uses 32 electrical contacts to stimulate 12 nerves; supraorbital/supratrochlear, auriculotemporal, and greater/lesser occipital. (PR Web)
Therapeutic Effect of Stimulation on Neural Circuit Revealed in Brain-Imaging Study
Feb. 25, 2013 - An fMRI study in patients who received deep brain stimulation for obsessive compulsive disorder showed the communication between the nucleus accumbens, which influences motivation, and the frontal cortex, which aids decision-making, was increased when stimulation was off, and was higher than in healthy participants. That excessive connectivity is what deep-brain stimulation seems to break, said investigator Martijn Figee, MD, of the Academic Medical Center in Amsterdam. Stimulation appears to override disease-linked oscillations between the two regions. (Technology Review)
Deep Brain Stimulation Developer Receives Additional Funding
Feb. 25, 2013 - Sapiens Steering Brain Stimulation B.V. of Eindhoven, the Netherlands and Munich, Germany, has added €7.5 m to its €16.5 m round of Series A financing. The investment supports development of a deep brain stimulation with the capacity to steer the electrical pulses away from areas which may produce side-effects. The most recent financing comes from the Dutch investment group INKEF Capital, whose founder Frank R. Landsberger, PhD, was appointed to the company's advisory board. Sapiens was spun out in 2011 from Royal Philips Electronics to commercialize a steering brain stimulation probe, implant and image-guided programming. (News-Medical.Net)
Feb. 24, 2013 - An FDA advisory panel voted on Friday 11-0, with two abstentions, to recommend approval of NeuroPace Inc.'s RNS System, a closed-loop neurostimulator that is placed just under the skull to control epilepsy. (Newsday)
Study: Effect of Deep Brain Stimulation on Obsessive Complusive Disorder
Feb. 24, 2013 - International Neuromodulation Society member Brian Snyder, MD, described obsessive compulsive disorder (OCD) as a "disorder of neurocircuitry" in an article describing a Dutch study of deep brain stimulation to a part of the brain that is involved in motivation and reward processing, the nucleus accumbens. Published in Nature Neuroscience, the study showed that stimulation essentially restored normal functioning to that part of the brain in 16 patients with OCD. (Medical Xpress)
Patients Sought for Ongoing Trial of Spinal Cord Stimulation in Refractory Angina
Feb. 22, 2013 - Additional patients are being recruited for a feasibility trial of spinal cord stimulation (SCS) in patients with refractory angina. The RASCAL (Refractory Angina Spinal Cord stimulation and usuAL care) pilot study compares SCS to usual care alone. The U.K.-based investigators include International Neuromodulation Society members Sam Eldabe, MB ChB, FFPMRCA; Jon Raphael, MB ChB MSc MD FRCA; Simon Thomson, MBBS, FRCA, FIPP; Brookes Morag, RGN, BSc; and Rod S. Taylor, PhD. (7th Space)
Feb. 22, 2013 - Cyberonics Inc. said Friday that its net income climbed 39 percent in the fiscal third quarter as it sold more of its nerve stimulation devices designed to treat epilepsy and depression by delivering electrical stimulation to the vagus nerve. Net income in the November-January quarter rose to $13.2 million, or 47 cents per share, from $9.5 million, or 34 cents per share. Revenue rose grew 15 percent, to $62.7 million from $54.5 million. (CNBC)
Agreement Reached to Distribute Neuromodulation Products in Japan
Feb. 20, 2013 - The Boston Scientific subsidiary Boston Scientific Japan K.K. has reached an agreement with Fukuda Denshi Co., Ltd. to market and sell the Boston Scientific Spinal Cord Precision Plus System and accessories throughout Japan. Fukuda Denshi will begin distributing Boston Scientific neuromodulation products April 1, 2013. (Boston Scientific)
Feb. 21, 2013 - An FDA advisory panel is scheduled to vote today on whether to recommend approval of the first neurostimulation device that operates in a responsive, closed-loop fashion through detecting possible seizure onset in epileptic patients and delivering stimulation when apparently needed. The RNS System by Mt. View, Calif.-based NeuroPace, Inc. will be presented today to the panel, along with comments from the public, including representatives of the Epilepsy Foundation highlighting the need for innovative treatments. (Medical Xpress)
Vagus Nerve Stimulation Trial in Heart Failure Comes to Mississippi
Feb. 21, 2013 - North Mississippi Medical Center implanted the first vagus nerve stimulation system in the state as part of a clinical trial to treat heart failure. The CardioFit device by BioControl Medical is undergoing a worldwide investigation through the Innovate-HF trial. Two patients were implanted in the fall at the Tupelo, Miss.-based medical center, and commented in an article by the center that they have noticed a difference since then in their quality of life or activity levels. (Marketwire)
