2016 News Briefs - International Neuromodulation SocietyEarlier News: Later News: January - December 2016 Article Describes Advantages of Neuromodulation for Pain ReliefDec. 30, 2016 - An article entitled, "Neuromodulation, a weapon in the fight against opioid addiction" quotes International Neuromodulation Society member Konstantin Slavin, MD, following a panel presentation at the AdvaMed 2016 medical conference. Dr. Slavin noted advantages of neuromodulation are that it can be trailed, is adjustable and reversible, and does not destroy tissue. He said as a pain-relief method it can “provide an alternative to opioids and help patients already on opioids as a replacement therapy.” (Addiction Now) Review Sums Up Potential Benefits of Deep Brain Stimulation for Treatment-Resistant DepressionDec. 30, 2016 - Researchers who reviewed mostly open-label research into deep brain stimulation for depression, published between 2010 and 2015, found the long-term response rates were between 40% and 70% and the clinical benefit lasted for months or years. (Medscape) Clinical Study Explores Focused Ultrasound to Treat Parkinson's DiseaseDec. 24, 2016 - In an article about a clinical study of ablation with focused ultrasound in Parkinson's disease, International Neuromodulation Society member Ali Rezai, MD is quoted as saying it provides "a whole new dimension in the way we can help people. We can perform brain surgery without ever cutting the skin." (Columbus Dispatch) Visual Prosthesis Receives Reimbursement ApprovalsDec. 22, 2016 - Second Sight Medical announced the U.K. National Health Service said “a selective group of severely blind patients with Retinits Pigementosa can have access" to the company's retinal prostheses system through two implantation centers, the Manchester Royal Eye Hospital and London’s Moorfields Eye Hospital. In November the company received http://www.massdevice.com/second-sight-wins-cms-reimbursement-codes-argus-ii-bionic-eye/ reimbursement codes from the U.S. Centers for Medicare & Medicaid Services. (Mass Device) U.S. Air Force and Company Parter to Study Non-invasive Neuromodulation to Augment Cognitive PerformanceDec. 20, 2016 - Rio Grande Neurosciences of Albuquerque and the U.S. Air Force 711th Human Performance Wing have reached a cooperative research and development agreement to develop and evaluate neuromodulation through testing on 36 recruited participants non-invasive stimulation approaches involving pulsed electromagnetic field stimulation, transcranial direct current stimulation paradigms, and transcranial alternating current stimulation. A technology transfer announcement said, "If shown to be effective in this project, these technologies and techniques may provide a new treatment for medical patients, as well as a simple and cost-effective method for sustaining airmen performance in critical Air Force jobs such as image analysts, cyber operators, and remotely piloted aircraft operators." (U.S. Air Force) Article Lists Neuromodulation Clinical Trials for FibromyalgiaDec. 20, 2016 - An overview of fibromyalgia treatments mentions clinical trials in repetitive transcranial magnetic stimulation and transcranial direct current stimulation. (ProHealth) Company Plans to Seek FDA Approval for Non-Invasive Brain Stimulation for Alzheimer's DiseaseDec. 20, 2016 - Neuronix Ltd. said a multi-center clinical trial involving 131 patients had "conclusive" results in patients with early-to-middle-stage Alzheimer's disease who received repetitive transcranial magnetic stimulation in conjunction with computer-based cognitive exercises. The company indicated it intends to pursue FDA approval for the treatment. (Globes) Sacral Neuromodulation System is Being Evaluated in Fecal IncontinenceDec. 6, 2016 - Axonics Modulation Technologies, Inc. said two patients in the U.K. have been implanted with its rechargeable sacral nerve stimulation system as part of a 12-patient evaluation of the system in the treatment of fecal incontinence. The system received CE mark approval in June 2016, and to date more than 25 patients in the Netherlands, Belgium, France and the U.K. have been implanted as part of a post-market clinical follow-up study in overactive bladder. (Business Wire) Children Whose Dystonia is Linked to a Mutation May Be Treated by Deep Brain Stimulation, Scientists SayDec. 19, 2016 - Researchers report they have identified a genetic mutation in movement-disorder patients whose condition was hard to diagnose previously. The discovery of this genetic basis for the patients' dystonia, they add, means the patients can be considered for treatment with deep brain stimulation. (The Telegraph) Iranian University Develops a Transcranial Direct Current Stimulation DeviceDec. 18, 2016 - Biomedical engineering researchers at Amirkabir University in Tehran said they have created a transcranial direct current stimulation device they say is ready for commercialization. (Meh News Agency) Researchers in Sweden Work on Flexible Electrodes Capable of Releasing NeurotransmittersDec. 16, 2016 - Researchers at Karolinska Institutet said they have developed a process to impregnate conducting polymer electrodes with the neurotransmitter acetylcholine, which was then released when the electrode was stimulated with an electrical signal. (Health Canal) Researchers Publish Long-Term Results in Study of Spinal Cord Stimulation in Refractory AnginaDec. 15, 2016 - A study that followed 100 patients in the U.K. National Refractory Angina Service for 14 years found that spinal cord stimulation resulted in improvement with a satisfaction rate of more than 90%. Noting that the range of complications were within the range reported in the literature, the authors conclude the treatment seems to be safe and effective for refractory angina. (Medscape) Research Associates Dopamine Deficiency with Brain-Wave and Cognitive Processing IssuesDec. 15, 2016 - A research team observed that Parkinson's disease patients who performed poorly on a judging several seconds of time also lacked delta-wave brain function, of 1-4 Hertz, in their frontal cortex. The scientists studied mice who lacked dopamine in their prefrontal cortex and found they improved performance in a timing task if their dopamine receptors in this brain area were stimulated at 2 Hertz by pulses of light. The researchers say they believe they were able to demonstrate improved cognitive function from brain stimulation in the mice. They added that stimulation of specific neural networks in the cortex might improve cognitive processes that depend on dopamine. (Medical Xpress) First Patient is Enrolled in Study of an Implanted Tibial Nerve StimulatorDec. 15, 2016 - Stimguard LLC announced it has enrolled its first patient with overactive bladder in a study of chronic, nightly, tibial nerve stimulation therapy. The randomized, comparative study will enroll up to 242 patients. In it, weekly office-based stimulation will be compared to the company's device that uses an external transmitter to power a small implanted stimulator at night. (Yahoo Finance) Spinal Cord Stimulator Helps Paralyzed Patient Regain Use of His HandsDec. 13, 2016 - Researchers at UCLA report implanting a 32-electrode spinal cord stimulator in a spine-injury patient, allowing him to regain some usable strength in his hands, five years after the accident that left him a functional quadriplegic. (EurekAlert) Medical Technology Panel Addresses Opioid Issues and AlternativesDec. 12, 2016 - Members of the International Neuromodulation Society spoke at a recent panel where medical technology was discussed as part of a solution for the U.S. opioid epidemic. Panelists discussed a variety of neuromodulation approaches for spinal cord stimulation, and also aspects of intrathecal drug delivery. INS President Timothy Deer, MD, said he calls the recent rapid development of non-opioid approaches to pain a "neuromodulation revolution". INS Director-at-Large Konstantin Slavin, MD, commented that there is not an opioid epidemic where patients receive very different treatment for similar conditions outside the U.S., Canada and Australia. (Pain Medicine News) Spinal Cord Stimulation System Receives CE Mark Approval for Conditional Full-Body Magnetic Resonance ImagingDec. 8, 2016 - St. Jude Medical, Inc. has received CE mark approval for conditional labeling of a spinal cord stimulation system for full-body magnetic resonance imaging. (BusinessWire) Memory-Formation Study Fails to Show Improvements from Stimulating Certain Brain TargetsDec. 7, 2016 - A study in 49 patients with epilepsy failed to show improvements in forming memories from stimulation of the entorhinal cortex or hippocampus. The subjects were asked to perform eight times as many memory retrievals -- 48 -- as were seven subjects in a 2012 study that suggested a potential memory benefit from stimulation to these brain regions. In the current study, stimulation resulted in reduced accuracy in memory retrieval that ranged from 5 - 20% in all regions stimulated for the tasks. (Medical Xpress) Developers Eye Potential Future Human Clinical Trials of Light Stimulation to Treat Alzheimer's DiseaseDec. 7, 2016 - MIT researchers reported in Nature that stimulating the brain in a mouse model of Alzheimer's disease using LED light at 40 flashes per second restored gamma oscillation, which activated glial cells to clear beta amyloid plaques. The technology is being licensed to the startup Cognito Therapeutics. The Boston Globe reported that the company's lighting system is being prepared for human clinical trials at the San Francisco-based medical device incubator TheraNova LLC. (Financial Times) Company to Enroll Alzheimer's Patients in Clinical Trial of Non-Invasive Brain Stimulation DeviceDec. 6, 2016 - NeuroEM Therapeutics, Inc. plans a clinical trial of up to 14 patients aged 65 or older who have mild to moderate Alzheimer's disease, to determine the safety and initial efficacy of transcranial electromagnetic treatment -- interdigitated electric and magnetic waves -- to improve biomarkers of the condition in functional brain imaging and testing of blood/cerebrospinal fluid. The plans for the phase 1 clinical trial follow preclinical studies showing that daily stimulation for two months with wavelengths on the order of those used for cell-phone transmissions led to lower levels of beta-amyloid plaque within and around neurons, while metabolic activity increased in diseased neurons. (PR Newswire) Academic Researcher Designs and Tests Non-Invasive Brain Stimulation DevicesDec. 6, 2016 - A researcher in New York has received a combined $4 million in grants for research into non-invasive brain stimulation. His laboratory focuses on design and testing of devices to address neuropsychiatric disorders or brain injury. (City College of New York) Patients with Fecal Incontinence Receive Implants in a Clinical Trial of a Rechargeable Sacral Neuromodulation DeviceDec. 6, 2016 - Axionics Modulation Technologies, Inc. is undertaking a 12-patient evaluation of its rechargeable sacral neuromodulation system for fecal incontinence, and announced two patients have been implanted with the device in the U.K. (Business Wire) Article Presents Vagus Nerve Stimulation as an Alternative to PharmaceuticalsDec. 5, 2016 - An article talks about existing and emerging uses of vagus nerve stimulation in a number of disorders, with comments by a number of academic researchers. (Wall Street Journal) Data Over Seven Years Show Seizure Rate Decline with Responsive NeurostimulationDec. 5, 2016 - NeuroPace, Inc. presented seven years of clinical data on 185 epilepsy patients who have used the company's closed-loop responsive neurostimulation system. The company reported a median reduction in seizure frequency of 72% in the patients, whose condition is medically refractory. The results were presented at the American Epilepsy Society meeting in Houston. (Mass Device) Article Presents Sacral Neuromodulation as an Alternative Treatment for Bladder DysfunctionDec. 4, 2016 - A publication in Singapore features the use of sacral nerve stimulation as a potential option not many patients know about for either urinary retention or overactive bladder. Patients who have one or the other of those conditions are interviewed in the article, as well as their physician. (Star 2.com) Geneticist Studies Brain Stimulation in Preclinical Investigation of Childhood Neurological DisorderDec. 4, 2016 - A geneticist who received a $3 million Breakthrough Prize in the fifth year of the Silicon Valley science gala saw significant improvements in learning and memory through the use of deep brain stimulation in mouse models of the rare childhood disorder Rett syndrome. She said the findings may translate to other disorders. (Houston Chronicle) Weekly Science Show Presents Neuromodulation for ParalysisDec. 3, 2016 - A weekly radio program presents research into spinal cord stimulation and brain-computer interfaces in paraplegia. (PRI) Vagus Nerve Stimulation Shows Promise in Small Crohn's Disease StudyDec. 1, 2016 - A small study of seven patients shows vagus nerve stimulation may address the symptoms of Crohn's disease. Over six months, five of the seven patients achieved endoscopic remission and four experienced clinical remission. (Gastroenterology & Endoscopy News) Non-Invasive Brain Stimulation Apparently Reveals an Additional Memory CapacityDec. 1, 2016 - The journal Science published results of a memory study involving transcranial magnetic stimulation (TMS). In the study, subjects were asked to recall a cue and then given other memory tasks to hold in their short-term memory. With TMS stimulation, neural activity associated with the "forgotten" item spiked. An accompanying news article in the journal describes the observation of latent recall as a second level of working memory, saying that it might be based in synapses or other neural features. (Medical Xpress) Neuromodulation Start-Up Pursues a Pulse Generator Without an Application-Specific Integrated CircuitDec. 1, 2016 - A medical technology start-up, Lone Star Neuromodulation, says it has created a programmable, wirelessly rechargeable, 17-electrode pulse generator primarily using off-the-shelf components and no custom integrated circuits. The company adds that the device "is subject to future testing, trials and regulatory approval." (PR Newswire) Study Shows No Advantage to Changing Epilepsy Medication Following Vagus Nerve Stimulation TreatmentNov. 28, 2016 - An 85-person comparative study from 2005 - 2014 showed there was no outcome improvement from changing anti-epileptic drugs after a patient started vagus nerve stimulation therapy. The authors suggest keeping the same medication may allow optimizing stimulation parameters. (Epilepsy Research UK) Clinical Trials Explore Subperception Spinal Cord StimulationNov. 23, 2016 - A pilot cross-over study published in Neuromodulation: Technology at the Neural Interface, compared three weeks of subperception spinal cord stimulation (SCS) with conventional SCS with parathesia at 10 kHz. An article suggests subperception SCS may be an effective alternative for some pain patients to find relief. The study is being followed by a subsequent multicenter, randomized, controlled, crossover, open-label study of 146 previously implanted patients that will document the efficacy of subperception SCS at up to 1.2 kHz. (Anesthesiology News) French Research Center Raises Funds to Study Brain-Based Neural-Interface DevicesNov. 22, 2016 - The French biomedical research center Clinatec has raised €10 million in the past 12 months in a matching-funds campaign with the Edmond J. Safra Foundation. The center is pursuing innovative treatments for cancer, neurodegenerative diseases and motor disorders. They include a brain-computer interface project for patients with quadriplegia; a near-infrared project to potentially provide neuroprotection and slow disease progression through use of an intracranial device delivering therapeutic light; and the Epicool project that aims to develop a cooling system implanted in the brain to block seizures. Also, the center is participating in the Equoloc project that studies potential brain dysfunctions in drug-resistant obsessive compulsive disorder, using imaging, including the center's MEG capability. (Business Wire) Clinical Trial to Study the Use of Vagus Nerve Stimulation in Postpartum HemorrhageNov. 22, 2016 - Partners were announced in a clinical trial of vagus nerve stimulation as a potential way to halt postpartum hemorrhage. The partners are the Global Good Fund, the Feinstein Institute, and Sanguistat, Inc., which licensed the technology from the Feinstein Institute. (PR Newswire) Company to Expand and Extend Clinical Trial of Non-Invasive Device to Treat Symptoms of Neurological Disease or TraumaNov. 22, 2016 - Helius Medical Technologies amended its contract with the U.S. Army Medical Research and Material Command to extend it to the end of 2017 and include additional study sites for the clinical trial of the portable neuromodulation stimulator to treat neurological symptoms caused by disease or trauma. (FDA News) Researchers Plan a Multi-Center Clinical Trial After Showing a Sustained Benefit from Deep Brain Stimulation in Early Parkinson's DiseaseNov. 17, 2016 - A 30-patient randomized study of patients with early Parkinson's disease found that individuals who had deep brain stimulation had better motor scores five years later, compared to those who only had medical treatment. The pilot study was presented in October at the annual meeting of the American Neurological Association. The researchers at Vanderbilt University said they are now pursuing funding for an FDA-approved Phase 3 clinical trial of 280 patients at 18 centers. (Neurology Today) Study Investigates Non-Invasive Peripheral Nerve Stimulation in Veterans with Post-Traumatic Stress DisorderNov. 17, 2016 - Compared to sham stimulation, combat veterans with post-traumatic stress disorder showed improvements in autonomic nervous system electrophysiological measures and in the emotionally-modulated startle response following non-invasive peripheral nerve stimulation, researchers reported in an abstract at the Society for Neuroscience Annual Meeting. (Psychiatry Advisor) Transcranial Direct Current Stimulation Investigated in DepressionNov. 16, 2016 - A researcher described her small pilot study of transcranial direct current stimulation (tDCS) on depressed pregnant women who do not want to take antidepressants. At the University of Kansas, another researcher received $70,000 in funding to use brain imaging to compare the effects of tDCS on 40 subjects, half of whom have depression. (PBS) Researcher Targets Brain Structures with Overlapping Non-Invasive StimulationNov. 15, 2016 - A researcher presented early studies in healthy subjects to use non-invasive brain stimulation to target the hippocampi as a potential treatment for Alzheimer's disease. Imaging showed increased localized brain activity as a result of the stimulation. He also plans to target areas involved in depression and addiction. The stimulation involves using overlapping high-frequency stimulation that only exerts a physiological effect where the fields overlap and result in a lower-frequency stimulation. (New Scientist) Researchers Seek an "Ideal Bioelectronic Interface"Nov. 15, 2016 - An article described research into printing microelectronics on hydrogels as potential future brain-machine interfaces. (SPIE) Retrospective Review Analyzes Post-Surgical Complications of Deep Brain StimulationNov. 5, 2016 - A review of 650 cases in which Parkinson's disease patients underwent deep brain stimulation provides data that "can be used as an adjunct for short-term risk stratification" when patients are considered for the therapy, the authors state. (World Neurosurgery) Researchers Explore a Hydrogel for Optogenetics ApplicationsNov. 15, 2016 - Researchers at MIT and Harvard Medical School are working on a biocompatible, stretchable material with potential applications in optogenetics, according to an MIT news release. (Medica Magazine) Spinal Cord Stimulation System Receives Approval for Full-Body, Conditional, MRI ScansNov. 14, 2016 - St. Jude Medical has received FDA approval for conditional full-body MRI using its spinal cord stimulation system that was approved in November 2015. (Fierce Biotech) Company Demonstrates a Robotic Transcranial Magnetic Stimulation SystemNov. 14, 2016 - During the Medica 2016 trade show currently taking place in Germany, the ICube spinoff Axilum Robotics presented a robotic transcranial magnetic stimulation system intended for precision and repeatability in treatments of patients with chronic pain and other conditions. (Medical Plastics News) Investigators Say Spinal Cord Stimulation Improved Gait in Patients with Advanced Parkinson's DiseaseNov. 10, 2016 - An article says that four patients who had advanced Parkinson's disease and had had deep brain stimulation experienced improved gait after spinal cord stimulation. (Movement Disorders) Reviewers Examine Possible Mechanisms in Deep Brain Stimulation for Obsessive Compulsive DisorderNov. 9, 2016 - In a review, authors interested in the role of deep brain stimulation to the subthalamic nucleus for obsessive compulsive disorder say this target "has a coordinating role in decision-making and action-selection mechanisms" and they believe the treatment helps to normalize the disturbed circuit activity seen in the condition. (European Neuropsychopharmacology) Column Describes Reimbursement Issues in Pre-Approved, Off-Label Deep Brain StimulationNov. 7, 2016 - A viewpoint article raises the issue of third-party payers, including federal insurance providers, not reimbursing pre-approved off-label use of deep brain stimulation for severe, medication-refractory neurological and psychiatric disorders such as Tourette syndrome and obsessive compulsive disorder. (JAMA Neurology) Brain-Machine Interface Study: Sensorimotor Plasticity Connected to Phantom Limb PainNov. 4, 2016 - International Neuromodulation Society members Koichi Hosomi, MD, PhD; Haruhiko Kishima, MD, PhD; and Youchi Saitoh, MD, PhD and colleagues co-authored an article in Nature Communications, "Induced sensorimotor brain plasticity controls pain in phantom limb patients" The article describes phantom limb pain observed when study subjects used a brain-machine interface to move a robotic hand. When the interface used sensorimotor signals representing the missing limb, the pain increased -- perhaps due to the lack of sensory feedback, the authors commented. (Clinical Pain Advisor) Patient with Locked-In Syndrome Uses Brain-Machine Interface to TypeNov. 12, 2016 - Researchers in Utrecht reported in the New England Journal of Medicine that they have demonstrated a brain-computer interface that allowed an ALS patient who has no voluntary movement except for her eyes to use cortical brain signals to slowly spell words using typing software. The interface responds to her imagining she is moving her hand. A member of the team said the implant provides a way to communicate immediate needs. He added that she had been avoiding going outdoors because the eye-tracker she uses to communicate must be re-calibrated in different light conditions. (The Seattle Times) U.S. Army Veterans to Participate in a Clinical Trial of Non-Invasive Vagus Nerve Stimulation for Pain and Related SymptomsNov. 10, 2016 - Researchers in New York plan to undertake a randomized clinical trial of 40 veterans of the 1990 - 1991 Gulf War who have widespread pain and migraines. The study, funded by a $703,200 medical research grant from the U.S. Army, will investigate the use of non-invasive vagus nerve stimulation to treat their symptoms. (Newswise) Article Covers High-Frequency Spinal Cord Stimulation Clinical Trial ResultsNov. 9, 2016 - International Neuromodulation Society members Leonardo Kapural, MD, PhD, and Kiran Patel, MD, were quoted in an article about a recently published study of high-frequency spinal cord stimulation. (UPI) Preclinical Study Demonstrates a Neuroprosthetic that Overcomes a Partial Spinal LesionNov. 9, 2016 - An international research team reported in a letter to Nature that they had demonstrated two monkeys the capability of restoring movement to a lower limb through dual electrode interfaces at the brain's motor cortex and the lower spinal cord. With the neuroprosthetic implant, the research subjects regained the ability to walk following a spinal lesion that paralyzed one leg. (Seeker) Newly Public Device Company Reports Quarterly EarningsNov. 9, 2016 - Nuvectra Corporation announced a 196.3% increase in revenue in the third quarter of 2016, compared to the third quarter of 2015, related to a deep brain stimulation development agreement with Aleva Neurotherapeutics and commercial launch of Nuvectra's spinal cord stimulation system. The revenue of $3.8 million for the third quarter of 2016 was offset by operating expenses of $11.1 million. The company said the costs reflect its investment in a sales and marketing team and increased headcount after becoming a publicly traded company. (Globe Newswire) Authors Review Deep Brain Stimulation in Psychiatric ConditionsNov. 8, 2016 - A journal article says relative safety and efficacy of deep brain stimulation has become more widely accepted, adding that investigations into its use in psychiatric disorders "suggest moderate benefit in many cases and remain encouraging." (Psychiatric Annals) Device-Maker Raises Equity FundsNov. 