2015 News Briefs - International Neuromodulation Society

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January - December 2015

Review Examines Treatment Gap for Patients with Medication-Resistant Epilepsy

December 2015 - International Neuromodulation Society members Paul Boon, MD and Kensuke Kawai, MD, PhD joined colleagues in co-authoring a review about access to other treatments for patients who have drug-resistant epilepsy, including vagus nerve stimulation (VNS) and deep brain stimulation. They point out that education of patients and government payers in Japan helped raise awareness of the palliative benefits of VNS, which they say moved the technology from an orphan device status in the early 2000s to an approved status in 2010. There is currently an all-patient registry for people in Japan with epilepsy who are receiving VNS therapy, which shows 39% of patients achieved a seizure reduction of 50% or more. However, they add that a treatment gap continues, in which an estimated less than 1% of patients with drug-resistant epilepsy receive VNS treatment, although some two-thirds to three-quarters of patients with drug-resistant epilepsy are generally considered candidates for non-medical interventions. (European Neurological Review)

Column Describes Company's Interest in Vagus Nerve Stimulation for Tinnitus and Stroke

Dec. 31, 2015 - Frank McEachern, the CEO of Dallas, TX-based MicroTransponder, Inc. was interviewed about the company's interest in potentially applying vagus nerve stimulation to treat tinnitus or aid stroke rehabilitation. (Med City News)

Local News Outlet Follows Up Patient Whose Surgery Was Televised

Dec. 29, 2015 - International Neuromodulation Society member Jonathan Miller, MD was quoted in an article about a Parkinson's disease patient whose deep brain stimulation surgery was televised live in October. The neurosurgeon said many patients expressed feeling more informed and less fearful after seeing what takes place during the procedure. (IndeOnline)

Specialists' Evaluation Appeared to Anticipate Risks in an Essential Tremor Cohort

Dec. 28, 2015 - International Neuromodulation Society member Daniel Martinez-Ramirez, MD and colleagues at the University of Florida in Gainesville published an analysis of deep brain stimulation screening in 44 patients with essential tremor that examined the rate of unintended hospitalization within a year of surgery. In the retrospective analysis, the authors found that surgical concerns raised by seven specialties during the interdisciplinary screening directly related to the degree of unintended hospitalizations. They reason that such evaluation may help anticipate risk of complications, although prospective comparative research would need to confirm the results. (PLoS One)

Authors Present a Case Report of Closed-Loop Spinal Cord Stimulation for Neuropathic Pain

December 2015 - International Neuromodulation Society members Marc Russo, MBBS,DA (UK), FANZCA, FFPMANZCA, Timothy Deer, MD, and Jason Pope, MD co-authored a case report about a spinal cord stimulation patient who could not tolerate changes in stimulation due to positional changes. The patient enrolled in a clinical trial of a closed-loop system and has been satisfied with that pain relief method. The authors say continued research may demonstrate that feedback-loop control of paresthesia can provide a more constant therapeutic effect. (Pain Medicine News)

Burst-Mode Spinal Cord Stimulation Described in Case Report

December 2015 - International Neuromodulation Society members Ganesan Baranidharan, MD, Timothy Deer, MD, and Jason Pope, MD about a man with refractory peripheral neuropathic pain whose replacement pulse generator for his spinal cord stimulator allowed switching to burst stimulation. The man had less pain and more mobility. While he had been used to paresthesia, reprogramming of the new device eliminated unpleasant stimulation effects. The authors conclude "electrical dosing may be the key to further understanding the best methods of delivery of neuromodulation going forward." (Pain Medicine News)

Two Cases Presented of Pain Management in Limbs from Dorsal Root Ganglion Stimulation

December 2015 - International Neuromodulation Society members Timothy Deer, MD, Ganesan Baranidharan, MD, Jason Pope, MD, and Marc Russo, MBBS,DA (UK), FANZCA, FFPMANZCA present two cases of patients with chronic foot or arm pain. The patients were treated with unilateral stimulation of the dorsal root ganglion (DRG). At 6 - 12 months followup, they reported significant pain reduction. The authors report that DRG stimulation is approved in Europe and Australia and they anticipate a request for FDA approval based on findings from a prospective, randomized clinical trial that compared DRG stimulation to spinal cord stimulation. Meanwhile, they add, "additional studies are planned for DRG of the cervical and thoracic spine and new waveforms and frequencies on the DRG target." (Pain Medicine News)

Publication Profiles the International Neuromodulation Society President

Dec. 23, 2015 - International Neuromodulation Society President Timothy Deer, MD, was profiled in the December issue of NeuroNews. He spoke about the importance of research in improving outcomes and function and lowering costs of care. He also spoke about an evolution in technical capabilities so that patients may have more than one option from a single spinal cord stimulation device. (NeuroNews)

Authors Advise Primary Care Doctors When to Refer Patients for Spinal Cord Stimulation

December 2015 - An article advising primary care providers when to refer patients to spinal cord stimulation states that timely referral can have substantial effects on outcomes in appropriate candidates, and mentions indications in which it has been shown to be superior to conservative medical management or reoperation, has demonstrated clinical benefit, and been shown to be cost-effective. The indications cited are failed back surgery syndrome, complex regional pain syndrome, limb ischemia, and refractory angina pectoris. The article provides an efficacy table and a suggested treatment algorithm for certain types of back pain. The accompanying commentary summarizes peer-review papers by a number of International Neuromodulation Society members, and mentions authors Krishna Kumar, MD; Sam Eldabe, MD; Richard North, MD; Konstantin Slavin, MD; Rod Turner, PhD; and Nagy Mekhail, MD, PhD. (Pain Medicine News)

Company Raises Capital to Support a Clinical Trial of a Neuromodulation Device for Overactive Bladder

Dec. 21, 2015 - Axonics Modulation Technologies announced $38.5 million in Series B financing that it intends to use to support a clinical trial next year of its rechargeable sacral nerve stimulation system in patients with overactive bladder. The company has raised $59 million since it formed in 2013 to commercialize technology licensed from the Alfred E. Mann Foundation. (PE Hub Network)

Article: Deep Brain Stimulation to the Fornix is Feasible and Was Well-Tolerated in Study Subjects

Dec. 18, 2015 - An article documents the preoperative period in 46 patients with probable early Alzheimer's disease who received deep brain stimulation to the fornix during the 12-month ADvance clinical trial. The authors conclude that it is feasible to target this brain structure without directly injuring it, and the surgery was well-tolerated at 90 days. In 26 patients, there were 64 adverse events, seven serious, but no neurological deficits or deaths were reported. (Journal of Neurosurgery)

Company Plans Clinical Trial in France of Visual Prosthetic Device

Dec. 14, 2015 - Pixium Vision obtained regulatory approval to launch a clinical study in France of an epi-retinal implant designed to restore some vision in patients who have retinitis pigmentosa. This second-generation device has 150 electrodes. The company announced Dec. 21 it applied for CE Mark approval for the system. (Business Wire)

Researcher Explores Potential for Regulating Do-It-Yourself Brain Stimulation

Dec. 18, 2015 -  An MIT PhD student, Anna Wexler, has published two papers this fall in academic journals that have been noted by colleagues to encapsulate recent history and regulatory concerns about the do-it-yourself movement in transcranial direct current stimulation. She suggests that regulators should engage with the community to determine the extent of use and need for new guidelines, since as a practical matter, hobbyists are free to build their own devices. Meanwhile, she said there are "multiple, distinct" pathways in the U.S. where such devices might be regulated. For example, beyond the FDA, the U.S. Consumer Product Safety Commission and the Federal Trade Commission oversee regular consumer products' safety and advertising laws. Her papers appeared in the Journal of Medical Ethics and the Journal of Law and Biosciences (Bioscience Technology)

Funding Announcement Seeks Brain-Science Proposals

Dec. 18, 2015 - The National Institutes of Health is requesting applications for BRAIN Initiative funding to support projects that focus on tool development and mechanistic understanding of non-invasive neuromodulation techniques. An announcement notes that international organizations are welcome to apply. The application deadlines are in February and March 2016. (BRAIN Update)

Forum Focuses on Emerging Neurotechnology

December 2015 - The 15th annual Neurotech Leaders Forum in San Francisco in November featured regulators, funders, and entrepreneurs who discussed emerging technologies and the path to market. Speakers included the FDA's director of Neurological and Physical Medicine Devices, Carlos Pena, who described how FDA intends to decide investigational device exemption requests within 30 days, and other ways the agency is endeavoring to make its processes timely and effective. Other sessions focused on considerations for device security. (Neurotech Business Report)

Company Says Cohort Group Comparison Demonstrates Improvements from Newest Spinal Cord Stimulator

Dec. 16, 2015 - Data presented at the North American Neuromodulation Society meeting in December updated initial results from the long-term LUMINA spinal cord stimulation (SCS) study, initially shown at the International Neuromodulation Society 12th World Congress in June. Boston Scientific Corporation announced the data from four patient groups who were followed for up to 24 months demonstrate that the company's most-recent SCS system provides a 70% improvement in lower back pain relief compared to the previous-generation device. The latest system has 32 contacts and four lead ports, along with programming software that is based on three-dimensional modeling of spinal cords. (Med Device Online)

Study Indicates Non-invasive Optic Nerve Stimulation Can Improve Neuropathic Vision Loss

Dec. 14, 2015 - Data were presented at the North American Neuromodulation Society on a controlled clinical trial of transorbital optic nerve stimulation in patients with optic neuropathy that caused visual field loss. In the study, 45 patients received stimulation and 37 received placebo. The results indicate the stimulation group benefited from a significantly improved visual field compared to the control group, according to an announcement by EBS Technologies GmbH, which has received CE Mark approval to market the therapy in the European Union. (Sys-con.com)

Company Plans U.S. Clinical Trial of Percutaneous Stimulation in Chronic Migraine

Dec, 11, 2015 - StimRelieve LLC announced FDA investigational device exemption approval to begin a clinical trial of percutaneous, wirelessly powered neurostimulators to treat medically refractory chronic migraine. (Business Wire)

Long-Term Data Show Benefits of Dorsal Root Ganglion Stimulation for Pain Conditions

Dec. 11, 2015 - St. Jude Medical, Inc. announced long-term data presented in a plenary session at the North American Neuromodulation Society meeting show dorsal root ganglion stimulation provides sustained and superior pain relief over traditional spinal cord stimulation in patients with complex regional pain syndrome or peripheral causalgia.The data from the ACCURATE study confirm three-month primary endpoint data that was originally presented at the International Neuromodulation Society World Congress in June 2015. (Business Wire)

Study Results Presented Comparing Tonic and Burst Spinal Cord Stimulation

Dec. 11, 2015 - St. Jude Medical, Inc. announced the SUNBURST study has demonstrated that burst stimulation is superior to traditional tonic spinal cord stimulation in relieving chronic pain. The study results presented in a plenary session at the North American Neuromodulation Society meeting  showed patients preferred burst stimulation and most experienced less paresthesia or none. (Business Wire)

Vagus Nerve Stimulation Studied for Preventing Blood Flow After Trauma or Surgery

Dec. 10, 2015 - International Neuromodulation Society member Jared Huston, MD, PhD was scheduled to present data Doc. 12 at the North American Neuromodulation Society meeting that indicates vagus nerve stimulation is a potentially efficacious and safe way to stop bleeding and prevent hemorrhagic complications following surgery and other invasive procedures. (Blackbird)

Company Announces Mobile Application Partnership

Dec. 11, 2015 - Medtronic plc is expanding a partnership with Samsung Electronics America that began in june with smart devices for diabetes to now also develop Android mobile applications for neuromodulation devices. (Fierce Medical Devices)

Company Anticipates Medicare New Device Payment Specifications in January

Dec. 10, 2015 - Nevro Corp. announced the Centers for Medicare & Medicaid Services approved a transitional pass-through payment, under a new device category, for high frequency stimulation under the Medicare hospital outpatient prospective payment system to begin Jan. 1, 2016. (Street Insider)

Equipment Manufacturer Expands Access to Implantable Pulse Generator Platform Technology

Dec. 10, 2015 - Evergreen Medical Technologies, Inc. announced it is expanding product development services through access to AdvaStim's customizable, modular core electronic components for implantable pulse generators, the ASICore platform. These components can be applied to various neurostimulation applications, from spinal cord stimulation and deep brain stimulation to prosthetic control. (Business Wire)

Company Says Injectable Spinal Cord Stimulation System Received Marketing Clearance in Europe

Dec. 10, 2015 - Medical device distributor Stimwave Neuro LP announced CE Mark approval for Stimwave Technologies Incorporated's Freedom spinal cord stimulation system for pain relief of the back or legs. The system incorporates up to eight electrode contacts and an embedded chip, that are introduced into the body through a needle. (Business Wire)

Preliminary Results Presented in Phase I Clinical Trial of External Trigeminal Nerve Stimulation in Post Traumatic Stress Disorder

Dec. 10, 2015 - At the North American Neuromodulation Society meeting, NeuroSigma, Inc. presented preliminary findings from a Phase I clinical trial of external trigeminal nerve stimulation in combat veterans who have post traumatic stress disorder. The preliminary results indicate improvements in symptoms and desired changes in brain activity. (Pharmiweb.com)

Company Announces Its Deep Brain Stimulation Systems Have Expanded Conditional Approval for MRIs

Dec. 9, 2015 - Medtronic plc announced that systems within its Activa® portfolio of deep brain stimulation devices have received FDA approval for full-body magnetic resonance imaging under specific conditions of use. (Street Insider)

Company Announces FDA Approval of Its Neuromodulation Device for Chronic Back and Leg Pain

Dec. 9, 2015 - Stimwave Technologies announced it has received FDA clearance to market its  wireless neuromodulation device for relief of chronic back and leg pain. (Digital Journal)

Results Published in Clinical Trial of Vagus Nerve Stimulation During Stroke Rehabilitation; Company Plans Further Research and Announces Additional Funding

Dec. 9, 2015 - International Neuromodulation Society member Jesse Dawson, MD was quoted in an article about a small controlled study he and colleagues published in Stroke that suggests pairing vagus nerve stimulation with upper-limb rehabilitation is safe and feasible after stroke. Based on those results, MicroTransponder, Inc. is conducting a 20-patient followup study in the U.S. and the U.K. The privately held company announced that it has closed a $5.5 million round of funding to support its activities. (Medgadget)

Company Anticipates Distributing Its Transcranial Magnetic Stimulation Systems in Mexico in 2016

Dec. 8, 2015 - Brainsway Ltd. announced an exclusive distribution agreement with moksha8 in Mexico, where the distributor plans to make Brainsway's deep transcranial magnetic stimulation system available in 2016 as a treatment for major depressive disorder. (Globes)

Researchers Study Transcranial Magnetic Stimulation in Cocaine Addiction

Dec. 3, 2015 - A paper in European Neuropsychopharmacology reports on a small, controlled study of repetitive transcranial magnetic stimulation (rTMS) to the dorsolateral prefrontal cortex as a potential treatment for cocaine addiction. Of the 32 patients in the study, 19 received active treatment for one month, while the other 13 in the control group received usual care. After one month, 69% of the patients in the treatment group had no positive drug tests, compared to 19% of patients in the control group. (Health Day)

Neurosurgeon is Recruiting Study Subjects to Test Spinal Stimulation in Paraplegia

Dec. 3, 2015 - International Neuromodulation Society member Peter Konrad, MD, PhD, is seeking patients with paraplegia for a proof-of-concept study of intraspinal microstimulation as a possible way to restore some complex body movement. (Vanderbilt)

Research Group Receives $2.4 Million to Study High Frequency Stimulation for Pain

Dec. 2, 2015 - The National Institute of Neurological Disorders and Stroke awarded a $2.4 million grant to scientists associated with the Cleveland Functional Electrical Stimulation (FES) Center for preclinical research into the pain-relieving mechanisms of high frequency spinal cord stimulation. (EurekAlert)

Company Receives Clearance to Test Implantable Device in Craniofacial Neuropathic Pain

Dec. 2, 2015 - StimRelieve LLC, announced it has received an FDA Investigational Device Exemption for a clinical trial of its injectable, wirelessly powered, stimulator to test the device for the treatment of refractory craniofacial neuropathic pain. Its Halo CFNS system is powered by an external transmitter placed on the ear. (Businesswire)

Stimulation Therapy for GERD Receives Approval in Brazil

Dec. 2, 2015 - EndoStim announced that ANVISA, the Brazilian health authority, approved its minimally-invasive therapy for gastroesophageal reflux disease (GERD) in Brazil. The EndoStim II LES Stimulation System is intended for patients who "may not be ideally treated with medication therapy," the company said. The stimulation targets the lower esophageal sphincter between the stomach and esophagus to improve or strengthen its function. (PR Newswire)

Projected Sacral Nerve Stimulation Costs to Be Presented at NANS

Dec. 2, 2015 - Axonics Modulation Technologies, Inc. announced that an abstract will be presented on Dec. 12 at the North American Neuromodulation Society (NANS) meeting that compares estimates of long-term treatment costs for overactive bladder using either rechargeable, or non-rechargeable, sacral nerve stimulators (SNS). The analysis is based on a model that uses a U.S. payer perspective. Results indicate a rechargeable system would have significantly lower costs per patient. Axonics is developing a rechargeable SNS system. (Businesswire)

Petition for Review Denied on U.S. Patent for High Frequency Spinal Cord Stimulation

Dec. 1, 2015 -  Despite two petitions challenging validity of some patent claims for high frequency spinal cord stimulation, the Patent Trial and Appeals Board (PTAB) at the U.S. Patent Office has decided to not conduct an inter partes review, the patent-holder, Nevro Corp., announced. http://www.prnewswire.com/news-releases/nevro-announces-the-us-patent-and-trademark-offices-denial-of-boston-scientific-petitions-for-inter-partes-review-of-us-patent-no-8359102-300185543.html The PTAB decided against holding a review after considering two petitions filed in May 2015 by Boston Scientific Corporation that challenged certain claims in Nevro's patent (U.S. Patent No. 8,359,102). (Fierce Medical Devices)

Company Announces FDA Approval for Spinal Cord Stimulation System

Nov. 30, 2015 - Greatbatch, Inc. announced FDA approval for its spinal cord stimulation system, Algovita®, which was developed by the company's subsidiary, QiG Group. The subsidiary is in the process of being spun out as Nuvectra Corporation, a process that is expected to be complete in the first quarter of 2016. (Nasdaq)

Regional Brain Center Opens in Southwest England

Nov. 27, 2015 - The University of Bristol is pooling expertise with the North Bistrol NHS Trust in the new Bristol Brain Centre that opened on November 25. The facility includes a deep brain stimulation service and health integration team for movement disorders that is designed to fully integrate all aspects of clinical care, translational research and education. (University of Bristol)

Review: Evidence for Neuromodulation in Emerging Indications

Nov. 25, 2015 - A review of clinical trials of neuromodulation in treating pain from coronary artery disease, peripheral vascular disease, headache, and peripheral field stimulation found "compelling evidence . . . that neuromodulation can be of benefit for patients with serious painful conditions that are not currently approved by the FDA." (Pain Practice)

Company Opens an International Headquarters in Germany

Nov. 25, 2015 - Autonomic Technologies, Inc. is opening a new international headquarters in Munich, Germany. The company is commercializing sphenopalatine ganglion stimulation for cluster headache, and its device has received CE Mark in Europe. (Market Wired)

Dopamine Detection Points to More-Complex Role in Learning

Nov. 23, 2015 - Rapid detection of dopamine in the brains of 17 patients with Parkinson's disease who were undergoing deep brain stimulation surgery suggests dopamine's role in learning and decision making is more complex than previously thought. The researchers used a carbon fiber electrode and fast-scan cyclic voltammetry to record dopamine fluctuations while the patients played an investment game. The data indicated that dopamine neurons appear to track not merely risk and reward, but also whether an outcome could have been better or worse. (EurkeAlert)

Deep Brain Stimulation Surgery Performed with Continuous MRI Guidance

Nov. 23, 2015 - MRI Interventions, Inc. announced the first MRI-guided electrode placement for deep brain stimulation surgery in Arizona, at the Banner - University Medical Center in Tucson. (CNN Money)

Researchers Investigate Impact of Vagus Nerve Stimulation on Sleep Breathing Disorders

Nov. 23, 2015 - A research study evaluated the effects of vagus nerve stimulator implantation on 23 patients with epilepsy. After implantation, 57.9% of the patients developed new-onset mild to moderate sleep breathing disorders. The researchers linked the problems to laryngeal motility patterns, and call for the need to routinely examine these issues before and after implantation, through collaboration between neurologists and otolaryngologists. (Neurology Advisor)

Group Eyes Commercialization of Neuromodulation to Control Bleeding

Nov. 22, 2015 - A nerve-stimulation device under development to control bleeding is expected to be subject to a new spin-out company in three months, as a step toward preparation for clinical trials. (Innovate Long Island)

Company Announces FDA Approval of Spinal Cord Stimulation System

Nov. 19, 2015 - St. Jude Medical announced FDA approval of its Proclaim Elite Spinal Cord Stimulation System, a non-rechargeable device that is upgradable to allow for new simulation waveforms and software updates. The patient controller and physician programmer use wireless and mobile technology for use during a trial phase and for tailoring stimulation parameters, respectively. (Fierce Medical Devices)

Company Says Its Device to Address Heart Failure Will Have Expedited FDA Review

Nov. 19, 2015 - Minneapolis-based CVRx announced that its neuromodulator to treat heart failure is the fifth device to enter the six-month-old FDA Expedited Access Pathway. The device is designed to reduce the workload of the heart through modulating the baroreflex system that helps control blood flow. The device activates the baroflex through the afferent (sensory) pathway, helping to restore autonomic balance between the sympathetic and parasympathetic systems. (Fierce Medical Devices)

Article Reports Factors Influencing Reluctance to Have Deep Brain Stimulation for Parkinson's Disease

Nov. 18, 2015 - Researchers in Seoul reported that of 186 patients who underwent deep brain stimulation (DBS) to the subthalamic nucleus for Parkinson's disease, 45% were reluctant. The main reasons were fear of complications (74%) and economic burden (50%). The main reasons they decided to undergo DBS were trusting the doctor’s decision (80%) and family encouragement (36%). (Parkinsonism & Related Disorders)

Company Receives Clearance to Market Non-Invasive Stimulation System in Europe

Nov. 16, 2015 - NeuroSigma Systems announced CE Mark approval for its external trigeminal nerve stimulation system to treat attention-deficit hyperactivity disorder in people aged 7 years or older. (Mass Device)

Clinical Trial Results Presented of Stimulation Therapy for Optic Neuropathy

Nov. 16, 2015 - EBS Technologies GmbH presented clinical trial results this month at an Annual Scientific Meeting of the Neuromodulation Society of the United Kingdom and Ireland, held jointly with and the German and Swiss neuromodulation societies in London. In the randomized controlled clinical trial that was presented at the meeting, 51 patients with optic neuropathy who received transorbital optic nerve stimulation, compared to 47 who received a placebo, were reported to show a significantly improved visual field. (Marketwired)