Feb. 20, 2013 - A new clinic aimed at streamlining the evaluation and approval process for the growing number of patients who are potential candidates for deep brain stimulation has opened at the Muhammad Ali Parkinson Center of the Barrow Neurological Institute. The process should now be completed in six weeks or less, rather than up to one year, and includes comprehensive treatment education. (PR Newswire)
International Neuromodulation Society Member is a Key Figure in Proposed U.S. Brain Activity Map (BAM) Project
Feb. 19, 2013 - International Neuromodulation Society member John Donoghue, professor of neuroscience at Brown University, is described as "one of the core scientists" involved in the proposal for U.S. agencies to create brain-activity-mapping scientific observatories to produce open-source data, similar to the Human Genome Project, over the next decade. He was quoted as saying the effort should unite neuroscientists working in the field and attract engineers and computational scientists to find ways to better understand the function of neural networks and their role in brain disorders and treatment. (Time)
February 2013 - The pre-conference sessions on June 8 and 9 for the 11th World Congress, Technology Transforming Chronic Illness Management, are now $360.53 each day, or $600 for both days. Register for one or two pre-conference days and the main congress and receive a 10% discount on the pre-conference fee. (International Neuromodulation Society)
Brazilian Chapter of the International Neuromodulation Society Launches Website
February 2013 - The Brazilian chapter of the INS (Sociedade Brasileira Neuromodulação - SBNM) has published its website listing articles, conferences, and members and their specialties, which include interventional pain treatment, movement disorders, spasticity, and neurosurgery.
Researcher Describes Plans to Implant Prosthetic Hand Controlled by Thought
Feb. 17, 2013 - Later this year, a man in his 20s in Rome will be fitted with a neuroprosthetic hand integrated with sensors linked to his nerves. He lost the lower part of his arm after an accident. The prosthetic is designed to provide sensory information from the fingertips, palm and wrists. It is intended to be attached to his arm's ulnar and median nerve branches to permit control of the hand's movement and provide sensory input, according to a talk by Silvestro Micera of the Ecole Polytechnique Federale de Lausanne in Switzerland at the American Association for the Advancement of Science meeting in Boston. (Independent)
Patient Describes His Experience with Deep Brain Stimulation Therapy for Essential Tremor
Feb. 15, 2013 - In an account that mentions International Neuromodulation Society member Ashwini Sharan, MD, a patient with essential tremor describes his decision to receive deep brain stimulation therapy after learning about it on television. (Jefferson University Hospitals)
Feb. 19, 2013 - New Jersey-based ElectroCore announced approval from Australia and Colombia for its non-invasive vagus nerve stimulation (nVNS) therapies for the acute and/or prophylactic treatment of primary headache (migraine, cluster headache and hemicrania continua) and medication-overuse headache in adults. The GammaCore therapy is available in Australia with physician authorization, and is expected to be available in Colombia in the first half of 2013. (MarketWatch)
Feb. 14, 2013 - The U.S. FDA announced it has approved the first implantable device to treat advanced retinitis pigmentosa (RP) in adult patients, the Argus II Retinal Prosthesis System by Second Sight Medical Products, Inc. is based in Sylmar, Calif. The device uses a small video camera and transmitter mounted on eyeglasses and an artificial retina to improve the ability to detect light and dark. RP is a rare genetic disorder affecting about 100,000 patients in the U.S. Multimedia coverage of the Humanitarian Device approval appeared in the Wall Street Journal (FDA)
Steering Repetitive Transcranial Magnetic Stimulation to Deep Brain May Relieve Pain
Feb. 15, 2013 - In work presented at the 2012 annual meeting of the Society for Neuroscience, Stanford University researchers demonstrated in healthy subjects and fibromyalgia patients that transcranial magnetic field pulses directed to the anterior cingulate cortex may be effective in reducing acute or chronic pain. The researchers used four magnets and mathematically directed steering. (Scientific American Mind)
Neurologist Recounts Path of Development of Potential Deep Brain Stimulation Treatment of Alzheimer's Disease
Feb. 15, 2013 - Neurologist and author Richard C. Senelick, MD, writes in a column about the slow but potentially promising application of deep brain stimulation (DBS) to delay the effects of Alzheimer's disease. He notes the use of DBS for essential tremor and Parkinson's disease has become routine in the United States and Europe, improving the lives of over 100,000 people. In addition, new studies explore the use of DBS for depression, obsessive-compulsive disorder, obesity, and chronic pain. While studying the use of DBS in obesity, researchers observed that it produced increased memory. This led to safety trials and then clinical trials as a potential Alzheimer's disease therapy. (The Atlantic)