8, 2016 - An SEC filing shows that Inspire Medical Systems, which developed and produces a sleep-apnea implant, raised $12.5 million in equity financing. (Mass Device) Non-invasive Brain Stimulation Improved Study Participants' Ability to Multi-taskNov.8, 2016 - A controlled study of 20 Air Force personnel found that transcranial direct current stimulation increased working memory when they undertook a test that required them to multitask. The authors think the stimulation may help with attention and vigilance. (International Business Times) Company's MRI-Conditional Leads Enter Use in CanadaNov. 8, 2016 - Medtronic Canada announced the first patients had been implanted with its spinal cord stimulation leads that are licensed for full-body MRIs under specified conditions. The announcement noted the leads have been approved by the regulatory body Health Canada. (Newswire) Scotland Centre for Deep Brain Stimulation is DelayedNov. 8, 2016 - The BBC reports that a specialty center to provide deep brain stimulation for movement disorder patients in the north and east of Scotland is delayed and not expected to open until the spring after final equipment and staffing arrangements are made. (BBC News) First U.K. Implant Announced in a Clinical Trial of a Retinal ProsthesisNov. 7, 2016 - The first retinitis pigmentosa patient in the U.K. received an implanted retinal prosthesis in a clinical trial by the device company Pixium Vision. (Mass Device) Article Profiles Participant in a Clinical Trial of Deep Brain Stimulation for Alzheimer's DiseaseNov. 4, 2016 - A Canadian woman who is participating in a clinical trial of deep brain stimulation in Alzheimer's disease describes her experience in an article that mentions the search for 97 more participants to enter the third phase of the clinical trial. Results of the second phase, published in September, showed a trend toward a benefit in patients above age 65. The clinical trial investigates stimulation of the fornix as a potential intervention for mild Alzheimer's disease. (CBS News) Study Examines Repetitive Transcranial Magnetic Stimulation in Phantom Limb PainNov. 3, 2016 - A randomized controlled clinical study of 54 patients with phantom limb pain following traumatic limb loss from land mine explosions indicated that repetitive transcranial magnetic stimulation produced better results than sham over the two-week treatment period, but the effects faded by 30 days post-treatment. The study author commented that in other pain disorders, periodic maintenance stimulation treatments have been safe and effective for sustaining benefit. (Pain Medicine News) Company Announces Medicare Payment Decisions for Its Retinal ProsthesisNov. 2, 2016 - Second Sight Medical announced that in 2017 its retinal prosthesis will have a new Medicare implantation payment rate and billing codes for programming or reprogramming. (Mass Device) Patient Organization to Present Talk on Deep Brain StimulationNov. 2, 2016 - International Neuromodulation Society member David VanSickle, MD, discussed changing guidelines of when to consider deep brain stimulation for Parkinson's disease in an article announcing an upcoming presentation organized by the Parkinson's Association of the Rockies. (Steamboat Today) Report Sees Growing Role for Deep Brain StimulationNov. 2, 2016 - A market report predicts that by the end of the year 2021, deep brain stimulation will represent almost 20% of the market share for neurostimulation devices. (Business Wire) Laboratory Device May Enable Neurostimulation Implants to Also Administer Chemical AgentsNov. 2, 2016 - A research team has demonstrated the capability of delivering neurotransmitters at nearly the same rate as neurons. An article says this technology could be coupled with deep brain stimulation to provide chemical treatment in addition to electrical stimulation in conditions such as epilepsy. (IEEE Spectrum) Single-Center Study Showed One-Year Benefit from Occipital Nerve Stimulation in Chronic MigraineOct. 28, 2016 - International Neuromodulation Society member Nagy Mekhail, MD, PhD, and colleagues published a single-center study in Pain Practice showing occipital nerve stimulation (ONS) reduced the frequency, and/or intensity, of chronic migraine. The study included 20 patients who were followed for 12 months. All patients received ONS for the final 40 weeks. In the first 12 weeks, half were randomized to a control group that did not receive active stimulation during that time. (Doctors Lounge) Journal Publishes Comparative Clinical Study of Spinal Cord Stimulation Frequency ModesOct. 28, 2016 - The November issue of Neurosurgery carries two-year results of a multi-center study comparing spinal cord stimulation using either conventional stimulation or high-frequency stimulation. (EurekAlert) Column Cites Neuromodulation As One Part of the Solution to an Opioid EpidemicOct. 27, 2016 - International Neuromodulation Society member Peter Staats, MD, authored a blog about combating the opioid epidemic. He states, "Many times, there are interventional therapies that physicians could and should employ before a patient ever swallows his first pill." He continues to say that neuromodulation options such as spinal cord stimulation have been around for decades and "are proven effective at decreasing pain and opiate use while improving function." (Huffington Post) Brain-Computer Interface Under Development to Provide Positional Sensing for HandOct. 26, 2016 - Researchers at the University of Washington are studying how to provide cortical stimulation to allow study subjects to sense the position of their hand and its grasp. (Newswire) Prosthetics Allow Users to Sense and Control the Pressure of Their GripOct. 26, 2016 - Two volunteers who use a prosthetic hand have been able to use a system that includes pressure sensors to detect and control the amount of pressure they exert, helping them to perform tasks. (Medical Xpress) Review Looks at Role of Sacral NeuromodulationOct. 26, 2016 - Sacral neuromodulation continues to have a role in managing overactive bladder patients, authors of a review conclude, despite the rate of adverse events and long-term cost equivalence to botulinum toxin A. They add that the indications are "continuously expanding". (Dove Press) First Patient Receives Visual Cortex Prosthetic ImplantOct. 25, 2016 - Second Sight Medical announced its first patient was implanted with a visual cortical prosthesis to restore some vision to blind patients. The system will include a camera and glasses. The company hopes to win approval for an initial clinical trial of the complete system. Previously, Second Sight developed a retinal prosthesis. This later device bypasses the optic nerve entirely. (Mass Device) Article Summarizes Neuromodulation Approaches to Headache DisordersOctober 2016 - An opinion piece summarizes recent findings in neuromodulation for headache disorders and possible mechanisms of action. (U.S. Neurology) Brain-Computer Interface Delivers Sense of Touch Via Robotic HandOct. 13, 2016 - A volunteer who is paralyzed from the chest down was able to identify fingers of a robotic hand through a brain-computer interface when each finger was individually touched. The work was reported in Science Translational Medicine. (DARPA) News Report Addresses Access to Sacral Neuromodulation in Wales for Fecal IncontinenceOct. 24, 2016 - A BBC radio program focuses on disparities in access to sacral neuromodulation in Wales, compared to England or Scotland, for fecal incontinence. (BBC Radio) Preliminary Results Reported of Vagus Nerve Stimulation in Crohn's DiseaseOct. 24, 2016 - An article presents preliminary results of vagus nerve stimulation in Crohn's disease. Results in six patients, presented at the United European Gastroenterology Week, showed reduced signs of excessive inflammation in the gut. Full results of the 20-patient study at four centers in Europe are expected next year. The article says a placebo-controlled study is planned. (Daily Mail) Clinical Study Investigates Phrenic Nerve Stimulation for Central Sleep Apnea in Heart Failure PatientsOct. 24, 2016 - In a pilot study, 46 heart failure patients with central sleep apnea showed improvement in sleep parameters and cardiac endpoints after undergoing one year of transvenous phrenic nerve stimulation. The implant regularized breathing by stimulating contraction of the diaphragm, (Heart Health) New Brain Region Implicated in the Exercise of Self-ControlOct. 19, 2016 - Brain-stimulation studies reported in Science Advances suggest new possibilities for therapeutic interventions for self-control deficits in disorders like addiction and obesity. A research team showed activity of the temporo-parietal junction allowed study subjects to resist an impulsive choice and make decisions based on their own future needs. The researchers explained they believe that, in addition to the prefrontal cortex, this area is important in the self-control involved in delayed gratification. (Medical Xpress) Company Reports Double-Digit Growth in Neuromodulation SalesOct. 19, 2016 - St. Jude Medical reported in its third-quarter earnings report that neuromodulation sales increased 17% compared to the same quarter one year ago. Overall net sales were up approximately 2% compared to the third quarter of 2015. (Mass Device) Clinical Data Presented About Vagus Nerve Stimulation in an Inflammatory ConditionOct. 19, 2016 - SetPoint Medical presented data on eight Crohn's disease patients who had received vagus nerve stimulation implants in an open-label trial. After 16 weeks, the company said that six patients had improved so that their Crohn's Disease Activity Index dropped at least 70 points (a score higher than 450 is severe). Three of those patients also reached remission based on endoscopic findings that their bowel lining had renormalized. The investigational treatment is intended to address the body's inflammatory reflex. (Fierce Biotech) Doctors Plan to Publish a Case Involving Deep Brain Stimulation Successfully Treating Status EplieplicusOct. 19, 2016 - Physicians in Taipei are submitting a case report for publication concerning a 17-year-old girl who received a deep brain stimulation (DBS) implant targeting the anterior thalamic nucleus because she had developed status epilepticus. They said to their knowledge, this is the first case of DBS being used to successfully treat the serious and potentially life-threatening condition. (Taipei Times) Funding Agency Describes the Scope of Its Neuromodulation-Related FundingOct. 18, 2016 - The National Institutes of Health announced its third round of grants for the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) initiative. The more than $70 million brings the agency's fiscal 2016 investments to about $150 million. The most recent grants, a spokesman said, involve more projects that are based at least in part on human data. The nine funding categories include neuromodulation and related technologies. For instance, both invasive and non-invasive devices are covered, and new concepts, technologies, and optimization of large-scale recording and modulation, in addition to research for understanding neural circuits. (Healio) Study Targets Chronic MigraineOct. 17, 2016 - Pain Medicine News reports that a sham-controlled clinical trial of 59 patients with chronic migraine, published in Neurology, showed noninvasive vagus nerve stimulation was safe, tolerable, and potentially effective. (Pain Medicine News) Newer Spinal Cord Stimulation Implants Have Begun in the U.K.Oct. 17, 2016 - International Neuromodulation Society member Nigel Kellow, MD, was quoted in an article about a back-pain patient who received a newer spinal cord stimulator. The article covered her treatment and the device features. (Daily Mail) Grant Will Help Fund Deep Brain Stimulation Cross-Over Trial in Parkinson's DiseaseOct. 17, 2016 - The University of Alabama at Birmingham announced a $7.3 million, five-year grant from the U.S. BRAIN Initiative to undertake a cross-over study of deep brain stimulation using directional current for patients with Parkinson's disease. The researchers are also studying cortical activation patterns, through electroencephalography, to see if that could help improve programming. (Newswire) Optogenetics Project May Explain Processes in NeuroplasticityOct. 17, 2016 - Collaborators will use a $1.4 million, three-year grant from the U.S. National Institute of Mental Health to examine processes in learning and memory using ontogenetic tools. Specifically, they will analyze protein activity in neurons during synaptic and behavioral plasticity. (Max Planck Florida Institute for Neuroscience) "Large Scale Recording and Modulation" Among Research Areas to Receive Federal FundingOct. 15, 2016 - The National Institutes of Health announced more than $150 million in funding that includes grants for research projects to develop ways to record brain activity, analyze data to diagnose conditions such as Alzheimer's disease, and improve deep brain stimulation for disorders that include stroke, Parkinson’s disease, and obsessive compulsive disorder. The funding represents the third round of grants to support the goals of the Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative. (Pharmabiz) Grant Will Fund Clinical Study of Deep Brain Stimulation in Stroke RehabilitationOct. 13, 2016 - International Neuromodulation Society member Andre Machado, MD, PhD received nearly $5 million from the National Institutes of Health's BRAIN Initiative (Brain Research through Advancing Innovative Neurotechnologies) to start a clinical trial building upon his preclinical research into deep brain stimulation as a possible therapy to aid motor recovery during rehabilitation following stroke. (Cleveland Business) Collaborators Receive a Grant to Pursue Closed-Loop Deep Brain Stimulation for Obsessive Compulsive DisorderOct. 13, 2016 - Collaborators at the Baylor College of Medicine, Brown University, and the University of Pittsburgh received a grant from the National Institutes of Health's BRAIN Initiative (Brain Research through Advancing Innovative Neurotechnologies) of $1.5 million annually for five years to develop new deep brain stimulation (DBS) technology to help treat treatment-resistant obsessive compulsive disorder. The collaborators are seeking to create an adaptive stimulation mode that responds to the patient's changing clinical needs. They said they would like to use a closed-loop approach similar to what exists for epilepsy. They proposed a pilot study of 10 subjects. The first five would receive a DBS system that targets the ventral striatum and can both stimulate and record activity. The project also involves training a computer to recognize patient moods as programming is adjusted. (Baylor College of Medicine) Grants Announced for Peripheral Nerve Stimulation ResearchOct. 13, 2016 - International Neuromodulation Society members Jeffrey Ardell, PhD and Jiande Chen, PhD, were among researchers highlighted in an article about $20 million in funding from the National Institute's of Health that was announced last week. The funding dividing among 27 research teams supports various lines of research into peripheral nerve stimulation therapies. (IEEE Spectrum) Researchers: Microelectrode Array Allows Man with Tetraplegia to Sense Fingers of Prosthetic ArmOct. 13, 2016 - Researchers published in Science Translational Medicine about adding the sense of touch to a prosthetic limb. (Live Science) FDA Approval for Deep Brain Stimulation System AnnouncedOct. 6, 2016 - St. Jude Medical announced that its deep brain stimulation system with directional leads received FDA approval for the treatment of Parkinson's disease and essential tremor. The system received CE mark approval in September 2015 and was subsequently launched in Europe in June. (Mass Device) Company Describes a Growing Receptiveness to Drug-Free Pain InterventionsOct. 5, 2016 - SPR Therapeutics followed up on the July 27, 2016 announcement of FDA approval for its peripheral nerve stimulation system for post-traumatic and post-operative pain with a announcement about neurostimulation emerging as an alternative to opioid analgesics. (Market Wired) Study Compares Treatments for Urinary Urge Incontinence Using Sacral Neuromodulation or Botulinum ToxinOct. 5, 2016 - In a comparative study of 350 women with persistent urgency urinary incontinence, onabotulinumtoxinA conferred small improvements compared to sacral neuromodulation (SNM), but also significant adverse effects over the 6-month study period. The number of daily incontinence episodes dropped by 3.9 for the onabotulinumtoxinA group and 3.3 for the SNM group. However, 35% of the patients treated with onabotulinumtoxinA had urinary tract infections vs. 11% of the SNM patients. Also 20% of the onabotulinumtoxinA patients required intermittent self-catherization. (NEJM Journal Watch) Company Announces FDA Approval for New Mode of Spinal Cord StimulationOct. 4, 2016 - St. Jude Medical announced the FDA has approved its burst form of spinal cord stimulation for chronic pain relief. (Business Wire) Company Plans Pivotal Trial for Implanted Anti-Hypertension DeviceOct. 3, 2016 - Valencia Technologies announced the FDA granted an Investigational Device Exemption for a clinical trial of its implanted median nerve stimulator for hypertension. The company said it plans to enroll 300 patients in a multicenter study. Patients who have been taking at least three hypertension drugs will receive six months of neurostimulation. They will be evaluated for ambulatory and clinic blood pressure. (Fierce Biotech) Grant Supports Research in Neurostimulation for Spinal Cord Injury RehabilitationSept. 30, 2016 - The New York State Department of Health gave a $4.27 million grant to a medical researcher at the City College of New York, who is pursuing a project to translate spinal-cord injury rehabilitation findings from preclinical animal models to humans. The approach involves special patterns of combined brain and cervical spinal cord stimulation to promote repair of residual nerve circuits to hand muscles. (City University of New York) Grant Will Fund Brain-Stimulation Research for Parkinson's DiseaseSept. 27, 2016 - The University of Minnesota is receiving a $9.07 million grant over five years from the National Institute of Health for its research into Parkinson's disease, including deep brain stimulation to the palladium and effects on brain circuitry. (Life Science Daily) Study Indicates How Stimulation Activates Other Brain RegionsSept. 26, 2016 - A computational study of eight research subjects' brain activity recorded in diffusion spectrum imaging showed how stimulation of 83 different areas affected activation of other regions and large-scale activity within the brain, providing insight into different potential therapeutic approaches for neurological or psychiatric disorders. (The Science Explorer) Grant Supports Research in Neurostimulation for Spinal Cord Injury RehabilitationSept. 30, 2016 - The New York State Department of Health gave a $4.27 million grant to a medical researcher at the City College of New York, who is pursuing a project to translate spinal-cord injury rehabilitation findings from preclinical animal models to humans. The approach involves special patterns of combined brain and cervical spinal cord stimulation to promote repair of residual nerve circuits to hand muscles. (City University of New York) Grant Will Fund Brain-Stimulation Research for Parkinson's DiseaseSept. 27, 2016 - The University of Minnesota is receiving a $9.07 million grant over five years from the National Institute of Health for its research into Parkinson's disease, including deep brain stimulation to the palladium and effects on brain circuitry. (Life Science Daily) Study Indicates How Stimulation Activates Other Brain RegionsSept. 26, 2016 - A computational study of eight research subjects' brain activity recorded in diffusion spectrum imaging showed how stimulation of 83 different areas affected activation of other regions and large-scale activity within the brain, providing insight into different potential therapeutic approaches for neurological or psychiatric disorders. (The Science Explorer) Study Examines Deep Brain Stimulation in Traumatic Brain InjurySept. 22, 2016 - International Neuromodulation Society member Ali Rezai, MD, was quoted in an article about research into deep brain stimulation as therapy for traumatic brain injury (TBI), which he said causes 80,000 new cases of disability a year. The journal Neurosurgery published an open-label prospective study by Rezai and colleagues of four TBI patients who had problems with behavioral control and emotional self-regulation and were treated with deep brain stimulation to the nucleus accumbens and anterior limb of the internal capsule to modulate the prefrontal cortex. All participants had improved outcomes, the researchers reported, mainly in "behavioral and emotional adjustment, which in turn improved functional independence." (Philly.com) Company Targeting Low-Back Pain Issues Half-Year ReportSept. 22, 2017 - Mainstay Medical International plc announced publication of its half-year report for the period ended June 30, 20176. The company had $42.8 million cash on hand and operating expenses of $8.0 million. This increase reflected expansion of the team, preparation for its clinical trial of its neurostimulator for chronic low back pain, and preparation for commercial launch. The launch is being concentrated for now in Germany, where a direct sales force has been recruited and initial customers have been trained. (Business Wire) Israeli Startup Raises Money for Its Migraine PatchSept. 20, 2016 - Theranica Bio-Electronics closed a round of seed financing for an undisclosed amount. The Israeli company is developing wearable electrical stimulation patches to treat migraine. (Pharmweb) Article Presents Recent Neuromodulation Therapies for PainSept. 20, 2016 - An overview of advances in pain medicine has sections on developments in neurostimulation an intrathecal drug delivery. (Yahoo! News) Device Company Announces European Patent for Its Vagal Nerve StimulatorSept. 20, 2016 - EnteroMedics Inc. announced issuance of a European patent for its implantable vagus nerve stimulation system that was developed to treat obesity and metabolic diseases. (Scibility Media) Back Pain Neurostimulator One-Year Results AnnouncedSept. 20, 2016 - Mainstay Medical International plc announced positive one-year follow-up results for 41 patients who completed 12 months in its single-arm clinical trial of a neurostimulation device for chronic low back pain. The device received CE mark in May 2016 and the clinical trial continues to enroll patients for a post-market clinical follow-up for safety and performance data. (Business Wire) Study: Continuous Sub-threshold Cortical Stimulation Reduced Seizure Rate in Epilepsy PatientsSept. 19, 2016 - Researchers report in JAMA Neurology that a majority of 13 epilepsy patients who had continuous sub-threshold cortical stimulation had a reduction in seizures of at least 50 percent. The patients were offered this investigational treatment when temporary stimulation during evaluation provided a clinical benefit. None of the patients were suitable for resection surgery. (Newswire) Brain Stimulation to Aid Investigation into Motor Control and RehabilitationSept. 19, 2016 - A researcher studying motor control to gain knowledge to aid rehabilitation plans to use transcranial magnetic stimulation when subjects are using an exoskeleton. He would like to understand what parts of planned arm movement involve the cortical level of the brain, and which involve the peripheral nervous system. (UC Merced) Review Examines Epidural Spinal Cord Stimulation in Spinal Cord Injury RehabilitationSept. 19, 2016 - A review summarizes current research on epidural spinal cord stimulation in restoring some function to select spinal cord injury patients. The authors conclude further research is warranted, including potentially the "development of dedicated technological hardware and software." (Journal of Neurorestoratology) Grant Supports Work on Blood-Pressure NeurostimulatorSept. 19, 2016 - Researchers at the National Institutes of Health received a $440,670 grant for research of a "Closed-Loop Blood Pressure Control by Neural Stimulation for Cardiac Care Environment." Their device would stimulate the sciatic nerve or its branches, using a flexible micro-channel electrode array and implanted catheter-based blood-pressure sensor. (Medical Xpress) Collaborators Pursue a Predictive Capability for Spinal Cord Stimulator ProgrammingSept. 19, 2016 - A predictive algorithm for programming spinal cord stimulation in pain patients was validated retrospectively in 12 patients, and is set to enter a prospective clinical trial of about 30 patients, according to an article that follows up on a presentation at the 2016 Neural Interfaces Conference by International Neuromodulation Society member Warren Grill, PhD. Grill collaborated on the work with INS member Shivanand Lad, MD, PhD and engineers. The article includes comments by INS President Timothy Deer, MD, on the importance of translational research. (Pain Medicine News) Article Chronicles Essential Tremor Patient's Start of Deep Brain Stimulation TherapySept. 