Column Addresses Spinal Cord Stimulation for Chronic Pain

Nov. 16, 2015 - A physician responded in his column to questions from a grandmother whose grandson was referred to spinal cord stimulation for post-herpetic neuralgia in the UK. He points out that the treatment is usually considered after more conservative measures have failed, and is recommended for neuropathic pain by the National Institute for Health and Care Excellence. (Daily Mail)

Researchers Develop Proof-of-Concept Brain-Monitoring Probe

Nov. 16, 2015 - An article details development of flexible polymer fibers that were demonstrated in mice for use as simultaneous electrical, optical, and chemical probes of brain activity. (SPIE)

Patients Recount Their Experiences with Transcranial Magnetic Stimulation

Nov. 15, 2015 - A long article on transcranial magnetic stimulation for depression describes the experience of two patients whose symptoms were lessened through using the therapy. (Lowell Sun)

News Feature Describes Potential for Vagus Nerve Stimulation Therapies

Nov. 13, 2015 - A news feature about vagus nerve stimulation covers its potential as a therapy for inflammatory disease and heart disease, as well as touching upon other existing or emerging indications, such as epilepsy and depression. (Science News)

Another Partner is Announced for Diaphragm-Pacing System

November 2015 - Oberlin, Ohio-based Valtronic is partnering with Synapse Biomedical to commercialize a third-generation, fully implantable diaphragm pacing technology. Valtronic and other partners plan to provide matching funds for the commercialization, which is being supported by a $3 million economic-development grant from Ohio Third Frontier. The device is also being commercialized in Asia with help from another partner, USCI Japan Ltd. (U.S. Tech)

Researchers Combine a Sensing Array with Light Stimulation for Optogenetic Studies

Oct. 12, 2015 - An article in Nature Methods describes development of a cortical sensing array with the capability to deliver light in a controlled pattern for optogentic studies. The array on transparent zinc oxide includes an optoelectronic actuator. The device was applied in transgenic mice to investigate light-perturbed cortical microcircuit dynamics and effects on their behavior. (Kurzweil)

Company Plans to Present Peripheral Nerve Stimulation Data Next Month

Nov. 12, 2015 - Israel-based BlueWind Medical plans to present details of its miniature leafless neurostimulator clinical trial in neuropathic pain patients during the North American Neuromodulation Society meeting in Las Vegas in December. The study was performed in four centers in Belgium and Poland, with up to six months' follow-up. (PR Businesswire)

Study Focuses on the Role of Brain Activity in Eating Behavior

Nov. 11, 2015 - International Neuromodulation Society member Brian Kopell, MD, commented in a news article about a small study of transcranial direct current stimulation as a potential intervention in obesity. He said such an intervention theoretically may block the impulse to eat high-sugar foods and allow the brain to return to its normal state in terms of sugar craving. (Endocrine Web)

Authors Voice Caution Regarding Brain Stimulation for Cognitive Issues

December 2015 - Co-authors based in Italy write that any use of deep brain stimulation in cognitive impairment, especially memory loss, should be reserved for investigational settings that have clear protocols and strict inclusion criteria. (Current Opinion in Neurology)

Optogenetics Researchers Receive a Technology Prize

Nov. 9, 2015 - Ed Boyden, PhD of MIT and Karl Deisseroth, MD, PhD of Stanford University were among five scientists to win Breakthough Prizes in life sciences at the third annual gala founded by Silicon Valley entrepreneurs. The prize is worth $3 million. The recognition they received acknowledges their work in developing optogenetics as a tool for understanding the function of brain circuits, and potentially developing therapies that address circuit disorders. (Business Insider)

Article Examines Concerns About "Home-Made" Electrical Stimulation Devices

Nov. 9, 2015 - An article covers concerns about interest in transcranial direct current stimulation among do-it-yourself enthusiasts. (Wall Street Journal)

Older Subgroup Showed Gains in Small Clinical Trial of Brain Stimulation in Alzheimer's Disease

Nov. 9, 2015 - In further details about Functional Neuromodulation's small Phase 2 clinical trial of deep brain stimulation to the fornix in patients with mild Alzheimer's disease, results showed some clinical benefit to a subgroup of patients aged 65 or older. This 30-patient subgroup had 15 patients in each of the sham and treatment arms, who were followed for 12 months. In the subgroup, treatment yielded a significant improvement, compared to the control group, in glucose metabolism. The subgroup patients who were treated also showed reduced cognitive decline but the study wasn't adequately powered to achieve statistical significance on the clinical measures used to track cognitive performance. (Fierce Medical Devices)

Optogenetics Recognized by Prize Competition

Nov. 10, 2015 - Breakthrough Prize winners announced in Northern California on Sunday included co-developers of optogenetics, who will receive $3 million each from organizers, who amassed fortunes through technology advances in Silicon Valley. The event is in its third year. (Reuters)

Company Reports on Past Fourth Months of Activities

Nov. 9, 2015 - Mainstay Medical International plc issues an Interim Management Statement from July 1, 2015 to the present. The statement said that the company submitted an application for CE Mark for its neurostimulation system for chronic low back pain, closed a debt financing for up to $15 million, and announced issuance of three U.S. patents during that period. (Business Wire)

Team Develops a Three-Dimensional Printed Brain Model

Nov. 8, 2015 - International Neuromodulation Society member Ivar Mendez, MD, PhD, head of surgery at the University of Saskatchewan, has worked with a team of engineers, MRI technicians, neuropsychology specialists and a radiologist to convert MRI data into a clear, three-dimensional printed structure that may be used in planning deep brain stimulation. (3dprint.com)

Company Plans to Enter Phase 3 Clinical Trial of Deep Brain Stimulation in Alzheimer's Disease

Nov. 6, 2015 - Functional Neuromodulation Ltd. announced it will start a Phase 3 trial of deep brain stimulation to the fornix in mid-2016. The company presented an analysis of its Phase 2 study, ADvance, at the 2015 Clinical Trials in Alzheimer's Disease meeting in Barcelona, Spain. The double-blind randomized controlled trial examined deep brain stimulation for mild Alzheimer's disease. (PR Newswire)

Patient Receives New Neurostimulator Device to Treat Heart Failure

Nov. 5, 2015 - A patient in Croatia is the first to begin using a catheter-based neurostimulator device to treat congestive heart failure, Enopace Biomedical, announced. The leadless, active miniature stimulator and is implanted in a 30-minute percutaneous procedure, and is designed to increase cardiac efficiency by reducing left ventricular workload. (PR Newswire)

Article Describes an Overactive Bladder Patient's Sacral Nerve Stimulation Therapy in India

Nov. 5, 2015 - An article says an elderly woman who had refractory overactive bladder for three years underwent the "new and specialized" treatment of sacral nerve stimulation. (Hans India)

Woman Says Her Depression Has Been Lessened Through Transcranial Magnetic Stimulation

Nov. 5, 2015 - A woman describes the benefits she received from transcranial magnetic stimulation treatment for depression. (KOAA)

Newscast Features Teen-Ager Who Receives Deep Brain Stimulation to Manage Dystonia

Nov. 4, 2015 - An article about a young man who received deep brain stimulation for dystonia calls it a rare and complicated surgery. The patient's mother added that she feels it has given him his life back. (KSTP)

Researchers Publish Proof-of-Concept Non-invasive Stimulation Approach to Weight Loss

Nov. 4, 2015 - A proof-of-concept study published in Obesity suggests that anodal transcranial direct current stimulation to the left dorsolateral prefrontal cortex may facilitate weight loss. (NIH)

Responsive Neurostimulation System Receives Recognition

Nov. 4, 2015 - NeuroPace, Inc. announced it received an award that recognizes its responsive neurostimulation system as the most promising new product of the year. The award was presented at the 2015 Phoenix Medical Device CEO Conference, which is comprised of medical device and diagnostic industry executives. (Business Wire)

Enrollment Opens in Clinical Trial of Transcranial Magnetic Stimulation in Adolescents with Treatment-Resistant Depression

Nov. 2, 2015 - Neuronetics, Inc. announced enrollment is beginning for a randomized controlled clinical trial to evaluate the acute and long-term effectiveness of transcranial magnetic stimulation in adolescent patients  aged 12-21 who have treatment-resistant depression. (PR Newswire)

Article Features Research Into Development of Prosthetic Devices to Address Memory Impairment

Nov. 3, 2015 - Two presentations at the Society for Neuroscience meeting in October described work funded by the Defense Advanced Research Projects Agency intended to develop devices to address memory impairment. The studies involved cortical readings made during assessment of epilepsy patients. One approach is based on mapping signals in the hippocampus associated with memory formation, which led to development of an algorithm that mimics that signaling with about 80% accuracy. Another approach is based on the observation that stimulation of the medial temporal lobe, which houses the hippocampus, improves periods of poor memory but impedes memory when it is functioning well. By stimulating only when memory was predicted to be poor, the researchers could boost recall up to 140%, (Nature)

Study Investigates Transcranial Direct Current Stimulation in Motor-Task Training

Nov. 2, 2015 - A Phase 2 double-blind trial of transcranial direct current stimulation, presented at the 44th Child Neurology Society Annual Meeting, involved 24 children aged 6 to 18 years old who had experienced a stroke at birth with resulting weaknesses at one side. Results showed that combining stimulation sessions with after-school occupational therapy led to improvements in subjects' ability to complete motor tasks, such as tying shoes. (Medscape)

Show Features Use of Deep Brain Stimulation to Treat Parkinson's Disease

Nov. 2, 2015 - International Neuromodulation Society member Corneliu Luca, MD, PhD was interviewed in a telecast about a Miami, FL-area woman who received a deep brain stimulation system to manage symptoms of Parkinson's disease. (WNDU)

Low Back Pain Therapy Developer Applies for CE Mark

Nov. 2, 2015 - Dublin-based Mainstay Medical has applied for CE Mark approval of its neurostimulation device to treat lower back pain. The company said that a study with 46 patients showed almost two-thirds had less lower-back pain three months after implantation, and more than half had their condition improve. In addition, the company said a little more than two-thirds of people treated reported a better quality of life and the benefits continued for six months. (Fierce Medical Devices)

Column Describes Promise of Noninvasive Approach to Potentially Enhance Brain Plasticity

Nov. 2, 2015 - Helius Medical Technologies, Inc. is developing a therapeutic approach to improve injury-associated brain-function impairment and related symptoms by combining physiotherapy with neurostimulation of the tongue. A columnist writes that the approach "will have a long path forward, but could be a real catalyst for retraining the human brain." (Forbes)

Results Reported in Pilot Clinical Trial of Noninvasive Stimulation for Multiple Sclerosis

Nov. 2, 2015 - A pilot study of a potential therapy for multiple sclerosis that combined physiotherapy with portable neuromodulation stimulation met all its objectives, Helius Medical Technologies, Inc. reported. The controlled clinical trial of 14 patients in Montreal suggested that a definitive clinical trial would require 128 subjects. Functional MRI results suggested that the investigational device may facilitate neural plasticity. (Business Wire)

Pilot Study Explores Effects of Vagus Nerve Stimulation on Breathing and Heart Rate

Oct. 23, 2015 - A pilot study by International Neuromodulation Society member Cecile de Vos, PhD and colleagues compared effects of vagus nerve stimulation (VNS) in five patients who experience impacts on breathing and heart rate during exercise, and five patients who don't. For controls, the study also included five persons who do not have VNS systems. Data showed most VNS patients had more rapid breathing and slowed heart rate when resting or exercising. (Seizure)

Ambulatory Surgery Centers Consider Neuromodulation as an Alternative to Opioids for Pain Management

Oct. 30, 2015 - An article calls neuromodulation an up-and-coming trend in pain management in the ambulatory surgery clinical setting. For instance, the head of an ambulatory surgery center said he was interested in neuromodulation as a non-narcotic option for pain management. (Becker's ASC Review)

Publication Features Overview of Neuromodulation

Oct. 29, 2015 - An annotated set of 30 slides co-authored by a neurohospitalist and by the editorial director of Medscape Psychiatry introduces "Pain, the Brain, and Many Uses of Neurostimulation." (Medscape)

Neurosurgeons Apply Focused Ultrasound to Treat Essential Tremor

Oct. 28, 2015 - International Neuromodulation Society member Ali Rezai, MD, is quoted in a video clip about a procedure that treats essential tremor using focused ultrasound. He called it "brain surgery without cutting the skin." (DOTmed News)

Researchers Seek to Improve Spinal Cord Stimulation Through Varying the Stimulation Pattern

Oct. 28, 2015 - International Neuromodulation Society member Nandan Lad, MD, PhD, is working on new programming paradigms for spinal cord stimulation (SCS) that may provide a 30% improvement in pain control and also potentially use less energy, based on predictive modeling he has done with a university colleague. Patients with existing SCS systems are being sought to see if reprogramming their devices yields improvements, as suggested by preclinical studies. (Duke Pratt School of Engineering)

Interest Grows in Potentially Relieving Fibromyalgia Using Transcranial Direct Current Stimulation

Oct. 28, 2015 - A news feature recounts recent studies showing potential promise of transcranial direct current stimulation to help relieve fibromyalgia. (National Pain Report)

Article Notes Neuroprosthetics May Be Closer to Commercialization

Oct. 28, 2015 - A brief article suggests that neuroprosthetic devices to help people with spinal cord injury move their muscles may be marketed as early as 2017. (Healthline News)

Developer of Cardiac Neuromodulation Device Announces Financing Round

Oct. 27, 2015 - Minneapolis-based Cardionomic, Inc. says it is developing a short-term neuromodulation therapy  to treat acute decompensated heart failure through stimulation of selected cardiac nerve branches. The stimulation is intended to increase heart muscle contractibility. The company announced $20 million in Series A financing from a number of investors, including New Enterprise Associates (NEA), the Cleveland Clinic, and Greatbatch, Inc. The therapy under development is expected to be delivered for 1 - 3 days upon a patient's admission to the hospital. The intent is to improve the heart's pumping performance to rebalance blood flow to the kidneys, brain, and other organs. The rebalance should help improve kidney function in order to reduce fluid retention. (Fierce Medical)

Radio Interview Features International Neuromodulation Society Activities

Sept. 15, 2015 - A radio station at McGill University devoted two program sessions to interviews about the International Neuromodulation Society (INS) 12th World Congress in Montreal, speaking with the head of the local organizing committee, Canadian Neuromodulation Society President Michel Prudhomme, MD, PhD, and INS President Timothy Deer, MD, who chaired the scientific program. Dr. Prudhomme pointed out that a recent survey showed about 70 percent of pain patients who might be appropriate to refer to neuromodulation had not heard about the treatment, and nor had a similar percentage of referring physicians, although its efficacy and cost-effectiveness has been established. Among a number of topics discussed, Dr. Deer talked about globalization of access and emerging new neurostimulation targets and waveforms. (The recording can be played after downloading the audio file.) (Health on Earth)

Neuromodulation Company Announces New Investment

Oct. 26, 2015 - Helius Medical, which is commercializing a portable neuromodulation stimulator in several countries in Asia, raised $2 million in new financing from an anonymous donor, and intends to raise up to $12.3 million for the round. (Mass Device)

Column Profiles Patient with Chronic Limb Pain Who Was Aided by Dorsal Root Ganglion Stimulation

Oct. 26, 2015 - A man with complex regional pain syndrome in his hand had dorsal root ganglion (DRG) stimulation in England to reduce his chronic pain symptoms. International Neuromodulation Society member Vivek Mehta, FRCA, MD, FFPMRCA, commented that DRG stimulation is exciting because it allows precise pinpointing of the treatment. (Daily Mail)

Presenter Suggests Noninvasive Stimulation May Help Manage Overactive Bladder Symptoms

Oct. 26, 2015 - A transcutaneous foot stimulation approach using external electrodes was described at the International Continence Society annual meeting as a potential way to treat overactive bladder through home-based treatment. Nineteen women stimulated the plantar surface of their sole for three hours each evening for seven days to activate lateral and medial plantar nerves. The presenter said the results of the small study were comparable to pharmaceutical treatment. He is planning a larger, randomized, sham-controlled trial to examine different stimulation periods to define the ideal time frame. (Urology Times)

Televised Deep Brain Stimulation Surgery Went Smoothly, News Outlet Reports

Oct. 26, 2015 - National Geographic reported that a deep brain stimulation surgery that was aired on television in real time in the U.S. went smoothly, and a neurologist who followed the coverage but was not personally involved was quoted as noting the media coverage of the Parkinson's disease patient's surgery was handled appropriately. (National Geographic)

First Patients are Enrolled in a Phrenic Pacing Neurostimulation Trial

Oct. 21, 2015 - Lungpacer, Inc. announced it has successfully tested the first five patients in the Phrenic ACtivation for Enhanced Respiration (PACER) early feasibility trial of its intravenous electrode catheter and diaphragm pacing system. The system stimulates the phrenic nerve of critical-care patients who need ventilation support. (Medgadget)

Neurostimulation System for Gastroesophogeal Reflux Disease Receives Expanded CE Mark Approval for Magnetic Resonance Imaging

Oct. 20, 2015 - Endostim announced CE Mark approval that expands magnetic resonance imaging (MRI) options for patients with gastroesophageal reflux disease who have its EndoStim II implant that provides stimulation of the lower esophageal sphincter muscle between the esophagus and stomach. Current or future patients may have full body MRI scans using 3.0 Tesla MRI machines, and imaging of the head and extremities may also continue to be performed using both 1.5-Tesla and 3-Tesla systems. (PR Newswire)

Early View: International Survey of Infection Control Practices for Spinal Cord Stimulation

Oct. 22, 2015 - International Neuromodulation Society members David A. Provenzano, MD; Timothy Deer, MD; Simon Thomson, MBBS; Salim M. Hayek MD, PhD; and Maunak V. Rana, MD have published results of a survey undertaken with colleagues that will help guide development of consensus policy and education about evidence-based infection-control strategies during spinal cord stimulation trial procedures and permanent implantation. The international survey of more than 500 physicians, believed to be the first of its kind, showed areas for improvement in infection control during preoperative, intraoperative, and postoperative periods. (Neuromodulation: Technology at the Neural Interface)

Case Report: Sacral Nerve Stimulation Improved Proctitis Symptoms

November/December 2015 - In a case the authors say demonstrates the relevance of exploring sacral nerve stimulation (SNS) for indications beyond fecal incontinence, a team of doctors in France report that a patient with medically refractory bleeding, inflammation, and fecal incontinence due to proctitis improved during three weeks of temporary SNS. The patient's endoscopic and histologic scores improved, junctional protein mRNA expression transiently increased, and rectal barrier permeability decreased. After 18 months of permanent stimulation, the patient remained improved. (Journal of Clinical Gastroenterology)

Retrospective Analysis Supports Option of Peripheral Nerve Stimulation for Refractory Headache

Oct. 22, 2015 - A review of records of 46 patients who received peripheral nerve stimulation between 2005 and 2012 for chronic intractable headache showed 87% of patients had pain scores reduce by 50% or more after one year, with pain decreasing even more the longer the device was in place. The authors conclude that peripheral nerve stimulation should be considered a viable treatment option. (Neurology Advisor)

Body-Worn Sensors Investigated for Adjusting Deep Brain Stimulation to Manage Tremor

Oct. 23, 2015 - A research group at Stanford is developing a wearable sensor system to detect and respond to tremors in patients who have deep brain stimulation systems. (KGO-TV)

Company Acquires Technology for Multi-Coil Transcranial Magnetic Stimulation

Oct. 20, 2015 - Rio Grande Neurosciences announced it has acquired Cervel Neurotech’s multi-coil transcranial magnetic stimulation technology, including all related patent applications, issued patents, trademarks and equipment. (Business Wire)

Study: Responsive Neurostimulation Does Not Affect Cognition in Epilepsy Patients

Oct. 20, 2015 - A paper in Epilepsia reports that, although epilepsy can have impacts on cognition, there was no effect on cognition in 175 patients with medically intractable partial onset epilepsy who had responsive neurostimulation systems, according to data analyses from the open label period of a randomized, controlled, double-blinded pivotal trial with follow up at one and two years. (Business Wire)

Researchers Investigate Noninvasive Brain Stimulation for Severely Affected Stroke Patients

Oct. 20, 2015 - A 30-patient, proof-of-principle study of patients with severe post-stroke impairment of an arm showed that stimulating the uninjured side of the brain using transcranial magnetic stimulation "altered motor function in a way that was not observed in patients with more mild arm impairment," according to a news release. The results were presented at the Society for Neuroscience annual meeting. (Medical Daily)

Epilepsy Patient Receives Deep Brain Stimulation System That Records Brain Activity

Oct. 20, 2015 - A brief article describes a deep brain stimulation system implanted in a patient with epilepsy that records data, which can be downloaded by her doctor. The article says this development is a step toward automated adjustment of future devices. (Popular Science)

Findings Presented in Controlled Clinical Trial of Deep Brain in Thalamic Pain Syndrome

Oct. 19, 2015 - Results of a 10-patient clinical trial of deep brain stimulation (DBS) for the management of thalamic pain syndrome were presented at the most recent Biennial Meeting of the American Society for Stereotactic and Functional Neurosurgery. International Neuromodulation Society member Andre Machado, MD, PhD, said this was the first randomized, double-blind, controlled clinical trial of DBS in chronic pain. The crossover study was supported by the NIH Director’s New Innovator Award. The study included fMRI imaging during the blinded phase, and involved three months of active stimulation that targeted the ventral striatum/anterior limb of the internal capsule, structures that process emotion and affective behavior. (Cleveland Clinic)

Interview Focuses on Deep Brain Stimulation in Parkinson's Disease

Oct. 7, 2015 - A 30-minute podcast about Parkinson's disease research and treatment features an interview with deep brain stimulation (DBS) researcher Andres Lozano, MD, PhD, of the University of Toronto. In the interview, Dr. Lozano says about 125,000 DBS procedures have been performed, and occur these days at a rate of about 8,000 - 10,000 patients per year at about 700 centers worldwide. He added that deciding who is a good candidate for DBS has shifted as more is learned, and that while DBS used to be performed about 12 - 14 years post-diagnosis, it is now considered at 4 - 5 years, as a way for patients to sustain more-productive years. He added that DBS has been examined in some 740 conditions, such as ones that affect the brain's mood or cognitive circuits. He described Parkinson's as involving a monotonous oscillatory brain-circuit rhythm rather than a more complex pattern that could be likened to a symphony. (Parkinson's Life EU)

Neuromodulation Company Undergoes Merger

Oct. 19, 2015 - The merger between neuromodulation company Cyberonics, Inc. and Sorin S.p.A. was completed and the new company, LivaNova PLC began trading on NASDAQ and the London Stock Exchange. Besides its existing portfolio in cardiac surgery and neuromodulation, LivaNova is pursuing therapies for heart failure, mitral valve repair, and sleep apnea. (Globe Newswire)