Feb. 14, 2013 - In a two-year study, researchers from Germany and France conclude that subthalmic stimulation was superior to medical therapy in patients with Parkinson's disease and early motor complications. In the study, 251 patients were randomly assigned to either deep brain stimulation plus medical therapy, or medical therapy alone. (New England Journal of Medicine)
Feb. 13, 2013 - International Neuromodulation Society member Alex Green, MD, and Tipu Aziz, FMedSci, of the University of Oxford report in Neurosurgery that deep brain stimulation (DBS) can lead to long-term improvement in pain scores and other outcomes. The researchers present information about 59 patients teated between 1999 and 2011. The authors conclude that up to four years later, 66% of patients significantly improved their health status. Treatment was beneficial for 89% for patients with amputation and 70% of those with stroke, compared to 50% of those with brachial plexus injury. The study accounts for about 5% of all reported patients treated worldwide with DBS for neuropathic pain. (Newswise)
Feb. 11, 2013 - International Neuromodulation Society North American chapter president Ali Rezai, MD, described deep brain stimulation research at Ohio State University that aims to slow the progress of Alzheimer's disease. In the research, an area of the frontal lobe is targeted. In different research, a team at Johns Hopkins University is looking at the fornix, which is involved in memory formation. The recently initiated study in Ohio will run two years. (Cleveland Plain Dealer)
Feb. 7, 2013 - In a study published Feb. 6 in JAMA Psychiatry, Dr. Felipe Fregni from the Harvard Medical School in Boston and Brazilian colleagues report that a combined treatment with antidepressant medication and transcranial direct current stimulation helped relieve symptoms in nearly two-thirds of patients after six weeks of treatment. Of 120 people in Brazil with moderate or severe depression, depression scores in the one-fourth of patients who received active combined stimulation and medication dropped to an average of 13 on a 0-to-60 scale. Before treatment study subjects' depression scores averaged 30 to 31. The untreated "sham" group's score dropped to 25 during the study. (Reuters)
Feb. 5, 2013 - NeuroSigma, Inc. of California has received a Fast Track Small Business Innovation Research grant from the National Institute of Neurological Disorders and Stroke of the National Institutes of Health to develop its implantable subcutaneous trigeminal nerve stimulation (sTNSTM) System. The company will receive $600,000 in Phase I, with $3 million in Phase II, dependent on the availability of funds and satisfactory progress. It is envisioned that patients who have drug-resistant epilepsy may chose to use an sTNSTM implant if their condition responds to external stimulation. The sTNSTM includes leads placed under the skin, but above the skull of the forehead and a pulse generator to be placed at the chest wall. (News-Medical.net)
Chronic Cluster Headache On-Demand Neurostimulation Treatment Results Published
Feb. 5, 2013 - International Neuromodulation Society member Ben Pless, president and chief executive officer of Autonomic Technologies, Inc., is quoted in a press release about results of a multi-center European study of the company's implant being developed to treat chronic cluster headache through on-demand stimulation of the sphenopalatine ganglion. As reported in Cephalalgia, the device was shown to be highly effective in achieving fast pain relief with acceptable safety profile compared to similar surgical procedures. The novel therapy also decreased attack frequency. In the study, patients received low- or no stimulation on a random basis for purposes of comparing controls in a blinded fashion. The experimental period was 30 attacks or eight weeks; 19 of 28 (68%) patients experienced a clinically significant improvement: seven (25%) achieved pain relief in ≥50% of treated attacks, 10 (36%), a ≥50% reduction in attack frequency, and two (7%), both. (Business Wire)
Feb. 5, 2013 - SPR Therapeutics LLC has received CE mark approval to sell its Smartpatch nerve stimulation system for use in patients with chronic shoulder pain. (Crains Cleveland Business)
External Supraorbital Nerve Stimulation May Decrease Migraine Episodes
Feb. 4, 2013 - A study based at Liège University in Belgium indicates that external supraorbital nerve stimulation delivered daily for 20 minutes at a time may help to prevent migraine. In the study, 67 patients were followed for three months in the treated or control arms of the trial. The group that received clinical stimulation doses had 2.1 fewer migraine days per month, while there was no change in the control group. (American Academy of Neurology)