18, 2016 - An article about a woman whose benign essential tremor was treated by deep brain stimulation quotes International Neuromodulation Society member Stuart Goodman, MD, her neurosurgeon. The patient, 68, said she only recently heard about the therapy in an advertisement at a movie theater and did an online search to find someone for a consultation in her area. (Billings Gazette) Company Plans Brain Stimulation Clinical Trial for Stroke, Announces Financing DealSept. 15, 2016 - Nexstim Plc announced it is finalizing plans with the FDA for a multicenter pivotal clinical trial of repetitive transcranial magnetic stimulation following stroke. The company expects the clinical trial, which is being designed to include a sham comparator, will start in 2017. Nextstim also announced a financing agreement with Bracknor Investment to convert €20,000 of its convertible loan into 51,633 shares at €0.387345 each. (Globe Newswire) Article: A Shorter Delay between Chronic Pain Diagnosis and Spinal Cord Stimulation Treatment May Increase Chances of Lasting EfficacySept. 15, 2016 - Neuro News reports that an article published earlier this year in Neuromodulation: Technology at the Neural Interface suggests "a shorter delay time from chronic pain diagnosis to spinal cord stimulation implantation may make it more likely to achieve lasting therapeutic efficacy with spinal cord stimulation." (Neuro News) Patient Describes Treatment with Dorsal Root Ganglion Stimulation at New Jersey FacilitySept. 14, 2016 - International Neuromodulation Society member Antonios Mammis, MD, was interviewed in a television segment about a patient who was one of the first in a Newark, New Jersey medical center to receive dorsal root ganglion stimulation for lower limb pain. The patient, a former dancer who had chronic foot pain, commented that he feels like he was able to "just get some kind of life back" after receiving the treatment. (FIOS 1) Columnist Gives Overview of Depression Treatments, Including NeuromodulationSept. 14, 2016 - An article about non-medical treatments for depression mentions several current or investigational neuromodulation approaches; transcranial magnetic stimulation; vagus nerve stimulation, and deep brain stimulation. (Troy Media) First Patient is Enrolled for Clinical Trial of Neurostimulator for Chronic Lower Back PainSept. 14, 2016 - Mainstay Medical International plc announced the first subject with chronic lower back pain has been enrolled in Australia for its clinical trial of a neurostimulator that is designed to electrically stimulate the nerves responsible for contracting muscles that stabilize the lumbar spine. (Business Wire) Medical Device Portfolio Company with Deep Brain Stimulation Technology Files for Public OfferingSept. 12, 2016 - Nexeon MedSystems Inc. of Lexington, KY recently filed a registration statement to become publicly traded. The company is seeking FDA approval for a rechargeable deep brain stimulation system for Parkinson's disease. (Med City News) Article Looks Back at Teen-aged Dystonia Patient's First Year After Deep Brain StimulationSept. 12, 2016 - The Denver Post reports on a dystonia patient who received a deep brain stimulation system a year ago at the age of 17. His family says that plus physical therapy have resulted in improved functional abilities. (Denver Post) Cluster Headache Treatment Guidelines Include NeuromodulationSept. 11, 2016 - Two types of neuromodulation were included in new guidelines for cluster headache treatment. Sphenopalatine ganglion stimulation in chronic cluster headache was added to the guidelines of the American Headache Society with a Level B recommendation indicating it is "probably effective," based on a single Class I study in 28 patients. A Level B recommendation was also given to deep brain stimulation in this indication. Neither treatment is available in the U.S., the authors pointed out. The guidelines update 2010 guidelines endorsed by the American Academy of Neurology. (Medpage Today) Project Aims to Tailor Deep Brain Stimulation TreatmentSept. 9, 2016 - An article says that prototypes of a deep brain stimulation (DBS) targeting tool are under clinical evaluation, as a four-year project comes to an end that combines pre- and post-operative imaging data (MRI, X-ray), high-resolution electrical recordings of the patient’s brain activity and bio-statistical data about DBS target areas. (CORDIS) Paper Reports Advantages of New Electrical Stimulation Therapy for Post-Stroke Hand RehabilitationSept. 8, 2016 - A clinical trial of 80 stroke survivors published in Stroke shows that a new form of electrical stimulation therapy can restore some dexterity to a hand that's been paralyzed by stroke. A sensor-laden glove on the patient's good hand sends signals to stimulators attached to the paralyzed hand, prompting muscles there to simulate movements of the functioning hand while the patient imagines using both hands. (UPI) Study: Episodic Cluster Headache Patients Responded More to Non-invasive Vagus Nerve Stimulation Than to Sham TreatmentSept. 4, 2016 - A sham-controlled study of non-invasive vagus nerve stimulation for the treatment of cluster headache, published in the journal Headache, showed that more patients who had episodic cluster headache responded to stimulation than to sham treatment, but not more patients who have chronic cluster headache. (Headache) Peripheral Nerve Stimulator Receives CE MarkSept. 7, 2016 - BlueWind Medical announced its has received CE mark approval for its neurostimulator to treat peripheral neuropathic pain. The device is implanted on the tibial nerve and powered by a control unit worn on the ankle. The company said patients select stimulation for up to eight hour a day, with pain reduction typically lasting for 30 minutes to a few hours afterwards. (PR Newswire) Researchers: Transcranial Magnetic Stimulation Selectively Affects Other Brain RegionsSept. 7, 2016 - Researchers published a study they said shows that when transcranial magnetic stimulation is applied to one area of the brain, it selectively alters communication between distant brain regions. They say they believe the effect occurs by changing the timing of local neural operations. (University of Queensland) Company Announces Peripheral Neuralgia TreatmentsSept. 7, 2016 - Bioness, Inc. announced a series of implantations of its peripheral nerve stimulation system to treat peripheral neuralgias. The company said there is a specific focus on these areas or conditions: axillary nerve (e.g. post-stroke shoulder pain); ulnar nerve (e.g. cubital tunnel syndrome); ilioinguinal (e.g. post-surgical hernia complication); superior cluneal nerve (e.g. lower back neuralgia). (PR Newswire) Long-Term Results Published in Prospective, Randomized Clinical Trial That Compares Spinal Cord Stimulation TherapiesSept. 6, 2016 - Nevro Corp. announced that long-term data were published in Neurosurgery from its prospective, randomized clinical trial that compares high-frequency and traditional spinal cord stimulation in patients with chronic back and leg pain. Based on data from 156 subjects who were assessed at 24 months, secondary outcomes were reported that included the percentage of subjects who responded for leg pain, the percent of pain relief for back and leg pain, and the disability level over the follow-up period. (Street Insider) Study: Phrenic Nerve Stimulation Improved Central Sleep ApneaSept. 1, 2016 - A study of 151 patients with central sleep apnea showed benefits from a transvenous phrenic nerve stimulator, according to a news release about the publication in The Lancet. The device was developed by Respicardia, Mass Device reported. (Mass Device) Company Announces Success Among Neurostimulator's "Early Adapters"Aug. 29, 2016 - Stimwave LLC announced it has "achieved long-term success" in the early adapter rollout of its neurostimulator to address chronic pain. The first patients were treated in 2015 for back and leg pain. In March 2016 the FDA approved uses for peripheral neuropathic pain as well. (Business Wire)
Robotic Surgical Assistant to be Exhibited at September Neurosurgical EventsAug. 29, 2016 - Medtech announced it will exhibit its surgical assistance robot at three meetings for stereotactic neurosurgeons during September. The robot was developed for use in deep brain stimulation implantation procedures and other brain and spine surgeries. (Globe Newswire) News Outlet Offers Overview of One Medical Device Company's ActivitiesAug. 25, 2016 - A news feature about the Alfred Mann Foundation describes its work in neurostimulation for functional restoration and other research programs. (Globes) Deep Brain Stimulation Improved Function of Patients With Chronic Traumatic Brain InjuriesAug. 23, 2016 - International Neuromodulation Society member Ali Rezai, MD, discusses a clinical trial of deep brain stimulation to the nucleus accumbens in which all four traumatic brain injury patients in the study showed improved cognitive and motor functions, at least six years after their injuries. Three of the four also had improved disability scales. (Medical Design and Outsourcing) Researchers Report Occipital Nerve Stimulation Aided Migraine SufferersAug. 22, 2016 - In a single-arm study from the U.K., more than 40% of 53 chronic migraine sufferers who received bilateral occipital nerve stimulation implants between 2007 and 2013 showed long-term improvements, with at least 30% fewer headache days. Pain intensity was also reduced. (Clinical Pain Advisor)
Authors Review Deep Brain Stimulation in Tourette SyndromeSeptember 2016 - A review about deep brain stimulation (DBS) in Tourette syndrome summarizes the outcomes of DBS at different targets, explores possible mechanisms of action, and the potential of adaptive DBS. The authors also address future challenges faced in designing optimized trials. (Brain Sciences)
Review Notes Deep Brain Stimulation Could Offer a Therapy Alternative for Alzheimer's DiseaseAug. 19, 2016 - A review discusses deep brain stimulation as a potential therapeutic strategy that aims to restore brain activity in Alzheimer's disease. It also notes the importance of hippocampal damage in brain diseases such as Parkinson's disease, Pick disease, frontotemporal dementia, Down syndrome and Alzheimer's, disease. The authors also touch upon the limbic formation as a promising neuroanatomical target for cognitive deficit restoration. (Current Alzheimer Research) National Health Service Proposed Cuts May Eliminate Local Spinal Cord Stimulation ServicesAug. 10, 2016 - A "Fit for the Future" National Health Service initiative that aims to close a projected £14million deficit means that in the region of the Basildon and Brentwood Clinical Commissioning Group outside London, "patients who need hip and spinal injections, spinal cord stimulation or facet joint injections could be referred to NHS centres outside the area or forced to seek private treatment." (Yellow Ad)
Drug Company's Venture Arm Sees Promise in NeuromodulationAug. 18, 2016 - A question-and-answer column about neuromodulation investments by the venture arm of Johnson & Johnson discusses potential indications in heart failure. In it, an executive describes the company's anticipation that neuromodulation therapies could address unmet needs in the company's areas of interest, such as "epilepsy, pain, Parkinson’s disease, sleep apnea, as well as many other chronic disease and conditions not well managed by drugs or that are drug resistant." (Med City News)
Article Says Neuromodulation is a Growth Area for CompanyAug. 18, 2016 - An article says Boston Scientific Corporation registered 12% growth in the second quarter of 2016, compared to the same quarter one year ago, which was up from its growth of about 8% in the first quarter of 2016. The article calls spinal cord stimulators a key growth area for the company's neuromodulation business, and deep brain stimulation a potential market. (Market Realist)
Brain Recordings Document the Importance of the Striatum in Parkinson's DiseaseAug. 18, 2016 - A research team recorded activity in the striatum of patients who received deep brain stimulation for Parkinson's disease, essential tremor, or dystonia. They found firing spikes in striatal projection neurons in the patients with Parkinson's disease, underscoring the role of this brain structure in the condition. (Parkinson's News Today)
Peripheral Nerve Stimulation System to Be Presented at Military Health SymposiumAug. 16, 2016 - SPR® Therapeutics planned to present recent clinical findings concerning its peripheral nerve stimulation system for acute and chronic pain control at the 2016 Military Health System Research Symposium in Florida. (Market Wired)
Researchers Report That Paraplegic Patients Achieved Gains in 12 Months of Multi-Modal TherapyAug. 11, 2016 - A research team reports that 12 months of immersive therapy, including virtual-reality sessions and use of a brain-machine interface and exoskeletons, led to half of eight paraplegic patients being upgraded to an incomplete paraplegia definition. All the patients showed improved ability to perceive touch and position. Patients gained some voluntary muscle control, which paralleled reemergence of lower limb imagery at a cortical level. (Scientific Reports)
Case Report: Spinal Cord Stimulation Helped Woman with a Painful Peripheral Vascular DisorderAug. 9, 2016 - A case report details how an 80-year-old woman with lower limb pain from the rare peripheral vascular disorder erythromelalgia achieved excellent pain control through spinal cord stimulation, with relief maintained at 18 months post-implant. (Regional Anesthesia & Pain Medicine)
Column Looks Beyond Opioids in the Management of Chronic PainAug. 12, 2016 - International Neuromodulation Society member Richard Vaglienti, MD, is among physicians whose views were sought for a column about the U.S. Centers for Disease Control and Prevention's March 2016 guidelines regarding opioids and chronic pain, "Beyond oral opioids — Spinal cord stimulators, targeted drug delivery & the future of pain management." (Becker's Spine Review)
Neurosurgeons Use Neurostimulators to Help Comatose Patients in Poland Regain ConsciousnessAug. 12, 2016 - International Neuromodulation Society members Wojciech Maksymowicz, MD, PhD, and Isao Morita, MD, were featured in an article about implanting spinal cord stimulation systems in the cervical column to help comatose patients regain consciousness. Dr. Maksymowicz performed the procedure on four patients since May in Poland, with oversight from Dr. Morita, who initiated the procedure a number of years ago in Japan. (Sputnik News)
Dutch Researchers to Study Cortical Stimulation for Central Lobe EpilepsyAug. 10, 2016 - Researchers in the Netherlands have received €100,000 from the Dutch Epilepsy Fund to study cortical stimulation as treatment of central lobe epilepsy for the next four years. The researchers say medication works poorly for this type of epilepsy and surgery is not recommended due to the risk of non-reversible paralysis. (UMC Utrecht)
Journal Announces Brain Stimulation Award to Pioneering ResearcherAug. 10, 2016 - A medical physicist who was among the first to report the clinical demonstration of transcranial magnetic stimulation, in 1985, has received the first International Brain Stimulation Award from the journal Brain Stimulation: Basic, Translational and Clinical Research in Neuromodulation. (PR Newswire)
Study: Repetitive Transcranial Magnetic Stimulation Shows Promise for Treating Phantom Limb PainAug. 10, 2016 - In a placebo-controlled study of 54 amputees with phantom limb pain, a 10-day course of 20-minute sessions with repetitive transcranial magnetic stimulation to the motor cortex contralateral to the amputated leg resulted in pain reduction for up to 15 days after treatment. (News-medical.net)
Healthcare Columnist Features Spinal Cord StimulationAug. 10, 2016 - In a question-and-answer column, a health reporter cites comments from an interventional pain physician in answering the question, "Is a spinal cord stimulator for back pain something new, and is it something to try instead of surgery or pain pills?" (The News-Gazette)
Mote-sized Implants Developed for Bioelectronic Medicine ApplicationsAug. 3, 2016 - Researchers reported in Neuron they have developed implantable grain-sized, batteryless sensors they call "neural dust" that might be used to control prosthetics, treat disorders such as epilepsy, stimulate the immune system, or tamp down inflammation. The devices are powered and read by ultrasound. (UC Berkeley)
Deep Brain Stimulation Software Earns CE Mark
August 9, 2016 - Medtronic’s SureTune2™ deep brain stimulation software has received CE Mark approval in Europe. The software offers patient-specific visualization of anatomy, physiology and stimulation field — information physicians can use to configure patients' stimulation settings. (Fierce Biotech)
Article Highlights Alternatives to Opioids for Chronic Pain TreatmentAugust 5, 2016 - A recent article published in Nature emphasizes the need to look beyond opioids for the management of chronic pain. International Neuromodulation Society Members, Drs. Marc Russo, and Charles Brooker, share their insights on utilizing early interventions for acute and chronic pain, and applying non-opioid therapies, such as spinal cord stimulation, earlier in the treatment continuum. They note that new technologies rapidly are becoming available and have the potential to further refine the management of chronic pain. (Nature)
Study: Use of Non-Invasive Vagus Nerve Stimulation for Chronic Migraine
August 3, 2016 - International Neuromodulation Society Member, Joel Saper, MD, and colleagues reported the findings of their randomized pilot study of non-invasive vagus nerve stimulation (nVNS) for the treatment of chronic migraine (CM) in the online version of Neurology. In the study of 59 patients, the researchers observed, “Therapy with nVNS was well-tolerated with no safety issues. Persistent prophylactic use may reduce the number of headache days in CM; larger sham-controlled studies are needed.” (Neurology Today) Mechanisms of Vagus Nerve Stimulation for Rheumatoid Arthritis Identified in Study
August 3, 2016 - In a study published in the Proceedings of the National Academy of Sciences (PNAS), researchers from the University of Amsterdam, the Feinstein Institute for Medical Research, and SetPoint Medical, reported that stimulating the vagus nerve with an implanted neuro-stimulator reduced levels of tumor necrosis factor, other cytokines and inflammation in 17 patients with rheumatoid arthritis (RA) refractory to conventional therapies. They concluded that this understanding of the mechanism by which vagus nerve stimulation (VNS) activates the immune system to selectively block the production of inflammatory proteins will inform further research on the application of VNS for the treatment of RA and other cytokine-mediated autoimmune disorders. (Healio)
Device Developer Merges with Device Component Manufacturer
August 1, 2016 - Cirtec Medical, LLC, a provider of outsourced medical device design, engineering and manufacturing, has acquired Stellar Technologies, Inc., a component and assembly manufacturer, to expand their offerings, specifically in the neuromodulation device market. (Business Wire) Study Shows Promise for Treating Traumatic Brain Injury with Deep Brain Stimulation
August 1, 2016 - In an article published in the journal Neurosurgery, International Neuromodulation Society Member, Ali Rezai, MD, and colleagues at The Ohio State University, report five-year results of their study on four patients with traumatic brain injury, using bilateral deep brain stimulation of the nucleus accumbens and anterior limb of the internal capsule to modulate the prefrontal cortex. All four patients, who had impairments in executive function prior to the therapy, showed improvement in “behavioral and functional adjustment, which in turn improved functional independence.” (Neurosurgery; The Columbia Dispatch) Pharmaceutical Company Teams with Tech Giant to Develop Bioelectronic Medicines
August 1, 2016 - GlaxoSmithKline PLC has entered a partnership with Verily Life Sciences LLC (formerly known as Google Life Sciences), a part of Alphabet, Inc., to establish Galvani Bioelectronics to “enable the research, development and commercialisation of bioelectronic medicines.” The companies could invest up to £540 million over seven years if certain milestones are met, and will test clinical applications of targeted electrical stimulation for chronic endocrine, inflammatory and metabolic disorders. (The Wall Street Journal) Study Finds Non-Invasive Stimulation During Sleep May Enhance Memory
July 29, 2016 - In an article in Current Biology, Researchers at the University of North Carolina School of Medicine report the findings of their study in which transcranial alternating current stimulation (tACS) was applied to 16 healthy patients to selectively enhance sleep spindle activity during sleep. Lead author Caroline Lustenberger, PhD, stated in a press release, "We're excited about this because we know sleep spindles, along with memory formation, are impaired in a number of disorders, such as schizophrenia and Alzheimer's. We hope that targeting these sleep spindles could be a new type of treatment for memory impairment and cognitive deficits.” (Nature World News) Sacral Nerve Stimulation System Receives Conditional MRI Labeling in Europe
July 29, 2016 - Axonics® Modulation Technologies’ Sacral Neuromodulation (SNM) System, which received a CE Mark for the treatment of urinary and fecal dysfunction in June, has has been granted magnetic resonance imaging (MRI) conditional labeling approval in Europe. This labeling allows patients who are implanted with this device to undergo head and neck MRI scans with 1.5 Tesla and 3 Tesla systems. (Yahoo Finance) FDA Clears Peripheral Nerve Stimulation System
July 29, 2016 - The Sprint™ peripheral nerve stimulator from SPR® Therapeutics has received 510(k) approval from the FDA for the treatment of chronic and acute pain, including post-traumatic injury and post-operative pain. (Mass Device) Neuromodulation Business Acquires Radiofrequency Device Company
July 28, 2016 - Boston Scientific has acquired Cosman Medical, a company specializing in radiofrequency devices for the treatment of chronic pain and neurological disorders. Cosman Medical’s systems will fall under Boston Scientific’s neuromodulation business. (FierceBiotech) FDA Issues Guidance on Adaptive Design for Device Research