Basic Science Studies Investigate Technical Approaches that Might Add Touch Sensations to Prosthetics

Oct. 15, 2015 - An article presents research into developing materials that provide a sense of touch and might be incorporated into prosthetic limbs. The article describes optogenetics to transmit the sensory information to cultured mouse brain cells. (Gizmodo)

Study Explores the Influence of a Brain Center Involved in Threat Detection on Ideological Perspectives

Oct. 14, 2015 - Using transcranial magnetic stimulation to decrease activity temporarily in the part of the brain involved with detecting and solving problems, the posterior medial frontal cortex, was associated with a lessening of firmly held ideological views on religion or immigration, according to a study published in the journal Social Cognitive and Affective Neuroscience. The study by two psychologists involved 38 participants, whose views on religion and immigration issues decreased by 32.8% and 28.5% respectively. The authors anticipated that the area of the brain that evolved to deal with concrete threats would also mediate reactions to more-abstract issues involving ideology. "Our brains are using the same basic mental machinery," they concluded, "whether we're trying to clamber over a fallen tree that we find in our path, find solace in religion, or resolve issues related to immigration." (Daily Mail)

Closed-Loop Spinal Cord Stimulation System is Implanted in First Patient in Australia

Oct. 14, 2015 - The first chronic pain patient to receive a new spinal cord stimulation system that senses, and adjusts stimulation to, responses of the nerves was fitted with the device by International Neuromodulation Society member Charles Brooker, MBBS; MRCP (UK); FANZCA; FFPMANZCA, news outlets in Australia reported. The device was developed with an investment from a New South Wales medical device fund, which anticipates re-investing the $5 million that was put toward commercialization after the company becomes profitable, the Sydney Morning Herald reported. (ABC News)

Collaboration Announced to Commercialize a Functional Electrical Neurostimulation System

Oct. 15, 2015 - Synapse Biomedical and Case Western Reserve University will collaborate to commercialize diaphragm-pacing neurostimulation, potentially expanding services for spinal-cord injured patients, ALS, and pediatric patients. The collaboration is being supported by a $3 million Ohio Third Frontier Innovation Platform Program grant. In addition, Synapse is enlisting commercialization partners in the U.S. and Japan. (PR Newswire)

Presentation Details Results of Clinical Trial Investigating Minimally Invasive Stimulation for Fecal Incontinence

October 2015 - Results of a double-blind, randomized controlled clinical trill at 17 centers in the UK suggest that percutaneous tibial nerve stimulation may not be effective in fecal incontinence. Although the investigators declined to be interviewed because of a pending journal publication, study results were presented at the 2015 annual meeting of the European Association for the Study of the Liver. In the study, 115 patients received active stimulation and 112 received sham. An improvement of at least a 50% reduction in weekly fecal incontinence episodes was reported in 38% of treated patients and 31% of patients in the sham group. The research was led by International Neuromodulation Society member Prof. Charles Knowles, PhD, FRCS, of the National Centre for Bowel Research and Surgical Innovation, in London, part of Barts and The London School of Medicine and Dentistry. (Gastroenterology & Endoscopy News)

In Preclinical Research, Brain Stimulation Appears Potentially Promising to Address Cognitive Deficit

Oct. 14, 2015 - In a mouse model of the intellectual-disability disorder Rett Syndrome, deep brain stimulation of the fornix was found to lessen some features of the syndrome, according to research published in the journal Nature. (Medical Express)

Research Papers Explore Brain Connectivity in Conditions of Impairment or Injury

Oct. 14, 2015 - A special issue of the journal Brain Connectivity offers free online content about brain injury and disease until Nov. 14, 2015. A study of brain connectivity and information flow associated with working memory across brain hemispheres found patients with traumatic brain injury exhibited hyperconnectivity and less coherent information flow. Another study shows that ischemic damage in one hemisphere leads to remodeling of neuronal axons and myelin in the injured brain network, and also, in the uninjured motor area on the other side. A third paper reports that patients who have multiple system atrophy demonstrated improvement in motor positive changes seen in related functional brain connectivity following treatment using transcranial magnetic stimulation. (EurekAlert)

Academics Interviewed About Noninvasive Brain Stimulation for Consumers

Oct. 13, 2015 - In a radio segment, researchers are interviewed about the emergence of consumer brain-stimulation systems. (CBC.CA)

Company Receives Medical Coverage Decision in Germany

Oct. 13, 2015 - EndoStim announced that in 2016, approved treatment with its device for gastroesophageal reflux disease will be routinely reimbursed in Germany. (PR Newswire)

Neurostimulation Company Strikes Development Agreement in Asia

Oct. 13, 2015 - Helius Medical has entered into a $7 million agreement with the Hong Kong-based investment and development company A&B Company Limited. In the sales and licensing transaction, A&B will acquire certain Asian patents, patent applications, and product support material to develop and commercialize the Portable Neuromodulation Stimulator, PoNS™, in China, Hong Kong, Macao, Taiwan and Singapore. A news release mentions A&B's interest in its potential as a treatment for chronic neurological symptoms of traumatic brain injury. Helius said it will repay $2 million drawn down from A&B's provision of a $7 million credit facility by issuing 2.1 million shares of Helius at 96¢ per share and 1 million 3-year warrants at $1.44 per share. (Mass Device)

Column: Issues Surrounding Access to Neurostimulation Therapies

Oct. 12, 2015 - Despite proven clinical and cost-effectiveness of the most-accepted neurostimulation therapies -- spinal cord stimulation for neuropathic pain, deep brain stimulation for Parkinson's disease, and sacral nerve stimulation for voiding disorders -- "only a small percentage of those patients in developed health economies that should have access actually have it," according to a column by International Neuromodulation Society Past President Simon Thomson. Among factors that impede access to these therapies, he concludes, "We are not getting the message across to our professional colleagues where they are acting as gatekeepers to patient access. Cross specialty education in an age of super specialisation is more important than ever." (NeuroNews)

Researchers Explore Refinements in Deep Brain Stimulation for Obsessive Compulsive Disorder

Oct. 12, 2015 - An article describes research in Massachusetts into refining deep brain stimulation (DBS) treatment of obsessive compulsive disorder. The research includes development of a prototype closed-loop DBS system that is intended to record and respond to brain activity, potentially enabling other maladies to be addressed by the therapy. (Fierce Medical Devices)

Device Maker Says Deep Brain Stimulation Patient is the First in the U.S. to Receive a New Anti-Infective Implant

Oct. 8, 2015 - Medtronic announced the first patient use of its Tyrx infection-fighting envelope, which it is launching for use with deep-brain stimulation devices in the U.S. The device releases two anti-microbial drugs, minocycline and rifampin, for seven days. The envelope then dissolves over roughly nine weeks. Medtronic acquired Tyrx for $160 million in January 2014 and received 510(k) clearance from the FDA for its use with neurostimulation implants, including sacral nerve stimulators, spinal cord stimulators and vagus nerve stimulators. Tyrx won CE Mark approval for cardiac devices in September 2014. (Mass Device)

Company Plans Clinical Trial of Injectable Tibial Nerve Stimulator

Oct. 8, 2015 - StimGuard announced FDA Investigational Device Exemption approval to launch a clinical trial this winter of its percutaneously implantable tibial nerve stimulation device to treat overactive bladder. (Sys-Con Media)

Media Outlets to Show Live Deep Brain Stimulation Surgery

Oct. 8, 2015 - International Neuromodulation Society member Jonathan Miller, MD, and his neurosurgical colleagues at University Hospitals Case Medical Center in Cleveland, Ohio are scheduled to perform deep brain stimulation surgery during a two-hour live telecast on Oct. 25th. The program is set to be shown on the National Geographic channel and Mental Floss with commentary by a neurosurgeon, a neuroscientist, and host Bryant Gumbel, a former national network television morning talk show host and sportscaster. (Medical Daily)

Pain Patient in the U.K. Seeks Screening for Neurostimulation Therapy

Oct. 7, 2015 - A woman with complex regional pain syndrome hopes to transfer from North Manchester Hospital to Salford Royal Hospital to potentially receive neurostimulation treatment. Her family said she has been on morphine for 15 months without regaining the ability to independently handle activities of daily living. (Bury Times)

Bioelectronic Medicine Center Names a Managing Director

Oct. 7, 2015 - International Neuromodulation Society (INS) member Chad Bouton will leave his research leadership role at Battelle to become a managing director of the Feinstein Institute’s new Center for Bioelectronic Medicine. At Battelle, his work included a project to develop neural implants to bypass spinal cord damage and return some voluntary hand and arm movement to a patient with paralysis (described in an announcement of the 2015 INS abstract winners).  (Innovate LI)

Funding Will Support Basic Investigations of Brain Circuits

Oct. 7, 2015 - The National Institute of Neurological Disorders and Stroke has announced a three-year, $1.15 million grant to researchers at Ohio State University who are developing tools to visualize brain circuits in laboratory animals. (Portland Business Journal)

Collaborators Receive Funding to Develop "Smart" Epilepsy Implant

Oct. 7, 2015 - The National Institutes of Health announced a $6.8 million, five-year grant to develop an implantable "smart device" to predict, track and treat epileptic seizures. The grant will support researchers in a collaborative team at the Mayo Clinic, the University of Pennsylvania, the University of Minnesota and Medtronic. The funding is part of the the U.S. BRAIN (Brain Research Through Advancing Innovative Neurotechnologies) Initiative. (Fierce Medical Devices)

Researcher Receives Support for Investigations of Deep Brain Stimulation and Obsessive Compulsive Disorder

Oct. 7, 2015 - The Brain & Behavior Research Foundation has given a NARSAD Young Investigator Grant for research into deep brain stimulation using a mouse model of obsessive compulsive disorder. The Young Investigator grants provide up to $70,000 in support over two years. NARSAD stands for National Alliance for Research on Schizophrenia and Depression, the former name of the Brain & Behavior Research Foundation. (Stevens Institute of Technology)

Defense Advanced Research Projects Agency Funds Seven Peripheral Nerve Stimulation Projects

Oct. 6, 2015 - International Neuromodulation Society member Jiande Chen, PhD, a professor of medicine at Johns Hopkins University, is mentioned in an article about programs being funded by the Defense Advanced Research Projects Agency (DARPA) through its Electrical Prescriptions (ElectRx) program. The article says the program is funding seven projects around the world, and "has as its goal the development of a closed-loop system that treats diseases by modulating the activity of peripheral nerves." Prof. Chen is researching basic mechanisms of neuromodulation and inflammatory bowel disease. The University of Texas at Dallas issued a news release about a project funded by DARPA there, which aims to reduce symptoms of post traumatic stress disorder by combining vagus nerve stimulation and exposure therapy. (Daily Mail)

Scientists Demonstrate Flexible Brain Probe in Preclinical Work

Oct. 6, 2015 - A paper in Nature Materials describes how laboratory research with electrodes in a polymer mesh allowed scientists to monitor individual neurons in a rat, locating the region of the cortex associated with movement of a single whisker. The mesh forms a cylinder that was stiffened temporarily by dipping into liquid nitrogen prior to inserting into the rat's brain. When not in that chilled state, the authors say, the mesh is up to seven orders of magnitude less stiff than conventional probes, which they believe would make the sensor array less likely to induce scarring. Also, the article states that the array should be more likely to move as the brain shifts during day-to-day movement, so sensors would be more likely to continuously sample the same part of the brain. (Chemistry World)

Study Evaluates Noninvasive Vagus Nerve Stimulation as an Acute Intervention in Cluster Headache

October 2015 - Noninvasive vagus nerve stimulation was associated with a higher proportion of sustained responders compared to sham treatment in a clinical trial of the treatment as an acute intervention in cluster headache, according to results of the ACT1 (Non-invasive Vagus Nerve Stimulation for the Acute Treatment) study, presented at the American Headache Society’s 2015 Annual Scientific Meeting. The trial had 73 patients randomly assigned to active treatment, and 77 to sham. The sustained response rates at one month were 26.7% for the treatment group, and 12.3% for the sham group, respectively. (Pain Medicine News)

Study: Vagus Nerve Stimulation in Heart Failure Patients Safe and Well-Tolerated

Oct. 2, 2015 - Extending the follow-up time of the six-month ANTHEM-HF study to 12 months, the ENCORE study demonstrated that vagus nerve stimulation was safe and well tolerated on both the left and right vagus nerves of patients who have heart failure with reduced ejection fraction, according to results presented at the Heart Failure Society of America Annual Scientific Meeting. (Healio)

Company's Trial Stimulation System Receives Expanded FDA Approval

Oct. 2, 2015 - Medtronic plc was reported to have received expanded FDA approval for its Verify Evaluation System that allows basic evaluations of patient benefit from sacral nerve stimulation for bladder or bowel control. The system has a wireless touchscreen and is used in conduction with trial stimulation of three to seven days. (FDA News)

Neuroscience Grants Include Funding for Deep Brain Stimulation Research

Oct. 1, 2015 - Deep brain stimulation for traumatic brain injuries is among the research areas that the National Institutes of Mental Health is funding in $85 million in research grants for 131 investigators in fiscal 2015. The funding is part of the U.S. Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative. The initiative also received $100 million in unrestricted funds for neuroscience research from the Kavli Foundation and partner universities that will establish new institutes in neuroscience -- the University of California, San Francisco; Johns Hopkins University; and Rockefeller University. Kavli also announced $40 million will go to existing neuroscience institutes at Yale University, UC San Diego, Columbia University, and the Norwegian University of Science and Technology. (AAAS)

Researchers Explore Brain Network Structure to Explain Cognitive-State Changes

Oct. 1, 2015 - In a paper in Nature Communications, neuroscience collaborators have published studies that use brain imaging and network control theory  for insight into how brain brain-computer interfaces and neuromodulation may provide regional stimuli that affect dynamics of the whole brain. (Bioscience Technology)

24-Month Results Presented in a Pilot Study of Deep Brain Stimulation in Early Parkinson's Disease

Oct. 1, 2015 - A post hoc analysis of a randomized pilot study that compared deep brain stimulation (DBS) to standard medical therapy in 30 patients with early Parkinson's disease showed that after two years, the people in the DBS group had 50% less risk of motor symptoms worsening, compared to the treatment group that received optimum medical therapy alone. The results were presented at the American Neurological Association Annual Meeting. The presenters added that a pivotal trial has been approved in the U.S. to test the use of DBS in early Parkinson's disease. (Neurology Advisor)

Scientists Present Early Research on an Implant Meant to Aid Memory Formation

Sept. 30, 2015 - With hopes of eventually developing a memory prosthetic device, scientists have used computer software to record brain signals and mirror their translation in the hippocampus. This area of the brain is important to long-term memory formation, and is damaged in Alzheimer's disease. An early study in nine patients who were undergoing brain stimulation for epilepsy indicated the system was likely to work with 90% accuracy, according to news coverage of a presentation at the Annual International Conference of the IEEE Engineering in Medicine and Biology Society in Milan. The article adds that the actual implant, an electrode array, has only been tested in animals. (Herald Scotland)

Patients with Bipolar II Depression Receive Cranial Electrotherapy Stimulation in Sham-Controlled Pilot Study

Sept. 25, 2015 - In a double-bland, sham-controlled study, cranial electrotherapy stimulation sessions five days a week for two weeks was associated with significant reduction in depression symptoms, compared to sham treatment, according to published results of a study at the Family Center for Bipolar Disorder at Mount Sinai Beth Israel in New York City. The authors say that results of the 16-patient study suggest further safety and efficacy studies may be warranted. (Journal of Nervous & Mental Disease)

Researchers Publish Trial Design of Study of Non-invasive Brain Stimulation to Potentially Enhance Cognitive Recovery from Stroke

Sept. 29, 2015 - Researchers in Brazil have published the design of a clinical trial in which they hope to assess in 60 chronic stroke patients whether transcranial direct current stimulation to the fronto-parietal region or the cingulo-opercular region affects cognition. (Trials)

Researchers Hoping to Fine-Tune Deep Brain Stimulation in Parkinson's Disease Receive Research Grant

Sept. 28, 2015 - The Parkinson's Western Australia Zrinski Research Grant of $200,000 will support research into using the posterior subthalamic area as a stimulation target for deep brain stimulation. Researchers at the University of Western Australia, who received the grant, have completged a pilot study of 9 patients with Parkinson's disease and observed significant motor improvements with no cognitive or psychiatric changes, they said. They have begun using brain imaging analysis in 15 more patients to identify structural and metabolic markers that predict the best motor response, and may help identify patients who would most benefit. With the funding, they hope to study up to 25 more patients. (DPS News)

Article Presents Comparative Data on Neuromodulation for Cluster Headache

Sept. 30, 2015 - Prophylactic use of non-invasive vagus nerve stimulation reduced the number of cluster headache attacks at three times the rate of the best available standard of care, a paper in Cephalagia reports. The paper presents results of a multi-center randomized controlled clinical trial that enrolled 93 participants whose treatment was followed for several weeks. (PR Log)

Study Assesses Hypoglossal Nerve Stimulation Treatment in Obstructive Sleep Apnea Patients

Sept. 29, 2015 - Findings from a prospective study of hyoglossal nerve stimulation for obstructive sleep apnea were reported at the annual meeting of the American Academy of Otolaryngology-Head & Neck Surgery. The findings involved 111 patients who had previously failed to adhere to continuous airway positive pressure treatment. More than half the enrollees benefitted from the implant and at 30 months follow-up, 81% still routinely used the device, according to results presented at the meeting. (Doctors Lounge)

Article Raises Public Awareness of Neuromodulation for Chronic Pain

Sept. 29, 2015 - A overview of current and emerging neuromodulation therapies is part of a special online pain awareness supplement. The article, commissioned by Mediaplanet, was prepared by International Neuromodulation Society (INS) President Timothy Deer, MD, and quotes INS public education volunteer Lawrence Poree, MD, PhD. He says in appropriate patients, neuromodulation saves costs over time and improves function -- but chronic pain patients who may be candidates need to hear about it sooner than occurs today. (Mediaplanet)

Company Raises Funds to Pursue a Clinical Trial of a Noninvasive Device for Tinnitus

Sept. 29, 2015 - Neuromod Devices  Ltd. of Ireland as raised €5.5 million from Fountain Healthcare Partners to fund clinical trials in the U.S. for its bi-modal system to treat some forms of tinnitus. The system uses simultaneous auditory stimulation in the ear and sensory stimulation on the tongue. The device received CE Mark approval in Europe in October 2014 and a U.S. patent September 2015. (Irish Times)

Company Halts Plans for Initial Public Offering

Sept. 28, 2015 - According to an SEC filing, NeuroSigma Systems has decided to not pursue an initial public offering at this time. The Los Angeles-based company had registered for an initial public offering on the NASDAQ last August. The company is marketing its external trigeminal nerve stimulation system in Canada and Europe as an adjunctive treatment of drug-resistant epilepsy and major depressive disorder. The FDA also has permitted an investigational device exemption for clinical trials in the U.S. (MedCity News)

Review: Deep Brain Stimulation Addresses Circuit Disorders

Sept. 26, 2015 - A review of deep brain stimulation (DBS) in movement disorders and conditions such as obsessive compulsive disorder, which are considered a circuit disorder involving the basal ganglia, presents surgical interventions as highly focused approaches that spare uninvolved areas, unlike systemic medications. The reviewers add that there are efforts to target circuit dysfunction outside the basal ganglia-thalamocortical system. For instance, the pedunculopontine nucleus is an investigational target to address gait disorders that respond poorly to levodopa and conventional DBS targets. (JAMA Neurology)

Studies Examine Potential of White Matter Tracts as a Biomarker of Depression

Sept. 26, 2015 - Researchers provide early results of investigations into white matter structure and stimulation as part of a quest to identify an intraoperative biomarker for treatment-resistant depression. Such a biomarker could help guide both implantation of deep brain stimulation leads and selection of stimulation contacts. (JAMA Neurology)

Article Details Proposed Merger Involving U.S. Neuromodulation Company

Sept. 24, 2015 - The proposed merger between Cyberonics, Inc. of Houston, Texas and Italy-based Sorin Group moved closer when Cyberonics' stockholders approved it on Sept. 22. Sorin Group stockholders previously approved the merger in May. The merger is expected to become final on Oct. 19, 2015. At that time, a U.S. subsidiary would go into effect, Cypher Merger Sub, Inc. Neuromodulation would be one of three business units in the newly merged company. (Zacks)

U.S. Defense Advanced Research Projects Agency Presents Medical Device Research

Sept. 11, 2015 - At a "Wait, What?" conference from Sept. 9th - 11th in St. Louis, DARPA presented ongoing health and neuroscience programs that involve medical and prosthetic research and development. The presentations described efforts to overcome injury-induced memory deficits, mitigate the symptoms of post-traumatic stress disorder, and enhance prosthetic hands with a sense of touch. DARPA said its Restoring Active Memory (RAM) Replay program is "poised to begin in October." It also presented Electrical Prescriptions (ElectRx), Hand Proprioception and Touch Interfaces (HAPTIX), Neuro Function, Activity, Structure, and Technology (Neuro-FAST) and System-Based Neurotechnology for Emerging Therapies (SUBNETS). (DARPA)

National Health Service Consultant Organizes a Weekend Day of Spinal Cord Stimulator Implant Procedures

Sept. 28, 2015 - An NHS consultant in Leeds organized 10 90-minute spinal cord stimulation (SCS) implant procedures on a Saturday to demonstrate the efficiency of doing that in groups rather than tying up an operating theatre on 10 different days. The article states the "The NICE-recommended devices . . .  are seen as a last resort that the NHS deem are a one-off investment that prevents further hospital visits and drug therapy." The Leeds Neuromodulation and Pain Management Centre is reported to be one of four centers that deliver the most SCS implants in England, with about 100 patients benefitting each year. (Yorkshire Evening Post)

Column in New York Times Presents Transcranial Magnetic Stimulation for Depression

Sept. 28, 2015 - A Brazilian newspaper columnist who has not found success with counseling and medications for depression describes trying transcranial magnetic stimulation. She said it had been approved in Brazil as a depression treatment in 2012. She mentioned that four weeks' therapy exceeds her monthly income, and that in the U.S. a course of treatment may total $6,000 - $9,000. (New York Times)

Laboratory Research Suggests Nerve Stimulation Could Break Down Fat

Sept. 25, 2015 - Research collaborators write in Cell that they observed that sympathetic nerve fibers establish neuro-adipose junctions, and speculate that "direct activation of sympathetic inputs to adipose tissues may . . . induce fat loss, circumventing central leptin resistance." (GEN News)

Companies Receive Clearance for Merger

Sept. 23, 2015 - The High Court of England and Wales approved the $2.7 billion merger of Cyberonics and the Sorin Group, now known as LivaNova. The merger will go into effect October 19, according to the companies. (Mass Device)