Feb. 1, 2013 - The International Neuromodulation Society has added an 11th World Congress "event" area to its Facebook page about the June 2013 meeting in Berlin that features a map of the meeting location at the Estrel Hotel, and provides an opportunity to share information, post a photo, video, or link, and network with upcoming attendees. (Facebook)
Feb. 1, 2013 - Preclinical brain stimulation magnetic implant research by International Medical Society member John T. Gale of the Cleveland Clinic and colleagues at Harvard Medical School was featured in a column based on their June 2012 publication in Nature Communications http://www.nature.com/ncomms/journal/v3/n6/full/ncomms1914.html (Scientific American Mind)
Jan. 31, 2013 - The University of Florida in Gainesville is participating in Functional Neuromodulation Inc.'s 20-patient study of deep brain stimulation in mild Alzheimer's disease, and posted a short video interview of site principal investigator Dr. Michael Okun discussing the study goal of trying to slow memory loss through neurostimulation to the fornix. (University of Florida)
Jan. 30, 2013 - International Neuromodulation Society member Ian Cook, MD, and colleagues at the University of California, Los Angeles and NeuroSigma, Inc., published results of a double-blind randomized active-control trial of 50 subjects who have drug-resistant epilepsy. The trail tested the suitability of external trigeminal nerve stimulation. The treatment group experienced a significant improvement in response over the 18-week treatment period, increasing from 17.8% at 6 weeks and 40.5% at 18 weeks. Overall 30.2% of the treatment group had a more than 50% reduction in seizure, compared to 21.1% for the active control group. The results will be used to design a larger, multi-center phase III clinical trial. (Neurology)
January 30, 2013 - An article about potential treatments for acute illnesses with ElectroCore, Medical LLC's non-invasive vagus nerve stimulation system describes a next-generation device that would be rechargeable and web-enabled to receive refills and to communicate compliance and outcome information to the company, prescribing physicians, and insurance providers. The charging station would resemble an iTunes model that is web-enabled to provide additional doses that are downloaded after physician authorization. "This is the first example of a web refill," said J.P. Errico, founder of the New Jersey-based company. He explained the device, which is CE marked in Europe, relies on proprietary waveform and delivery technology to stimulate the vagus nerve through the skin. The company began patient enrollment at 10 U.S. centers in January for randomized, sham-controlled trial of chronic migraine prevention. (Medical Device Daily)
Jan. 29, 2013 - Since fellowships will likely evolve to include other technologies, and other nervous system regions beyond typical deep brain stimulation therapy, Drs. Anhar Hassan and Michael Okun suggest in an article for residents and fellows that a more accurate term for this potential niche of specialization for neurologists may be electrical neuro-network modulation. (Neurology)
Jan. 31, 2013 - In response to letters accepted for publication about his October 2012 article on deep brain stimulation, Michael S. Okun, MD, of the University of Florida Center for Movement Disorders and Neurorestoration described an anticipated future of electrical neural-network modulation with the use of more leads and more targets per patient, especially as new symptoms emerge across various disease states; real-time monitoring of the inherent electrical signatures of the brain; more access to patients' personal electrical settings, so they may be able to “tune themselves"; telemedicine to improve satisfaction and to alleviate access problems; and the potential of coupling deep-brain stimulation to other therapies (such as gene therapy, the use of neurotrophic factors, and stem-cell therapy). In addition, he foresees hardware will become smaller and neurostimulator placement in the chest (with connector wires) will disappear, while leads may be coated to lessen infection risk. (New England Journal of Medicine)
Jan. 30, 2013 - Medtronic, Inc. released in Europe the first spinal cord stimulation systems for use in treating chronic back and/or leg pain that are designed for compatibility with full-body magnetic resonance imaging (MRI) scans under specific conditions. The devices recently received CE Mark approval. They include special leads that can withstand MRI scanning and a proprietary programming option, SureScan, which sets an appropriate mode for an MRI environment. International Neuromodulation Society member J.P. Van Buyten, MD, from the AZ Niklaas Hospital in Belgium, was quoted as calling the development an important advancement. (National Pain Report)
Jan. 30, 2013 - Only two weeks remain to submit abstracts to the International Neuromodulation Society's 11th World Congress in Berlin, Germany, the preeminent scientific conference that covers all aspects of neuromodulation. Please view the preliminary program and complete your submission through the abstract submission site.