July 27, 2016 - The FDA issued its final Guidance for Industry on adaptive design clinical trials for drugs and biologics stating, “Adaptive design, when properly implemented, can reduce resource requirements, decrease time to study completion, and/or increase the chance of study success.” (U.S. Food and Drug Administration) Analysis Finds Deep Brain Stimulation for Early Motor Symptoms of Parkinson's Disease is Cost-EffectiveJuly 21, 2016 - International Neuromodulation Society members Paul Eldridge, MD and Rod Taylor, PhD and colleagues co-authored an analysis of the cost-effectiveness, over a 15-year time frame, of deep brain stimulation (DBS) for Parkinson's disease with early motor complications. They conclude that DBS is cost-effective compared to existing interventions, and offers additional health benefits at acceptable incremental cost. (PLoS ONE) Review Finds Some Effect of Transcranial Magnetic Stimulation on Food CravingJuly 19, 2016 - A review of 11 studies of noninvasive brain stimulation of the dorsolateral prefrontal cortex indicated that repetitive transcranial magnetic stimulation (rTNS) has a significant, moderate effect on food cravings. Studies that looked at actual food consumption had results that, while inconsistent, did suggest a possible effect on the intake of carbohydrates through treatment with rTMS. By contrast, studies did not show a significant effect of transcranial direct current stimulation on food cravings. (EurekAlert) Writer Speaks Out About Use of Noninvasive Brain Stimulation for Anxiety and DepressionJuly 19, 2016 - A guest columnist describes using cranial electrotherapy stimulation to help with his anxiety for the past six years. He supports viewing electrical stimulation of the brain as a good alternative for many people, especially those who have not responded to other therapies. (Scientific American) Article: Repetitive Transcranial Magnetic Stimulation to Be Available Now in NigeriaJuly 19, 2016 - An article describes repetitive transcranial magnetic stimulation (rTMS) services coming to Nigeria. The article included comments by physicians who appreciated the chance to add to existing treatment options for mental health conditions and pointed out the technology also has applications for diagnostic purposes and motor recovery following strike, pain and seizure. The article said previously in Africa, rTMS was only available in South Africa and Egypt. The article characterized the extent of unmet need, saying 20 to 40% of patients are resistant to pharmacological antidepressant treatments while another 33% show poor response. (All Africa) Study: Tau Protein Moves Through Extra-Cellular SpaceJuly 18, 2016 - Researchers working with a mouse model of Alzheimer's disease found that increased neuronal activity enhances the propagation and pathology of the tau protein responsible for the disease. The senior author said the findings suggest that investigative treatments for the disease that increase brain activity should be monitored carefully. (EurkeAlert) Company to Seek Approval for Its Device to Treat Dry EyeJuly 18, 2016 - Allergan announced it is applying for FDA approval of a handheld intranasal neuromodulation device to stimulate tear production in people who have dry eye disease due to decreased tear production. (MPR) Company Releases Second Version of Its External Neurostimulator for Episodic MigraineJuly 18, 2016 - Cefaly Technology is releasing the next version of its external trigeminal nerve stimulation device for the prevention of frequent episodic migraine attacks. The Cefaly® II device is available in the U.S. and will be available next in Europe in September. (PR Newswire) Study: Combined Limb and Brain Stimulation Aided Functional RecoveryJuly 14, 2016 - Researchers in Helsinki published a proof-of-principle study in which transcranial magnetic stimulation, synchronized to electrical peripheral nerve stimulation, helped two patients with partial spinal cord injuries regain some voluntary muscle control after six months. (UPI) Review Assesses Evidence for Spinal Cord Stimulation in Chronic PainJuly 14, 2016 - International Neuromodulation Society member Paul Verrills, MD, and co-authors have prepared a review concerning spinal cord stimulation (SCS) for chronic pain. The review in the Journal of Pain Research states, "A number of variables have been identified that can affect SCS efficacy: implanter experience, appropriate patient selection, etiologies of patient pain, existence of comorbidities, including psychiatric illness, smoking status, and delay to SCS implant following pain onset." It concludes that SCS is a safe, effective, and drug-free treatment for many types of chronic pain. (MD Magazine) Study: Deep Brain Stimulation Parameters for Parkinson's Disease Might be Tuned Via Phasic BurstsJuly 14, 2016 - A team of researchers created a computer model that predicts that delivering deep brain stimulation in bursts at select phases of brain oscillation may be most efficient. Their paper, "Phasic Burst Stimulation: A Closed-Loop Approach to Tuning Deep Brain Stimulation Parameters for Parkinson’s Disease," was published in PLoS Computational Biology. (Medical Xpress) Company Eyes $21.5 Million Acquisition of Non-invasive Neurostimulation Development FirmJuly 11, 2016 - Endonovo Therapeutics, Inc. announced it intends to acquire Rio Grande Neurosciences, Inc. for $21.5 million following execution of a definitive purchase agreement, shareholder approvals, and raising more capital. Privately held Rio Grande Neurosciences develops non-invasive technology for the treatment of neuro-inflammation and central nervous system diseases and disorders. The company's devices include an FDA-cleared device for treating pain and edema, a proprietary multi-coil repetitive transcranial magnetic stimulation system with pending 510(k) application, which is currently being adapted for the treatment of neuro-inflammatory conditions, including traumatic brain injury, acute concussion, post concussion syndrome and multiple sclerosis; and targeted pulsed electromagnetic field therapy for the treatment of post surgical neuroinflammation. The deal is expected to be completed by Sept. 30 and entails $15 million in Endonovo common stock, $5 million in Endonovo warrants and $1.5 million in cash. (Fierce Biotech) U.K. Hospital Lauded For Its Dedicated Outpatient Neurostimulation ServiceJuly 11, 2016 - Lynn’s Queen Elizabeth Hospital's Brancaster Outpatients Unit has been awarded a Centre of Excellence for its high standard of care in a dedicated clinical room used for percutaneous tibial nerve stimulation services for treatment of voiding conditions. (Lynn News) Heart Failure Company Says Device Had Neuromodulatory Effect and Will Investigate Modifying Its DevelopmentJuly 11, 2016 - Sunshine Heart announced its device to augment cardiac function will focus on neuromodulation via baroreceptors rather than its originally envisioned approach of counterpulsation to reduce left-ventricle load in heart failure patients. A clinical trial had shown that the counterpulsation device on the ascending aorta was activating baroreceptors, so the observed positive effect had a neuromodulatory basis. The new approach may be more cost-effective to develop, the company said, in describing anticipated upcoming studies, which start with a current physician-led five-patient study of the device looking at sympathetic nerve activity. (Mass Device) Article Describes a Deep Brain Stimulation ProcedureJuly 8, 2016 - A reporter observes deep brain stimulation surgery on a Parkinson's disease patient, performed by International Neuromodulation Society member Ali Rezai, MD, in Ohio. (Columbus Business First) Company Raises Funds for Commercialization of Sleep Apnea NeurostimulatorJuly 7, 2016 - Nyxoah, of Israel and Belgium, raised €18 million ($20 million) for development of its neurostimulation system for obstructive sleep apnea. Its implant is powered by a disposable patch placed on the patient's skin. (Fierce Biotech) Feasibility Study Looks at Using Neurostimulation to Limit Knee-Replacement PainJune 29, 2016 - The potential of neurostimulation in perioperative pain control was described in a presentation of a five-patient prospective feasibility study of ultrasound-guided percutaneous peripheral nerve stimulation following primary unilateral total knee arthroplasty. (Anesthesiology News) Neurostimulation Company to Be Tracked in a Fund IndexJune 28, 2016 - The neurostimulation company Nuvectra Corporation was added June 24 to the Russell Microcap® Index. Membership in the index lasts for one year. Indexes are used for investment or benchmarking purposes by fund managers. (Nasdaq) Developer of Noninvasive Brain Stimulation Technology Announces a PatentJune 28, 2016 - Nexstim Plc announced it received a U.S. patent for its way of estimating motor threshold when delivering transcranial magnetic stimulation to targets below the cortex. The method involves a scan of 60 - 90 seconds combined with an electromyography measurement. (Nasdaq) Review Assesses Emerging Therapies That Use Autonomic Nervous System StimulationJune 28, 2016 - A review looks at vagus nerve stimulation in heart failure and obesity, and concludes that results may be improved through advanced stimulation delivery, with most findings from animal studies still to be shown in clinical investigations. (Journal of Neural Engineering) Clinician Anticipates the Start of a Clinical Trial of Deep Brain Stimulation for Stroke RecoveryJune 28, 2016 - International Neuromodulation Society member Andre Machado, MD, PhD, is quoted in an article about an upcoming clinical study of deep brain stimulation after ischemic stroke. It is hoped the brain stimulation will augment physical training by increasing neuroplasticity. (Time) Report: Adding Motor Cortex Stimulation May Deter Tolerance to Spinal Cord StimulationMay/June 2016 - A case report describes the effect of dual stimulation in a woman with complex regional pain syndrome whose response to spinal cord stimulation decreased. She received an additional motor cortex implant that was connected to the same pulse generator. The two targets were stimulated in cycling mode with independent parameters. The authors say their encouraging results suggest motor cortex stimulation may be an add-on possible rescue therapy in managing this pain condition. (Pain Physician) Column Highlights Emerging Medical Technologies, Including NeuromodulationJune 26, 2016 - Of six medical technologies a news column calls "worth watching," two involve neuromodulation. One is a collaboration with Battelle involving International Neuromodulation Society member Ali Rezai, MD, to use a device to bypass a damaged spinal cord and send brain signals directly to a paralyzed limb to allow a spinal-cord injury patient to regain some use of his hand. Another is SetPoint Medical's work on a small neuromodulation implant to potentially treat inflammatory conditions such as rheumatoid arthritis and Crohn's disease. (Wall Street Journal) University of Toronto Researchers Work on Overactive Bladder DeviceJune 24, 2016 - International Neuromodulation Society member Magdy Hassouna, MD, PhD, is helping design and conduct clinical trials of peripheral nerve-stimulation technology, developed at the University of Toronto, to potentially treat overactive bladder. The device developers recently received a commercialization grant. (U of T Engineering News) Article Details Operation of a Neurostimulator to Treat Cluster HeadacheJune 24, 2016 - An article describes how sphenopalatine ganglion stimulators are being implanted in some cluster headache sufferers at two U.K. centers. (Daily Mail) Company Announces Presentation of Small Study of Neurostimulator to Augment Gait Therapy in Multiple SclerosisJune 24, 2016 - A six-person study presented at the 2016 Annual Meeting of the Consortium of Multiple Sclerosis Centers was subject to a news release by Helius Medical Technologies. The study involved use of the company's noninvasive portable nerve stimulation system, PoNS, in combination with physical training. At the end of the trial, the company said, all patients could be considered improved, with those who had better functional status at the start making the most gains. (Mass Device) Researchers Present Studies of Vagus Nerve Stimulation in HeadacheJune 24, 2016 - New Jersey-based electroCore LLC issued a news release summarizing three clinical studies and two preclinical studies regarding the mode of action of noninvasive vagus nerve stimulation in primary headache. The studies were presented at the annual meeting of the American Headache Society. (BioSpace) Paper Explores Patients' Expectations for Deep Brain StimulationJune 23, 2016 - A review looks at the experience of 116 patients with advanced Parkinson's disease, and nine spouses, and their expectations before and after initiating treatment with deep brain stimulation. (BMJ Open) Clinicians Complete a Meta-Analysis Comparing Two Deep Brain Stimulation Targets in Parkinson's DiseaseJune 22, 2016 - A meta-analysis of 13 studies comprising 1,148 patients with Parkinson's disease compared deep brain stimulation that targeted the subthalamic nucleus or the globus pallidus internus to treat advanced Parkinson's disease. (Neuropsychiatric Disease and Treatment) Paper Reviews Evidence of Combined Use of Antipsychotic Medication and Electrical Brain Stimulation in SchizophreniaJune 20, 2016 - A review of treatment for medication-refractory schizophrenia explores the evidence from published literature concerning co-administration of electrical brain stimulation, such as repetitive transcranial magnetic stimulation or transcranial direct current stimulation, with the antipsychotic clozapine. (Expert Review of Clinical Pharmacology) Clinicians Launch Study of Rechargeable Neurostimulator for Overactive BladderJune 20, 2016 - Axonics Modulation Technologies, Inc. announced its small, rechargeable sacral nerve stimulation system has been implanted in the first patients as part of a post-market follow-up study in overactive bladder. The study is being conducted in England, Belgium, the Netherlands and France. (Business Wire) Concerns Raised About U.S. Insurers' Classification of High Frequency Spinal Cord StimulationJune 20, 2016 - International Neuromodulation Society (INS) member David Provenzano, MD mentions a randomized controlled clinical trial by INS member Leonardo Kapural, MD, PhD and colleagues in remarks published in an article about letters written by the American Society of Regional Anesthesia (ASRA) to Blue Cross Blue Shield of Tennessee and Highmark Blue Cross Blue Shield of Pennsylvania regarding classification of high-frequency spinal cord stimulation (SCS) for chronic pain. In an April 2016 medical policy, the insurers classified this type of SCS, which is approved by the FDA, to be experimental and investigational. The letters say beneficiaries should be provided access to this "evidence-based therapy when deemed medically necessary." ASRA pointed out the importance of patient access to non-drug options for chronic pain in light of the U.S. opioid epidemic. (News-medical.net) Company Targeting Heart Failure Raises FundsJune 18, 2016 - CVRx has raised $46 million for development of its potential heart-failure intervention, an implantable neurostimulator that targets the baroreflex to restore autonomic balance through lowering sympathetic activity and raising parasympathetic activity. A pivotal clinical trial involving 310 patients is expected to conclude in September 2017. (Med City News) Article Describes Pain Relief From Injectable, Wireless NeurostimulatorJune 18, 2016 - Coverage of a pilot study of a wireless neurostimulator for pain relief describes how it can be injected into the epidural space, or into "clusters of spinal nerves." (The pilot study concerned dorsal root ganglion stimulation.) (Daily Mail) Research Suggests Relieving Neuropathic Pain by Lowering a Brain Circuit's Theta OscillationsJune 17, 2016 - An article summarizes research into deep brain stimulation for central pain syndrome and says the authors hypothesize that relief may be obtained through tailoring deep brain stimulation frequencies to suppress theta oscillations in the thalamus and the periventricular gray/periaqueductal gray. Dysrhythmia and alterations of burst firing in the thalamus have been associated with neuropathic pain. During the dysrhythmia, theta oscillations trigger cortical dysfunction, leading to dysfunction of the thalamocortical circuit, which causes neuropathic pain. (Neurology Advisor) Company Developing Neurostimulator for Low Back Pain Raises FundsJune 17, 2016 - Mainstay Medical has raised €30 million through placing shares that represent roughly one-third of all the company's shares. As part of the placement, KCK, a family investment group, is taking ownership of half the shares. The company is addressing certain types of lower back pain through commercialization of an implantable device that stimulates nerves to strengthen muscles that stabilize the lower back. (Irish Times) Company Launches a Deep Brain Stimulation System in EuropeJune 16, 2016 - St. Jude Medical has launched a deep brain stimulation system in Europe that has stimulation leads designed to steer current. The system also allows commercial handheld wireless devices to be used as controllers by patients and physicians. (Mass Device) Startup's Tibial Nerve Stimulator Receives CE MarkJune 15, 2016 - BlueWind Medical received CE mark approval for a wirelessly powered tibial nerve stimulator to treat overactive bladder. (Fierce Medical Devices) Grant Will Help Support Clinical Trial of Brain Stimulation to Augment Stroke RecoveryJune 15, 2016 - Soterix Medical, Inc. announced the company has received a $2.5 million grant from the National Institute of Neurological Disorders and Stroke to support a Phase II clinical trial of non-invasive brain stimulation for post-stroke aphasia. The company plans to test transcranial direct current nerve stimulation as an adjunctive treatment for aphasia patients. Stimulation will be individualized based on functional MRI results. (Business Wire) Clinicians Use Proprioceptive Stimulation to Reduce Apnea of PrematurityJune 15, 2016 - Physicians who placed vibratory devices on the hand and foot of premature babies to stimulate limb movement say it encouraged reflexive breathing. They called it a low-cost neuromodulataory way to reduce apnea that is common at less than 34 weeks gestation. (PLoS ONE) International Neuromodulation Society Member Gives Video Interview about the Emergence of Deep Brain Stimulation TherapyJune 14, 2016 - International Neuromodulation Society member Ali Rezai, MD, is interviewed about the emergence, and basic concepts, of deep brain stimulation in a science-column video. (Huffington Post) Startup Raises Funds for Development of Closed-Loop Deep Brain StimulationJune 15, 2016 - The Italian startup Newronika has raised €1.7 million in venture financing to help support development of an adaptive, closed-loop, deep brain stimulation system for Parkinson's disease. The company spun out of the Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico in Milan and Università degli Studi di Milano. (FINSMES) Case Report: Sacral Nerve Stimulation Aids Patient Despite Her Partial Sacral Nerve ResectionJune 13, 2016 - Authors of a case report published in Neuromodulation: Technology at the Neural Interface describe treating a woman who developed urinary retention after cancer surgery removed part of her sacral nerve. They report the woman's voiding symptoms resolved following implantation of a sacral nerve stimulation system. (Uro Today) Inventor Award Recognizes Clinical Application of Deep Brain Stimulation for Movement DisorderJune 13, 2016 - French neurosurgeon Alim-Louis Benabid received a 2016 European Inventor Award from the European Patent Office for bringing into clinical practice the application of high-frequency deep brain stimulation help control motor symptoms of movement disorders such as Parkinson's disease. (Quartz) Researchers in Iran Pursue Development of Deep-Brain-Stimulation ElectrodesJune 14, 2016 - Researchers in Iran have been working for two years to develop deep brain stimulation electrodes. In March, they implanted the electrodes in monkeys after tests in mice. The electrodes might eventually be used to treat Parkinson's disease and possibly addiction, according to an interview with one of the researchers. (MEHR News Agency) Headache Meeting Poster Summarizes Interim Analysis of Neurostimulation Data in Cluster HeadacheJune 11, 2016 - An interim analysis of registry data concerning a neurostimulation device for cluster headaches was presented in a poster session at the 58th Annual Scientific Meeting of the American Headache Society. Sphenopalatine ganglion stimulation received CE mark for cluster headache in 2012. A post-market registry study showed that 68% of 85 patients with the device experienced either 50% fewer cluster headache attacks or decreased symptoms in at least half of their attacks, or both. The population also had a 52% reduction in acute medication usage. (PR Newswire) Review Explores Safety of Sacral Nerve Stimulation During PregnancyJune 10, 2016 - International Neuromodulation Society member Tariq Al-Shaiji, MD and colleagues reviewed literature related to sacral nerve modulation and related modes of neuromodulation during pregnancy. Based on case reports and studies reported in animals, they conclude there were no significant reports of negative effects on the fetus, mother, or device. They say hypothesized effects have limited its use although women of childbearing age and pregnant women constitute a fair number of sufferers of overactive bladder and nonobstructive urinary retention. They add that expanded data may move the therapy toward being considered safe during pregnancy. (Neuromodulation: Technology at the Neural Interface) Article Profiles Drugmaker's Bioelectronics PushJune 10, 2016 - An article summarizing an interview by Bloomberg says GlaxoSmithKline plans three clinical trials that combine drugs and other companies' electrical stimulation devices, and aims to develop an implant of its own in 2019. The article said the company's overall investment would be "on par" with the amount that is often seen quoted for "molecular" medicines, that is, in the billions of dollars. It adds that determining how to modulate individual neurons will be a challenge, but it is hoped that ensuing generations of devices can be modified slightly to treat other diseases, making those versions less costly to produce than a medication. The company is limiting its focus to systems that treat the peripheral nervous system. (Mass Device) Study Documents Treatment Effects of Hypglossal Nerve Stimulation in Obstructive Sleep ApneaJune 10, 2016 - An abstract from the University of Pennsylvania about hypoglossal nerve stimulation system indicates the device yields similar outcomes in a general clinical population with obstructive sleep apnea as it did in a controlled clinical study prior to its approval in 2014. The neurostimulation treatment received approval for individuals who have moderate-to-severe obstructive sleep apnea and cannot tolerate using a continuous positive airway pressure (CPAP) system. The abstract, being presented at the 30th annual meeting of the Associated Professional Sleep Societies LLC, concerns results from 20 patients who received the implant between January 2015 and March 2016. (Medical Xpress) Review: Non-invasive Brain Stimulation May Benefit Patients with Deficiencies in Emotional RegulationJune 10, 2016 - A review article summarizes research into the influence of repetitive transcranial magnetic stimulation or transcranial direct current stimulation on emotional regulation and decision making. (Neuropsychiatric Electrophysiology) Physicians Describe Relieving Pelvic Neuropathy with Combined Sacral and Pudendal Nerve StimulationJune 9, 2016 - International Neuromodulation Society member Thierry Vancaillie, MD, a clinical professor and gynecologist in Australia, co-authored a case report about a woman with a complex pelvic neuropathy. Her diagnoses included interstitial cystitis and persistent genital arousal disorder. The symptoms responded to an intervention that combined decompression of the pudendal nerves along with implantation of a sacral and pudendal nerve neuromodulation device. (BMJ Case Reports) Article Recounts Emergence of Noninvasive Electrical Brain Stimulation Methods for Psychiatric ConditionsJune 2, 2016 - An article about the future psychiatric potential of noninvasive brain stimulation for some conditions in some patients describes two emerging electrical-based therapies, external trigeminal nerve stimulation, and transcutaneous vagus nerve stimulation. (Psychiatric News) Article Features Company's Work on a Neurostimulator for Post-Amputation PainMay 26, 2016 - An article profiles development by Neuros Medical of emerging electrical devices to block post-amputation pain. (Tech Ohio) Company Prices Public Offering of Convertible Senior NotesJune 8, 2016 - Nevro Corp. announced its public offering of convertible senior notes will pay an interest rate of 1.75% a year. In addition, the company revised the amount it expected to raise from $125 million to $150 million. (Mass Device) TV Segment Features Transcranial Magnetic Stimulation Treatment for DepressionJune 1, 2016 - News coverage of transcranial magnetic stimulation for depression calls the therapy "a sort of depression fighting helmet" and features one patient describing how she has benefited from the treatment. (KING5) Device Company Announces Upcoming Financing RoundJune 7, 2016 - Nevro Corp. announced it plans to offer $125 million in convertible senior notes to support repayment of a term loan agreement, general corporate purposes, and continued commercialization of its high-frequency spinal cord stimulation system. (Mass Device) Researchers Pursue a Clinical Trial of Noninvasive Brain Stimulation in DepressionJune 6, 2016 - The Black Dog Institute in Australia is recruiting patients for a clinical trial of transcranial direct current stimulation in depression. (Newsmaker) Rechargeable Sacral Nerve Stimulation System Receives CE MarkJune 6, 2016 - Axonics Modulation Technologies, Inc. announced it has received CE mark approval for its rechargeable sacral nerve stimulation (SNS) system. The system is designed to treat overactive bladder, urinary retention, and fecal incontinence. The company also announced publication of a study in Neurology and Urodynamics in April that modeled comparative costs of a rechargeable SNS system versus a non-rechargeable one. (Mass Device) Visual Prosthetics Company Raises $19.4 MillionJune 1, 2016 - Second Sight Medical Products, Inc. said it netted about $19.4 million in a rights offering that was oversubscribed. The company will use the proceeds on the research and development of its visual prosthetics. (Business Wire) Company Plans Reorganization of Unit That Includes NeuromodulationJune 1, 2016 - Medtronic said its restorative therapies group, which includes neuromodulation, posted a 1% gain over the previous year. This was the smallest growth margin of the company's four divisions. The restorative therapies group will be reorganized into a general-manager model and the focus will shift to diseases and conditions over technology. The company will focus its pain stimulation strategies toward the opioid epidemic. (Twin Cities Business) Researcher Reports That the Rate of Sudden Unexpected Death in Epilepsy is Lower After Vagus Nerve StimulationMay 30, 2016 - At the 2nd Congress of the European Academy of Neurology, a researcher from Switzerland presented an analysis of 24 years of data from the U.S. concerning vagus nerve stimulation (VNS) in epilepsy. The results suggest that patients who received VNS had a reduced risk of sudden unexpected death in epilepsy. (Medscape) Newscast Features Research Interest in Potentially Treating Psychiatric Conditions with Brain StimulationMay 27, 2016 - A newscast describes interest in using brain stimulation for psychiatric conditions, including depression and post-traumatic stress disorder. (CNBC) Researchers