Brain-Computer Interface Research Highlighted

Sept. 23, 2015 - A list of this year's 10 "brightest young minds' includes a brain-computer-interface neuroengineer who decodes neural systems with the ultimate goal of helping paralyzed people move or helping other people self-regulate mood. (Popular Science)

News Coverage Presents Spinal Cord Stimulation as Newly Improved

Sept. 22, 2015 - A news report about alternatives for chronic pain care says that spinal cord stimulation has become more advanced and accessible. (KSAT)

Company Announces European Approval for Deep Brain Stimulation Technology

Sept. 22, 2015 - St. Jude Medical announced it has received European CE Mark approval for its Infinity deep brain stimulation (DBS) device, and a directional lead that permits physicians to "steer" current to different targets. The DBS device incorporates Bluetooth connectivity that allows patients and physicians to use some Apple™ mobile devices as wireless controllers. (Mass Device)

Company Receives Funding to Develop Wearable Sensors for Deep Brain Stimulation Programming

Sept. 21, 2015 - The National Institute of Neurological Disorders and Stroke is providing $1.9 million in Phase II Small Business Innovation Research funding to Cleveland-based Great Lakes NeuroTechnologies to integrate their wearable sensors into a platform for programming deep brain stimulation (DBS) systems. The company's wearable sensors were initially used for assessing Parkinson's disease. The integrated system should provide real time, closed-loop feedback to adjust DBS programming. (PR Newswire)

Article Describes Epilepsy Treatment Using Closed-Loop Vagus Nerve Stimulation

Sept. 21, 2015 - A girl with epilepsy in Minnesota is one of the first adolescents in the U.S. to be implanted with a closed-loop vagus nerve stimulation system, which has allowed her to reduce her medication. (Fox News)

Autism Studies Explore Transcranial Magnetic Stimulation

Sept. 21, 2015 - Transcranial magnetic stimulation research studies in autism include work by a researcher who is interested in differences seen in the brains of people with autism in the inhibition and excitation of gamma wave activity. (Autism Daily Newscast)

Article Presents Results of Feasibility Study to Compare Spinal Cord Stimulation and Usual Care in Angina

Sept. 21, 2015 - An Early View article reports results of the first publicly funded, pilot clinical trial to compare spinal cord stimulation (SCS) to usual care for ischemic pain from refractory angina. The randomized feasibility study was not formally powered to compare outcomes between or within groups. However, the results did show a trend towards larger improvements in the SCS group on all outcome measures, which included attack frequency, quality of life, and exercise capacity. The paper's co-authors include International Neuromodulation Society (INS) members Sam Eldabe, MD; Simon Thomson, MD; Morag Brookes, RGN, MSc; Jon Raphael, MD; and Rod Taylor, PhD. A scientific abstract regarding the study was presented at the INS 12th World Congress in June. (Neuromodulation: Technology at the Neural Interface)

Study Follows Parkinson's Disease Patients for Five Years Post-Implant

Sept. 20, 2015 - A study in China followed 10 Parkinson's disease patients before they received deep brain stimulation to the subthalamic nucleus, with follow-up at 1, 3 and 5 years after the implantation procedure. The authors conclude the intervention is effective, although they say it was associated with a slightly diminished efficacy after 5 years. Motor scores improved and medication use dropped. Quality of life improved by 58.18% at 3 years, then gradually declined. (Chinese Medical Journal)

University Undertakes Clinical Trial of Focused Ultrasound in Parkinson's Disease

Sept. 19, 2015 - Parkinson's disease patients whose medication has failed to satisfactorily control dyskinesias are being sought for a clinical trial of noninvasive focused ultrasound at the University of Virginia. The intervention is being studied as a potential alternative to deep brain stimulation. (Daily Progress)

Article Covers the State of Epilepsy Diagnosis and Treatment in Nigeria

Sept. 18, 2015 - Epilepsy experts were quoted as saying that with fewer misconceptions and myths about epilepsy in Nigeria, more cases would be diagnosed. They add that with the right treatment, symptoms can be managed in 70 - 75% of cases. With regard to treatment, a neurologist in Delhi, India, said his hospital has performed 100 deep brain stimulation surgeries and 20 of those were for epilepsy patients from Nigeria. (All Africa)

Federal Grant to Support Research Into Recovery from Brain Injury

Sept. 18, 2015 - The National Institute of General Medical Sciences gave a five-year $11.6 million grant to the University of New Mexico’s Brain and Behavioral Health Institute to support junior faculty members and help establish a new Center for Brain Recovery and Repair. Among the research envisioned there are studies into the use of regenerative or brain stimulation technologies to potentially help people recover from brain damage due to stroke and traumatic brain injuries. The envisioned investigational interventions include transcranial direct current stimulation and stem cell therapy.(Albuquerque Journal)

Company Reports Use of Its Peripheral Nerve Stimulator

Sept. 16, 2015 - Bioness, Inc.'s StimRouter™ peripheral nerve stimulator has FDA clearance for adjunctive use to treat chronic, intractable pain of peripheral nerve origin. The company announced its first commercial use occurred in Cleveland. The system is a minimally invasive prescription device with an implanted lead, external pulse transmitter, and conductive electrode that is powered transdermally. (BioPortfolio)

Laboratory Research Demonstrates the Ability to Modify Nerve Cells to Change Activity Due to Sound Stimulation

Sept. 15, 2015 - Researchers genetically introduced ultrasonic-responsive ion channels into the motor neuron cells of laboratory-bred nematodes. They have demonstrated, in a paper published in Nature Communications, that the nematodes change direction in response to a burst of inaudible, high-pitched sound waves. The technique, sonogenetics, may have clinical application in humans to temporarily make neurons, muscle cells, or insulin-producing cells responsive to sonic stimulation. The authors say the low-pressure, non-invasive stimulation would be easier to apply than the light that is applied through fiber optics for optogenetic stimulation. (The Guardian)

Study: Anxiety and Depression Screen Did Not Predict Outcomes of Sacral Nerve Stimulation Trial Phase

Sept. 9, 2015 - A study of 86 patients who received sacral nerve stimulation for lower urinary tract symptoms such as overactive bladder did not reveal a significant relationship between anxiety and depression scores and whether the neurostimulation test period was successful. (Neurology Urodynamics)

Non-rechargeable Deep Brain Stimulation System Receives European Marketing Approval

Sept. 14, 2015 - Boston Scientific Corporation announced CE Mark designation for its Vercise non-rechargeable, primary cell, deep brain stimulation (DBS) system for patients with Parkinson's disease, primary and secondary dystonia, and essential tremor. The system has an eight-contact directional lead with multiple independent current control. The non-rechargeable Vercise primary cell system is not available in the U.S., although its counterpart, the rechargeable Vercise DBS system, is cleared in the U.S. for investigational use to evaluate its effectiveness in Parkinson's disease in the INTREPID study. (Med Device Online)

Researchers Record Neuronal Response to Deep Brain Stimulation in Real Time

Sept. 11, 2015 - International Neuromodulation Society member Jamie Henderson, MD, and colleagues report a study in 15 Parkinson's disease patients receiving deep brain stimulation (DBS) systems in whom beta oscillations were recorded in real time. The recordings in the subthalamic nucleus were made as the patients moved freely. Beta waves are considered a potential biomarker for closed-loop, adaptive stimulation. In the study, beta power was conserved during walking and resting states and attenuated in a voltage-dependent manner during 140-Hz DBS. (Movement Disorders)

Journal Article Describes Deep Brain Stimulation to Treat Post-Traumatic Stress Disorder

Sept. 10, 2015 - A research paper describes deep brain stimulation of the basolateral nucleus of the amygdala (BLn) to treat post-traumatic stress disorder. Normally, fear extinction is mediated by the BLn and the medial prefrontal cortex. (Biological Psychiatry)

Authors Consider Development of an Evidence Base for Neurostimulation for Neuropathic Pain

September 2015 - An overview of neurostimulation for neuropathic pain says evidence of efficacy and cost-effectiveness is growing with recent well-conducted studies. The authors add that "difficulties in successfully conducting controlled clinical trials with interventional therapies ... stresses the need for alternative methods such as large registries to study the indications and clinical benefits of this
important therapy." (IASP Pain Clinical Updates)

Neuromodulation Treatments Presented as Technological Options for Pain Management

Sept. 10, 2015 - A news release from the American Society of Anesthesiologists presents such pain control technologies as spinal cord stimulation and intrathecal drug delivery. (Newswise)

Pilot Study Indicates Non-Invasive Brain Stimulation Temporarily Improves Motor Symptoms in Parkinson's Disease
Sept. 10, 2015 - A pilot study of patients with Parkinson's disease, published in the Journal of Neuroscience suggests that transcranial direct current stimulation can at least temporarily limit some motor symptoms in Parkinson's disease patients. The authors say the stimulation may compensate somewhat for the loss of dopamine by decreasing the effort the brain has to put into getting its motor neurons to fire. They suggest this non-invasive approach might potentially be developed for home use. (Johns Hopkins)

Study of Smokers Who Had Strokes Suggests a Brain Area Associated with Addiction

Sept. 8, 2015 - Research involving 156 smokers who suffered strokes, published in the journals Addiction and Addictive Behaviors, indicates that stroke damage in the insular cortex was associated with fewer withdrawal symptoms from a hospital-imposed halt in smoking. In a three-month follow up, the patients whose strokes affected the insular cortex were nearly twice as likely as the patients whose strokes were in other areas to not resume smoking. (EurekAlert)

Tourette Patient Gains More Independence After Deep Brain Stimulation Treatment

Sept. 8, 2015 - A young woman whose activities had become extremely limited due to Tourette syndrome said receiving deep brain stimulation in March 2014 has relieved 85 percent of her tics, and she is excited by the idea of having a job one day. (Daily Mail)

Company Extends Equity Financing Round

Sept. 8, 2015 - SetPoint Medical, Corp., which is developing bioelectronic therapy for inflammatory disease, has raised an additional $25 million in an extension of its Series C equity financing, bringing the total raised to $43 million. Current investors in the Valencia, CA-based company include Morgenthaler Ventures, Foundation Medical Partners, Topspin Partners, Covidien Ventures, Action Potential Venture Capital Limited and Boston Scientific. (PE HUB)

Review Cites Evidence in Functional Electrical Stimulation During Early Rehabilitation for Spinal Injury

Sept. 8, 2015 - A literature review found level II evidence that exercise initiated early after spinal cord injury, including exercise involving functional electrical stimulation, helped to increase muscle mass. (Spinal Cord)

Study Uses Patch Electrodes to Assess Tibial Nerve Stimulation vs. Sham in Children Treated for Overactive Bladder

Sept. 7, 2015 - A prospective, randomized clinical trial in 40 children with treatment-resistant overactive bladder compared sham stimulation and transcutaneous posterior tibial nerve stimulation. The children in the active stimulation group received stimulation for 30 minutes a week for 12 weeks. An assessment of subjective symptom improvement found 90% of patients in the treatment group reported significant improvement or better, but only 6.25% of patients in the sham group reported significant improvement. Meanwhile, 71.42% of treated patients reported their incontinence completely improved, compared to 12.5% of patients in the sham group. (Uro Today)

Study Examines Potential of Non-Invasive Stimulation to Limit Motion Sickness

Sept. 7, 2015 - Researchers from Imperial College London compared cathodal and anodal transcutaneous direct current stimulation (tDCS) of the left parietal cortex, and reported in Neurology that approximately 10 minutes of cathodal tDCS (that dampens inner-ear signals) increased the time to development of moderate nausea, and shortened time to recovery. (Medical News Today)

Massachusetts Medical Schools Consider Pain Management Curricula

Sept. 7, 2015 - Four medical schools in Massachusetts are teaming up to improve training for doctors in pain management in order to curb over-prescription of opioid medications. The schools that were reported to be in discussions about this were Harvard Medical School, Boston University School of Medicine, Tufts School of Medicine and the University of Massachusetts Medical School. (National Pain Report)

Specialists Advocate Better Access to Epilepsy Interventions

Sept. 5, 2015 - Neurology specialists commented at the 31st International Epilepsy Congress in Istanbul that access to interventions such as vagus nerve stimulation could save costs in the long term. (Epilepsy Society UK)

Study Explores Protective Effect of Deep Brain Stimulation in Epileptic Rats

Sept. 4, 2015 - A group of collaborators has published results of a laboratory study in which deep brain stimulation (DBS) was shown to induce cell-protective and anti-inflammatory effects in rats who underwent epileptic seizures. The researchers say although a direct causal relationship cannot be established, they did find DBS influenced certain pro-inflammatory cytokines and they observed reduced neuronal death. While loss of neurons is usually attributed to excitotoxicity after a seizure, they say, inflammation may play a role. In addition, spectral analysis indicated DBS may have decreased the severity of the seizure, compared to controls. (Journal of Neuroinflammation)

External Spinal Cord Stimulation, Robotic Assistance Help Paralyzed Man Display Some Mobility

Sept. 1, 2015 - Researchers say that five hour-long sessions of noninvasive spinal cord stimulation coupled with physical training for a few weeks allowed a 39-year-old man whose legs were paralyzed in 2010 to voluntarily make leg movements with the assistance of a robotic exoskeleton. They say the accomplishment marks the first time a person with chronic, complete paralysis regained enough voluntary control to be able to actively work with a robotic device designed to enhance mobility. The advance was demonstrated by a research team at the University of California, Los Angeles, whose abstract is published online in the journal IEEE Engineering in Medicine and Biology Society. (Medical Xpress)

Researchers Cite Safety Precautions Around Deep Brain Stimulation Implantation

Sept. 1, 2015 - News coverage about the identification of a new protein infectious agent, a prion that causes multiple system atrophy in people with parkinsonism, mentions the importance of carefully sterilizing surgical tools. They say that a previous laboratory study found that prions survived a decontamination procedure when stuck to stainless steel wires, and were able to infect mice on brain implantation, as well as to infect cultures of susceptible cells. (ABC News)

Bioelectronics Researcher is Trying to Miniaturize a Neural Interface

Aug. 25, 2015 - A bioelectronics research leader blogged about his early stages of trying to create miniaturized electrodes that might treat disease. He said they are intended to read and alter signals along autonomic nervous-system circuits that influence specific organs. He added the devices are meant to be more subtle and targeted than existing neurostimulation approaches. (RiAus)

Company Releases Data in Clinical Trial of Neurostimulation Device for Back Pain

Aug. 31, 2015 - Mainstay Medical International plc announced positive results from the international clinical trial of its neurostimulation device to treat chronic disabling back pain by stimulating nerves for the muscles that stabilize the lumbar spine. In 47 patients who had at least 90 days of follow-up, the company said, 63% had clinically important improvement in back pain and 72% of patients improved who had no financial compensation related to back pain. The clinical trial is being conducted prior to application for CE Mark approval. (Business Wire)

Teen with Dystonia Receives Deep Brain Stimulation

Aug. 29, 2015 - Children's Hospital in Colorado performed its first deep brain stimulation (DBS) implant, on a 17-year-old with dystonia due to cerebral palsy. It is hoped that with DBS, he will be able to use his hand. (Denver Post)

Study Suggests Mechanisms of Transcranial Magnetic Stimulation

Aug. 29, 2015 - Placebo-controlled research presented in an Amsterdam meeting of the European College of Neuropsycholopharmacology indicates treatment effects of transcranial magnetic stimulation (TMS), suggesting how it may work when used to treat depression. In the study, 27 healthy volunteers who received a single TMS session had modified connectivity of large-scale brain networks, particularly in the right anterior insula, and altered neurotransmitter concentration. (EurekAlert)

Task Force Proposes a Coordinated Registry Network for Medical Devices

Aug. 28, 2015 - Leveraging international medical device data efforts is among the goals of a proposed coordinated registries network. The proposal, by a task force of the U.S. FDA, was published in a summary report in the Aug. 24, 2015 issue of the Journal of the American Medical Association. The network could provide a foundational architecture with interoperability solutions for incorporating data from non-registry sources, such as unique device identifiers when they are implemented; electronic health records; administrative claims data; and mobile device outputs. The task force said the data should include information that may not all be captured in existing registries, such as device and procedural details, patient descriptors, and long-term outcomes. (Healthcare Informatics)

Transcranial Magnetic Stimulation System Cleared for U.S. Use in Certain Cases of Depression

Aug. 28, 2015 - Denmark-based MagVenture, Inc. announced its MagVita transcranial magnetic therapy (TMS) system has received FDA clearance for the treatment of major depressive disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. The company said it is the fourth to receive clearance for this technique. Its system was CE marked in the European Union in 2011. (PR Newswire)

Company Releases Data in Clinical Trial of Neurostimulation Device for Back Pain

Aug. 31, 2015 - Mainstay Medical International plc announced positive results from the international clinical trial of its neurostimulation device to treat chronic disabling back pain by stimulating nerves for the muscles that stabilize the lumbar spine. In 47 patients who had at least 90 days of follow-up, the company said, 63% had clinically important improvement in back pain and 72% of patients improved who had no financial compensation related to back pain. The clinical trial is being conducted prior to application for CE Mark approval. (Business Wire)

Teen with Dystonia Receives Deep Brain Stimulation

Aug. 29, 2015 - Children's Hospital in Colorado performed its first deep brain stimulation (DBS) implant, on a 17-year-old with dystonia due to cerebral palsy. It is hoped that with DBS, he will be able to use his hand. (Denver Post)

Study Suggests Mechanisms of Transcranial Magnetic Stimulation

Aug. 29, 2015 - Placebo-controlled research presented in an Amsterdam meeting of the European College of Neuropsycholopharmacology indicates treatment effects of transcranial magnetic stimulation (TMS), suggesting how it may work when used to treat depression. In the study, 27 healthy volunteers who received a single TMS session had modified connectivity of large-scale brain networks, particularly in the right anterior insula, and altered neurotransmitter concentration. (EurekAlert)

Task Force Proposes a Coordinated Registry Network for Medical Devices

Aug. 28, 2015 - Leveraging international medical device data efforts is among the goals of a proposed coordinated registries network. The proposal, by a task force of the U.S. FDA, was published in a summary report in the Aug. 24, 2015 issue of the Journal of the American Medical Association. The network could provide a foundational architecture with interoperability solutions for incorporating data from non-registry sources, such as unique device identifiers when they are implemented; electronic health records; administrative claims data; and mobile device outputs. The task force said the data should include information that may not all be captured in existing registries, such as device and procedural details, patient descriptors, and long-term outcomes. (Healthcare Informatics)

Transcranial Magnetic Stimulation System Cleared for U.S. Use in Certain Cases of Depression

Aug. 28, 2015 - Denmark-based MagVenture, Inc. announced its MagVita transcranial magnetic therapy (TMS) system has received FDA clearance for the treatment of major depressive disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode. The company said it is the fourth to receive clearance for this technique. Its system was CE marked in the European Union in 2011. (PR Newswire)

Abstracts from the 12th World Congress of the International Neuromodulation Society are Published Online

Aug. 28, 2015 - Abstracts from the 12th World Congress of the International Neuromodulation Society in June in Montreal are now available in the online issue of Neuromodulation: Technology at the Neural Interface. (Neuromodulation: Technology at the Neural Interface)

Clinical Trial Enrollment Complete in Mutli-Center Study of Vagus Nerve Stimulation in Heart Failure

Aug. 27, 2015 - BioControl Medical announced completion of enrollment in its INOVATE-HF (INcrease Of VAgal TonE in Heart Failure) clinical trial that assesses its vagus nerve stimulation system in the treatment of congestive heart failure. The neurostimulation system includes a stimulator that targets the right vagus nerve in the neck, and a sensor that is place in the right ventricle of the heart. Enrollment began in 2011, and consists of 725 patients at 86 centers in the United States and Europe. In the randomized controlled study, for each three patients who are implanted with the CardioFit device, two are placed in the control group and receive standard, evidence-based management. The system is designed to stimulate the parasympathetic branch of the autonomic nervous system, in order to reduce stress on the heart. Based on an earlier pilot study, the system was CE certified in 2008. (Business Wire)

Researchers Propose Using Three-Dimensional Printing to Enclose Neurostimulation Components

Aug. 27, 2015 - A team of researchers from Deakin University and the Mayo Clinic propose making biocompatible silicon enclosures for deep brain stimulation parts on a three-dimensional printer in a paper in Procedia Technology. (3D Print.com)

International Neuromodulation Society Offers Select Presentations from June 2015 World Congress for Members' Access

Aug. 27, 2015 - Select audio files and links to a number of slide presentations from the International Neuromodulation Society (INS) 12th World Congress are now available for members to access from the INS Members Only section of the INS website. Members may use their credentials to log on and access the material. (International Neuromodulation Society)

Retrospective Study Documents Satisfaction With Spinal Cord Stimulation

Aug. 27, 2015 - A retrospective review of 199 patients who received permanent spinal cord stimulator implants at one center between 2001 and 2011 found that at 6 and 12 months, all patients in all indications had lower numerical pain scores, and that oral morphine equivalents decreased significantly in patients treated for failed back surgery syndrome or complex regional pain syndrome. In addition, patient satisfaction was significant at one year for all groups. (Pain Practice)

Company Receives Grant to Study Peripheral Nerve Stimulation in Knee-Replacement Patients

Aug. 26, 2015 - The National Institutes of Health has given SPR Therapeutics a $1.6 million grant to study whether the company's peripheral nerve stimulation system could be used to control the post-operative pain of knee replacement surgery. Biospace reported that the company has received permission to undertake a clinical trial of the stimulation for up to 60 days in post-operative knee-replacement patients. (Crain's Cleveland Business)

U.S. Patent Issued for an Approach Under Development to Address Low Back Pain

Aug. 26, 2015 - Mainstay Medical International plc announced issuance of a new U.S. patent, “Apparatus and Methods for Rehabilitating a Muscle And Assessing Progress of Rehabilitation.” The company is developing a new implantable neurostimulation system to treat chronic low back pain. (Business Wire)

Authors Report a Promising Brain Stimulation Target for Treatment-Resistant Obsessive Compulsive Disorder

Aug. 25, 2015 - A long-term follow-up of 24 patients with treatment-resistant obsessive compulsive disorder indicates that deep brain stimulation of the bed nucleus of the stria terminalis is a promising therapeutic option, according to a journal article by researchers in Belgium. (Molecular Psychiatry)

A Geographic Change to Be Considered in Scotland for Access to Deep Brain Stimulation Services

Aug. 25, 2015 - People in the eastern part of Scotland who have had to travel to England to receive deep brain stimulation surgery and follow-up care may no longer have to if a proposal for a single national service in Scotland is adopted when it is considered next month, according to a news report about the issue. The site under discussion for the service is the new Queen Elizabeth University Hospital in Glasgow. The article quotes patients who have had to travel to Newcastle in England for this type of care. (BBC News)

Device Maker Announces CE Mark for MRI-Conditional Implantable Pulse Generator

Aug. 24, 2015 - St. Jude Medical Inc. announced receiving CE Mark approval for magnetic resonance imaging-conditional labeling of its soon-to-be-launched implantable pulse generator, the Prodigy MRI chronic pain system, saying the approval applies with select leads. (Business Wire)