Jan. 29, 2013 - Second Sight Medical of Sylmar, Calif. registered with the Securities and Exchange Commission on Monday to raise $25 million while waiting for the FDA to decide whether to approve its retinal implant, Argus II, which has been sold in Europe since 2011. (MassDevice)
Jan. 29, 2013 - International Neuromodulation Society president Simon Thomson, MBBS, FRCA, FIPP, FFPMRCA, commented in conjunction with release of a survey of more than 1,000 chronic pain sufferers across Europe, "The Painful Truth Survey: The State of Pain Management in Europe," sponsored by Boston Scientific and supported by a number of regional pain associations. He noted that healthcare systems throughout the world have not really produced specific answers to the needs of patients who suffer chronic pain that is not resolved by addressing any identifiable underlying condition. Some 17% of Europeans, he continued, will have significant chronic pain affecting daily living, with about 1/3 of those having pain that is really quite severe. About half suffer from neuropathic pain that arises spontaneously from damage to the nervous system. Of the patients whose neuropathic pain does not respond to pharmacological treatment, he said, spinal cord stimulation becomes an option, and has been advancing technologically since he first began using it slightly more than 20 years ago. (Boston Scientific)
Global Randomized Clinical Trial to Compare Medical Management With Or Without Spinal Cord Stimulation for Lower Back Pain
Jan. 28, 2013 - International Neuromodulation Society member Philippe Rigoard, M.D., is principal investigator of a global randomized clinical trial of patients with predominant low back pain due to failed back surgery syndrome. The study, sponsored by Medtronic, Inc., compares optimal medical management combined with use of a multicolumn, implantable lead for neurostimulation treatment and optimal medical management alone. The first of up to 300 patients in the PROMISE trial began treatment in the U.S. earlier this month, and Dr. Rigoard started enrolling patients January 14 at Poitiers University Hospital in France. The study is designed to assess the value of spinal cord stimulation (SCS) for predominant low back pain with leg pain. Previous studies focused on predominant leg pain. Health care utilization data will be collected to develop cost analysis models to potentially evaluate the long-term economic impact of SCS. (Yahoo Finance)
Jan. 28, 2013 - Stroke researchers at Glagsow University are starting a clinical trial in which results of patients who receive vagus nerve stimulation during physiotherapy to improve arm movement will be compared to another group who receive stroke rehabilitation without the stimulation. The trail is using the Vivistim vagus nerve stimulation system being developed by Dallas-based Microtransponder Inc., which is sponsoring the study. (Herald Scotland)
Jan. 25, 2013 - International Neuromodulation Society member Ali Rezai, MD, director of the Center for Neuromodulation at Wexner Medical Center in Ohio, was quoted as commenting on a published report about deep brain stimulation to the amygdaloid complex and supra-amygdaloid projection helping improve self-injurious behavior in an autistic patient whose case was reported in Frontiers in Neuroscience on Jan. 21. He was quoted as calling the patient's gains after 24 months "intriguing and promising". The authors report that the case supports a hypothesis about role of the amygdala, especially the basolateral part, in the pathogenesis of the condition. (Science News)
Jan. 25, 2013 - An applied mathematician presents a concept-in-progress of using voice analysis to quickly and remotely spot potential signs of Parkinson's disease motor symptoms. The project director, Max Little, PhD, received his doctorate at the University of Oxford and became a Wellcome Trust/MIT fellow at the MIT Media Lab, where he applies his background in digital signal processing. The work is based on a dataset of 10,000 voices voluntarily provided by callers over the telephone. (TED)
Jan. 24, 2013 - A Parkinson's disease patient is reported to be the first to receive deep brain stimulation treatment in Gujaret, India. One member of the Sterling Hospitals surgical team, Dr. Paresh Doshi, previously conducted stereotactic and functional neurosurgery in Mumbai. He was quoted as calling India "the most sought-after and cost effective medical tourism destination of the world," saying costs are about 15% that of North America and the U.K. (Times of Udaipur)
Jan. 24, 2013 - Nationwide Children's Hospital in Columbus, Ohio now offers sacral nerve stimulation for the a small percentage of children with chronic incontinence of the bowel, bladder, or both who do not respond to medication or behavioral modification. (News-Medical.net)