Summarize Findings Concerning Brain Stimulation in Huntington's DiseaseMay 27, 2016 - International Neuromodulation Society members Jan Vesper, MD, PhD, and Lars Wojtecki, MD, and colleagues have published a review about brain stimulation in Huntington's disease that considers cortical excitability and plasticity in the disease and the potential therapeutic role of non-invasive or invasive brain stimulation methods. (Neurodegenerative Disease Management) Review Presents Genetic Variations that May Contribute to Differing Responses to Brain StimulationMay 26, 2016 - A review looks into research concerning combinations of genotypes that have been reported to interact with effects of brain stimulation. An expert commentary says that understanding the genetic factors affecting the heterogenous nature of patients' response to brain stimulation might help with selection of treatment candidates. (Expert Review of Neurotherapeutics) Scientists Model Nerve Stimulation to Examine Safety CriteriaMay 25, 2016 - A research paper about computer modeling of electromagnetic nerve stimulation concludes that a combined approach of accounting for realistic anatomies and neuronal dynamics offers value in establishing safety criteria. (Physics in Medicine and Biology) Company Receives CE Mark Approval for Neurostimulation Device Targeting Back PainMay 25, 2016 - Mainstay Medical International plc announced it has received CE mark approval for its implantable neurostimulation system to treat disabling chronic low back pain. The company plans a commercial launch in Germany. These plans include conducting a post-market clinical data follow up. A clinical trial in the U.S. may follow. (Business Wire) Texas Company to Work With Pittsburgh Researchers on A Bladder-Control Implant for Spine-Injured PatientsMay 24, 2016 - InCube Labs of San Antonio, TX has been awarded a $10 million subcontract, part of a U.S. Department of Defense contract, to work with the University of Pittsburgh on developing an implant that could improve or restore bladder function in patients who have suffered spinal cord injuries. (My SA) TV Show Publicizes Montreal Clinical Trial of Non-invasive Neurostimulation for Gait RehabilitationMay 23, 2016 - A television news show reports on a clinical trial into a non-invasive neurostimulation device that is applied on the tongue and is being investigated to augment physical therapy for gait in patients who have multiple sclerosis or suffered a traumatic brain injury. The news segment features a former U.S. talk show host and military veteran, Montel Williams. He has multiple sclerosis and became involved with the device's commercialization after having been one of its early study subjects. (CTV Montreal) Article: Vagus Nerve Stimulation Offers Potential Promise in Addressing ObesityMay 21, 2016 - An article published in the United Arab Emirates describes hopes of being able to address obesity through vagus nerve stimulation, calling the concept "tweaking the behaviour of specific organs by remote control." (The National) Academic Team Will Study Non-Invasive Brain Stimulation and Alzheimer's DiseaseMay 21, 2016 - The Fremont (Nebraska) Area Alzheimer’s Collaborative presented early stage research funding to Alzheimer's disease researchers at the University of Nebraska Medical Center. The researchers plan to use non-invasive brain stimulation to explore the role of the hippocampus in memory and cognitive function. (Fremont Tribune) Young Girl Resuscitated After Almost Drowning Will Undergo Deep Brain StimulationMay 20, 2016 - An article published in South Africa tells the story of a 6-year-old who will undergo deep brain stimulation for a movement disorder subsequent to a near-drowning at age 2. (Independent Online) Device Company Announces Launch of MRI-Compatible Spinal Cord Stimulation SystemMay 19, 2016 - Boston Scientific Corporation announced it received FDA approval of its MRI-safe spinal cord stimulation system, which it will launch during the World Institute of Pain annual meeting, taking place May 20 - 23, 2016. The company said the FDA cleared the system for full-body, 1.5 Tesla MRI scans, and that it is designed to deliver multiple waveforms. (Mass Device) Optogenetics Studies Move Beyond Retinal Applications to Potentially Address Pain or Other ConditionsMay 19, 2016 - A news feature describes the start of a safety trial that is investigating an optogenetic intervention to potentially restore some vision to patients who have retinitis pigmentosa, through inducing retinal ganglion cells to produce light-sensitive proteins. Meanwhile, the article notes that preclinical work has begun to potentially use optogenetics to treat pain, via a light-sensitive patch worn on the skin. Other potential indications being considered for an optogenetic intervention include hearing, function of vocal cords, bladder function, and Parkinson's disease and other brain disorders. (Nature) Twins Said to Be the First in Colorado to Receive Deep Brain Stimulation for OCDMay 18, 2016 - International Neuromodulation Society member David VanSickle, MD, PhD, was interviewed in a television newscast about treating what were said to be the first patients in Colorado to receive deep brain stimulation for obsessive compulsive disorder. He said he worked to convince the insurance company to cover the operation for a pair of young adult twin girls who were severely disabled by the condition. The patients said their symptoms have lessened since the treatment. Their story was also featured as a cover article in the Spring 2016 issue of the Littleton Adventist Hospital health magazine. In that article, Dr. VanSickle said the procedure has become "more consistent, faster, much less expensive . . . yet it's highly underutilized as a therapy." (9News.com) Study: Spinal Cord Stimulation Helped Tetraplegic Patients Regain Some Use of Their HandsMay 17, 2016 - A publication reports that cervical spinal cord stimulation and motor training in two patients who had been paralyzed for more than 18 months following severe spinal cord injury allowed them to gain the ability to grasp and hold small objects. By the end of the study, the patients retained some improvement even after the stimulator was turned off. (National Institute of Biomedical Imaging and Bioengineering) Physician Explains Interest in Neurostimulation for Cluster HeadacheMay 16, 2016 - A local T.V. segment focuses on a cluster headache patient in the Washington, D.C. area whose doctor is thinking of enrolling him in a clinical trial of sphenopalatine ganglion stimulation. (WUSA) Researchers Model Effectiveness and Costs of Non-invasive Vagus Nerve Stimulation for Cluster HeadacheMay 16, 2016 - The company electroCore has issued a press release about research published last month showing that non-invasive vagus nerve stimulation for cluster headache is effective and cost-effective, according to scenarios modeled from a German health economy perspective. (PRLog) Review Ponders Vagus Nerve Stimulation for Heart FailureMay 13, 2016 - A review of the INOVATE-HF controlled clinical trial of vagus nerve stimulation concludes that despite intriguing improvements in secondary endpoints, the approach "has to go back to the drawing board." The reviewer cite the lack of significant differences in the main endpoint of death or worsening heart failure, and the occurrence of device complications in almost one out of 10 patients. (NEJM Journal Watch) Paper Calls Vagus Nerve Stimulation in Drug-Resistant Epilepsy a "Viable Alternative"May 12, 2016 - A retrospective study of 20 patients with drug-resistant epilepsy who received a vagus nerve stimulation implant between 2001 and 2010 at two institutions in Turkey calls the treatment a "viable alternative" for patients who have drug-resistant epilepsy or who either could not have epilepsy surgery or did not benefit from it. (Univadis) Review Looks at Incidence and Management of Postdural Puncture Headache After Spinal Cord Stimulator ImplantationMay 12, 2016 - International Neuromodulation Society member Thomas Simopoulos, MD and colleagues found an incidence of 0.81% of postdural puncture headache following implantation of 745 spinal cord stimulation leads at a large academic medical center from 2002 to 2014. The six cases they reviewed all occurred before imaging via contralateral oblique fluoroscopic view entered the practice in 2011. They conclude that with meticulous aseptic technique, managing the puncture with epidural blood patch is safe and efficacious even in the presence of hardware. (Neuromodulation: Technology at the Neural Interface) Electroceutical Startup Raises $8 MillionMay 12, 2016 - An article reports that Silicon Valley startup NeuSpera Medical has raised $8 million in Series A financing for its injectable neuromodulation technology. The company was founded in 2014 as Vivonda Medical, and is targeting applications in electroceuticals, which the article calls "a futuristic field that already has substantial strategic interest." (Fierce Medical Devices) Company Targeting Gastro-esophogeal Reflux Disease Raises $25 MillionMay 12, 2016 - EndoStim, Inc. completed a Series D financing round of $25 million that will go in part toward clinical trials of its neurostimulation therapy for acid reflux. (PE Hub Network) Company Announces Fast-Track Designation from the FDAMay 11, 2016 - Lungpacer Medical received approval to use the FDA expedited access pathway for its diaphragm pacing system. The system provides temporary transcatheter stimulation of the phrenic nerve to aid weaning patients from mechanical ventilation. (Mass Device) Device Maker Releases First-Quarter Financial ReportMay 11, 2016 - Nuvectra Corporation announced first-quarter financial results. The company's total revenue was $2.1 million, up 76% from the same quarter one year ago. Operating expenses were $8.1 million, a 42% increase from one year ago. The company completed its spin-out March 14. The company established a term loan agreement in March. Overall its net loss for the quarter was $0.70 per share, compared to $0.54 per share in the first quarter of 2015. The first commercial implants began in April for its first product, a spinal cord stimulation system. (Nasdaq) Clinicians Present Data on Neuromodulation Device Outcomes for Bladder IndicationsMay 10, 2016 - A summary from a presentation at the American Urological Association's annual meeting reported data from a 5-year projection of comparative costs of percutaneous tribal nerve stimulation (PTNS) versus medical management. The data developed in London, U.K. led to a conclusion that PTNS has a greater overall cost, but is more effective than single or dual drug therapy and therefore provides reasonable value in treating overactive bladder. Another summary from the meeting concerned data from a single Cleveland, Ohio institution where 1,033 sacral neuromodulation procedures had an overall infection rate of 1.8%. In addition, the authors found the rate varied by primary indication. Non-obstructive urinary retention had higher rates, although the reason for this unexpected finding was not explored. (Uro Today) Company's Pain-Relief Device Sales Were Higher Than AnticipatedMay 10, 2016 - First-quarter sales for Nevro Corp. were higher than analysts' forecasts and the company raised its guidance about 2016 anticipated earnings. The company's spinal cord stimulation system received FDA approval last May. (Fierce Medical Devices) Columnist: Are Non-drug Therapies Gaining Favor?May 10, 2016 - A column discusses the total lifetime costs of drug therapies compared to neuromodulation therapy and mentions a recent article http://onlinelibrary.wiley.com/doi/10.1111/ner.12389/abstract in Neuromodulation: Technology at the Neural Interface. (Neurotech Business Report) Researchers Pursue Potential Therapies Based on Vagus Nerve StimulationMay 10, 2016 - An article describes some research in the European Union into advanced vagus nerve stimulation for obesity or inflammation. (Horizon) Urologists Hear Analysis of Sacral Neuromodulation Study DataMay 9, 2016 - A physician who presented clinical research data about sacral neuromodulation at the annual meeting of the American Urological Association said the findings suggest that physicians should probably move to third-line therapies more quickly, after patients have failed just a few medications. The study of 272 subjects was a retrospective sub-analysis of a 5-year prospective study into the use of tined leads. (Urology Times) Pilot Study Will Investigate Hypoglossal Nerve Stimulation in Certain Pediatric Patients Who Have Sleep ApneaMay 9, 2010 - A pilot clinical trial https://clinicaltrials.gov/ct2/show/NCT02344108?term=hypoglossal+nerve+sleep+apnea+down+syndrome&rank=1 of hypoglossal nerve stimulation for sleep apnea has started in pediatric patients with Down syndrome who cannot tolerate wearing continuous positive airway pressure masks at night. (Medical Xpress) Company Plans a Stock Offering to ShareholdersMay 9, 2016 - Second Sight Medical Products, Inc. is offering its shareholders subscription rights to purchase a proportionate amount of additional stock at $4.25 per share or 85% of the Nasdaq closing price by May 31, 2016. The proceeds will be used to fund operations and research, such as development of a cortical visual prosthesis as well as continuing a post-market clinical study of the company's retinal prosthetic for age-related macular degeneration. (Yahoo Finance) Company Targeting Urogenital Indications Announces PatentsMay 9, 2016 - Axonics Modulation Technologies, Inc. announced it received six U.S. patents relating to implantable neuromodulation technology and recharging systems in the past 12 months. The company said its initial clinical application is sacral neuromodulation to treat urinary and fecal dysfunction, which it said affects more than 100 million adults in the U.S. and Europe. (Yahoo Finance) Review: Further Investigation of Potential Neuromodulation Therapies is Warranted in Memory-and-Learning DisordersMay 2016 - A review summarizes cortical-subcortical brain circuits that are important in learning and memory disorders such as Alzheimer's disease. The paper discusses mechanisms such as firing patterns, neural plasticity and neurogenesis, and goes over the current potential neurostimulation targets in those circuits, in addition to other possible therapies. (Journal of Neuroscience) Paper Examines Importance of Total Charge Delivery Over Time in Spinal Cord StimulationMay 6, 2016 - International Neuromodulation Society members Jonathan Miller, MD, Sam Eldabe, MD, Eric Buchser, MD, Lisa Johanek, PhD, Yun Guan, MD, PhD, and Bengt Linderoth MD, PhD published an article about spinal cord stimulation (SCS) that considers the overall rate of charge delivery, in addition to the the programming parameters of pulse width, amplitude, and frequency. The authors say SCS parameters that deliver different amounts of energy through different duty cycles may exert distinct therapeutic effects, such as little or no sensory perception of the stimulation. They say considering total charge delivery over time is a concept that applies to both conventional. tonic SCS and newer forms such as high frequency and burst stimulation. (Neuromodulation: Technology at the Neural Interface) Pain Publication Covers International Neuromodulation Society Journal ArticleMay 6, 2016 - Coverage of an article about spinal cord stimulation and the emotional aspect of pain in Neuromodulation: Technology at the Neural Interface includes a comment from International Neuromodulation Society member Ali Rezai, MD. He said, “Being able to modulate the connections between the brain areas involved in emotions and those linked to sensations may be an important mechanism involved in pain relief linked to spinal cord stimulation.” (National Pain Report) International Neuromodulation Society Member Investigates Potential New Brain Stimulation Target for Bipolar DisorderMay 5, 2016 - International Neuromodulation Society member Jennifer Sweet, MD, is beginning a clinical trial of deep brain stimulation (DBS) in bipolar disorder. In the first phase, in diffusion-weighted imaging of neural connectivity, medication-resistant patients will be compared to patients who respond to medication and to healthy controls. In the second phase, six medication-resistant patients who have abnormal connectivity will be recruited for a randomized, double-blinded pilot study of DBS targeting the rostral dorsal cingulum bundle, which plays a role in cognitive control. (University Hospitals Case Medical Center) Meta-Analysis Summarizes Studies Comparing Deep Brain Stimulation Targets in Parkinson's DiseaseMay 4, 2016 - A review analyzes 16 studies that compare deep brain stimulation (DBS) to the subthalamic nucleus (STN) or the globus pallidus internus (GPi) in Parkinson's disease. The results show STN-DBS was more effective in reducing medication usage and GPi-DBS was more effective in resulting in a higher quality-of-life score. (Scientific Reports) Computer Simulation Suggests Mechanisms Underlying Paresthesia-Free High-Frequency Spinal Cord StimulationMay 4, 2016 - International Neuromodulation Society members Jeffrey Arle, MD, PhD, and Jay Shils, PhD, and colleagues have modeled high-frequency stimulation of dorsal column axons. According to their simulation, high-frequency, paresthesia-free stimulation leads to action potential blockade as hypothesized, preferentially occurring in larger diameter fibers, with recruitment of smaller and medium fibers. The effects arise from ion channel gate and virtual anode dynamics. (Neuromodulation: Technology at the Neural Interface) Ongoing Clinical Trial of Deep Brain Stimulation in Alzheimer's Disease ExplainedMay 4, 2016 - A clinician involved in a study of deep brain stimulation in Alzheimer's disease was interviewed about the ongoing 10-person study to evaluate electrical stimulation of white matter in the ventral capsule of the frontal lobes, a region important in executive function and decision-making. (Medscape Multispecialty) Review: Eligibility for Deep Brain Stimulation in Movement DisordersMay 3, 2016 - International Neuromodulation Society member Christopher Honey, MD, DPhil, and colleagues, published a review on currently available guidance about patient eligibility for deep brain stimulation in Parkinson's disease, tremor, and dystonia. (Canadian Journal of Neurological Sciences) British TV Documentary Shows Tremor Relief from Deep Brain StimulationMay 3, 2016 - The channel ITV will run a documentary of a man whose tremors were treated with deep brain stimulation. The show is part of the series "What Would Be Your Miracle?" about inspirational medical interventions. (Exeter Express & Echo) Former Canadian Radio Host Appears in a Documentary about Deep Brain Stimulation for Parkinson's DiseaseMay 3, 2016 - A former radio announcer with Parkinson's disease is the subject of a documentary about his deep brain stimulation surgery. The film, "The Voice," is debuting at an international documentary film festival in Canada. (CBC News) Neurostimulator Company Raises More Money in an Over-allotment OfferingMay 3, 2016 - Helius Medical Technologies raised an additional $857,083 in an over-allotment to its latest offering, bringing the total to $8.1 million. The company said the proceeds will help fund completion of a clinical registry trial of its portable neuromodulation stimulator to evaluate treating traumatic brain injury, prior to seeking 510(k) clearance from the FDA. The company plans to also pursue indications in multiple sclerosis and stroke. (Mass Device) Company Raises Capital to Commercialize Obesity-Treatment NeurostimulatorMay 3, 2016 - EnteroMedics closed a third tranche in a $25 million offering, bringing in $6.3 million. The company is commercializing an implantable vagus nerve stimulator for obesity treatment. (Mass Device) Device to Potentially Address Peripheral Nerve Pain Moves Forward in CompetitionMay 3, 2016 - Bioness, Inc. announced its implantable neurostimulator for peripheral neuropathic pain is a finalist for the 2016 Medical Device Excellence Awards. Results of the competition will be announced in June. (PR Newswire) Columnist Sees Promise in April Developments in the Neurotechnology IndustryApril 2016 - A column by an industry observer says that following St. Jude Medical's acquisition by Abott, other large healthcare firms may take greater interest in entering the neurotech arena. The column adds that proposed U.S. legislation, if passed, would require Medicare to automatically cover newly approved medical devices. Finally, the column notes the FDA is moving toward expediting access to market by considering lowering classification, from class III to class II, of cranial electrical stimulation systems for some indications. (Neurotech Business Reports) Review Evaluates Evidence Base for Burst StimulationMay 3, 2016 - A review of five published studies of burst spinal cord stimulation (SCS), involving 117 chronic pain patients, evaluates the evidence base and concludes that further study should use a standardized design, a large sample of patients who have not previously had SCS, and entail long-term follow-up. However, the study notes that new mechanisms may be at play in this stimulation mode, according to animal studies, and says, "understanding other potential spinal inhibitory mechanisms may lead to enhanced analgesia during burst stimulation." (Neuromodulation: Technology at the Neural Interface) Editorial Considers Tailoring of Deep Brain Stimulation in DepressionMay 2, 2016 - Commenting on a recent study into deep brain stimulation (DBS) for treatment-resistant depression, a psychiatrist notes that symptom improvement in the blinded study was not a placebo effect, and dosage adjustment led to better results. He adds that electrode placement may also be reconsidered as the potential intervention evolves, saying, "DBS is most likely to become a viable choice for highly refractory major depression when electrode location is matched to individual pathophysiology as indicated by functional neuroimaging." (NEJM Journal Watch) Review Recounts History of Deep Brain StimulationApril 29, 2016 - A review looks at the development of brain neuromodulation techniques and the current state of the art, including new research into stimulation using ultrasound, micro-scale magnetic fields and optogenetics. (Neuroscientist) Researchers Report Non-invasive Brain Stimulation Led to More Cortical Excitability and Higher Pain ThresholdsMay 2, 2016 - Researchers report a more-robust non-invasive brain stimulation method that increases cortical excitability and may help in devising interventions that raise the pain threshold for patients suffering from chronic pain. They used two electrodes on one side of the head and ran a constant low-intensity current between the electrodes for 10 minutes. Compared to previous studies that only used a single site for transcranial direct current stimulation (tDCS), this method, unihemispheric dual site tDCS, led to more-pronounced and more durable cortical excitation that lasted 24 hours, they report. Further tests showed that participants had an increased pain threshold. (Health Canal) Neuromodulation Company is Acquired by Healthcare GiantApril 28, 2016 - Abbott is acquiring St. Jude Medical, Inc. for $25 billion. The deal provides a broader cardiovascular portfolio and also confers "a leading position in the high-growth neuromodulation market," it was reported today. Abbott, which has product lines in cardiovascular, diabetes, and vision care, will assume or refinance St. Jude's net debt of approximately $5.7 billion. (Street Insider) Researchers Explore Non-Invasive Brain Stimulation in Alzheimer's DiseaseApril 27, 2016 - A pilot study in the Journal of Alzhemier's Disease explored, in 18 patients with mild, moderate, or severe Alzhemier's disease, a potential alternative brain-stimulation method to restore mental function. The researchers reported that there were temporary improvements in thinking skills and memory after six sessions of exposure to sound pulses at 40-hertz. This gamma wave rhythm has been shown to be a fundamental frequency of a healthy brain. The study builds on 2013 findings showing that vibrations delivered through the index finger stimulated a steady 40-hertz oscillation in the brains, as seen in magnetoencephalography. (The Globe and Mail) Researcher Explains Obesity Research at Science FestivalApril 26, 2016 - A talk at TechfestNW in Oregon presented the rationale for investigating deep brain stimulation of the hypothalamus as a therapeutic intervention in obesity. (Willamette Week) News Feature Surveys the State of Research Into Minimally Conscious StateApril 26, 2016 - An article about minimally conscious states mentions deep brain stimulation that helped to restore more conscious awareness to one patient. (Newsweek) Authors Recount State of an International Registry of Tourette Syndrome Patients Who Have Received Deep Brain StimulationApril 25, 2016 - A review details an international registry of patients with Tourette syndrome who received deep brain stimulation. The registry has 157 patients so far, from 10 countries. The review lists 16 studies published since 2007 that have more than four patients who received DBS as an investigational intervention in Tourette syndrome. (Frontiers in Neuroscience) Review