Device Developer Announces New Financing

Aug. 24, 2015 - Mainstay Medical International plc has secured $15 million in debt financing for commercialization of its neurostimulation device that is designed to address low back pain by contracting the muscles that provide stability. The funding from IPF Partners includes milestone payments for progress toward CE Mark approval of the device for the Dublin-based company. (Business Wire)

Clinical Trial Will Examine Non-invasive Stimulation for Children With Epilepsy

Aug. 21, 2015 - A research group at the China Academy of Chinese Medical Sciences in Beijing has published a clinical trial protocol to compare six months of daily treatment using two potential interventions in pediatric epilepsy, transcutaneous auricular non-vagus nerve stimulation (tan-VNS), or transcutaneous auricular vagus nerve stimulation (ta-VNS). The two treatment arms will be compared to a control group. (Trials)

Texas Man Participates in Clinical Trial of Deep Brain Stimulation in Depression

Aug. 19, 2015 - An article describes one man's deep brain stimulation surgery as part of a 10-person clinical trial that investigates addressing treatment-resistant depression with stimulation to the supero-lateral branch of the medial forebrain bundle. (Houston Chronicle)

Non-invasive Neurostimulation Company Raises Capital

Aug. 19, 2015 - A company that is developing a therapy for loss of the visual field that involves 10 daily sessions of non-invasive electrical brain stimulation, EBS Technologies of Berlin, has raised 1.1 million Euros. The external device, operated by a technician, delivers alternating current to the retina. The stimulation is intended to activate the optic nerve and visual cortex, with the stimulation adjusted in response to monitoring of the patient's EEG. (Market Watch)

Hospital Highlights Urologist's Congress Presentations

Aug. 17, 2015 - Beaumont Hospital in Royal Oak, MI highlighted three presentations made by urologist Ken Peters, MD, at the International Neuromodulation Society 12th World Congress in June about neuromodulation for bladder dysfunction and pelvic pain. (Newswise)

Small Study Indicates a Commercial Device Impaired Working Memory

Aug. 18, 2015 - A single-blind, sham-controlled study of 24 healthy subjects showed that a commercial transcranial direct current stimulation device decreased cognitive performance on a standard test of working memory. (Experimental Brain Research)

Researchers Do Away With Tether to Power Supply in Preclinical Optogenetics Development

Aug. 17, 2015 - Stanford University researchers have demonstrated that a fully enclosed implant can deliver light stimulation to the leg-muscle nerves of a mouse, powered by the animal's own body. (Stanford Report)

Article Describes Child's Experience as a Recipient of an Auditory Brainstem Implant

Aug. 17, 2015 - A 5-year-old boy born without a cochlea is participating in a clinical trial of pediatric patients who are receiving auditory brainstem implants to provide some sense of sound. The procedure had been previously approved in the U.S. for patients 12 years and older with neurofibromatosis type II. (The Blaze)

Lecture Describes Investigations Into Deep Brain Stimulation in Depression

Aug. 14, 2015 -  In a lecture at the National Institute of Mental Health concerning patients who participated in clinical research of deep brain stimulation for depression, Neurologist Helen Mayberg said that mapping white matter connections around Area 25 in the brain has guided stimulation parameters and demonstrated that initial non-responders can be converted to responders. She added that response rates using refined new methods now exceed 70% in a recent studies of 13 new patients. (NIH Record)

Consultants Foresee Broader Role for Neuromodulation

Aug. 13, 2015 - A product design innovator in the U.K., Cambridge Consultants, is publicizing its vision of future neuromodulation devices that it says might address what a news column terms  "lifestyle" issues -- such as migraine, obesity and incontinence. (Business Weekly)

Executive Changes Take Place at Company that Develops Neuromodulation Systems to Address Vision Problems

Aug. 13, 2015 - Second Sight Medical will get a new CEO this month when Robert Greenberg, MD, PhD steps down from that position and becomes chairman of the board, replacing Alfred Mann who will become chairman emeritus. The new CEO, Will McGuire, was an executive at medical-device-industry companies Volcano, Covidien and AtheroMed. An article notes that Greenberg had said the company intends to treat most types of blindness, such as glaucoma and diabetic retinopathy. The company's next-generation device "would bypass the retina with an electrode array implanted directly on the portion of the brain that deals with signals from the retina." (Mass Device)

Paper Points Out Apparent Clinical Benefits of Deep Brain Stimulation in Early Parkinson's Disease

Aug. 11, 2015 - A post-hoc analysis of patients involved in a pilot study of deep brain stimulation in early Parkinson's disease shows the therapy may reduce the risk of the condition worsening in clinically important ways by 50-80% .(Parkinsonism & Related Disorders)

Review: Network Effects of Deep Brain Stimulation is a Promising Area of Study

Aug. 12, 2015 - Assessing the network effects of deep brain stimulation will be critical to better understanding the underlying pathophysiology of various brain disorders, according to a review of the literature concerning studies using cerebral blood flow and metabolic imaging, functional imaging, and electrophysiology (including scalp and intracranial electroencephalography, and magnetoencephalography). (Journal of Neurophysiology)

Neuromodulation Device Developer Acquired by Pharmaceutical Firm

Aug. 11, 2015 - Dublin-based Allergan announced it has closed its purchase of dry-eye disease, neuromodulation-device developer Oculeve for $125 million in up-front payments plus commercialization milestone payments. (Mass Device)

Health Technology Assessment Issued About Functional Electrical Stimulation

Aug. 6, 2015 - An analysis of the scientific literature about functional electrical stimulation in children with spinal cord injuries or cerebral palsy examined three systematic reviews, six randomized controlled trials, and six non-randomized studies. The analysis concluded that the majority of studies found the intervention to be effective and well-tolerated by patients. (Canadian Agency for Drugs and Technologies in Health)

Research Paper Tracks Benefits of Deep Brain Stimulation in Epilepsy

Aug. 3, 2015 - A five-year follow-up study of deep-brain stimulation of the anterior nucleus of the thalamus in epilepsy suggests seizure control improves with time and notes that there may be greater benefits in patients with temporal lobe epilepsy compared to frontal lobe epilepsy, with reductions in seizure frequency of 76% and 59% respectively. (Epilepsy Currents)

Clinicians Start Trial of Non-Invasive Neurostimulator to Aid Balance Therapy

Aug. 11, 2015 - A double-blind, randomized, sham-controlled clinical trial has begun that will investigate the safety and effectiveness of a noninvasive cranial nerve stimulation device to augment physiotherapy for a chronic balance deficit due to mild-to-moderate traumatic brain injury. The device stimulates cranial nerves through the tongue, and the study is intended to precede marketing approval applications in the U.S. and Canada. The clinical trial of up to 120 subjects is taking place in Montreal, the Pacific Northwest, and Orlando, Florida through Helius Medical Technologies and the U.S. Army Medical Research and Materiel Command. (Business Wire)

Charity Vows to Continue Seeking Treatment Access

Aug. 10, 2015 - The UK epilepsy health research charity announced plans to work alongside the National Health Service in England with hope of overturning a recent decision to not allow deep brain stimulation in refractory epilepsy. It had been expected that a handful of cases would be allowed each year. Now only patients in clinically critical need may be considered as exceptions. Provision of the treatment had been sought by the health charity because it can help reduce seizure activity. (The National Society for Epilepsy)

Brain-to-Brain Noninvasive Stimulation Studied

Aug. 10, 2015 - A news column describes research into brain-to-brain communication using brain-computer interfaces and non-invasive stimulation. Some researchers interested in this area are also looking into trying to create networks of linked individuals (such as laboratory research animals), or develop brain-wave synchronization; while others hope to apply insights to better understand the neural basis of social behavior. (Irish Business Times)

Child Receives Newly Approved Vagus Nerve Stimulation System to Treat Her Epilepsy

July 30, 2015 - A 13-year-old girl with epilepsy was the first in Minnesota to receive a vagus-nerve-simulation-system implant that provides stimulation based on sensing changes in heart rate. The device was FDA approved in June. (KARE)

Company Names Two Business Leaders for Its Proposed Spin-out

July 30, 2015 - Greatbatch Inc., proposes a tax-free spin-off of its subsidiary, the QiG Group, into a medical device company, Nuvectra Corporation. In a Form 10 registration statement filed with the U.S. Securities and Exchange Commission, Greatbatch said neuromodulation industry veteran Scott Drees will be chief executive officer of Nuvectra; and Joseph A. Miller, Jr., PhD, its director and chairman of the board. (Globe Newswire)

Researchers Report Progress with Noninvasive Spinal Stimulation in Paralyzed Subjects

July 30, 2015 - In a study funded in part by the National Institutes of Health, researchers in California and Russia have demonstrated the ability of five men with complete motor paralysis to make voluntary step-like movements after about 18 weekly sessions of noninvasive electrical stimulation to their spinal cord. The results, published in the Journal of Neurotrauma, reportedly represent the first time this voluntary motion was achieved using transcutaneous stimulation. The lead researcher was quoted as saying he is interested in finding if autonomic functions may also be enhanced with similar therapy, saying the studies seem to have reawakened some networks and could contribute to a clinical toolbox to aid patients by widening the selection of available therapies. (EurekAlert)

Workshop Examines Issues Surrounding Interest in Noninvasive Neuromodulation

July 29, 2015 - An article summarizing a recent workshop on noninvasive neuromodulation says there is increasing interest from clinicians, patients, health systems, payers and industry. Although these devices may lead to more personalized care, the article says, their use could blurr the distinction between medical and non-medical approaches, which could potentially make it harder to develop an evidence base. (Medscape)

Data Show Greater Response of Back- and Leg-Pain Patients to High-Frequency Spinal Cord Stimulation

July 28, 2015 - A randomized controlled clinical trial reported in Anesthesiology showed a superior response rate for high-frequency spinal cord stimulation, compared to traditional, in back or leg pain among 171 study subjects at three months. The ratio of responders was 1.9 for back pain and 1.5 for leg pain. The authors report that the superiority was sustained through 12 months. (UPI)

Study: Sacral Neuromodulation Might Be an Additional Option for Patients with Neurogenic Lower Urinary Tract Dysfunction

July 28, 2015 - Co-authors who reviewed the charts of 50 patients who received sacral neuromodulation to treat neurogenic lower urinary tract dysfunction conclude that the treatment might be an additional therapy option in carefully selected patients. They report that 94% of the patients who received a permanent implant were either very satisfied or satisfied with the therapy. (Spinal Cord)

No Significant Difference Seen at Three Months in Sham-Controlled Clinical Trial of Deep Brain Stimulation in Depression

July 28, 2015 - A sham-controlled clinical trial of deep brain stimulation (DBS) to the ventral capsule and ventral striatum failed to show a significant difference in reduction of depression symptoms, according to results published in Biological Psychiatry. The clinical trial involved 30 patients. After 16 weeks, three of 15 patients (20%) responded to active stimulation, while two of 14 patients (14.3%) improved in the control group. Patients then entered a two-year open-label phase, in which the response rate was 20%, 26.7%, and 23.3% at 12, 18, and 24 months. The authors suggest that alternative study designs and stimulation parameters might be considered. (EurekAlert)

Woman Recounts Her Symptom Improvement Following Dorsal Root Ganglion Stimulation

July 27, 2015 - International Neuromodulation Society member Simon Thomson, MBBS FRCA FIPP FFPMRCA, was quoted about the importance of early detection and a multi-disciplinary approach in an article about a patient with complex regional pain syndrome who received dorsal root ganglion stimulation for her condition. (The Guardian)

Researchers Report Combining Delivery of Therapeutic Agents and Light Through Neural Probes

July 16, 2015 -  In preclinical brain-stimulation research, a team reports developing wireless optofluidic neural probes that combine ultrathin, soft microfluidic drug delivery with cellular-scale inorganic light-emitting diode arrays. The researchers say they demonstrated these devices in freely moving animals "to modify gene expression, deliver peptide ligands, and provide concurrent photostimulation with antagonist drug delivery to manipulate mesoaccumbens reward-related behavior." (Cell)

Interim Results Presented in Clinical Study of Deep Brain Stimulation in Early Alzheimer's Disease

July 24, 2015 - Interim results were presented at the Alzheimer's Association International Conference regarding a Phase II clinical trial of patients with early Alzheimer's disease who were implanted with deep brain stimulation (DBS) systems targeting the fornix, a part of the memory circuit. Half of the 42 patients in the clinical trial did not have their DBS system turned on for the first 12 months. Results from the first year show similar changes in cognitive measures between the two groups. Evalulation of the two groups will continue for four years. The researchers said an examination of trends among subgroups, who showed differences in glucose metabolism, can inform the design of future clinical trials. (Medpage Today)

Authors Compare Sacral Neuromodulation Implant Procedures

July 23, 2015 - In a "Beyond the Abstract" feature, authors say they found that sacral nerve stimulation that is guided solely by motor provocation during the implant procedure is more straightforward and requires less reprogramming, compared to procedures that include guidance from sensory feedback from patients. They encourage consideration of prospective studies to confirm those results. Their observational study appeared online in Neuromodulation: Technology at the Neural Interface in April. (Uro Today)

Study Evaluates Non-invasive Migraine Treatment in Patients Who Have Infrequent Episodes

July 22, 2015 - Twenty patients who never had been treated for their infrequent migraine without aura were enrolled in a safety-and-efficacy trial of transcutaneous supraorbital neurostimulation. These patients used the device more than 2/3rd of the time expected and experienced fewer migraine attacks and migraine days, with most having a reduction in symptoms of at least 50%. (The Journal of Headache and Pain)

Effect of Transcranial Direct Current Stimulation on Neuropathic Pain from Spine Injury Analyzed

July 21, 2015 - A meta-analysis of clinical trials of transcranial direct current stimulation for neuropathic pain resulting from back injury indicated a moderate effect that was not maintained at follow-up. (Spinal Cord)

Non-invasive Brain Stimulation Under Study for Dystonia

July 21, 2015 - A physiotherapy professor at the Graduate School of Health at the University of Technology Sydney is conducting clinical research into non-invasive brain stimulation for dystonia. She is comparing transcranial magnetic stimulation in neck dystonia and earlier results of transcranial direct current stimulation in patients who have hand dystonia. She anticipates later combining brain stimulation with more traditional physiotherapy treatments. (Brisbane Times)

Transcranial Magnetic Stimulation Reduced Tinnitus Symptoms More Than Sham, Study Finds

July 20, 2015 - Ten daily sessions of repetitive transcranial magnetic stimulation reduced tinnitus symptoms in a randomized, blinded, placebo-controlled clinical trial carried out and funded by the Veterans Affairs Rehabilitation Research and Development Service in Portland, OR. The study involved 64 participants, half of whom received sham stimulation. The responder rate in the active stimulation group was 56% and in the sham stimulation group, 22%. The symptom improvement seen in the group that had active stimulation was sustained for 26 weeks, according to the researchers' paper in JAMA Otolaryngology – Head & Neck Surgery. (Pharmabiz.com)

Patient Receiving Deep Brain Stimulation Notices Effect on Her Irritable Bowel Syndrome

July 2015 - A case report describes an effect on irritable bowel syndrome (IBS) that was noticed in a woman who received deep brain stimulation (DBS) to the anterior limb of the internal capsule for obsessive compulsive disorder. The patient reported substantial relief of her IBS symptoms after DBS. The authors noted in their report that "the reduction depended on specific stimulation parameters, was reproducible over time, and was not directly associated with improvements in obsessive compulsive disorder symptoms." (Clinical Gastroenterology and Hepatology)

Wirelessly Controlled Spinal Cord Stimulation System Receives FDA Approval

July 16, 2015 - The FDA has approved St. Jude Medical's Invisible Trial System, which patients can control with an iPod Touch and clinicians can program and track with an iPad Mini. The wirelessly controlled trial spinal cord stimulation system includes a small external pulse generator. (Fierce Medical Devices)

Device Company Targeting Low-Back Pain Announces Two U.S. Patents

July 15, 2015 - Mainstay Medical International plc announced issuance of two U.S. patents concerning its neurostimulation therapy for chronic low back pain. The company's device stimulates muscles in the lower spine to provide more control over these stabilizing muscles. (Business Wire)

Article Describes Prototype Device Intended to Guide Placement of Neurostimulators

July 15, 2015 - An article about a prototype neurostimulator-delivery tool in development by Cambridge Consultants says the Chimaera hand-held instrument is designed to be used in conjunction with a wearable optical device such as Google glass to provide the operator a visual overlay of the target area. It combines pre-operative 3D imaging and real-time sensing of nerves. (Reuters)

Company Announces Patent Allowance for High-Frequency Peripheral Nerve Stimulation

July 14, 2015 - Bioness, Inc. received clearance from the U.S. Patent Office for a patent claiming use of high-frequency stimulation with its implantable peripheral nerve stimulation device, StimRouter. The device is FDA-approved to treat chronic, intractable pain of peripheral nerve origin as an adjunct to other modes of therapy. (Business Wire)

Article Focuses on Preclinical Studies of Deep Brain Stimulation as a Potential Intervention to Aid Stroke Rehabilitation

July 13, 2015 - International Neuromodulation Society (INS) member Andre Machado, MD, PhD, was interviewed about his preclinical studies into the potential for deep brain stimulation to aid in stroke rehabilitation. INS member Konstantin Slavin, MD, was also quoted in the story about unanswered questions posed by the potential to translate the findings through possible future clinical trials. (Wall Street Journal)

Series Describes Pain Patients' Exploration of Spinal Cord Stimulation as an Option

July 12, 2015 - A man who has been chronicling his exploration of whether to have spinal cord stimulation decides to go forward with a permanent implant. (National Pain Report)

Rehabilitation Researchers Study the Feasibility of Using EEG-Controlled Functional Electrical Stimulation

July 11, 2015 - Researchers undertook a safety study of a novel approach to rehabilitation for foot drop in patients who had chronic impairment from stroke. They had nine study participants use an EEG cap while the peroneal nerve was stimulated. Over the course of 12 hour-long sessions, patients followed cues to flex or relax their foot. A post-hoc analysis suggests there was statistically significant, but not clinically significant, improvement of lower motor performance such as gait speed, walk distance and range of motion. (Journal of Neuroengineering and Rehabilitation)

Researchers Add Sensory Transmissions to Model of Neurostimulation Mechanism of Action

July 9, 2015 - International Neuromodulation Society member Yun Guan, MD, PhD, and colleagues write that they have developed a simple simulation test bed that goes beyond existing models by including fundamental underlying sensory activity transmitted in dorsal column fibers. They say they have found so far that "interactions between stimulation-evoked and underlying activities are mainly due to collisions of action potentials and losses of excitability due to the refractory period following an action potential." (Cornell University Library)

Study Indicates External Trigeminal Nerve Stimulation May Provide Adjunctive Relief in Depression

July 9, 2015 - A study presented at the American Society of Clinical Psychopharmacology annual meeting in Miami indicates external trigeminal nerve stimulation may help alleviate symptoms of major depressive disorder. In the study, 43 patients were randomly assigned to active or sham treatment for six weeks. Patients wore electrode patches for eight hours at night. Data collected at six weeks showed that symptoms, and their severity, improved on average after six weeks in patients who had failed at least one antidepressant. The treatment was originally investigated for drug-resistant epilepsy, and later has been explored for potential efficacy in psychiatric disorders like depression, PTSD, and ADHD. (Medscape)

Girl is First in England to Undergo a Pediatric Auditory Brainstem Implant

July 9, 2015 - A 4-year-old girl who was born without a cochlea and auditory nerve had an auditory brainstem implant at 23 months of age, and is making progress in understanding spoken language. (Daily Mail)

Brain Stimulation Research Helps to Identify Potential for Improvement in Minimally Conscious State

July 8, 2015 - A column recaps brain research into increasing responsiveness of patients who are in a minimally conscious state, including findings from investigations involving deep brain stimulation. (Wall Street Journal)

Hypothesis Proposes a Deep Brain Stimulation Mechanism Stemming from Extracellular Potassium

July 6, 2015 - Authors of a scholarly article propose that excess extracellular potassium may mediate some effects of deep brain stimulation, through affecting inhibition and excitation of cells and axons, thereby interrupting pathological activity. (The Neuroscientist)

Pain Relief in Diabetic Peripheral Neuropathy is Sustained After 24 Months of Spinal Cord Stimulation

June 26, 2015 - International Neuromodulation Society member Robert van Dongen, MD, PhD, and colleagues report a 24-month follow-up of a prospective randomized controlled trial of spinal cord stimulation in painful diabetic peripheral neuropathy. From 17 patients who were implanted after a positive trial stimulation phase at two centers, 11 (65%) reported treatment success at 24 months. (Diabetes Care)

Contract Finalized to Support Clinical Trial of Neuromodulation Device to Address Balance Issues Arising from Traumatic Brain Injury

July 7, 2015 - Helius Medical Technologies, Inc.'s  NeuroHabilitation Corporation division has entered into a cost-sharing contract with the U.S. Army Medical Research and Materiel Command to support a clinical trial investigating the safety and effectiveness of the company's non-invasive Portable Neuromodulation Stimulator (PoNS™) for the treatment of balance disorder in patients with mild-to-moderate traumatic brain injury. The (PoNS™) device is placed on the tongue to stimulate cranial nerves that innervate muscles there. (Business Wire)

Firm Acquires Developer of Dry-Eye Neurostimulation Therapy

July 6, 2015 - Allergan of Dublin, Ireland will pay $125 million acquire South San Francisco-based Oculeve, a development-stage company that is developing a nasal neurostimulation device designed to increase tear production in patients with dry eye disease. The deal includes milestone payments for development of Oculeve's OD-01 neurostimulation therapy. Two pivotal trials are planned, with commercialization potentially occurring in 2017 after FDA approval, the company said. (Mass Device)

Patients with Paralysis or Neuromuscular Disease Exercise Using Functional Electrical Stimulation

June 29, 2015 - Rhode Island has its first functional electrical stimulation bicycle, which can help prevent muscle atrophy in people with motor impairment. The bike was donated through a fund-raising drive begun by a spine-injury patient who had used similar equipment during his post-injury rehabilitation in Boston. (Providence Journal)

Review Seeks to Assess Newer Studies of Spinal Cord Stimulation in Cancer-Related Pain

June 29, 2015 - A literature search for controlled trials of spinal cord stimulation in cancer-related pain did not identify new studies that had not already been included in a 2013 systematic review. Four case series that represented 92 patients were previously reported and found decreases in mean pain scores and analgesic use. (Cochrane Database of Systemic Reviews)

Future Name of Newly Merged Company Announced

June 25, 2015 - Sorin Group and Cyberonics said when their merger is complete the new company will be named LivaNova. Its three business units in cardiac surgery, cardiac rhythm management and neuromodulation will have headquarters in Mirandola, Italy; Clamart, France; and Houston, Texas, respectively. (Mass Device)