Jan. 24, 2013 - The latest addition to the International Neuromodulation Society's list of descriptions of terminology for use by patients or the general public is a brief overview about neuromodulation therapy. Since its inception one year ago -- through the efforts of the website's editorial contributors, the list of short explanations for treatment and condition terms has been viewed some 30,000 times by INS website visitors. (International Neuromodulation Society)
Jan. 22, 2013 - Functional Neuromodulation, founded in Toronto in 2010, has added Vince Owens, former CEO and director of Intelect Medical, to its board of directors. Other board members are company co-founder and CEO Dan O’Connell; founding scientist Andres Lozano, MD, PhD; Kelly Holman, managing director of Genesys Capital; and Andrew D. Firlik, MD, managing partner at Foundation Medical Partners. Lothar Krinke, PhD, vice president and general manager of Medtronic’s Deep Brain Stimulation business serves as an active board observer. Dedicated to applying deep brain stimulation (DBS) to memory and other cognitive disorders, the company is conducting the ADvance Study in North America to evaluate DBS of the fornix, a major pathway in the brain’s memory circuit, for patients with mild Alzheimer’s disease. (BioSpace)
Jan. 22, 2013 - A positron-emission study of 12 Parkinson's disease patients at Hamamatsu University School of Medicine in Japan, published in the Journal of Cerebral Blood Flow and Metabolism, suggests beneficial effects of subthalamic nucleus stimulation in patients with Parkinson's disease are partly down to compensatory activation of non-motor dopamine pathways during exercise. (medwireNews)
Jan. 22, 2013 - The National Institutes of Health, National Institute of Neurological Disorders and Stroke is funding a clinical feasibility study at the University of Alabama at Birmingham through a $283,828 Phase I Small Business Innovation Research grant to Cleveland, OH-based Great Lakes NeuroTechnologies to explore using intelligent algorithms to aid programming deep brain stimulation in Parkinson’s disease. The system will leverage existing technology to quantify Parkinson’s motor symptoms such as tremor, bradykinesia, and dyskinesia into a functional map. Intelligent algorithms will determine optimal parameters for symptom relief while minimizing side effects and battery consumption. (News-Medical.Net)
Jan. 22, 2013 - Valencia, Calif.-based Bioness Inc. announced it has received FDA clearance to market to pediatric patients and their caregivers its L300 system to treat foot drop, a condition which causes walking difficulty in adults and children who have motor-impairment conditions such as cerebral palsy, stroke or traumatic brain injury. The system consists of a small wireless sensor in the shoe, a sport brace-like leg cuff worn just below the knee, and a hand-held remote control. In addition to being used to assist walking, it can also be used for rehabilitation purposes. (Business Wire)
Jan. 21, 2013 - The first U.S. patient has received a deep brain stimulation (DBS) implant in a clinical trial exploring DBS as a treatment option for early-state Alzheimer's disease according to an announcement by the Ohio State University's Wexner Medical Center, which calls the neuromodulation team at Ohio State pioneers in the use of DBS to treat Parkinson’s disease, as well as exploring the use of DBS for other neurological and neurobehavioral conditions. (Wexner Medical Center - Ohio State University)
Jan. 21, 2013 - Brainsway Inc. of Israel expects to name a U.S. partner this quarter to distribute its noninvasive transcranial magnetic stimulation system for treatment-resistant depression, a technology it licensed from the National Institutes of Health. This step would precede seeking listing on the Nasdaq exchange, according to an article in Bloomberg BusinessWeek. (Bloomberg)
January 2013 - Through March 15, the Therapeutic Goods Administration in Australia is seeking comment on proposed revisions to its premarket review process for medical devices, including subjecting surgically invasive and implantable systems designed for long-term use to the agency's mandatory application audit and easing its lower-risk device rules. (Australian Therapeutic Goods Administration)
Jan. 17, 2013 - International Neuromodulation Society member Brian Kopell, MD, was featured in a television segment about a patient's deep brain stimulation surgery for Parkinson's disease. Dr. Kopell likened it to receiving a brain pacemaker implant that could restore a more normal lifestyle, saying, "This is among the most technologically advanced surgeries that we do in medicine." (MYFOXNY)