Summarizes Neuromodulation Studies in Heart FailureApril 25, 2016 - A review examines clinical experience with studies of spinal cord stimulation and vagus nerve stimulation in heart failure, as well as baroreceptor activation therapy. The review analyzes challenges of determining proper excitation parameters and/or stimulator duty cycles, among other issues. Despite challenges, the authors say much progress has been made in the past five years and that one day clinicians may use both devices and drugs to restore the proper sympathovagal balance in heart failure. They add that enrollment will begin soon in a large pivotal trial, BeAT-HF (Barostim Therapy for Heart Failure; NCT02627196). In it, 480 heart-failure patients will be randomized to receive optimal medical therapy with or without BAT. Results, however, will not be expected for several years. (Basic to Translational Science) Study: Varying Stimulation Frequency May Aid Pain ControlApril 22, 2016 - International Neuromodulation Society member Julie Pilitsis, MD, PhD and colleagues published results of a pain study involving 19 patients receiving deep brain stimulation. The authors found that low-frequency stimulation modulates thermal and mechanical detection more than high frequency stimulation, as determined through quantitative sensory testing. They postulate that low frequency stimulation may be an option to consider for patients with Parkinson's disease whose pain is their predominant complaint. (Journal of Neurosurgery) Modeling Indicates that Adjunctive Neurostimulation in Chronic Cluster Headache Would Improve Outcomes and Lower Treatment CostsApril 22, 2016 - Using data from a prospective, randomized, open-label study of non-invasive vagus nerve stimulation, researchers in Germany modeled the cost-effectiveness of this adjunctive treatment for chronic cluster headache compared to the current standard of care alone. Their analysis found that after one year, the combined treatment of vagus nerve stimulation plus standard care was projected to result in greater quality of life and lower healthcare expenditures in a German setting. (The Journal of Headache and Pain) New Neurostimulation Company Receives up to $45 Million in Debt FinancingApril 22, 2016 - Nuvectra's first disclosed financing is a $40 million loan and $5 million line of credit from Oxford Finance and Silicon Valley Bank. The newly spun-out neurostimulation company's overall market capitalization is about $90 million. (Fierce Medical Devices) Company Acquires Startup's Neurostimulation PatentsApril 22, 2016 - Nexeon MedSystems Inc. has acquired neuromodulation patents from NeuroTek Medical, Inc. related to electrode design and occipital nerve stimulation for migraine headache. NeuroTek created a device that delivers transcutaneous occipital nerve electrical stimulation as an investigational treatment for migraine pain. Nexeon anticipates using this intellectual property in its research into similar technology for cardiovascular disease, cognitive enhancement, and sepsis. (Biospace) CE Mark Approved for Migraine Prevention LabelingApril 22, 2016 - The company eNeura has received an expanded CE mark for its single-pulse transcranial magnetic stimulation device to prevent migraine, as well as for acute treatment of migraine. (FDA News) Article Recaps Researchers' Non-invasive Brain Stimulation ResearchMay 2016 - A news feature describes military-funded research that examines cognitive effects of non-invasive brain stimulation. The Insight project, begun in 2014 with $12.7 million from the U.S. Office of the Director of National Intelligence, combines physical fitness training, nutrition monitoring, and cognitive training sessions that include transcutaneous direct current stimulation in healthy volunteers. The 42-month project tracks adaptive reasoning in novel situations. (Smithsonian) Cadaver Study Measured External Stimulation Entering the SkullApril 20, 2016 - Unpublished data presented at the annual meeting of the Cognitive Neuroscience Society earlier this month in New York City showed very little current entered a cadaver's skull which was fitted with transcutaneous electrodes to deliver alternating current, with most applied current shunted away by the skin. Regarding the findings, one researcher commented that transcutaneous brain stimulation in living subjects is not expected to deliver a stimulus strong enough to trigger neuron firing, but instead to make neurons more likely to fire or form new connections. In addition, he noted that living tissue conducts electricity differently. (Science) Early-Onset Parkinson's Disease Patient in Scotland Appreciates Neuromodulation TherapyApril 20, 2016 - A retired teacher who belongs to the Glasgow Young Onset Parkinson’s Group discussed being able to receive deep brain stimulation (DBS). The article says that at a cost of around £70,000 to the National Health Service, only 10 to 12 operations are carried out a year. (Daily Record) Survey Underscores Importance of Realistic Therapy Expectations in Parkinson's Disease PatientsApril 20, 2016 - Survey results presented at the 2016 annual meeting of the American Academy of Neurology showed that Parkinson's disease patients whose pre-operation expectations were realistic had improved quality-of-life scores after their deep brain stimulation (DBS) surgery. The article states that "most patients continued to be satisfied with their decision to undergo DBS, would elect to undergo the procedure again if necessary, and would recommend the procedure to others. In addition, most participants reported that they would have preferred to undergo DBS earlier." (Neurology Advisor) Research Team Unravels Dual Role of Brain Nucleus NeuronsApril 20, 2016 - Preclinical experiments untangled a dual role for cholinergic neurons in the pedunculopontine nucleus by following projections to midbrain structures. The work indicates that to address gait issues in movement disorder, brain stimulation might target the axonal projections in the substantia nigra. For reward disorders, on the other hand, stimulation might target projections in the ventral tegmental area. (Medical Xpress) FDA Ponders External Brain Stimulation Device ClassificationsApril 20, 2016 - The FDA is receiving comments on its proposal to reclassify cranial electrotherapy stimulator devices from Class III to Class II for insomnia and/or anxiety, while remaining Class III devices when intended for depression, requiring premarket approval. (Medical Device and Diagnostic Industry) Transcranial Magnetic Stimulation System Maker Announces New European PatentApril 20, 2016 - Nexstim Plc announced the European Patent Office has issued a patent for the company's technology that displays where an electric field is generated on the brain during transcranial magnetic stimulation. (Globe Newswire) Device Maker Cites Neuromodulation Revenue in Quarterly EarningsApril 20, 2016 - Neuromodulation sales at St. Jude Medical grew 8% in the first quarter and contributed to earnings and revenues the company said were above forecast. (Market Watch) Paper Compares MRI Capabilities in Guiding Targeting of Deep Brain StimulationApril 20, 2016 - Co-authors from the University of California, San Francisco compared deep brain stimulation (DBS) lead targeting during one year of operation using magnetic resonance imaging from ether a 3-tesla magnet (23 consecutive leads) or a 1.5-tesla magnet (26 consecutive leads). They concluded that accurate DBS lead targeting can be achieved with systems using either 1.5- or 3-tesla magnets, but a 3-tesla magnet provides better visualization of the target structures. (Stereotactic and Functional Neurosurgery) Neurostimulation Spin-off Completes Private Financing RoundApril 19, 2016 - A spinoff from the Swiss Federal Institute of Technology in Lausanne, G-Therapeutics, raised $41 million in a Series A round and debt. The company plans to use the proceeds on clinical trials for an implantable neurostimulation system to restore lower limb function spinal cord injury patients. (Fierce Medical Devices) Non-invasive Stimulation Startup Raises CapitalApril 18, 2016 - Helius Medical Technologies has raised $7.2 million in a Canadian short-form offering and a concurrent private placement in the U.S. The company is completing a clinical trial of non-invasive nerve stimulation for treatment of traumatic brain injury, in preparation for a request for FDA 510(k) clearance and an envisioned U.S. commercial launch. (Med City News) Study: Non-invasive Vagus Nerve Stimulation Reduced Menstrual Migraine Frequency and IntensityApril 19, 2016 - An open-label study of 56 patients presented at the American Academy of Neurology meeting showed that non-invasive vagus nerve stimulation reduced the frequency of menstrual migraine by 35%, down to 4.7 episodes per cycle. The migraine episodes were also less intense, resulting in 38% less use of rescue/analgesic medication. Another study at the meeting provided evidence that the non-invasive stimulation is stimulating afferent vagus nerve fibers as expected. (Newswire) Researchers Analyze Effect of Responsive Neurostimulation in Patients with Treatment-Resistant EpilepsyApril 18, 2016 - An analysis of 106 patients with medically intractable mesial temporal lobe epilepsy who participated in a clinical trial of responsive neurostimulation showed a median seizure reduction of 70%, according to data presented at the American Academy of Neurology meeting. (Neurology Advisor) Spinal Cord Stimulation Leads Receive Pre-Market ApprovalApril 18, 2016 - Nevro Corp. announced FDA pre-market approval of its spinal cord stimulation leads for use with its high-frequency spinal cord stimulation device, which was FDA-approved in May 2015. (Mass Device) Review Foresees Potentially Greater Role for Neuromodulation in Treatment-Resistant DepressionApril 2016 - A review of electroconvulsive therapy, transcranial magnetic stimulation (TMS), and deep brain stimulation (DBS) in treatment-resistant depression concludes that as additional knowledge is developed about the best use of the latter two treatments, circumstances may allow TMS and DBS to become mainstream treatments for treatment-resistant depression in the next decade. (Healio Psychiatric Annals) Researchers Say Non-invasive Brain Stimulation Improved Cognitive Reasoning on a Word-Analogy TestApril 14, 2016 - An article in Cerebral Cortex says research subjects performed better on a novel analogy-finding task after receiving high-definition tDCS-to the frontopolar cortex, an area whose activity was recently shown to predict changes in creative state. (Science Daily) Journal Features Work of International Neuromodulation Society Members to Reanimate the Limb of a QuadraplegicApril 13, 2016 - The New York Times covered the publication in Nature of research including International Neuromodulation Society members Ali Rezai, MD, and Chad Bouton regarding their collaboration to use a motor-cortex implant and an electrode sleeve to reanimate the hand and arm of a man with quadriplegia. Nature published an associated news article. An article by the BBC includes a video of the young man using the device. Ohio State University issued a news release saying the patient is the first of up to five to participate in the clinical study using this "neural bypass" system, NeuroLife. Bouton was recognized for this work in 2015 as one of five winners of the inaugural INS biennial congress abstract competition. (New York Times) Study: Deep Brain Stimulation Target Yielded Lasting Symptom Improvement in Parkinson's PatientsApril 13, 2016 - Researchers in Mexico City report that unilateral deep brain stimulation to the preleminiscal radiations (Rapri) in patients who have Parkinson's disease in stages II - III induced significant improvement in contralateral symptoms in the extremities over 2 - 4 years of followup. Fourteen of the 19 patients had more than an 80% decrease in symptoms. The other five had symptom decreases of 33 - 79%. (Neuromodulation: Technology at the Neural Interface) Advocacy Group's Survey in Ireland Shows Limited Access to Deep Brain StimulationApril 13, 2016 - An article about a survey of 1,000 patients by the Parkinson’s Association of Ireland says that despite Parkinson's disease being on the rise, only 3% of patients have had access to deep brain stimulation. For the treatment, they must travel to England, which is difficult for patients whose condition limits their mobility. (Irish Times) Man with Autism Recounts His Response as a Non-invasive Brain-Stimulation SubjectApril 13, 2016 - In a "Science of Us" column, a writer interviews a man with autism about his experiences as a clinical research subject who had repetitive transcranial magnetic stimulation in an attempt to mitigate some of his symptoms that interfered with socialization. (New York Magazine) Company Releases Dorsal Root Ganglion Neurostimulator in the U.S.April 11, 2016 - St. Jude Medical announced the U.S. launch of its dorsal root ganglion (DRG) neurostimulator, following FDA approval in February. Providers are being trained in use of the device to treat people with chronic pain from complex regional pain syndrome I and II for whom traditional neurostimulation is not sufficiently effective. The company announced the first two procedures in a news release and said it has partnered with implanting chronic pain specialists who will conduct more than 100 procedures in 59 centers nationwide in the first month after launch. (MedGadget) Authors Foresee Applying Laboratory Findings in Optogenetics to Deep Brain Stimulation TherapyApril 5, 2016 - Authors of a research review posit that optogenetics in animal models can identify neural circuits thought to contribute to behavioral disease, which then might be treated with deep brain stimulation. These possibly novel stimulation targets could be validated in the animal models. Then, the findings might be translated to humans. (Swiss Medical Weekly) Small Clinical Trial Starts to Potentially Remedy Vision Loss with OptogeneticsMarch 18, 2016 - A woman in Texas with loss of vision from retinitis pigmentosa is the first participant in a small clinical trial to receive optogenetic therapy. The treatment introduces genes for light-sensing proteins to ganglion cells in her retina. The intent is to allow these cells to signal the presence of light, and thereby restore some ability to perceive light and shadow. Restoring some vision could help patients better perceive and navigate their environment. (MIT Technology Review) Clinical Trial of Neurostimulation in Post-Amputation Pain Will Continue Following Interim Analysis of Early ResultsApril 7, 2016 - Neuros Medical, Inc. announced positive feedback from an analysis of interim results in the company's pivotal clinical study of high-frequency nerve stimulation for post-amputation pain. An independent data monitoring committee analyzed safety and efficacy outcomes for the first 20 patients in the study. Based on that analysis, the clinical trial will continue. The study seeks to ultimately enroll up to 130 patients at 15 institutions. (Business Wire) Researchers Explore Potential Deep Brain Stimulation Target to Treat PainApril 4, 2016 - The University of Texas at Arlington issued a news release about preclinical research into neurostimulation for pain that targets the ventral segmental area, a brain structure that plays roles in both the reward process and nociception. The researchers write in Experimental Brain Research that the stimulation may cause an analgesic effect and decrease nociceptive pain via descending modulatory pathways, possibly through connections to the brainstem and cerebral cortex. (Medial Xpress) Public Body Says National Health Service Can Use Noninvasive Vagus Nerve Stimulation for Chronic HeadacheApril 1, 2016 - In a news release, electroCore LLC reports that the National Institute for Health and Care Excellence (NICE) has issued guidance on transcutaneous stimulation of the cervical branch of the vagus nerve for cluster headache and migraine. NICE reviewed and summarized results of five clinical trials that documented the degree of benefit experienced by enrollees. The guidance to physicians encourages them to inform patients that evidence of efficacy is uncertain due to the extent and nature of the data published to date, but adds that further research is encouraged and "current evidence raises no major concerns". Based on the guidance issued by NICE, the intervention can now be used in the National Health Service. (PR Newswire) Company Evaluates Response of Stroke Patients to Different Forms of Noninvasive StimulationMarch 31, 2016 - Nexstim Plc of Finland plans to file for FDA 510(k) clearance for its navigated repetitive transcranial magnetic stimulation system in the second quarter of 2016, the company announced. The system is CE marked, and was undergoing a clinical trial at 12 centers in the U.S. to augment post-stroke arm and hand motor rehabilitation. The sham group received a different stimulation than the patients in the active-treatment arm. After 138 patients were treated, the study reached a futility criterion because both the sham and treatment groups showed clinically meaningful gains, with more than two-thirds of patients in each group responding. The company is filing a patent application on the sham stimulation method, based on this unexpected response. The company is halting the clinical trial and will unblind the data for further analysis. (Globe Newswire) Retinal Prosthesis Maker Gets CE Mark ApprovalMarch 31, 2016 - Retina Implant of Germany received CE Mark approval for its neuroprosthetic device designed to restore some vision in patients who have retinitis pigmentosa. (FDA News) Pilot Trial of a Wearable Pain-Relief Device Will Gather Data on Sleep Impact Through a Mobile AppMarch 31, 2016 - NeuroMetrix will offer its FDA-cleared wearable pain-relief device to people with chronic pain who work for Premera Blue Cross in the Pacific Northwest in a pilot trial in which data on device utilization and sleep quality will be gathered by a mobile app. (FDA News) Researcher Looks at Role of Modulation of Neural States in Motor TasksMarch 31, 2016 - In a finding that may help development of prosthetic devices, a researcher in Sweden reported in Current Biology that the signal patterns of sensory neurons associated with muscle spindles changed during learning of a motor task. Earlier, the researcher noted in an interview that insight into these mechanisms can also aid understanding of pathological states, such as spasticity. (Science Magazine) Physiologist Finds Some Capacity for the Spinal Cord to Adapt After InjuryMarch 30, 2016 - A news feature covers four decades of research by a physiologist whose neurostimulation studies have led to an understanding that following some spinal cord injuries, the spinal cord can adapt through neurorehabilitation and generate patterns of activity that have allowed some paralyzed research subjects to recover some limited function. (STAT) Researchers Investigate Stimulation of the Ventral Tegmental Area in Chronic Cluster HeadacheMarch 30, 2016 - British researchers report a prospective study of 21 patients who have medically refractory chronic cluster headache, and were treated with deep brain stimulation to the ventral tegmental area after either failing occipital nerve stimulation or having been denied it through the National Health Service. They report that patients improved significantly in a number of factors. The authors conclude that the study provides Class IV evidence that this intervention in this medically refractory condition decreases headache frequency, severity, and headache load. (Neurology) Company Launches a Minimally Invasive Neurostimulation Treatment for Overactive BladderMarch 30, 2016 - Medtronic plc has launched a percutaneous tibial nerve stimulation system to treat symptoms of overactive bladder. (Yahoo Finance) Article Describes Interest in BioelectronicsMarch 29, 2016 - An article describes the development of bioelectronics or electroceuticals following an observation in 2002 that an agent under investigation to limit swelling after a stroke was affecting the vagus nerve and the reaction of the immune system. The observation led to the concept that the nerve could be manipulated with electrical impulses instead of a pharmaceutical agent. (Wired.uk via Unknown Country) Case Report: Pudendal Nerve Stimulation in Pediatric Patent with Caudal RegressionMarch 28, 2016 - Physicians report on the use of pudendal nerve stimulation in a pediatric patient to treat the patient's refractory bladder/bowel dysfunction. Sacral neuromodulation was not pursued because the patient had a malformed lower spine due to caudal regression. (Urology) Noninvasive Brain Stimulation Researcher Seeks Enrollees with Parkinson's Disease to Investigate a Potential Depression TherapyMarch 28, 2016 - A researcher at the University of British Columbia is recruiting Parkinson's disease patients who have been diagnosed with depression to see if two weeks of daily sessions of transcranial direct current stimulation at home will help relieve symptoms. News coverage of his work highlights cautions that researchers and industry-watchers have voiced about the home use of brain-stimulation devices that are not regulated as medical devices. (Vancouver Sun) Deep Brain Stimulation Affects Oscillation of Distinct Networks in Parkinson's DiseaseMarch 26, 2016 - Researchers in the United Kingdom published findings showing that motor improvement in Parkinson’s disease patients receiving subthalamic deep brain stimulation correlates to suppressed synchrony of distinct brain networks. The findings were based on simultaneous magnetoencephalography recordings of the subthalamic nucleus and cortex. The authors conclude that further defining the activity of cortico-subcortical loops, and their connection to underlying symptoms, might aid development of patient-specific treatment that tailors the delivery and pattern of brain stimulation. (Brain) Neurologists Document Infection Rates Following Deep Brain Stimulation Implantation in a Diagnostic MRI SuiteMarch 25, 2016 - Physicians at the University of California, San Francisco prospectively collected data over 10 years from 164 procedures in which deep brain stimulation leads were implanted under MRI guidance in a sterile setting that lacked the air-handling qualities of operating rooms. They changed their sterile practice after the first 10 patients. Subsequently, the next four instances of postoperative hardware infection (2.6% of 154 patients) all occurred at the site of the implantable pulse generator, which had been implanted in a conventional operating room during a followup visit. In the whole group of patients, there were six infections for an overall rate of 3.6%. (Brain) Ukraine Patient Received Deep Brain Stimulation SystemMarch 27, 2016 - A boy with epilepsy received a deep brain stimulation (DBS) system in what is described as the first surgery of its type in the Ukraine. (Ukraine Today) Neuromodulation Center Joins Forces with Brain Science InstituteSummer 2016 - The Asia-Pacific Centre for Neuromodulation officially joined the Queensland Brain Institute in January. The neuromodulation-therapy research center was formed in 2012 as a joint initiative of the University of Queensland and St. Andrew’s War Memorial Hospital. (University of Queensland) Pilot Study Explores Medication-Free Maintenance Following Transcranial Magnetic Stimulation for DepressionMarch 24, 2016 - A prospective pilot study in Brain Stimulation randomized unmedicated patients with unipolar, nonpsychotic, treatment-resistant major depressive disorder to either observation, or monthly transcranial magnetic stimulation (TMS) sessions following a six-week acute-treatment phase. The patients in the randomized phase were among 49 responders who were followed for up to 12 months, out of 67 total who underwent the initial acute phase of treatment. Compared to the observation group, the ones who had been randomized to receive monthly treatment were able to go 91 days before intensive therapy needed to be introduced, compared to 77 days in the observation-only group, the article states. (Fierce Medical Devices) Company Starts to Market Peripheral Nerve StimulatorMarch 23, 2016 - Stimwave, LLC said it has begun to market its peripheral nerve stimulator that received 510K approval from the FDA earlier this month. Its indications include upper and lower extremity neuropathies and some pain of the mid or lower back, chest well, abdomen, or pelvic region.The device is wirelessly powered by a wearable fabric patch unit. (Business Wire) Researchers Investigate Non-invasive Brain Stimulation in AnorexiaMarch 23, 2016 - An article in PLOS ONE suggests repetitive transcranial stimulation (rTMS) to the dorsolateral prefrontal cortex reduced symptoms of anorexia. The researchers saw a statistical trend toward reduced symptoms in the active-stimulation group following one session of rTMS to this area of the brain, which is thought to be involved in some of the self-regulation difficulties associated with anorexia. (Medical Xpress) Study Examines Role of Brain Structure in Propensity to Make Eye ContactMarch 23, 2016 - Researchers in France published findings in which subjects whose superior temporal sulcus was inhibited by transcranial magnetic stimulation gazed less at the