Neuroscientist Receives $4 Million to Investigate Varying Deep Brain Stimulation Pulse Patterns in Parkinson's Disease

June 25, 2015 -  Duke University Professor of Biomedical Engineering Warren Grill, PhD received a  $4 million Javits Neuroscience Investigator Award, which will support studies for up to seven years. His team is interested in potential benefits of varying deep brain stimulation pulse patterns in patients with Parkinson's disease. (The News & Observer)

Study Reports Effectiveness of Low-field, Synchronized Transcranial Magnetic Stimulation in Major Depression

June 24, 2015 - An investigational device that synchronizes low-field transcranial magnetic stimulation to a patient's alpha brainwave frequency was more effective than sham in achieving a clinical response in patients with major depressive disorder, according to a safety and efficacy study of more than 200 patients that was published in Brain Stimulation. Patients whose active stimulation treatment was both accurate and consistent had a 34.2% response rate, compared to a 8.3% response rate from sham stimulation. (Eurekalert)

Neuromodulation: Technology at the Neural Interface Impact Factor Rises Almost One Full Point

June 18, 2015 - The Impact Factor of Neuromodulation: Technology at the Neural Interface continues to rise, and in 2014 rose from 1.785 to 2.701 -- almost one full point. The journal ranking in the Clinical Neurology category is now 76/192 (up from 122/194) and in the Medicine, Research & Experimental category it is 54/123 (up from 78/124). (Wiley Online Library)

Article Reviews Deep Brain Stimulation for Psychiatric Disease

June 2015 - A review summarizes the current evidence and development of deep brain stimulation for psychiatric disease. (Journal of Neurosurgery)

Neurosurgeons Review Brain-Stimulation Targets for Obesity

June 2015 - The lateral hypothalamic area "remains the primary DBS target for treating obesity because the LHA is the central hub for all circuits involved in the drive to eat," write International Neuromodulation Society members Derrick A. Dupré, MD; Nestor Tomycz, MD, and colleagues in a review of past, present and future deep brain stimulation targets for obesity. (Journal of Neurosurgery)

FDA Approves Deep Brain Stimulation System

June 12, 2015 - The U.S. FDA approved St. Jude Medical Inc.'s rechargeable Brio deep brain stimulation (DBS) system for management of medication-resistant motor symptoms of Parkinson's disease and essential tremor. The DBS system is the second to receive FDA approval, with Medtronic's Activa system approved in the U.S. in 1997 for essential tremor and in 2002 for Parkinson's disease. (FDA)

International Neuromodulation Society Names a Giant of Neuromodulation

June 10, 2015 - The International Neuromodulation Society named its third Giant of Neuromodulation, selecting Clinatec Chairman Alim-Louis Benabid, MD, PhD, for the honor for his development of deep brain stimulation to treat Parkinson's disease and other disorders. (News-medical.net)

Best Abstracts Announced at International Neuromodulation Society 12th World Congress

June 10, 2015 - Five abstracts were recognized in the International Neuromoduation Society's first best abstract competition at the12th World Congress in Montreal. The presentations ranged from clinical to basic science, such as a demonstration of a brain computer interface that permitted a man with tetraplegia to control his otherwise unresponsive hand, and a preclinical study that showed deep brain stimulation aided formation of new neural connections during stroke recovery. (News-medical.net)

Sustained Symptom Relief Reported in Pediatric Dystonia Patients Receiving Deep Brain Stimulation

June 10, 2015 - Children and adolescents who received deep brain stimulation for generalized dystonia maintained significant symptom relief for up to eight years, according to a study presented by Argentinean Neuromodulation Society President Juan Carlos Andreani, MD at the 12th World Congress of the International Neuromodulation Society. (News-medical.net)

Study Shows Chronic Pain Patients' Healthcare Expenditures Decreased After Spinal Cord Stimulation

June 10, 2015 - Mean annual healthcare expenditures increased in each of the three years before spinal cord stimulation treatment, and decreased in each of the three years after, according to a study based on data from the Vancouver Island Health Authority that was presented at the International Neuromodulation Society 12th World Congress. Hospital costs especially contributed to the overall expenditures. (Science Daily)

Researchers Conclude a Fully Powered Study is Feasible of Spinal Cord Stimulation in Refractory Angina Pectoris

June 10, 2015 - The first publicly funded pilot study of spinal cord stimulation (SCS) has shown that therapy and trial outcome measures of SCS in refractory chronic angina pectoris were appropriate and feasible. International Neuromodulation Society member Sam Eldabe, MD, and collaborators in the multi-center study will advise NICE that a fully powered nationwide study is feasible under the U.K. definition of refractory chronic angina pectoris. The findings were presented at the International Neuromodulation Society 12th World Congress. (Newsmedical.net)

Neural Targeting Software Improved Pain Relief from Spinal Cord Stimulation

June 10, 2015 - At the International Neuromodulation Society 12th World Congress, new observational data from more than 300 patients show use of 3D neural targeting software provided 1.5 times better overall pain relief and 2 times better low back pain relief than a previous-generation spinal cord stimulation system. (Fierce Medical Devices)

Device Company Announces Financing Round

June 9, 2015 - WISE Srl, which is developing next-generation neurostimulation leads, announced the closing of a EUR 3 million series A financing round, led by Principia SGR, an Italian Venture Capital firm. Existing investors High-Tech Gründerfonds, Atlante Seed and b-to-v Partners joined the round alongside with three new investors Atlante Ventures, F3F and Antares. (WISE Srl)

Study Data Indicate Dorsal Root Ganglion Stimulation Provided Superior Relief for Chronic Lower Limb Pain

June 8, 2015 - Research findings reported at the International Neuromodulation Society 12th World Congress showed that stimulation of the dorsal root ganglion (DRG) provided significant pain relief in 81.2% of patients with chronic lower limb pain from complex regional pain syndrome or peripheral causalgia. The data were obtained in the ACCURATE study of 152 patients at 22 centers in the U.S. The study subjects were randomized to receive either DRG stimulation or traditional spinal cord stimulation (SCS) for three months. In the SCS group, 55.7% of patients achieved significant relief of their chronic lower limb pain, which has been difficult to treat with traditional SCS. (Business Wire)

Presentation Features Potential Nanotechniques for Deep Brain Stimulation

June 8, 2015 - Neurosurgeons and engineers at NASA and the Mayo Clinic have collaborated on development of potential nanotechniques for future deep-brain-stimulation tools. The work was presented at the International Neuromodulation Society 12th World Congress. (Tech Times)

Company Announces Availability of Its Implantable Peripheral Nerve Stimulator

June 8, 2015 - Bioness, Inc. announced the commercial availability of StimRouter, its FDA-approved implantable neuromodulation device to treat chronic, intractable pain of peripheral nerve origin as an adjunct to other therapies, such as medications. (Business Wire)

Company Announces Name Change as Commercialization Starts for Spinal Cord Stimulation System

June 5, 2015 - Algostim, LLC, a subsidiary of Greatbatch, Inc.'s QiG Group, announced it will now do business as Nuvectra. The medical device company will commerciallze the Algovita spinal cord stimulation system to treat chronic intractable pain of the trunk and/or limbs. (NASDAQ)

Company Announces Launch of Compact Spinal Cord Stimulator System

June 5, 2015 - Boston Scientific announced the European launch of the Precision Novi™ spinal cord stimulation system at the 12th World Congress of the International Neuromodulation Society. The 16-contact primary cell (non-rechargeable) device has CE Mark approval for the treatment of chronic pain. (Newsmedical.net)

Company Announces App-Based, Wireless Neuromodulation Trialling System

June 4, 2015 - St. Jude Medical, Inc. announced CE Mark approval and the European launch of its Invisible Trial System, an app-based and wireless neuromodulation programming system that uses Apple™ iPod touch™ and iPad mini™ technology. The system consists of an external pulse controller, a patient iPod touch controller, and Bluetooth communication function that eliminates the programming trial cable. (Med Device Online)

Collaborators Announce Plans to Develop an Electrical Stimulation Device to Staunch Blood Loss

June 4, 2015 - A collaboration between Battelle and the Feinstein Institute for Medical Research, the research arm of The North Shore-LIJ Health System, was announced in which Battelle plans to create a “neural tourniquet” device, based on science developed at the Feinstein Institute, to help staunch blood loss through electronic stimulation of neural pathways to the spleen, preparing the body for clotting in response to a wound. (Med Device Online)

Grant Establishes Center to Study Brain Networks for Translational Research in Obsessive Compulsive Disorder

June 4, 2015 - A five-year, $10 million grant from the National Institute of Mental Health establishes a new center at the University of Rochester to improve understanding of brain networks and their "hubs" that are key in obsessive compulsive disorder. The new Silvio O. Conte Center for Basic and Translational Mental Health Research includes mental health researchers at Harvard University, the University of Pittsburgh, the University of Puerto Rico, and Brown University. (University of Rochester)

Researchers Publish Their Work to Aid Deep Brain Stimulation Surgery With Brainstem Mapping

June 4, 2015 - Researchers from Duke Medicine published in the journal Human Brain Mapping http://onlinelibrary.wiley.com/doi/10.1002/hbm.22836/abstract that they have created a high-resolution 3D map of the human brainstem to serve as a guide for deep brain stimulation, and to visualize complex neuronal connections. (Medical News Today)

University Researchers Look Into Creating Wireless Android App for Essential Tremor Patients to Switch On Neurostimulation

June 4, 2015 - Researchers from the University of Washington are adding Bluetooth communication to the Medtronic Activa PC+S Deep Brain Stimulation system for an Android smartwatch app so that when an essential tremor patient senses a tremor, the patients can initiate stimulation using that handheld device. (University of Washington)

Stakeholders and Specialists Discuss Brain Modulation and Recording Opportunities

June 3, 2015 - A two-day NIH Brain Initiative workshop presented information on opportunities for collaborative partnerships between clinical/academic researchers and corporate manufacturers of devices for human brain modulation and recording. The workshop was organized to accentuate the need for a streamlined path for developing and integrating innovative new technologies. One purpose of the workshop was to describe a proposed NIH framework for facilitating and lowering the cost of new studies using these devices. A second purpose was to discuss regulatory and intellectual property considerations. The organizers are also soliciting recommended approaches for data coordination and access. (NIH)

FDA Approves Vagus Nerve Stimulation System That Responds to Heart Rate Change in Epilepsy Patients

June 2, 2015 - Cyberonics announced FDA approval for its AspireSR generator designed for vagus nerve stimulation to treat drug-resistant epilepsy. It uses a proprietary, customizable cardiac algorithm to detect relative heart-rate increases and deliver automatic stimulation. (Mass Device)

Canadian Neuromodulation Society Holds Public Event, Invites Media to Briefing

June 1, 2015 - Members of the media were invited to a news briefing by the president of the Canadian Neuromodulation Society, Michel Prud'Homme, MD, PhD, immediately before a free public lecture on neuromodulation therapies, which was a local satellite event the weekend before the start of the International Neuromodulation Society 12th World Congress in Montreal. (Newsmedical.net)

PET Scans Show Non-Invasive Migraine Device Restored Normal Metabolic Activity to Specific Brain Areas

June 1, 2015 - Cefaly Technology announced results of a new PET trial in 28 patients who have at least four migraines per month. The trial showed that the company's transcutaneous electrical nerve stimulation  device, which is FDA-approved for use prior to migraine onset, returns normal metabolic activity to the areas in the brain, specifically the orbitofrontal cortex and rostral cingulate. (Pharmiweb.com)

Researchers Publish Work on Potential High-Performative Transistors for Bioelectronic Devices

May 26, 2015 - Researchers in France published in Science Advances http://advances.sciencemag.org/content/1/4/e1400251 about potential high-performance transistors for bioelectronic devices, that tune transconductance (to amplify brain signals) through channel thickness rather than electrode surface area. The organic electrochemical transistors use conductive polymers and liquid electrolytes, materials that could form an interface between the brain and conventional silicon electronics. (IEEE Spectrum)

Results Announced for Two Overactive Bladder Patients Receiving Wirelessly Powered Tibial Nerve Stimulation Since August 2014

May 28, 2015 - StimGuard LLC announced two patients who received injectable tibial stimulators in August 2014 for overactive bladder have ongoing reduction of voiding episodes and more than 80% relief. The treatment is carried out at night using a sock to cover the stimulation area. The wirelessly powered implant delivers stimulation that the company said enables the brain to remap specific urge signals in a fashion similar to acupuncture, but permanent. The company plans to complete regulatory studies for CE Mark in 2015 and seek FDA approval in 2016. (Business Wire)

News Feature Describes a Phrenic Nerve Stimulation System Under Development

May 21, 2015 - An article describes a phrenic-pacing development by Lungpacer Medical Inc., saying the innovation will be presented during a preconference of the International Neuromodulation Society 12th World Congress. The device is under development for patients who depend on mechanical ventilation, and is designed to stimulate the diaphragm of critically ill patients to contract in order to aid their recovery. (Vancouver Sun)

Interview Describes the Growth of Neuromodulation Therapy

May 22, 2015 - International Neuromodulation Society President-Elect Timothy Deer, MD, in an interview on FindaTopDoc radio, described the development and growth of neuromodulation therapy, noting how innovation is a collaborative effort that is allowing a widening number of patients to benefit. (BlogTalkRadio)

Researchers Demonstrate Neural Control of Robotic Arm in Clinical Trial of a Brain-Machine Interface in the Posterior Parietal Cortex

May 22, 2015 - Researchers from Caltech and the University of Southern California Keck School of Medicine reported in Science about a clinical trial in which a man paralyzed for more than 10 years was able to intentionally move a robotic arm controlled through two implanted neural arrays on his posterior parietal cortex. (Medical Xpress)

Essay Explores the Neuroscience Behind Deep Brain Stimulation

May 21, 2015 - A research scientist writes about the role of oscillations in helping neurons coordinate their communication, and implications for deep brain stimulation therapy. (Forbes)

Meeting Poster Shows Reasons Migraine Patients Cited for Use of Non-invasive Vagus Nerve Stimulation

May 21, 2015 - A poster at the International Headache Congress in Valencia, reports on a survey in which 49 respondents explained their attitude to electroCore’s non-invasive vagus nerve stimulation treatment for migraines. Respondents were allowed to cite more than one reason. The most-cited reason for starting the therapy (67.3%) was resistance to standard migraine therapy. The most-cited reason for continuation (69.5%) was efficacy. After treatment, 46% of attacks were minimized or halted after two hours, and 61% after four hours. (Briefing Wire)

Company Launches a Next-Generation Device for GERD in Europe

May 18, 2015 - EndoStim announced CE Mark approval and European launch of its second generation system, EndoStim II, to treat gastroesophageal reflux disease (GERD). (PR Newswire)

Sacral Neuromodulation Device Company to Present at Meeting

May 20, 2015 - Axonics Modulation Technologies, Inc. announced that it has been selected to present its technology advancements during the Innovations in Neuromodulation session at the International Neuromodulation Society's 12th World Congress on June 6th in Montreal. The company makes an implantable sacral neuromodulation system to manage chronic intractable urinary and fecal dysfunction. The system has a rechargeable implantable pulse generator designed to be small and long-lasting. (Business Wire)

Paper Elucidates Anti-Inflammatory Role of Vagus Nerve Stimulation

May 20, 2015 - Stimulation of either motor or sensory vagus nerve bundles can diminish inflammation, according to a paper in the journal Bioelectric Medicine. (Blackbird PR News)

Enrollment is Completed in a Pilot Clinical Trial Addressing Balance Issues in Multiple Sclerosis

May 20, 2015 - Helius Medical Technologies has completed enrollment for its pilot clinical trial at the Montreal Neurological Institute in which 14 patients with multiple sclerosis will be treated for balance and gait symptoms over the course of 14 weeks, undergoing a physiotherapy protocol combined with noninvasive stimulation of cranial nerves using the Portable Neuromodulation Stimulator (PoNS™). (Business Wire)

First Patient in Canada Receives Burst-Mode Spinal Cord Stimulator Implant

May 19, 2015 - Health Canada approved St. Jude Medical's Prodigy™ spinal cord stimulation system with burst technology, the company announced. The first Canadian patient was implanted with the system earlier this month by Ivar Mendez, M.D., Ph.D, FRCSC, FACS at Saskatoon Health Region’s Royal University Hospital. (Market Watch)

Woman With Lyme Disease Fares Better After Deep Brain Stimulation Treatment

May 14, 2015 - For Mother's Day, a woman writes about how her mother regained some function after treating Lyme Disease symptoms through deep brain stimulation. (Curry County Register)

Researchers Investigating Transcranial Magnetic Stimulation for Balance Disorder Seek to Expand Study

May 14, 2015 - Deakin University reported in the Journal of Neuropsychology http://onlinelibrary.wiley.com/doi/10.1111/jnp.12070/abstract that repetitive transcranial magnetic stimulation sessions helped reduce symptoms of Mal de debarquement syndrome in six out of seven patients. Now the researchers hope to receive funding to expand the clinical trial. (Herald Sun)

Project to Explore the Possibility of Adding Sensory Nerve Stimulation to Prosthetic Hands

May 13, 2015 - Researchers at Washington University in St. Louis have received a three-year, nearly $1.9 million grant from the Defense Advanced Research Projects Agency (DARPA) for a preclinical study to explore stimulating sensory nerves to add a sense of touch to prosthetic hands. (Newswise)

International Neuromodulation Society 12th World Congress Abstracts Reveal Field's Growth

May 14, 2015 - The International Neuromodulation Society issued a news release about the 12th World Congress abstracts that cover device innovation, expanding indications, and evidence of important outcome measures. Scientific Program Chair and President-Elect Dr. Timothy Deer is quoted as saying neuromodulation is viewed as a new treatment paradigm. (Newswise)

Poster on Vagus Nerve Stimulation at Headache Meeting Describes Treatment Efficacy

May 14, 2015 - A poster presentation at the International Headache Congress in Valencia, Spain reports that vagus nerve stimulation (VNS) inhibits cortical spreading depression (CSD), which is known to be the cause of migraine aura and a trigger for headache. Both invasive and noninvasive VNS were equally effective, and stimulation of less than 30 minutes reduced CSD for more than three hours, more quickly than prophylactic pharmaceutical migraine treatments. (electroCore)

Clinical Trial Will Explore Low-Frequency Stimulation Effects on Cognitive Decline in Parkinson's Disease Patients

May 14, 2015 - The University of California Davis Health System announced a clinical trial of a deep brain stimulation (DBS) approach that may limit cognitive decline in patients with Parkinson's disease. The approach involves DBS of the subthalamic nucleus (STN) using low-frequency theta stimulation targeting an isolated portion of the STN involved in cognition. The study will involve detailed before-and-after tests of memory, learning and rule use. (Health Canal)

Company Announces FDA Clearance for U.S. Sales of its Transcranial Magnetic Stimulation System for Major Depressive Disorder

May 14, 2015 - The Magstim Company Ltd. of Wales announced it has received FDA 510(k) clearance to market its Magstim Rapid2 Therapy System, a repetitive transcranial magnetic stimulation system, for the treatment of drug resistant Major Depressive Disorder in the United States. (Magstim)

Company Receives Permission to Start a U.S. Clinical Trial of a Needle-Implanted, Wirelessly Powered Device in Overactive Bladder Patients

May 11, 2015 - Privately held StimGuard announced the FDA has approved the start of a clinical trial to evaluate a micro-sized device for overactive bladder (OAB) that can be placed completely through a needle. The announcement says the implant is wirelessly powered by an external, "electroceutical" microchip from Stimwave, a company founded by StimGuard's co-founder, which delivers small pulses of energy to electrodes near surrounding nerves. The StimGuard-device clinical trial is due to start in the U.S. in the summer of 2015. (Business Wire)

Device Maker Raises $38 Million in Financing

May 12, 2015 - Autonomic Technologies, Inc. announced it has received a series D round of financing that raised $38 million. The company said it will use the money to expand its marketing in Europe of Pulsante™, its microstimulator to treat severe headaches, and to fund an ongoing clinical study of the device in the U.S. to treat chronic cluster headache. Pulsante™ has received CE mark approval in Europe for treatment of cluster headache. (Military Technologies)

Company Faces Patent-Claims Challenge

May 11, 2015 - Nevro Corp. said Boston Scientific Corporation has filed two petitions at the U.S. Patent Office for inter partes review of claims that were previously granted to Nevro. A inter partes  petition challenges patent claims based on prior art and publication. (CNN Money)

Clinical Trial Begins in the U.S. for Obstructive Sleep Apnea Device

May 11, 2015 - ImThera Medical said the first two patients with obstructive sleep apnea were implanted with its aura6000 system in its U.S. clinical study. ImThera's device has received CE Mark approval in Europe, and is commercially available in some markets outside the U.S. (Mass Device)

Preclinical Research Demonstrates a Neurostransmitter Delivery System

May 8, 2015 - A research team including International Neuromodulation Society member Bengt Linderoth, MD, PhD, has published in Science Advances a proof-of-concept demonstration in laboratory mice of an implantable organic electronic device for neuropathic pain treatment. The implantable device releases the inhibitory neurotransmitter GABA (gamma-aminobuyric acid) into the intrathecal space, electrically controlling the release of this positively charged molecule through by applying a current to drive it through an ion-screening electrophoretic gel in the device distribution channel. (IEEE Spectrum)

FDA Approves Paresthesia-Free Spinal Cord Stimulation System

May 8, 2015 - The FDA has approved the Senza system, Nevro Corp.'s spinal cord stimulation device that relieves trunk or limb pain without paresthesia. The company said in announcing the approval that the FDA is not restricting patients receiving the therapy from operating motor vehicles, that the system has 3T-conditional MRI compatibility, and received "superiority" labeling from the FDA. The FDA based its approval on a clinical study that showed 75% of patients treated had their chronic pain reduced by 50% within three months. Implant site pain and device lead dislocation were among the adverse events reported. (PR Newswire)

Woman in British Columbia Undergoes Deep Brain Stimulation for Multiple Sclerosis Tremor

May 8, 2015 - International Neuromodulation Society member Christopher Honey, MD, was described as the only neurosurgeon in British Columbia who performs deep brain stimulation (DBS), in an article about a woman with multiple sclerosis whose DBS surgery to control the tremor of multiple sclerosis was documented by the news team. (Global News)

INS Announces Preconference and Satellite Events

May 7, 2015 - The International Neuromodulation Society announced two preconferences of the 12th World Congress, an Innovation Day and a daylong set of talks on Mechanisms of Action, on June 6 and 7 respectively -- as well as the Canadian Neuromodulation Society's free public lecture on neuromodulation the afternoon of June 6. (Business Wire)

Dallas Site Will Be One Center in a Clinical Trial of Vagus Nerve Stimulation for Post-Stroke Arm Rehabilitation

May 7, 2015 - The University of Texas Southwestern Medical Center in Dallas will be one of three sites to offer enrollment in a clinical trial of MicroTransponder Inc.'s vagus nerve stimulation system, Vivistim®, during post-stroke rehabilitation of arm function. (News-Medical.net)