January 2013 - International Neuromodulation Society members Michael Labbe and Jeff Gagnon are names as inventors on a patent application that was cleared for further review on Jan. 10, 2013. Also named as inventors were Steven E. Wilder and Ben Cottrill. Aside from turning on or adjusting neurostimulation to an implant, the application states, few patients use advanced controls to adjust program frequency and individual pulse/area stimulation features such as pulse width. Since hand-held controllers are slightly large for readily carrying in a pocket, the application proposes creation of a smaller pocket controller to provide the main options while a patient is on the go, along with an integrated controller-charger and charging module as part of the set. The patent is assigned to Greatbatch, Inc. (Equities.com)
Jan. 13, 2013 - International Neuromodulation Society member Antonio De Salles, MD, PhD, who directs the Stereotactic Surgery program at the University of California, Los Angeles, is profiled in a detailed description of a patient undergoing deep brain stimulation (DBS) surgery for Parkinson's disease. The article also summarizes recent research into DBS as a potential intervention in early-stage Alzheimer's disease. (Alzheimer Research Forum)
Jan. 16, 2013 - International Neuromodulation Society member Ivar Mendez, MD, PhD was featured in an article about a feasibility study showing that neuromodulation device programming can be guided remotely by an expert using a telepresence robot with a digital camera, microphones, and laptop interface, as well as an arm that can remotely indicate which buttons to push on the programming screen. A preliminary study he led showed no significant difference in accuracy or clinical outcomes between 10 programming sessions carried out remotely and 10 performed by an expert in person. (Medical Xpress)
January 16, 2013 - At the request of the Ministry of Health, France's cost containment agency (HAS) will publish a notice for public comment seeking input from all stakeholders including patients on an updated reimbursement list for neurostimulation devices, based on an assessment of each device’s effectiveness and the value of its therapeutic indications. HAS is undertaking a health technology assessment review of all implantable spinal neurostimulation devices, whether rechargeable or not, that are intended for the treatment of chronic pain and on the list of Reimbursable Products and Services. (Regulatory Focus)
January 2013 - The Dutch Ministry of Health plans a national registry for patients who have received medical implants. In it, suppliers, producers, and insurance companies will be required to provide information on any device complications. (Dutch News via The Commonwealth Fund)
Jan. 8, 2013 - A study of six patients with treatment-resistant depression who received vagus nerve stimulation (VNS) was published by the Departments of Psychiatry and Mental Health, Fondazione IRCCS Cà Granda, Ospedale Maggiore Policlinico, University of Milan. The patients were followed for at least 12 months. After three months, the patients showed statistically significant improvements in depression scores, and after 12 months, they also showed improvements in depression rating scales as well as in clinical global impression. Also, the patients showed an overall favorable tolerability to the VNS implant. (The Journal of ECT)
Jan. 14, 2013 - The U.S.-based firm Marketsandmarkets forecasts the global neuromodulation market will reach $6.8 billion by 2017. Vagus nerve stimulation is expected to see the most growth due to being less invasive and with more development of applications anticipated. The key factors that drive the neuromodulation market are higher incidences of endemic diseases, rise in aging population, technological advancement, devices under approval, and presence of several niche players. Reimbursement in certain geographies and cost of devices are major challenges. North America is estimated to account for the maximum share of the neuromodulation market in 2012, followed by Europe, and Asia-Pacific countries like Japan, India, and China. (PR Newswire)
Jan. 11, 2013 - Revised regulations regarding medical device clearances in Russia reportedly took effect Jan. 1, 2013. It was previously reported that some of the anticipated changes were that final approval decisions will be made by “expert reviewers” rather than the regulator (Federal Service on Surveillance in Healthcare and Social Development of the Russian Federation, or Roszdravnadzor); there was an apparent lack of timelines for medical testing, meaning they could last for years; and medical device registration fees would be written into law. One anticipated change could mean expert reviewers would determine whether additional clinical testing of a device is necessary and provide a list of hospitals where that should occur. A registration certificate would be issued to an applicant based on a positive expert review, or a refusal would be based on a negative expert review. (Mass Device)