eyes of movie actors. The authors say this brain structure is different in some autistic people. They want to explore whether stimulating its activity could serve as a therapy to enhance social interactions by increasing eye contact. (Medical Xpress) Laboratory Brain-Stimulation Study Targets Circuits Involved in Feeding and MetabolismMarch 23, 2016 - A feeding-and-metabolism study in Nature, Nature "Bidirectional electromagnetic control of the hypothalamus regulates feeding and metabolism," investigated glucose homeostasis through stimulating the hypothalamus of mice via radio or magnetic waves. In the laboratory animals, the stimulation affected a ferritin fusion protein tethered to a calcium-ion pore. The authors note that "pancreatic hormones function as an effector mechanism of central nervous system circuits controlling blood glucose and behaviour. The method we employ obviates the need for permanent implants and could potentially be applied to study other neural processes or used to regulate other, even dispersed, cell types." (Rockefeller University) Cluster Headache Patient in Wales Wishes to Try NeurostimulationMarch 23, 2016 - A woman in Wales says she has not gotten approval to receive occipital nerve stimulation (ONS) for her cluster headache. Authorities said 2013 guidance from the National Institute for Health and Care Excellence does not support ONS on a routine basis. (The Leader) Call for Congress Proposals IssuedMarch 2016 - For its 13th World Congress, "Neuromodulation: Technology Changing Lives" May 21 - June 1, 2017 in Edinburgh, Scotland, the International Neuromodulation Society seeks proposals by May 1 regarding basic science, clinical studies and biomedical engineering presentations about neuromodulation for: Mice Studies Indicate Astrocytes Help Mediate Effects of Transcranial Direct Current StimulationMarch 22, 2016 - Researchers in Japan report in Nature Communications on an apparent mechanism of action of transcranial direct current stimulation (tDCS), seen in mouse studies. Fluorescent tagging indicated tDCS induced large surges of calcium ions in astrocytes, implicating activity of these non-nerve cells in mediation of neuronal responses to the stimulation. They add that there were no obvious changes in the local field potential. They suggest this tDCS mechanism may play a role in lowering symptoms of depression and increasing learning and brain plasticity. In a mouse model of stress-induced depression, tDCS normally reduces depression-like behavior. However, when astrocytic calcium surges were blocked, it did not. The researchers also found tDCS enhanced cortical responses to sensory input, such as light flashes or whisker deflection. (EurekAlert) Specialists Urge Progress on Deep Brain Stimulation Center in ScotlandMarch 22, 2016 - Twenty-five specialists have sent an open letter to the health secretary asking her to resolve a funding dispute that has delayed establishment of a deep brain stimulation (DBS) center in Scotland for patients in north and east, who must travel to England for the treatment. (BBC) News Release Publicizes Study Data About Neurostimulation Reducing the Emotional Aspect of PainMarch 17, 2016 - International Neuromodulation Society member, Ali Rezai, MD, was quoted in a news release about an article he published with colleagues, including fellow member Louis Vera-Portocarrero, PhD, in the current issue of Neuromodulation: Technology at the Neural Interface. He said, "spinal cord stimulation can reduce the emotional connectivity and processing in certain areas of the brain in those with chronic pain." The researchers examined functional MRI scans of 10 patients who had spinal cord stimulation (SCS) for complex regional pain syndrome or chronic leg pain. The findings suggest SCS reduces negative pain processing through decreasing connectivity of the limbic and somatosensory areas. (EurekAlert) Brain Stimulation Boosted Recall of a Short-Term Memory in a Mouse Model of Alzheimer's DiseaseMarch 16, 2016 - Optogenetic studies in a mouse model of Alzheimer's disease showed that stimulation of the hippocampus can elicit recall of an earlier painful stimulus (a box that delivered an electric shock). Normal mice learned to fear the box, but the mice designed to model Alzheimer's disease did not. When the memory-impaired mice received the brain stimulation, however, they did not move about the box, indicating they associated it with the shock. Cycling the simulation on and off as might occur naturally during repeated memory recall allowed the mice to retain and retrieve the memory, and dissection later indicated that repeated stimulation led to more connections between the hippocampus and the entorhinal cortex. (Nature) Study: Noninvasive Brain Stimulation Enhanced Motor RecoveryMarch 16, 2016 - A controlled study of transcranial direct current stimulation (tDCS) during stroke rehabilitation in 24 patients showed that the half who received active stimulation in conjunction with nine days of motor rehabilitation performed better at three months' followup than those who did not. The researchers applied anodal stimulation to the brain hemisphere ipsilateral to the lesion. (Medical Xpress) Military Research Agency Seeks to Use Peripheral Nerve Stimulation to Enhance Cognitive PerformanceMarch 16, 2016 - The U.S. Defense Advanced Research Project Agency (DARPA) announced a new peripheral-nerve-stimulation research program, Targeted Neuroplasticity Training (TNT), and will hold a Proposer's Day on April 8, 2016 in Arlington, VA. The research program concerns noninvasive nerve stimulation, and seeks to facilitate learning of cognitive skills "with a goal of reducing the cost and duration of the Defense Department’s extensive training regimen while improving outcomes," the announcement said. Unlike prior research programs, "it will aim not just to restore lost function but to advance capabilities beyond normal levels." (DARPA) Two-Year Pilot Study Finds Early Deep Brain Stimulation in Parkinson's Disease Lowered Medication CostsFeb. 26, 2016 - International Neuromodulation Society members Peter Konrad, MD, PhD, Fenna Phibbs, MD, and Joseph Neimat, MD, have published with co-authors a prospective, randomized, single-blind clinical trial testing the impact of subthalamic nucleus deep brain stimulation (DBS) in early Parkinson's disease on reduced medication costs. The 30-patient study found that over two years, patients who were randomized to only receive optimum drug treatment had their medication costs increase 72% from baseline. In the same period, the patients who also received DBS had their medication costs drop 16%. The cost savings amounted to $7,150 over two years. (Journal of Parkinson's Disease) Neurostimlation Company Spinout Concludes With Stock Exchange ListingMarch 14, 2016 - Nuvectra Corporation began trading under the symbol NVTR, completing its spinout from Greatbatch, Inc. Nuvectra's chief executive officer, Scott Drees, said the newly independent neurostimulation medical device company will begin focusing on launching its proprietary spinal cord system in the U.S.. (Yahoo Finance) Company"s Robotic Surgery System to Assist in Deep Brain Stimulation SurgeryMarch 14, 2016 - Montpellier-based Medtech announced sale of its brain robotic surgery system to the Yale School of Medicine's Comprehensive Epilepsy Center, where its uses will include deep brain stimulation surgery. The company said two additional units were sold in China, bringing their total there to nine. (Nasdaq.com) Report Issued on FDA Workshop Concerning Brain-Computer InterfacesApril 2016 - International Neuromodulation Society member John Donoghue, PhD, is among authors of a report that has been published following a November 2014 FDA meeting on brain-computer interfaces (BCI) for patients with paralysis or amputation. The report says FDA plans to develop guidance for premarket submissions for BCI devices. For the purposes of the workshop, BCI devices were defined as neuroprostheses that interface with the central or peripheral nervous system to restore lost motor or sensory capabilities. (Journal of Neural Engineering) Researcher Explores Minimizing Scar-Tissue Formation With Drug-Eluting ImplantApril 2016 - International Neuromodulation Society member James FitzGerald, PhD, has published preclinical data regarding suppression of scar tissue formation in peripheral nerve implants. His work involved a microchannel implant on the sciatic nerve of rats made of silicone doped with the inflammation-suppressing steroid dexamethasone. After periods of up to one year, the drug-eluting implants had less surrounding scar tissue compared to controls. Axon growth was initially much stronger in the control versions, but declined as scar tissue formed, whereas axon counts increased in the drug-eluting devices and by one year were significantly higher than controls. (Journal of Neural Engineering) Computational Model Seeks to Help Guide and Explain Deeper Stimulation from Transcranial Magnetic StimulationApril 2016 - A research team has modeled the brain's white fiber tracts, that connect cortical and subcortical regions and are theorized to potentially propagate action potentials toward deeper brain regions during transcranial magnetic stimulation. Their model, they say, combines electromagnetism and electrophysiology by computing, next to the induced electric fields in the brain, the spatial distribution of the membrane potentials along the fiber tracts and its dynamics over time. By factoring in the location and orientation of the coil, specific results for a patient or a case can be obtained. (Journal of Neural Engineering) Company Says the FDA Has Approved Its Processor to Wirelessly Stream Audio to Hearing ProsthesisMarch 14, 2016 - Cochlear announced the FDA approved the company's sound processor that uses wireless technology for users to stream audio directly to their device. The device is intended for people who have higher degrees of mixed-hearing loss. (FDA News) Executive Details His Company's Vision of Bioelectronic MedicineMarch 12, 2016 - In an interview, GlaxoSmithKline executive Moncef Slaoui said their bioelectronics initiative seeks wirelessly powered peripheral nerve stimulators that can interface with a single nerve and might one day be implanted laproscoptically in a matter of minutes. The initiative was presented at the SXSW Interactive technology conference in Austin, TX at a session called "Inner Space: Bioelectronics and Medicine's Future". (IEEE Spectrum) Researchers Explore Use of Transcranial Direct Current Stimulation in Aphasia TherapyMarch 10, 2016 - Two speech-language pathologist who teach at the University of Wisconsin-River Falls have begun gathering feasibility data in a pilot clinical study that involves sessions of transcranial direct current stimulation followed by rehabilitation training for post-stroke aphasia. They have been using facilities at the University of Minnesota, and are seeking more trial participants prior to filing a grant proposal for a larger study. (River Falls Journal) Paper Raises Issue of Guidance for Neuromodulation Implant Patients During Other SurgeriesFeb. 15, 2016 - International Neuromodulation Society member Ramsis Ghaly, MD, is first author on a paper that asks, "Do we need to establish guidelines for patients with neuromodulation implantable devices, including spinal cord stimulators undergoing nonspinal surgeries?" The article gives case reports of two patients who have spinal cord stimulator implants and either underwent a hysterectomy or a hip replacement. The implant manufacturers' representatives were contacted pre-surgery. With provisions made to avoid electrical conductance of the device during cautery, the procedures went without complication. (Surgical Neurology International) Faculty Collaborate on On-Demand Deep Brain Stimulation SystemMarch 8, 2016 - A profile of Daniela Tuninetti, an associate professor of electrical and computer engineering at the University of Illinois at Chicago (UIC), reports that she is collaborating with International Neuromodulation Society member Konstantin Slavin, MD, and UIC engineering professor Daniel Graupe in developing an on-demand system for deep brain stimulation. The system is being designed to identify and prevent onset of tremor. Tuninetti was quoted as saying that advantages include longer battery life and decreased side effects, such as speech issues. She added that the technology is envisioned to have broader applications beyond tremor disorders. (University of Illinois at Chicago) Article Recounts a Patient's Experience with Deep Brain Stimulation for TremorMarch 7, 2016 - International Neuromodulation Society member Paul Eldridge, a neurosurgeon at Walton Centre NHS Foundation Trust, was quoted in an article about the benefits a woman experienced after receiving deep brain stimulation for her essential tremor. The article stated, " 'On the whole this is an extremely effective and safe surgical procedure,' says Professor Eldridge. 'You can expect it to provide significant relief to 90 per cent of patients.' " (Daily Mail) Australian Research Institute Eyes Forming a Neural Bioengineering CenterMarch 7, 2016 - Queensland Brain Institute plans to open a new Centre for Neural Bioengineering next year to investigate ways to deliver deep brain stimulation without invasive surgery to potentially treat conditions such as Parkinson’s disease, obsessive compulsive disorder, epilepsy and anorexia. A new biobank is also planned. One researcher at the institute is carrying out preclinical studies of ultrasound as a potential Alzheimer's disease treatment. (The Courier-Mail) Case Report: Bipolar Patient Resumed Vagus Nerve Stimulation Following End-of-Battery Life RelapseMarch 7, 2016 - A case report about a bipolar patient who remained in stable remission for nine years after 20 months of vagus nerve stimulation therapy says the patient relapsed after the therapy was not re-initiated for several months after the battery died. Once the device was replaced, the patient regained remission after 17 months. "If the device malfunctions," the authors advise, "urgent surgical replacement is warranted with subsequent rapid titration to previous parameters as tolerated. Several months’ delay may trigger relapse and prove difficult to re-establish remission." (BMJ Case Reports) Company Receives FDA Approval for MRI-Safe Stimulation LeadsMarch 3, 2016 - Medtronic plc announced it has received FDA approval of its spinal cord stimulation leads that are designed for MRI compatibility. The company expects to begin marketing them later this month. (Mass Device) Researchers Investigate Thalamic Stimulation in Treatment-Refractory Tourette SyndromeMarch 3, 2016 - International Neuromodulation Society member Veerle Visser-Vandewalle and colleagues report a prospective case series of eight patients with treatment-refractory Tourette syndrome. The patients received high-frequency deep brain stimulation of the ventral anterior and ventrolateral motor part of the thalamus. The researchers found at six and 12 months' followup that the patients' motor tics were improved and their emotional state stabilized, they report in Biological Psychiatry. (Alpha Galileo) News Weekly Ponders Cognitive-Enhancement ConcernsMarch 3, 2016 - An editorial and an Outlook article in Nature raise the issues posed by consumer interest in non-invasive brain stimulation for cognitive enhancement. (Nature) Opinion Piece Forecasts Path for Further Technological Development of NeuromodulationMarch 2, 2016 - Cambridge Associates cites cost savings and quality-of-life enhancements offered by neuromodulation therapy, using as an example data presented at the International Neuromodulation Society's 12th World Congress about reductions in healthcare costs among chronic pain patients who received spinal cord stimulation through a Western Canada health authority. The article calls for pursuing better insight into disease mechanisms and integration of technical capabilities to make smaller, more easily accessible devices to fulfill the promise of neuromodulation therapy. (Medical Device and Diagnostic Industry) Visual Prosthetics Maker Garners $28.2 Million in InvestmentMarch 2, 2016 - Retina Implant of Reutlingen, Germany said it has raised $28.2 million for further commercialization of its subretinal microchip to treat retinitis pigmentosa. The device received CE Mark in 2013 and won reimbursement in Germany in 2014. (Mass Device) Article Describes Pursuit of Peripheral-Nerve-Stimulating Bioelectronic TherapiesMarch 2, 2016 - An article says GlaxoSmithKline has established a network of about 50 research collaborations in bioelectronic medicine, and most research is still at a preclinical stage. The article explains that bioelectronic medicine strives to read and correct signals in the peripheral nervous system to treat diseases such as inflammatory bowel disease, arthritis, asthma, hypertension and diabetes. The article adds that the National Institutes of Health has established a $248 million research-investment program, Stimulating Peripheral Activity to Relieve Conditions (SPARC). https://commonfund.nih.gov/sparc/grants (Financial Times) Neuromodulation Activity Adds to Bottom Line for CompanyMarch 1, 2016 - An analyst report says Greatbatch, Inc.'s cardiac/neuromodulation sales in the fourth quarter grew 44.5%, primarily driven by a neuromodulation product launch. Overall, the company reported adjusted gross earnings of 92 cents a share in the fourth quarter, and an 87.1% increase in sales from the previous year, totaling $317.6 million. (Zacks) Funding Agency Seeks Applicants to Carry Out Pre-clinical Tests in New Peripheral-Nerve-Stimulation IndicationsMarch 1, 2016 - The National Institutes of Health announced a funding opportunity as part of the Stimulating Peripheral Activity to Relieve Conditions (SPARC) program. Investigators are invited to propose conducting pre-clinical tests of existing neuromodulation devices, from SPARC’s industry partners, in support of new market indications. The pre-clinical data that emerge are expected to generate the necessary safety and efficacy evidence to support an Investigational Device Exemption submission for a later pilot clinical study. A required letter of intent is due April 2, 2016 and the application is due May 2, 2016. (NIH) Study Suggests Brain-Hemisphere Dominance May Influence Stimulation EffectsFeb. 29, 2016 - An abstract presented at the annual meeting of the American Association for the Advancement of Science suggests that noninvasive brain-stimulation treatments for depression should be tailored to the dominant hemisphere of the patient, as reflected in their handedness. In the research, 25 subjects who do not have depression were randomized to receive transcranial direct current stimulation (tDCS) to either the right or left side of the head. The subjects had a spectrum of hand preference, with four strongly preferring to use their left hand. After five days of tDCS sessions, tDCS to the left hemisphere -- the typical approach -- resulted in right-handers feeling better and left-handers feeling worse, while the reverse was true for stimulation of the right hemisphere, according to the article. (Science) Review Surveys Emerging Neurostimulation Options for Upper-Extremity Neuropathic PainFeb. 1, 2016 - Clinical Pain Advisor summarized a review in Hand Clinics that surveys emerging neurostimulation options for treatment of upper-extremity neuropathic pain. The journal article was authored by International Neuromodulation Society members Jason Pope, MD; David Provenzano, MD; Porter McRoberts, MD; and Timothy Deer, MD. (Clinical Pain Advisor) Longer Delay in Start of Spinal Cord Stimulation is Linked to Higher Healthcare UtilizationFeb. 29, 2016 - International Neuromodulation Society members Shivanand P. Lad MD, PhD; Alexander R. Kent; Peter Staats MD; and Ashwini Sharan MD and colleagues analyzed Medicare claims data from 2008- 2013 over 12 months post-implant in 762 chronic pain patients. Looking at time-to-implant, the authors found that for every one-year delay in receiving a spinal cord stimulator, the odds increased that patients would fall into a high medical expenditures group (33%), receive high opioid prescriptions (39%), and have a higher number of office visits and hospitalizations (44% and 55%). (Neuromodulation: Technology at the Neural Interface) Researchers Assess White-Matter Modulation During Deep Brain Stimulation in Parkinson's DiseaseFeb. 26, 2016 - In 22 Parkinson's disease patients who received bilateral deep brain stimulation of the subthalamic nucleus, an analysis suggests that favorable clinical outcomes are associated with the modulation of white matter tracts directed to the superior frontal gyrus and the thalamus. The researchers say their method using probabilistic tractography with diffusion-tensor data may aid deep brain stimulation programming. (Brain) Earnings Report Shows Growth in Neuromodulation RevenueFeb. 24, 2016 - LivaNova, PLC announced 2015 annual financial results and fourth-quarter results. For the twelve months ended December 31, 2015, worldwide sales were $1.2 billion. In neuromodulation, growth was primarily driven by launch of the company's vagus nerve stimulation system in the U.S. in June 2015, and continued sales in international markets. In the fourth quarter, neuromodulation sales were $92 million, an increase of 25.9% on a constant currency basis. The company said it expects growth in neuromodulation in 2016 to be between 9% and 11%. (Globe Newswire) Article: More Patients Are Being Offered Neuromodulation for Chronic Neuropathic and Ischemic PainFeb. 24, 2015 - An article about spinal cord stimulation options says that technological advances, and guidelines of the Neuromodulation Appropriateness Consensus Committee, have opened the door to more patients, with the therapy being considered earlier than as a last resort, prior to long-acting and strong opioid medications, leading to a better success rate. (Herald and Review) Conference Presentation Analyzes Effects of Obesity, Smoking on Spinal Cord Stimulation OutcomesFeb. 21, 2016 - In a retrospective analysis of 64 patients who received spinal cord stimulation (SCS) between January 2013 - July 2014, neither obesity nor smoking appeared to affect the efficacy of SCS or the infection rate. However, smokers had a 22.2% rate of lead migration, compared to 2.1% in the non-smokers. The study was presented at the American Academy of Pain Medicine Annual Meeting. International Neuromodulation Society President Timothy Deer, MD, who was not involved in the study, was quoted as commenting that there would need to be more patients in order to see a statistical difference. (Medscape) Startup Peripheral Nerve Stimulation Company Raises CapitalFeb. 18, 2016 - A startup company spun out of Stanford University has raised $18 million from Google Ventures, Johnson & Johnson Development Corporation, Lux Capital, Action Potential Venture Capital, DRX Capital and Lightstone Ventures, according to the Silicon Valley Business Journal. The company, Cala Health, has a 2014 patent application for a peripheral nerve stimulator to control tremor. (MobiHealthNews) Overview Summarizes Ongoing Clinical Trials of Vagus Nerve Stimulation for MigraineFeb. 22, 2016 - ElectroCore has expanded from studying noninvasive vagus nerve stimulation (VNS) in cluster headache. In Europe, the company is now conducting two randomized, double-blind, parallel-group, sham-controlled studies of noninvasive VNS in migraine. One multi-center study on the prevention of migraines attacks has enrolled more than 200 of up to 400 patients. A second study enrolled the first of up to 250 patients at 10 sites in Italy to investigate noninvasive VNS as an acute treatment to reduce pain in migraine attacks. (Life Scientist) Healthcare Chain Now Offers Spinal Cord Stimulation Services in QatarFeb. 21, 2016 - A network of 12 pain management clinics in Qatar began offering spinal cord stimulation therapy in August 2015. (The Peninsula) Dorsal Root Ganglion Stimulation is Approved in the U.S. for Complex Regional Pain Syndrome TherapyFeb. 17, 2016 - St. Jude Medical received FDA premarket approval for its dorsal root ganglion neurostimulation system. The device is designed to treat chronic intractable lower-limb pain in adults who have complex regional pain syndrome. (Modern Healthcare) Company Receives Broadened FDA Approval for Use of Its Deep Brain Stimulation System in Parkinson's DiseaseFeb. 17, 2016 - Medtronic plc received a broader FDA approval for its deep brain stimulation (DBS) system. The system is now approved for patients who have had Parkinson's disease for at least four years, with recent onset of motor symptoms, or who have had longstanding motor complications not adequately controlled by medication. (Fierce Medical Devices) Pharmaceutical Company Partners with Neurostimulation Device MakerFeb. 16, 2016 - GlaxoSmithKline has partnered with Nuviant Medical to use its neurostimulation implant systems as a research platform for clinical applications of bioelectronics medicine. Bioelectronics, the company specified, seeks to develop miniaturized implants to interface with the peripheral nervous system to modulate organ function in order to treat chronic disease. (Fierce Medical Devices) Researcher: Electrical Brain Stimulation May Aid Therapy for Progressive AphasiaFeb. 