Transcutaneous Vagus Nerve Stimulation Studied in Patients With Drug-Resistant Artrial Fibrillation

May 6, 2015 - Researchers report a first-in-human, sham-controlled study of transcutaneous electrical vagus nerve stimulation in 40 patients who planned to undergo ablation for atrial fibrillation. After following the patients for several months, they say the results support the emerging paradigm of using neuromodulation to manage drug-refractory atrial fibrillation, which is attract for being nonpharmacological and nonablative. In 20 patients in the treatment arm, the study authors used a metal clip on the right ear to apply low-level stimulation to the auricular branch of the vagus nerve at the tragus. (Cardiac Rhythm News)

Woman With Multiple Sclerosis Recounts Her Decision to Turn to Deep Brain Stimulaton

May 6, 2015 - A Canadian woman whose multiple sclerosis lead to disabling tremors received a deep brain stimulation implant that will be turned on in June. She said already her symptoms have lessoned now that the electrodes are in place. (Muskokaregion.com)

Research Presentation Supports Increased Efficacy for Spinal Cord Stimulation With Decreased Wait Time

May 6, 2015 - A paper presented at the American Association of Neurological Surgeons annual meeting, based on a retrospective analysis of 762 patients, appears to support earlier findings that spinal cord stimulation efficacy is inversely proportional to the wait time. (Healio)

Paper Discusses Optimizing Lead Placement with Intraoperative Monitoring

May 6, 2015 - Intraoperative monitoring during spinal cord stimulation implantation can help verify accurate placement of the leads, according to a paper presented at the American Association of Neurological Surgeons annual meeting. The prospective study of 73 patients indicated that electromyography in particular may help streamline programming by indicating which contacts may be ideal. (Healio)

Tailored Spinal Cord Stimulation Improved Outcomes

May 6, 2015 - An analysis of 350 patients at 36 centers in the St. Jude Medical EMP3OWERTM study  indicates that tailoring lead type, number, and targeting of stimulation area improved clinical outcomes and correlated with increased odds of decreased opioid usage, according to a presentation at the American Association of Neurological Surgeons annual meeting. (Healio)

Biomedical Researchers Find Novel Polymer Leads Reduce MRI Heating

May 6, 2015 - Researchers at Martinos Center for Biomedical Imaging at Massachusetts General Hospital reported using conductive polymers for novel potential neurostimulation leads that, through a similar radio-frequency interaction used to cloak some stealth aircraft, break up induced current, leading to less heating under magnetic resonance imaging conditions, according to tests with standard gel-filled models. They say the resistive tapered stripline technology reduces MRI-induced heating and allows use of higher-Tesla imaging systems. (The Engineer)

Device Company Completes Acquisition of Developer of Dorsal Root Ganglion Spinal Cord Stimulator

May 4, 2015 - St. Jude Medical announced it has completed acquisition of Spinal Modulation, Inc. The acquisition was completed on May 1. Spinal Modulation developed the Axium™ spinal cord stimulation system. That system has approval in the European Union and Australia. Results of a U.S. clinical trial, ACCURATE, will be presented at the International Neuromodulation Society 12th World Congress in June in Montreal, according to the company's announcement. (Business Wire)

Autistic Man Describes His Deep Brain Stimulation Treatment for Obsessive Compulsive Disorder

May 4, 2015 - A young man who has both obsessive compulsive disorder (OCD) and autism was treated for his severe, disabling OCD symptoms with deep brain stimulation (DBS). International Neuromodulation Society member Robert Buchanan, MD, said this case is the first in which a patient with that dual diagnosis has received DBS. He said it seems to help the brain's intrinsic rhythms of electrical activity become more normalized. The patient, who sought treatment two years ago, said he is more focused and interactive as a result. Researchers at Seton Brain and Spine Institute in Austin, Texas hope to focus on on why DBS worked, and whether it can help autism patients live fairly normal lives as well, the news coverage says. (KHOU)

Manufacturer Announces Plans to Spin Out Device Company

April 30, 2015 - Greatbatch, Inc. said it expects to spin off its QiG Group subsidiary, Algostim LLC, by the end of 2015, in order to create a new publicly traded company focused on commercializing the Algovita spinal cord stimulation system, which Greatbatch would continue to manufacture. (GlobeNewswire)

Company Announces FDA Approval of Spinal Cord Simulation System and Leads

April 30, 2015 - St. Jude Medial, Inc. said it has received FDA approval of its Protégé MRI™ spinal cord stimulation system, as well as approval for MRI compatibility of the company’s 60cm Octrode™ percutaneous leads. The leads received MR-conditional labeling for use with the Protégé MRI system. (Market Watch)

Sacral Neuromodulation Developer Raises Capital

April 30, 2015 - Axonics Modulation Technologies of Irvine, Calif. was reported to have raised $17.3 million, according to a regulatory filing. The company is developing sacral neuromodulation (SNM) technology to address bladder and fecal incontinence. A news article said the financing, on top of $32.6 million last year, is "proof that this neuromodulation trend [SNM] is really taking off." (Med City News)

Company Whose Stimulator Addresses Restless Leg Syndrome Announces U.S. Patent

April 30, 2015 - Sensory NeuroStimulation Inc., which produces a non-pharmacological stimulator for Restless Leg Syndrome, announced issuance of a U.S. patent covering technologies noninvasive treatment device, Relaxis (TM). (Business Wire)

Meeting Covers New Spinal Cord Stimulation Modes

April 2015 - An article about a presentation at the New York State Society of Anesthesiologists’ PostGraduate Assembly regarding spinal cord stimulation with burst or dorsal root ganglion (DRG) stimulation cites articles from Neuromodulation: Technology at the Neural Interface, calling a paper about a clinical study of DRG stimulation "perhaps the most notable . . . to date." (Anesthesiology News)

Article Calls Neuromodulation a Current Catchword

April 29, 2015 - Neuromodulation is in an article that lists the top 12 vetted, confirmed "bleeding edge" trends in neuropsychiatric care, which says "Neuromodulation is definitely a buzzword these days. Electroceuticals in particular are being explored to treat a range of neuropsychiatric disorders – from depression to Parkinson’s to schizophrenia."

Parkinson's Disease Patient Regains Quality of Life After Deep Brain Stimulation

April 29, 2015 - International Neuromodulation Society member Robert Buchanan, MD, was quoted in an article about a patient who was able to return to his hobby of piloting a small plane solo after having deep brain stimulation to control symptoms of his Parkinson's disease. (KXAN)

Device Company Strikes Strategic Agreement With Maker of Surgical Navigation Software

April 27, 2015 - Boston Scientific, Inc. announced that in select countries, along with its Vercise™ deep brain stimulation system, it will begin distributing Brainlab AG's surgical planning and navigation portfolio. The Vercise system is available to treat Parkinson's disease, tremor and dystonia in Europe, Israel, and Australia as well as in some parts of Latin America and Asia Pacific. A U.S. clinical trial, INTREPID, is currently enrolling patients to evaluate the system's safety and effectiveness for the treatment of Parkinson's disease. (PR Newswire)

Poster: No Serious Cardiovascular Effects from Noninvasive Vagus Nerve Stimulation

April 27, 2015 - A poster at the American Academy of Neurology annual meeting showed no meaningful cardiovascular adverse effects in 29 patients who use electroCore’s non-invasive vagus nerve stimulation as a home treatment for asthma. (Business Wire)

Wife of Well-Known Sports Figure Plans to Have Deep Brain Stimulation

April 25, 2015 - Deep brain stimulation (DBS) surgery "used to be given to older sufferers, but they now realize it can be better giving it to younger patients," says the wife of a well-known former rugby player in Scotland. She anticipates undergoing DBS for her Parkinson's disease, diagnosed in 2003. (Daily Mail)

Article Compares Tonic and Burst Mode Spinal Cord Stimulation

May 2015 - International Neuromodulation Society members Cecile De Vos, MSc, PhD and Tim Vancamp, PT, MBA, are among authors of a retrospective analysis of 102 patients at two centers in Benelux who received a trial of burst-mode spinal cord stimulation after having been receiving tonic stimulation for chronic pain. The article concludes that burst mode can further improve pain suppression in patients who respond to tonic stimulation and provide pain relief to a proportion of patients who no longer respond to tonic stimulation. (Clinical Journal of Pain)

Researchers Unveil Mapping Analysis for Transcranial Magnetic Stimulation

April 22, 2015 - Researchers at the University of Pennsylvania plan to test a software tool to predict optimal locations for transcranial magnetic stimulation (TMS) therapy, they announced at the American Academy of Neurology annual meeting. They are mapping white matter connections within the brain by applying network control theory to imaging data in order to improve TMS effectiveness. (Medical Xpress)

Deep Brain Stimulation System Receives European Approval for Full-Body MRI Scanning

April 22, 2015 - Medtronic announced that European regulators have approved the use of full-body MRI scans in patients who have one of their Activa deep brain stimulation systems. (Mass Device)

Researchers Recommend a Network Approach to Treating Central Post-Stroke Pain

April 21, 2015 - International Neuromodulation Society members Koichi Hosomi, MD, PhD and Youichi Saitoh, MD, PhD are among co-authors of a review that suggests characterizing central post-stroke pain as a disorder of brain network reorganization could allow progress in mechanism-based therapies, such as brain stimulation using either motor cortex stimulation, deep brain stimulation, or transcranial magnetic stimulation. (Nature Reviews Neurology)

Company Raises Series B Financing for System to Treat Depression

April 21, 2015 - Boston-based Tal Medical has raised $14 million in Series B financing, led by PureTech Ventures, to further develop its low-field magnetic stimulation system for use in depression and bipolar disorder. (Med City News)

Device Maker Exercises an Acquisition Option for $175 million, adding Dorsal Root Ganglion Stimulation to Its Portfolio

April 20, 2015 - St. Jude Medical, Inc. announced that, for $175 million and sales-based milestone payments, it will exercise its option to acquire Spinal Modulation, Inc., which has submitted a PMA application for marketing approval of its Axium™ system for stimulation of the dorsal root ganglion to manage intractable chronic pain. The system has received a CE Mark and is subject to a U.S. clinical trial, ACCURATE. The company said in its acquisition announcement that results from the clinical trial will be presented at the International Neuromodulation Society's 12th World Congress in June in Montreal. St. Jude Medical made an initial $40 million equity investment in Spinal Modulation in 2013.  (Business Wire)

Neurostimulation is Now Available in East Africa

April 2015 - Three types of neuromodulation are now offered at the Aga Khan University Hospital in Kenya -- spinal cord stimulation (SCS), sacral nerve stimulation and intrathecal drug delivery. An article says 43 patients have received neurostimulation systems, and that SCS is offer to both cancer and non-cancer patients when other methods do not relieve chronic pain. (allAfrica.com)

Study Suggests Stimulating Motor Networks May Be Better Option for Modulating Excitability

April 20, 2015 - A study in healthy subjects of distributed but functionally connected regions of the motor cortex indicates that stimulation of the brain network rather than particular, isolated regions, may be more effective in modulating motor excitability over time, according to a presentation at the American Academy of Neurology Annual meeting. (Neurology Advisor)

Clinical Trial in Australia to Investigate Noninvasive Stimulation in Teen-Agers with Severe Depression

April 19, 2015 - Monash Health in Melbourne is will investigate whether transcranial magnetic stimulation helps relieve severe depression in up to 40 teen-agers. (The Sydney Morning Herald)

Prospective Clinical Trial of Phrenic Nerve Stimulation in Central Sleep Apnea Meets Its Primary Endpoint

March 2015 - In a prospective multicenter trial, 57 patients with central sleep apnea underwent transvenous unilateral phrenic nerve stimulation. There was a 55% reduction in the apnea-hyponea index at three months, with efficacy maintained at six months. Scores for the patients who had heart failure also improved. Overall, favorable effects on quality of life and sleepiness were noted, although 26% of patients had device- or procedure-related adverse events in the first six months, primarily due to lead repositioning early on. (Journal of the American College of Cardiology)

Study Examines Globus Pallidus Internus Stimulation for Medically Refractory Tourette Syndrome

April 13, 2015 - Researchers in the U.K. report that bilateral globus pallidus internus stimulation for severe, medically refractory Tourette syndrome showed a "significant improvement in tic severity, with an overall acceptable safety profile" in a double-blind, randomized crossover trial of 15 patients who were at least 20 years old. The patients received three months each of active or sham stimulation in random order in the crossover trial, and were offered and continued to have open-label stimulation afterward for one month or more. The authors conclude that future research should help identify the most effective brain stimulation target to control both tics and associated comorbidities, as well as delineate factors that predict individual patient response. (The Lancet)

Research Indicates Deep Brain Stimulation Facilitates Shifts in Neural Signaling

April 16, 2015 - Researchers who recently published their work in Nature Neuroscience showing a de-coupling of brain oscillations involving the motor cortex during deep brain stimulation in Parkinson's disease patients had supposed stimulation would decrease the strength of beta waves (3 - 30 Hz), but instead found that there was less synchrony between those oscillations and the amplitude of broadband activity in the brain (50 - 200 Hz), an article in medwireNews explains. In coverage in the New York Times, the role of beta oscillations is described as facilitating coordination among different parts of the brain, with intentional movement involving a temporary decrease in synchronization of neurons in the motor cortex. The authors said phase-amplitude coupling might be a biomarker of parkinsonism that could be used as a control signal for a closed-loop neurostimulation system. (New York Times)

Neural Recording Suggests Two Resting-Tremor Subtypes in Parkinson's Disease

April 15, 2015 - Recording local field potentials in the subthalamic nucleus in Parkinson's disease patients indicates two distinct subgroups of patients with respect to resting tremor, and also suggests a new approach to demand-driven stimulation, by using artificial neural networks to detect signals associated with tremor and apply stimulation at that time, according to a recent paper in Biomedical Processing and Control. (Medical Xpress)

Authors Describe Closed-Loop Neurostimulation Systems for Epilepsy

April 14, 2015 - International Neuromodulation Society members Kristl Vonck, MD, PhD and Paul Boon, MD, PhD review closed-loop neurostimulation for epilepsy, asking, "Will neurostimulation close the treatment gap for patients with refractory epilepsy?" (Nature Neurology)

Article Describes Spinal Cord Stimulation Treatment in Northern Ireland

April 14, 2015 - International Neuromodulation Society member Paul McConaghy, MD commented on the impact of chronic pain in a person's life in an article that calls spinal cord stimulation "a revolutionary . . . treatment which is transforming the lives of people who have suffered years of debilitating pain." (Portadown Times)

U.S. Regulators Approve Merger Involving Vagus Nerve Stimulation Device Maker

April 14, 2015 - Cyberonics and Sorin Group announced approval from U.S. anti-trust regulators of their all-stock merger, which is expected to close by the end of the 3rd quarter. (Mass Device)

Pilot Clinical Trial Planned to Evaluate Neurostimulation for Balance Issues Due to Brain Injury

April 14, 2015 - Helius Medical Technologies received approval from the FDA to proceed with enrollment of a pilot clinical trial to evaluate its Portable Neuromodulation Stimulator (PoNS) in the treatment of patients with balance problems due to traumatic brain injury. The company plans to conduct the PoNS trial at medical centers in Portland, Ore., Orlando and Montreal. (Mass Device)

Study Supports Evidence that Spinal Cord Stimulation Does Not Affect Sensory Characteristics

May 2015 - International Neuromodulation Society member Kaare Meier, MD, PhD, and colleagues have published a randomized, blinded, crossover study whose results support existing evidence that spinal cord stimulation SCS does not change sensory characteristics. The study examined 14 long-term users of SCS. Their thresholds for thermal or mechanical stimuli were the same whether they were on or off stimulation. (Clinical Journal of Pain)

Canadian Neuromodulation Society Plans a Public Event Presenting Neuromodulation Therapies

April 14, 2015 - The Canadian chapter of the International Neuromodulation Society has announced a free public event, prior to the 12th World Congress in Montreal, for specialists and patients to present neuromodulation therapies -- spinal cord stimulation for chronic pain, sacral neuromodulation, and deep brain stimulation. The event in French and English takes place at the same hotel as the INS congress, the Fairmont Queen Elizabeth, on Saturday, June 6, 2015 from 12 - 4:30 p.m. (International Neuromodulation Society)

Research May Adapt Deep Brain Stimulation for Essential Tremor

April 14, 2015 - Researchers at the National Science Foundation-funded Center for Sensorimotor Neural Engineering (CSNE) at the University of Washington are starting to recruit essential tremor patients for a study of closed-loop deep brain stimulation (DBS), in order to provide DBS only when needed. This should allow longer battery life, and, the researchers say, they may be able to incorporate the choice for patients to switch stimulation parameters, for instance, to temporarily facilitate speech at the expense of tremor. Medtronic is an industry member of CSNE, and the research will use Medtronic’s Activa PC+S DBS device with the Nexus-D control system. (University of Washington)

Data Point to Role of Deep Brain Stimulation in Halting Excessive Neural Circuit Synchrony in Parkinson's Disease

April 13, 2015 - Scientists at the University of California, San Francisco have published research in Nature Neuroscience showing deep brain stimulation (DBS) halts excessive synchrony in the motor circuit of Parkinson's disease patients. The authors placed an array of six recording electrodes on the motor cortex during a DBS implantation procedure, and asked 12 of the 23 patients in the study to perform a reaching task of pointing to a dot. Recordings were taken in the motor area before, during, and after DBS, both when the patient was resting and when carrying out the task. (Medical Express)

Nonprofit Offers Parkinson's Disease-Specific Training for Speech Therapists and Patients

April 9, 2015 - A Dallas-area nonprofit, Parkinson Voice Project, trains speech pathologists to work with Parkinson's patients and provides out-patient speech therapy with the aid of charitable donations. One of the clients, who came to the agency after having deep brain stimulation surgery, says his articulation is better now that he has practiced consciously concentrating on aspects of speech -- such as formulating a statement, breathing, and enunciating -- that were automatic before. (Dallas Morning News)

Review: Alternatives to Tonic Spinal Cord Stimulation May Enhance Therapy's Cost-Effectiveness

April 6, 2015 - A literature review by International Neuromodulation Society members Jason Pope, MD; Steven Falowski, MD; and Timothy Deer, MD, says, "High-frequency and burst stimulation . . . may offer new salvage strategies to mitigate spinal cord stimulation failure and improve cost–effectiveness by reducing explant rate." (Informa)

Transcranial Direct Current Stimulation is Explored for Refractory Childhood Epilepsy

April 9, 2015 - Investigators at Princess Margaret Hospital are using transcranial direct current stimulation to investigate and treat childhood refractory and benign focal epilepsy. (Perth Now)

Adaptive Technology Recipients Cope With Niche Market Limitations

April 9, 2015 - An article describes the issue of spinal-cord injury patients who received adaptive technology implants that then went off the market. (MIT Technology Review)

Company Announces Grant to Fund Development of Optimized Implantable Pulse Generator for Post-Amputation Pain Indications

April 7, 2015 - SPR Therapeutics received a $1.45 million grant from the National Institutes of Health to develop an implantable peripheral nerve stimulation (PNS) system to treat post-amputation pain. The Small Business Innovation Research phase II grant follows a $2.8 million grant from the Department of Defense for ongoing safety and efficacy trials of the company's PNS therapy for post-amputation pain. The NIH grant will fund development of the company's second-generation implantable pulse generator that should be small enough to comfortably place in the residual limb of an amputee. (Crain's Cleveland Business)

Article Suggests Letting Parkinson's Disease Patients Know Sooner About Deep Brain Stimulation

April 3, 2015 - International Neuromodulation Society member Brian Kopell, MD was quoted in an article about a patient who received deep brain stimulation several years after his early-onset Parkinson's disease. His 57-year-old neurosurgery patient's symptoms improved to the point that he will be competing in the Mont Tremblant Half Ironman in Quebec in June. The patient learned about the treatment option from his wife, and Kopell said that patients who are encouraged to try additional medications and not told about the alternative miss the chance for better quality of life during "precious years of their lives". (New York Daily News)

Review Calls Vagus Nerve Stimulation for Partial Epilepsy Seizures "Effective and Well Tolerated"

April 3, 2015 - A Cochrane review of five studies, including two rated as high quality, found that "vagus nerve stimulation is effective, when used with one or more antiepileptic drugs, to reduce the number of seizures for people whose epilepsy does not respond to drugs alone." (Cochrane)

Presentation Covers Emerging Spinal Cord Stimulation Modalities

April 2015 - International Neuromodulation Society member Timothy Deer, MD, presented three spinal cord stimulation (SCS) approaches under development that could help patients who do not respond to conventional SCS or find associated paresthesias uncomfortable. In his presentation at the North American Neuromodulation Society 2014 annual meeting in December, he discussed high-frequency stimulation, dorsal root ganglion stimulation, and burst waveform stimulation. These emerging modalities are commercially available now in Europe and Australia. (Pain Medicine News)

Privately Held Company Appoints Medical Advisory Board Chair

April 3, 2015 - Stimwave Technologies Incorporated announced it has appointed Gabor Racz, MD, as chair of its medical advisory board. The privately held company is developing wirelessly powered, injectable, microtechnology neurostimulators. Widely acknowledged for his leadership in pain medicine, Dr. Racz is emeritus chairman of the Department of Anesthesiology at Texas Tech University Health Science Center, and belongs to the International Neuromodulation Society. Other INS members on the Stimwave board are David Kloth, MD, and Ralph Rashbaum, MD. (Business Wire)

Article Reviews Relevant Aspects of Neuropathic Pain for General Practitioners

April 3, 2015 - A comprehensive clinical review of neuropathic pain covers pathophysiology, diagnosis, management, and NICE guidelines. It discusses the role of spinal cord stimulation in managing such indications as failed back surgery syndrome and complex regional pain syndrome, and anticipated future developments in neurostimulation. (GPonline)

Interface Extended Perceptual Abilities of Laboratory Research Subjects

April 2, 2015 - Researchers at the University of Tokyo brought a sense of direction to blind rats through providing input from a geomagnetic compass. The input stimulated the animals' visual cortex via a prosthetic interface. The interface did not restore vision but permitted the animals to develop an awareness of their orientation in space, so that they learned to navigate mazes to find a food reward as well as their sighted counterparts. (Phys.org)

Researchers Demonstrate Substance-Releasing, Potentially Implantable, Electrodes

March 26, 2015 - A team of scientists modified bioelectronic sense-and-act systems to create electrodes capable of sensing and substance-releasing functions. A sensing electrode was activated by substances that ranged from small biomolecules to proteins and bacterial cells. Activation generated current and a reductive potential, which, on the second connected electrode, dissolved a matrix cross-linked by positively charged iron moieties (Fe3+). This action released a variety of compounds -- drug-like chemical species, antibacterial agents, and enzymes that activated a biofuel cell. The researchers propose applications for implanted devices that might operate autonomously. (The Journal of Physical Chemistry Letters)

Non-invasive Vagus Nerve Stimulation is a Finalist in a Technology Business Competition

March 30, 2015 - The New Jersey-based company electroCore, which announced that it was one of six finalists in a broad technology category of nominees that received recognition recently at the annual FT ArcelorMittal Boldness in Business awards in London. The company was nominated for its development of gammaCore, a non-invasive, hand-held vagus nerve stimulation device to treat and prevent severe, primary headache -- cluster headache and migraine. "We believe that stimulating the nervous system to alter the biochemistry of the brain is the future of medicine for many indications, and will, because of its safety, tolerability, cost effectiveness, and ease of use, soon represent the norm for resolving many medical conditions," said Chief Operating Officer Frank Amato. (electroCore)

National Newscast Features Research Intended to Boost Learning

March 31, 2015 - A television segment shows a science correspondent using a flight simulator before, and after, receiving transcranial direct current stimulation intended to help consolidate motor-memory training. (PBS News Hour)

Privately Held Firm Announces Patent Allowing "Beat Technology" Spinal Cord Stimulation Claims

March 20, 2015 - Privately held Meagan Medical, Inc., a research arm of RS Medical based in Vancouver, WA announced issuance of a U.S. patent for delivering high frequency stimulation to the spinal cord with the ability to direct a higher beat output toward the spinal column. The patent includes claims for delivering stimulation with base frequencies between 500 Hz to 20 kHz while generating a directionally controllable beat frequency between 0-250 Hz. (Megan Medical, Inc.)