Jan. 11, 2013 - Hypothesizing that transcutaneous electrical nerve stimulation (TENS) in kidney donors may aid postoperative pain relief, pulmonary function and mobility, a research team at the
Physical Therapy Department, University of the City of Sao Paulo in Brazil has published a protocol for a prospective, randomized trial using sham or active TENS in 74 patients. The trial is registered under the Registro Brasileiro de Ensaios Clinicos (ReBEC), number RBR-8xtkjp. (BMC Nephrology)
Jan. 9, 2013 - Brainsway Ltd. announced it has obtained FDA approval for its deep transcranial magnetic stimulation device to treat depression in patients who fail to respond to therapeutics during a depression cycle. (Globes)
January 2013 - Iowa State University will receive $395,280, to establish a laboratory for brain stimulation research, from the Roy J. Carver Charitable Trust of Muscatine, Iowa. One of the goals is to find noninvasive methods of stimulating deep-lying regions of the brain to potentially treat a wide range of issues – from concussion, depression and post-traumatic stress disorder, to degenerative issues such as Parkinson’s disease and stroke. (Iowa State University Foundation)
Neuromodulation, Emerging Markets, May Contribute to Device-Maker's Bottom Line
Jan. 8, 2013 - Medtronic expects stronger performance in areas like neuromodulation to lift overall corporate growth. In comments Monday at the J.P. Morgan Healthcare Conference, Chief Executive Omar Ishrak also said that the countries outside of China, such as India in particular, but also Central Europe, Middle East and Africa, Latin America, all would be expected to be big growth engines. (Fox Business)
Dec. 28, 2012 - A woman whose gastroparesis prevents her from eating solid food believes controlling the condition using neurostimulation would be more cost-effective than her repeated hospitalizations, but has been turned down for an implant by the National Health Service in West Sussex after a panel of four consultants, three general practitioners and two lay people felt there was not sufficient evidence the requested treatment would be effective for her. (Crowley and Horley Observer)
Jan. 9, 2013 - More than 1,500 attendees are expected at the INS 11th World Congress in Berlin in June that centers on all aspects of development of therapeutic applications of neuromodulation. (Newswise)
Jan. 9, 2013 - The Consumer Electronics Show included what was presented as a certified transcutaneous electrical nerve stimulation medical product by China-based E-Tek that uses an iPhone interface, according to a blog covering the event. (9to5Mac)
Jan. 8, 2013 - SPR Therapeutics expects CE mark certification for its Smartpatch peripheral nerve stimulator to be announced shortly, according to published comments by the chief executive officer of the Cleveland-based company. Also, the company plans clinical trials at six U.S. centers in the next few months, initially targeting post-stroke shoulder pain. Finally, the company was reported to have raised an additional $2.8 million in financing, bringing the total to $5 million from NDI Healthcare Fund, Public Square Partners and individual investors. (MedCity News)
Jan. 8, 2013 - London-based Visiongain predicts a $12.45 billion global market for neuromodulation devices by 2023, with sales of $3.03 billion in 2011. Hemant Mistry, healthcare industry analyst, says, "The neuromodulation device market has experienced substantial growth in recent years, as their benefits in cost saving particularly have become more evident. Such devices can not only provide long-term relief to patients, but can also offer an effective alternative to the use of drugs that are well-known to have side effects . . . (although the initial cost of the device and surgery to implant the device is high, their prescription is cost-effective in the long-term). With future developments in the pipeline such as phrenic nerve and gastric stimulators . . . the market for neuromodulation devices has significant potential to grow in the future". (PR Newswire)
Jan. 8, 2013 - The INS 11th World Congress that takes place June 8 - 13 in Berlin, "Neuromodulation: Technology Transforming Chronic Illness Management," is extending the abstract submission deadline by one month to 14 February 2013. This final deadline will have no further extensions. (INS)
Jan. 8, 2013 - The winter newsletter of the INS is now online, featuring a president's message, updates, and annual chapter recaps, including news that Japan now covers the cost of deep brain stimulation and spinal cord stimulation procedures. (INS)
Jan. 8, 2013 - INS is entering into a media partnership with Touch Medical Media, which publishes the European Neurological Review. INS may distribute information to members from them later, and the organization will also list the INS logo, contact information, and link on its website, www.neurology.com. (INS)
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