14, 2016 - A researcher is investigating transcranial direct current stimulation as an adjunct to speech therapy in primary progressive aphasia. She presented preliminary results involving 19 patients at the annual meeting of the American Association for the Advancement of Science. (Star Tribune) Article Weighs Cost-Effectiveness of Repetitive Transcranial Magnetic StimulationFeb. 12, 2016 - In a "Wise Buy" column, a writer looks at costs of repetitive transcranial magnetic stimulation (rTMS) for treatment-resistant depression compared to electroconvulsive therapy. The article says an analysis showed that the cost of achieving one quality adjusted life year was $36,000, and anything less than $50,000 is considered cost-effective. (MedPage Today) Authors Look at the Future of Flexible Electrodes in Neuroscience ApplicationsFeb. 11, 2016 - A team of co-authors reviews advances in implantable electrodes based upon soft materials, and their applications in neuroprosthetics, neural signal recording, and neuromodulation. (Lab on a Chip) Company Raises Financing for "Neuropriming" DevelopmentFeb. 10, 2016 - Halo Neuroscience announced it has raised $9 million in Series A financing and is pursuing both stroke rehabilitation and athletics with its headphones that are designed to provide brain stimulation to the motor cortex, an effect the company calls neuropriming. (Med City News) Researchers Demonstrate an Intravenous Brain-Machine Interface in Sheep, Say the Minimally Invasive Interface May Help Guide an Exoskeleton for Spine-Injury PatientsFeb. 10, 2016 - Australian researchers have published a preclinical demonstration of a minimally invasive, paperclip-sized brain machine interface comprised of an electrode-bearing stent, introduced into a vein to lie alongside the motor cortex. Their paper in Nature Biotechnology describes their experience taking neural recordings for up to six months in sheep. The project, funded by the U.S. Defense Advanced Projects Research Agency, may allow spine-injured patients to control an exoskeleton, or aid mobility of stroke patients. A clinical trial in three patients is planned next year in Victoria, Australia. Goals of the project are described by one team member in a column in The Conversation. (IEEE Spectrum) External Vagus Nerve Stimulation to Be Tested for Controlling ObesityFeb. 9, 2016 - An external vagus nerve stimulation system, the NeuroCoach II Stim, will be subject to a placebo-controlled clinical trial for 50 patients in France to potentially help control obesity. The device clips on the ear, and its potential to address obesity was discovered by chance after it was noticed that patients using the stimulation to treat other conditions lost weight. (Daily Mail) Article Describes Locally Available Pain InterventionsFeb. 8, 2016 - International Neuromodulation Society (INS) member Jason Pope, MD, was featured along with INS member Michael Yang, MD, in a newspaper article about the latest pain interventions being available in the Santa Rosa, CA area -- including high frequency spinal cord stimulation. (Press Democrat) Company Eyes Commercialization of Implantable Therapy for Chronic Low Back Pain.Feb. 8, 2016 - Mainstay Medical International plc announced 2015 preliminary results and a business update. The Dublin-based company said it awaits CE marking and is preparing to commercialize its implantable device for chronic low back pain in Europe, with the first target market located in Germany. Meanwhile, the company received two more U.S. patents, bringing the total number to seven, and is currently preparing for an international prospective randomized sham-controlled blinded clinical trial, to include sites in the U.S. (Business Wire) Newspaper Profiles a Local Epilepsy Patient Who Received a Neurostimulation ImplantFeb. 6, 2016 - An article about a young man who received a responsive neurostimulation system to treat medication-resistant epilepsy quotes International Neuromodulation Society members Ali Rezai, MD, and Konstantin Slavin, MD about the field of electrical brain stimulation therapy. (Journal Sentinel) Researchers Say Transcutaneous Vagus Nerve Stimulation May Hold Promise for Helping Treat DepressionFeb. 4, 2016 - Researchers from the China Academy of Chinese Medical Sciences and Harvard Medical school investigated the effects of transcutaneous vagus nerve stimulation in 34 patients with depression, who received either sham or active stimulation for a month. The results, in Biological Psychiatry, showed the active-stimulation group experienced symptom improvement. Neuroimaging before and after indicated increased functional connectivity between the default mode network and precuneus and orbital prefrontal cortex, a network that is known to be altered in depression. The authors conclude that the non-invasive, safe and low cost method shows potential promise as a possible treatment option, if efficacy is sustained. (EurekAlert) Review Considers Current Development of Spinal Cord Neuromodulation for Heart DiseaseFeb. 4, 2016 - International Neuromodulation Society member Jeffrey Ardell, PhD has published a review about heart failure and mechanisms of spinal cord neuromodulation for heart disease. The article says safety concerns for bioelectrical treatment of heart failure with reduced ejection fraction have been addressed, but optimization of spinal cord stimulation delivery remains a concern. (Nature Reviews Cardiology) Companies Announce Plans for Directional Deep Brain StimulationFeb. 1, 2016 - Aleva Neurotherapeutics announced a strategic development, supply, and manufacturing relationship with the Greatbatch, Inc. subsidiary Greatbatch Ltd. Aleva will license a neurostimulation platform for the field of use of deep brain stimulation for treatment of Parkinson’s disease and essential tremor. Aleva will incorporate its own proprietary electrode technology for directional deep brain stimulation (DBS) along with the in-licensed technology for a 24-channel neurostimulator and related programmers. Aleva is raising a Series C round of financing, led by Greatbatch, for completing a chronic study in 60 Parkinson's disease patients, and to support seeking CE Mark approval for the directional DBS system. Additionally, Greatbatch said it expects to be renamed Integer Holdings Corporation later this year, following its October 2015 acquisition of Lake Region Medical. (GlobeNewswire) Article Explains Goal of Using Implant to Stabilize Back and Relieve Chronic PainJan. 31, 2016 - Dublin-based Mainstay Medical has applied for CE Mark approval of a novel investigational neurostimulation device for back pain. The implant induces contractions of the multifidus muscle to stabilize the back. The company would like to offer the device later this year in Europe as an option when treatments such as physiotherapy have failed. An article says the application includes data from a clinical trial involving 45 patients in Belgium, Australia, and England. The coverage mentions International Neuromodulation Society member Sam Eldabe, MBBS, FRCA of Middlesbrough, England, who implanted four enrollees. (Daily Mail) Neurostimulation for Spine-Injury Patients Receives Research Funding in MinnesotaJan. 28, 2016 - The state of Minnesota has given a grant to the University of Minnesota and Hennepin County Medical Center to study epidural spinal cord stimulation as a way to potentially restore some function in spine-injured patients. A summary in Becker Spine Review says clinical trials in other states resulted in patients moving paralyzed muscles and that once the stimulator has been implanted for some time, the patients should experience some improved function even when it is inactive. (WCCO) Study: External Device Improved Post Traumatic Stress Disorder SymptomsJan. 28, 2016 - A proof-of-concept clinical trial of adjunctive treatment with external trigeminal nerve stimulation in 12 patients who have post traumatic stress disorder (PTSD) and major depressive disorder showed that eight weeks of nightly stimulation led to significant improvements in symptom severity. The research institution, the University of California, Los Angeles, is seeking military veterans with PTSD for additional clinical research with the modality. (Neuromodulation: Technology at the Neural Interface) Agency Seeks Proposals for Neural Interface TechnologyJan. 26, 2016 - The U.S. Defense Advanced Research Projects Agency (DARPA) announced a Neural Engineering System Design program, and invites proposals for modular, compact hardware that can record from more than 1 million neurons and stimulate more than 100,000 neurons. (TechNewsWorld) Analysis Compares Healthcare Utilization and Payments for Cancer-Pain Patients Who Receive Intrathecal Drug Delivery or Conventional Medical ManagementJan. 27, 2016 - Healthcare costs of conventional medical management vs. intrathecal drug delivery (IDD) were compared in 73 matched pairs of patients who had cancer-related pain. In the first year after IDD implant, the IDD patients had a consistent trend of lower medical utilization, and total payments were $3,195 mower. The analysis by International Neuromodulation Society member Lisa Stearns, MD and colleagues suggests that despite the high initial cost of IDD, those patients incur lower medical utilization and payments over the first year post-implant. (Neuromodulation: Technology at the Neural Interface) Media Cover Use of Deep Brain Stimulation for Focal Hand DisorderJan. 27, 2016 - A Chinese citizen with focal hand disorder was reported to receive deep brain stimulation (DBS) surgery while playing guitar, which he had had to give up due to his condition. His surgeon said this was the seventh known case where DBS was used for this disorder, a condition that was said to not be uncommon among athletes and musicians. The article described DBS therapy, noting that "it is thought that it will remain the main surgical therapy for Parkinson's for the next 30 years." (Daily Mail) European Researchers Examine Neuroendocrine Changes in Deep Brain Stimulation for Obsessive Compulsive DisorderJan. 26, 2016 - Researchers report that resuming deep brain stimulation (DBS) in patients with treatment-resistant obsessive compulsive disorder led to rapid release of the neuroendocrine factors prolactin and thyroid-stimulating hormone (TSH). The authors say the findings suggest that DBS is capable of inducing rapid psychiatric symptom changes through an alternative or additional underlying mechanism. For instance, seeing the increase in prolactin and TSH leads them to believe the observed acute mood elevation may be due to stimulation of hypothalamic thyrotropin-releasing hormone. They add that one patient who had previously become a DBS non-responder found some relief of his affective symptoms during the day by switching the DBS off at night and resuming it in the morning, thereby recreating a short-term acute stimulation effect. (Nature Translational Psychiatry) Company Looks to Gain More Capital for Its Visual Prosthesis PipelineJan. 25, 2016 - Second Sight Medical Products, Inc. filed a proposed rights offering with the Securities and Exchange Commission for its existing companies. The company would use the proceeds for an ongoing safety and efficacy trial of its Argus® II Retinal Prosthesis System for the treatment of age-related macular degeneration and development of a visual cortical prosthesis to potentially treat nearly all forms of blindness. (Business Wire) Pharmacy Publication Features Bioelectronic MedicineJanuary 2016 - An article about bioelectronic medicine defines it as "the use of neurostimulation to modulate disease pathways." For now, the article says, vagus nerve stimulation is receiving the most attention for potentially treating disease conditions. (PharmaTimes) Researchers Publish Results of Prospective Peripheral Nerve Stimulation Clinical TrialJan. 22, 2016 - International Neuromodulation Society members Timothy Deer, MD; Jason Pope, MD; Ramsin Benyamin, MD; Richardo Vallejo, MD, PhD; David Caraway, MD, PhD; Peter Staats, MD; Eric Grigsby, MD; Porter McRoberts, MD; Tory McJunkin, MD; Robert Levy, MD; Leonardo Kapural, MD, PhD; and Nagy Mekhail, MD, PhD and colleagues have published Early View results of a partial crossover trial of a novel peripheral nerve stimulation device. They conclude the implantable device is safe and effective for treating neuropathic pain of peripheral nerve origin. In the safety and efficacy trial, 94 patients were randomized in control and active stimulation groups. The results showed that three months of active stimulation led to a 38% response rate (vs. 10% in the control group); and the mean pain reduction in the treatment group was 27.2% vs. 2.3% in the control group. (Neuromodulation: Technology at the Neural Interface) Hospital in India Announces Implantation of a Vagus Nerve Stimulation System in a Patient with Heart FailureJan. 20, 2016 - A cardiac care hospital in India has implanted a vagus nerve stimulation system in a patient who has heart failure, in an effort to increase tone of the parasympathetic nervous system and improve her symptoms. (Equity Bulls) Review Evaluates Evidence for Spinal Cord StimulationJanuary 2016 - International Neuromodulation Society members Jay Grider, DO, PhD; Laxmaiah Manchikanti, MD; Alexios Carayannopoulos, DO, MPH; Carl Balog, MD; Michael E. Harned, MD; Salim M. Hayek, MD, PhD; Ricardo Vallejo, MD, PhD; and Paul Christo, MD, along with other co-authors, have published a systematic review of spinal cord stimulation (SCS) in spinal pain. They found there was significant evidence -- Level I to II -- of the efficacy of SCS in lower-back failed back surgery syndrome. In addition, they found moderate Level II to III evidence for the efficacy of high frequency stimulation based on one randomized controlled clinical trial. They conclude more studies are needed and said that based on a lack of high quality studies, there was limited evidence for adaptive stimulation and burst stimulation. (Pain Physician) Observational Study Suggests Percutaneous Electrical Nerve Stimulation is Effective and Feasible in Neuropathic PainJanuary 2016 - International Neuromodulation Society members Giuliano De Carolis, MD; Goffredo Liberatoscioli, MD; Paola Nosella, MD; and Luigi F. Nardi, MD and co-authors published results of a multi-center observational study of percutaneous electrical nerve stimulation (PENS) in neuropathic pain. There were 76 patients who had a variety of conditions, such as post-herpetic pain and occipital neuralgia. The authors concluded that the intervention produced significant pain relief and is safe and feasible. (Pain Physician) Study Shows Headache Reduction from Non-invasive Vagus Nerve StimulationJan. 19, 2016 - International Neuromodulation Society member Thomas Kinfe and colleagues published data in the Journal of Headache and Pain that showed cervical non-invasive vagus nerve stimulation twice daily reduced the number of headache days per month from 14.7 to 8.9, and the number of monthly migraine attacks from 7.3 to 4.5. (Business Wire) Analysis Finds Spinal Cord Stimulation Lowers Amputation Rate in Chronic Critical Limb IschemiaJan. 18, 2016 - A meta-analysis of 13 studies comprising 595 patients concludes that spinal cord stimulation is better than medical management alone in preventing limb amputation for patients who have chronic critical limb ischemia, particularly in patients with less severe disease. The findings were presented in a poster at the Annual Pain Medicine Meeting of the American Society of Regional Anesthesia and Pain Medicine. (Pain Medicine) Authors Present an Overview for Pharmacists of Medical and Surgical Treatment for Parkinson's DiseaseJan. 18, 2016 - An article summarizes Parkinson's disease treatment and informs pharmacists they may see a Parkinson's patient more often after deep brain stimulation surgery, as medication dosages are adjusted. (Pharmacy Times) Non-invasive Stimulation for Fibromyalgia StudiedJan. 17, 2016 - A Phase II open-label study of high-definition transcranial direct current stimulation in 14 fibromyalgia patients, published in the Journal of Pain, explored dosing regimens for pain reduction. (National Pain Report) Column Presents Transcranial Magnetic Stimulation Options for DepressionJan. 17, 2016 - An article about transcranial magnetic stimulation (TMS) for depression describes deep TMS as a newer option for treatment-resistant depression. (New York Daily News) Pair Exhibit a Consumer Device in Development for Vagus Nerve Stimulation through EarbudsJan. 15, 2016 - International Neuromodulation Society member Daniel Cartledge, MD, and his brother, a cardiac and thoracic surgeon, have co-developed a vagus nerve stimulation device that was voted a top new digital health device at the Consumer Electronics Show. The product is an earbud device designed to be used with music and improve mood, although the product has no medical claims. The device is expected to enter the market in the next few months. (Palm Beach Post) Column Asks If More Will Be Done For Patients in a Minimally Conscious StateJan. 14, 2016 - A newspaper column mentions motor cortex stimulation and describes the ability to distinguish and partially rehabilitate patients who are in a minimally conscious state in which they retain some awareness and ability to respond. The writer asks if society will more fully restore the lives of people who may currently only receive custodial care. (Houston Chronicle) Company Announces New Head of Neuromodulation Business UnitJan. 14, 20i6 - LivaNova, PLC has named former Cyberonics, Inc. executive Jason Richey president of LivaNova's neuromodulation business unit and a member of the executive team. He was previously vice president of global sales and marketing for neuromodulation. (Street Insider) Device Maker Announces Sales GrowthJan. 13, 2016 - St. Jude Medical, Inc. expected to report consolidated net sales of approximately $1.447 billion for the fourth quarter of 2015. That is an increase of 7% on a constant currency basis. Sales of its neuromodulation products in the fourth quarter amounted to approximately $128 million, an increase of 9% on a constant currency basis over the fourth quarter of 2014. (Business Wire) Vagus Nerve Stimulation System Developer Raises $11 MillionJan. 13, 2016 - Minnesota-based EnteroMedics Inc. brought in $11 million in the 2nd tranche of a $25 million offering, announced in November, of senior amortizing convertible notes. The company received $1.5 million at the initial offering in November 2015. In 45 days, a 3rd tranche of $12.5 million is scheduled. The company has developed a vagus nerve stimulation system to treat metabolic diseases and other gastrointestinal disorders. (Mass Device) Company Describes Pursuing a Potentially Therapeutic Brain-Stimulation HeadsetJan. 13, 2016 - A U.K. company founded in 2014, Cerestim, says it has demonstrated a proof-of-concept for an alternating transcranial direct-current stimulation device to be remotely monitored by physicians. The company is initially targeting the product for depression and pending regulatory approval, would expect to market the home-use device in three to five years. An article explains that the headset is intended to identify dysfunctional neural activity and reset that through stimulation via electrodes tailored for each individual. (International Business Times) Singapore Initiative is Working to Create a Wireless NeurostimulatorJan. 13, 2016 - An initiative in Singapore is developing a wireless implantable chronic pain management device that is anticipated to be about as small as a grain of rice. The neurostimulator is being developed by the Institute of Microelectronics of the Agency for Science, Technology and Research (A*STAR) and the local biotechnology firm Biospark Technologies. (Today Online) Patient Enrollment is Complete in Tibial Nerve Stimulation StudyJan. 11, 2016 - Israel-based BlueWind Medical announced it has completed enrollment of 36 patients with overactive bladder in a clinical trial of its wireless neurostimulation device. The patients in the U.K. and Netherlands will have the device implanted in their lower leg to stimulate the tibial nerve. The company expects to present initial results in February 2016, and is gathering the data to support a CE Mark application. (PR Newswire) Research Indicates Non-Invasive Stimulation Can Potentially Help Suppress Migraine OnsetJan. 11, 2016 - In preclinical studies reported in Pain non-invasive vagus nerve stimulation (VNS) was found as effective as surgically implanted VNS in suppressing, by up to 40%, cortical spreading depression that is associated with pre-migraine aura. (PR Rocket) Reprogramming Helped Restore Efficacy of Spinal Cord StimulationJan. 8, 2016 - At the combined annual scientific meeting in London of the Neuromodulation Society of the United Kingdom and Ireland and the International Neuromodulation Society (INS) chapters from Germany and Switzerland, INS member Frank Wille, MD presented results gathered between 2010 - 2011 in the Netherlands that showed that reprogramming existing spinal cord stimulation (SCS) devices could restore efficacy in managing back pain. He said that in this high-density mode, the leads were implanted as close as possible to the T9 - T10 target, and the devices were operated at maximum frequency, with the pulse width as broad as possible and amplitude adjusted for continuous stimulation. Rather than have devices explanted, 65% of the patients continued to use their SCS systems one year later. (NeuroNews) Neurostimulation Device Maker Receives Regional Government Grant in BelgiumJan. 8, 2016 - Neurostimulation device maker Nuviant Medical received a research grant of €3.4 million from the Walloon Region government and plans to expand manufacturing operations there in a program that incorporates digital healthcare in collaboration with regional innovators. (Fierce Medical Devices) Researchers Report Long-term Data on Deep Brain Stimulation in DystoniaJan. 8, 2016 - A group of Korean researchers published long-term data on 36 patients with several types of dystonia that compares outcomes of deep brain stimulation to the globus pallidus interna. Their results suggest a favorable outcome is expected for patients with DYT-1 dystonia and isolated dystonia without a known genetic cause. (PLoS ONE) Optogenetics Study Examines Role of Hippocampus in Social MemoryJan. 5, 2016 - Laboratory researchers used optogenetics in mice to excite a part of the hippocampus involved in memory formation and found the stimulation enhanced social memory if applied during memory formation, but not during retrieval. (Molecular Psychiatry) Post-Market Surveillance: External Trigeminal Nerve Stimulation Compliance Rate is Twice That of Medical Management for Chronic MigraineJan. 7, 2016 - CEFALY Technology released data about patient compliance among 14,745 migraine patients who acquired the Belgium-based company's trigeminal nerve stimulation device between March 2014 and October 2015. The external device was FDA-approved in March 2014 to reduce the frequency and intensity of migraines. Full compliance would entail replacing the electrode every month. Based on recurrent orders of electrodes, the company reported a 72.4% compliance rate, twice that of oral preventive migraine medication. (Fierce Medical Devices) Company Sets Up Distribution Agreement in Germany for Non-Invasive Treatment for Chronic HeadacheJan. 6, 2016 - The pan-European pharmaceutical company Desitin, a distributor of treatments for Parkinson's disease and epilepsy, entered an agreement Jan. 1 to distribute ElectroCore's non-invasive vagus nerve stimulation device, gammaCore, to neurologists in Germany who treat migraine and cluster headache. (Business Wire) Medical Society Plans Movement Disorders Registry in IndiaJan. 5, 2016 - The Movement Disorders Society of India announced it is planning to create a registry of Parkinson's and movement disorder cases in the interests of optimizing treatment. Besides deep brain stimulation, the society is interested in potential novel treatments and planned a conference on Jan. 8 to discuss those. (Times of India) Case Reports Detail Considerations for Intrathecal Drug DeliveryJan. 1, 2016 - Since intrathecal drug delivery systems have been in use for more than two decades, the need to manage patients at the end of the device life is increasingly common, note International Neuromodulation Society members Jason Pope, MD and Timothy Deer, MD in a case report about a patient who experienced a decrease in analgesia and needed a replacement infusion pump. The authors also report about a novel delivery system for ziconotide, in a separate case report on Dec. 30, 2015. (Pain Medicine News) Authors Examine Growth of Emerging Indications for Deep Brain StimulationJan. 1, 2016 - There was rapid growth in the percentage of deep brain stimulation patients in the U.S. who were treated for indications under a humanitarian device exemption or other emerging indication in the last decade, according to analysis of hospital discharge records. The newer indications were associated with greater costs, so the authors of this study conclude that "additional costs should be anticipated as surgeons gain experience with new patient populations and targets." (Journal of Neurosurgery) |
| Last Updated on Monday, November 22, 2021 12:21 PM |