Magazine Article Focuses on Transcranial Direct Current Stimulation

April 6, 2015 - A staff writer explores using transcranial direct current stimulation and the state of the approach in university research labs and do-it-yourself endeavors. (The New Yorker)

Researchers Model Effects of Kilohertz Frequency Spinal Cord Stimulation

March 30, 2015 - A paper by International Neuromodulation Society member Andre Machado, MD, PhD and co-authors about computer modeling of the effects of kilohertz frequency spinal cord stimulation predicted effects under various stimulation-target conditions. The results suggest that the mechanisms of reducing perception of chronic pain with this intervention may not occur through direct activation or conduction block of the dorsal column or dorsal root fibers. (Anesthesiology)

News Article Describes Use of Burst Spinal Cord Stimulation

March 30, 2015 - International Neuromodulation Society members Vivek Mehta, MD and Ganesan Baranidhavan, MD, are quoted in a story in the U.K. about a woman with chronic back pain who found relief through the use of burst-technology spinal cord stimulation. (Daily Mail)

Article Predicts Neuromodulation Will Change Neurologists' Approach to Headache Management

March 2015 - Citing a "rapidly growing bank of data about devices for neuromodulation," an article about the Eighth Annual Winter Conference of the Headache Cooperative of the Pacific says this intervention may soon change the way neurologists manage patients with headache, by potentially starting first with the least invasive devices before trying medications or progressively more invasive methods. (Neurology Reviews)

Research Study Links Serotonin Neuromodulation in the Brain to the Alleviation of Neuropathic Pain

March 2015 - A paper in Cell reports that increasing seritoninergic neuromodulation in the anterior cingulate cortex of laboratory animals restored normal integration of synaptic inputs following the development of neuropathic pain, such as from sciatic nerve injury. In the forebrain, in response to mechanical pain, enhanced excitation and neuronal firing was seen in the dendrites of layer 5 pyramidal neurons, specifically in the hyperpolarization-activated cyclic nucleotide-regulated channels, and that hypersensitivity was alleviated by activating serotonin receptors. (Cell)

Co-Authors Ask: "Is Deep Brain Stimulation a Treatment Option for Addiction?"

March 15, 2015  - An article by International Neuromodulation Society member Jens Kuhn, MD, and colleagues in the Netherlands describes the difficulty in recruiting and retaining clinical trial subjects who have cocaine or heroin addiction for studies of deep brain stimulation (DBS) in addiction, compared to the dedication observed in patients who pursue DBS for obsessive compulsive disorder. Differences in social support and other factors are discussed. (Addiction)

Blog Describes Obstructive Sleep Apnea Device Under Development

March 27, 2015 - A Belgium-based business pursuing neuromodulation applications, Nyxoah, was featured in a blog by the Health Cluster of Wallonia. The 20-person, clinical-stage company has R&D facilities in Israel and is developing an implant to treat obstructive sleep apnea that is wirelessly powered by an adhesive patch and activation chip worn at night. (Win Health)

Company Starts Pilot Study in Overactive Bladder

March 26, 2015 - Bioness, Inc. said four patients have successfully received tibial nerve stimulation implants in a Canadian pilot study of the company's StimRouter Neuromodulation System in refractory overactive bladder. The system uses an implanted lead and external pulse transmitter. (Business Wire)

Neural Synchronicity Study Explores Role of Low-Frequency Deep Brain Stimulation

March 25, 2015 - International Neuromodulation Society members Jamie Henderson, MD, and Hong Yu, MD, are among authors of a study that examined intraoperative effects of 60 Hz stimulation during implantation of deep brain stimulation (DBS) leads in the subthalamic nucleus (STN) of Parkinson's disease patients. The authors observed an effect on baseline neural synchronicity. The low-frequency stimulation reinforced or inhibited synchronicity of patient-specific cortico-basal ganglia-thalamic-cortical loop(s) that contribute to the baseline resting state neural synchrony in the STN. It is for this reason, they propose, that effects of 60 Hz DBS may vary from high frequency DBS in different patients on managing such symptoms as either freezing of gait and speech on one hand or tremor on the other. (PLOS One)

A Multimodal Approach to Noninvasive Brain Stimulation is Proposed

March 25, 2015 - Researchers at the University of Minnesota propose a new concept for noninvasively targeting deeper brain structures through activation of various pathways, such as auditory, visual, somatosensory, motor, cognitive and limbic. They activated auditory and somatosensory pathways in guinea pigs and observed differential, timing dependent plasticity in neural firing within the auditory system, both in the deep brain and cortical areas. Their proposed approach would be called Multimodal Synchronization Therapy (mSync). They say incorporating multiple types of pathways using different, precisely timed, activation patterns may enable treatment of various brain disorders. (Scientific Reports)

Meeting Presentation Shares Results of Randomized Controlled Clinical Trial of High Frequency Spinal Cord Stimulation

March 25, 2015 - International Neuromodulation Society member B. Todd Sitzman, MD, MPH reported results of a randomized controlled clinical trial of 171 chronic pain patients that compared high frequency spinal cord stimulation (SCS) to conventional SCS at the American Academy of Pain Medicine Annual Meeting in March. He said the high frequency device in the study, recently developed by Nevro Corp., was statistically superior in meeting study endpoints through up to 12 months of followup. (National Pain Report)

Physicians Document Successful Spinal Cord Stimulation Implant in a Scoliosis Patient

March 2015 - International Neuromodulation Society member Sanjay Sanstry, MD and colleagues report on a case of successfully implanting a spinal cord stimulator in a chronic pain patient despite an abnormally curved spine due to scoliosis. They report that patience and knowledge of spinal anatomy were essential in placing the stimulator appropriately for pain relief. (Anesthesiology News)

Noninvasive Neurostimulation Reduced Symptoms of Rare Balance Disorder

March 25, 2015 - Researchers in Australia report a preliminary study of 13 patients who have a rare condition that causes a persistent perception of motion for weeks, months or years after leaving a moving boat, car or airplane, mal de debarquement syndrome. Although the cause is unknown, neuroplasticity may be a contributing factor. The research team say that compared to sham, four weeks of twice-daily sessions of repetitive transcranial magnetic stimulation to the dorsolateral prefrontal cortex led to improved balance and confidence in daily activities in this group of patients. (Journal of Neuropsychology)

News Reports Detail Use of Rechargeable Deep Brain Stimulator in India

March 25, 2015 - In Mumbai, a retiree with Parkinson's disease and an adolescent with dystonia both received rechargeable deep brain stimulation (DBS) systems to treat their condition. The boy received four stimulation programs that his parents can choose between since he lives too far to return frequently for programming checkups, which commonly are done in Western countries for dystonia patients who receive DBS. Their systems' batteries are expected to last about 25 years, so the patients do not anticipate needing repeat surgery every few years to replace their implantable pulse generator. (Daily News & Analysis)

University Collaborators Explore Nanotube Strand as a Potential Closed-Loop Neurostimulation Lead

March 25, 2015 - Spun nanotubes combine into strong, soft, conductive fibers about one-fourth the diameter of a human hair, which may be suitable for biomedical devices when the strands are insulated with a polymer coating. Materials science and preclinical biomedical researchers at Rice University are collaborating on demonstrating the proof-of-concept for using such components in lieu of typical brain-stimulation leads. Their bidirectional neurostimulation work in a rat model of Parkinson's disease was published online in the American Chemical Society journal ACS Nano. (Controlled Environments)

Review Examines Potential of Deep Brain Stimulation Research in Obesity

March 25, 2015 - Co-authors from Stanford University review the potential of targeting the hypothalamus or reward circuitry of the brain through deep brain stimulation (DBS) for obesity, in light of recent clinical trials of DBS for chronic cluster headache, Alzheimer’s disease, and depression and obsessive-compulsive disorder. (Cureus)

Noninvasive Neurostimulation Reduced Tinnitus Symptoms

March 25, 2015 - International Neuromodulation Society member Christian Hauptmann, PhD and co-authors report in BioMed Research International on a multicenter clinical trial of 12 months of non-invasive neurostimulation in 189 patients in Germany who have chronic tonal tinnitus. The patients received acoustic coordinated reset neuromodulation, which delivers tones centered around the characteristic frequency of the patient's tinnnittus percept. This is designed to reduce neural synchrony within the primary auditory cortices. According to a news release from a clinic in the UK that offers this treatment, the treatment  reduced symptoms such as severity, loudness and annoyance by nearly 40%. (PR Newswire)

Will Nanoparticles Enable Wireless and Minimally Invasive Deep Brain Stimulation?

March 24, 2015 - An article reports on two streams of research that aim to introduce nanoparticles to neuronal tissue and expose it to light, heating the metallic nanoparticles and making the heat-sensitive neurons fire nervous impulses as a result. The article says the work might eventually allow "wireless and minimally invasive" deep brain stimulation of the human brain. Initially, one group plans to apply the technique to treat loss of light-sensitive cells in the retina. (The Guardian)

Summary of Published Study Recaps Benefits of Sacral Neuromodulation for Mild-to-Moderate Overactive Bladder

March 24, 2015 - A recent synopsis of a previously published study of sacral neuromodulation (SNM) in overactive bladder concludes that SNM is safe and effective in patients who have mild to moderate symptoms, and shows a superior reduction in symptoms and improved quality of life compared to standard medical treatment. (Practice Update)

Meeting Presentation Covers Neuromodulation Device to Treat Heart Failure

March 23, 2015 - The first randomized controlled trial of carotid baroreflex stimulation therapy for heart failure treatment was presented at the American College of Cardiology’s 64th Annual Scientific Sessions in March in San Diego and published in the Journal of the American College of Cardiology ‒ Heart Failure. The multicenter trial of 146 patients showed safety and improved functional status from the intervention that stimulates the carotid sinus to balance activity of the autonomic nervous system. The system helps reduce sympathetic activity and enhance vagal tone, and was described in the article as "a more global form of neuromodulation" than vagal nerve stimulation that targets only the parasympathetic nervous system. (Cardiac Rhythm News)

Study Shows Cortical Involvement in Chronic Pain Patients

March/April 2015 - An observational study seeking to better understand supraspinal mechanisms when long-term spinal cord stimulation (SCS) is beneficial in chronic pain examined cortical signaling in nine patients, comparing evoked potentials with SCS and after SCS is halted for 24 hours. The study showed SCS influenced both pain thresholds and cortical signalling. The data suggest regions involved with cognitive/associative processing of pain were involved. (Pain Physician)

Study: Deep Brain Stimulation Improved Existing Pain in Parkinson's Disease Patients

March 23, 2015 - In long-term followup of 24 patients who received deep brain stimulation for Parkinson's disease, patients experienced a reduction in preexisting pain after receiving the implant. In a followup eight years later, however, three-quarters of the patients had developed new pain in the muscles and joints for unknown reasons. (HealthDay)

Study Points to Potential Role for Peripheral Nerve Stimulation in Spinal Cord Injury Rehabilitation

March 18, 2015 - A research team in Australia determined that six weeks of peripheral nerve stimulation reversed axonal dysfunction following spinal cord injury, potentially ameliorating such post-injury effects as development of neuropathic pain or muscle atrophy, thereby enhancing rehabilitation outcomes. (Journal of Neurophysiology)

Company With Novel Implanted Stimulator for Pain Plans to Add Staff

March 18, 2015 - Stimwave Technologies of Miami Beach, FL announced plans to double in size by hiring 20 staff members, primarily for clinical support, over the coming year, and plans to move to Fort Lauderdale in May. The company relocated to Florida about a year ago from Arizona in order to be in a location that is central to customers in the U.S., Central America and Europe. The company has a 12-cm Freedom Stimulator for spinal cord stimulation to treat chronic pain, and plans to release a peripheral nerve stimulator later this year. (South Florida Business Journal)

Multicenter Study Provides Evidence for Deep Brain Stimulation in Dystonia

March 3, 2015 - A multicenter study of 55 dystonia patients who were followed for up to 92 months provided Class IV evidence that long-term deep brain stimulation (DBS) of the internal pallidum improved the condition in patients with monogenic isolated dystonia types DYTi and DYT6, as well as patients without known monogenic cause (non-DYT). The effect of DBS in the eight DYT6 patients appeared less predictable, suggesting that generic testing and counseling for known dystonia gene mutations may be indicated. Regardless of what type of dystonia the patients had, those with a shorter duration between onset and surgery had better control postoperatively. (Neurology)

Transcranial Direct Current Stimulation Rouses Popular Interest

March 7, 2015 - An article in a quarterly technology supplement of The Economist describes the state of interest in transcranial direct current stimulation, particular from home hobbyists or consumer-oriented startups. The article summarizes meta-analyses of published studies that cast doubt on claims of cognitive enhancement, but also quotes experimenters who say the stimulation can enhance some functional performance under some conditions. (The Economist)

University Talk Reviews State of Deep Brain Stimulation for Severe Depression

March 17, 2015 - International Neuromodulation Society member Christopher Honey, MD, was quoted about the desire to identify potential responders in advance in an article that reported on a University of British Columbia talk by neurologist Helen Mayberg about deep brain stimulation (DBS) research in depression. Dr. Honey, who is based in Vancouver, participated in an early clinical trial in this indication. The article says that in addition to Mayberg's studies, researchers are interested in the potential of DBS for obsessive-compulsive disorder, anorexia nervosa, Tourette syndrome and Alzheimer’s disease. (Vancouver Sun)

Engineers Demonstrate an Adhesive Electrode That Might Provide an External "Brain Computer Interface"

March 16, 2015 - Materials scientists have reported a soft, wearable electrode that stays on for more than two weeks and recorded EEGs of three volunteers when attached to the scalp behind the ear. The foldable collection of gold electrodes stays on using van der Waals forces, which are also used in nature to help geckoes climb vertical walls. The development was described as a potential "persistent" brain computer interface. (IEEE Spectrum)

Device Company Receives Technology Development Grant

March 16, 2015 - Highland Instruments, Inc. announced a fast-track SBIR grant from the National Center for Complementary and Integrative Health to evaluate its ElectroSonic Stimulation (“ESStim™”) for noninvasive brain stimulation to suppress pain from osteoarthritis of the knee. The technology combines independently controlled electromagnetic and ultrasonic fields that focus and boost neurostimulation currents via tuned electromechanical coupling in neural tissue. (Business Wire)

Company Says it is Bullish on Electroceuticals

March 12, 2015 - "You can easily see these devices getting really small and really smart," NIH neural engineering program director Kip Ludwig, PhD commented in an article about GlaxoSmithKline's interest in potentially ushering in a new wave of miniature, autonomous, bioelectronic neuromodulation treatments. GSK head of bioelectronics research and development Kristoffer Famm, PhD described the work as trying to "basically redefine neuromodulation." The article's sources said these treatments may enter clinics in a decade if hurdles such as improvements in capabilities of power sources are solved. (CNBC)

Review Notes Relief Provided by Spinal Cord Stimulation for Refractory Ischemic Pain

March 10, 2015 - Spinal cord stimulation "provides in part long-term pain relief in otherwise intractable chronic pain of ischemic origin with a relatively low complication rate," according to a literature review by authors from the Rheinische Friedrich Wilhelms University Hospital in Bonn, Germany. (The Clinical Journal of Pain)

International Neuromodulation Society Member to Summarize Deep Brain Stimulation in Webinar

March 2015 - International Neuromodulation Society member Jamie Henderson, MD will co-lead a webinar March 19 for the Michael J. Fox Foundation for Parkinson's Research on "Treating the Brain: New Approaches to Deep Brain Stimulation and Beyond." The hour-long session is intended for primary care physicians, family practice physicians, general medicine physicians, geriatricians, general neurologists, movement disorder specialists, and other practitioners who manage patients with Parkinson's disease. (Michael J. Fox Foundation)

Company Announces First Implants of Wireless Neurostimulator

March 10, 2015 - Stimwave Technologies Incorporated announced the first patients have been implanted with its wireless stimulator designed to manage chronic back and leg pain. The patients were implanted in January 2015 in Tampa, Florida under the care of International Neuromodulation Society member Sunil Panchal, MD. The company said in its announcement that the device essentially allows MRI examinations to be performed on all parts of the patient, under a 3-Tesla MRI conditional rating. An evaluation of the device's MRI compatibility was published in Neuromodulation: Technology at the Neural Interface by INS member, and lead author, Frank G. Shellock, PhD. (Business Wire)

Researchers Report Successful Outcome of Deep Brain Stimulation in Patients with Genetically-Caused Tremor

March 2015 - Researchers associated with the University of Tübingen report on bilateral deep brain stimulation of the nucleus ventralis intermedius in three patients who had fragile X-associated tremor/ataxia syndrome. The neurostimulation resulted in sustained improvement of both tremor and ataxia in a follow-up that lasted as long as four years. The authors conclude their data on patients who have a genetic cause of tremor "may contribute to improved patient stratification for neurostimulation therapy in the future." (Parkinsonism & Related Disorders)

Show Features One of the First Patients to Receive Deep Brain Stimulation for Anorexia

March 7, 2015 - Three years after she became the third clinical trial subject to undergo deep brain stimulation for anorexia, a young woman is profiled in a television special. Since her surgery and intensive in-patient participation in an eating disorders program, a total of 17 other patients have now participated in the clinical trial of the intervention that her neurosurgeon cautions is thought of as a symptomatic treatment. (CTV 5)

Decision-Analysis Study Examines Potential Effectiveness of Deep Brain Stimulation in Alzheimer's Disease

March 6, 2015 - If deep brain stimulation (DBS) for Alzheimer's disease brings the condition to a mild state or better for a year before continuing on its natural course, that would considered a success according to a decision analysis model that compared alternative courses of treatment and quality of life. The authors conclude that a success rate of 20 - 75% would be cost-effective for DBS in this condition, and above 80%, the treatment would be both clinically more effective, and more cost-effective, than standard treatment. (Journal of Neurology)

Foundations Team Up to Support Research Into Neurostimulation for Spine-Injured Patients

March 5, 2015 - The Wings for Life Spinal Cord Research Foundation and the Christopher & Dana Reeve Foundation are supporting eight of 36 individuals living with spinal cord injury who will undergo a clinical trial expected to start this year that explores whether, in certain spine-injured patients, epidural stimulation can be used to recover a significant level of autonomic control. (PR Newswire)

Focal Modulation With Novel Means May Help to Develop Future Neural-Circuit-Specific Therapeutic Interventions

April 2015 - DREADDs (Designer Receptors Exclusively Activated by Designer Drugs) are synthetic molecules that modulate cellular activity by affecting signaling cascades; a recent review describes how this slower-onset modulation regulates behavior over time. A perspective article in the Feb. 24, 2015 issue of Nature Neuroscience says both "designer receptor technologies" and optogenetics, aid in development of new interventions or may form the basis of new therapeutics. These tools, the article states, "provide unprecedented and much needed specificity, allowing for spatial, temporal and cell type-selective modulation of neuronal circuits." (Current Opinion in Behavioral Sciences)

Report Details Deep Brain Stimulation in Progressive Supranuclear Palsy

March 2, 2015 - A neurosurgeon in India describes an observational study in four patients from 2010 to 2012 who had progressive supranuclear palsy (PSP) in which mobility problems do not respond to medication. Bilateral stimulation of the pedunculopontine nucleus (between the lower midbrain and the brainstem) at 20-45 Hz improved gait in the patients at 6 months followup. Two patients with a subtype of the degenerative disorder lost improvements at 18 months. The author concludes the procedure can be safely performed in PSP patients despite mid-brain atrophy. (The Times of India)

Study: Spinal Cord Stimulation Decreased Moderate, Predominantly Lower-Limb, Spasticity

Feb. 27, 2015 - In a retrospective case series of 71 patients with spasticity who were followed up from 2 to 7 years, a team at the Burdenko Neurosurgery Institute in Moscow found that spinal cord stimulation (SCS) improved symptoms in all 19 patients whose spasticity was caused by spinal injury. Meanwhile, in a group of 52 patients who had spasticity of the lower limbs or all four limbs due to cerebral palsy, only the patients whose spasticity was confined to the lower limbs showed a significant improvement in symptoms. In a small group of patients (11%), the spasticity improved to the point that no further SCS was needed. The authors conclude that this phenomenon should be investigated further. (Stereotactic and Functional Neurosurgery)

Article Recounts Amputee's Positive Experience With Dorsal Root Ganglion Stimulation

Feb. 27, 2015 - An amputee who suffered phantom pain from his missing lower leg for 20 years could not find relief from spinal cord stimulation, but has benefitted from participating in a clinical trial of dorsal root ganglion stimulation, he said, with his pain diminishing from 9 out of 10 to 2 out of 10.(Runcorn and Widnes World)

Weekend Magazine Article Recaps Research Into Auditory Brainstem Implants in Young Children

Feb. 27, 2015 - An article describes a clinical trial that extends auditory brainstem implantation, which has mainly been carried out on adults with auditory nerve tumors, to young children whose auditory nerves are missing or defective, making them ineligible for a cochlea implant. An audiologist involved in the study and her colleague explained that the sounds are presented in a more-scrambled fashion than is experienced with a cochlear implant, requiring time and intensive rehabilitation for the children to learn to interpret and distinguish different characteristics of what they sense through the device. (FT Magazine)

Research Offers Evidence About Side-Effects of Deep Brain Stimulation in Parkinson's Disease

Feb. 27, 2015 - International Neuromodulation Society members Dr. Yasukazu Kajita and Dr. Masaru Yamamoto and colleagues report in the Journal of Neurology on characteristics of voice and speech disorders associated with subthalamic nucleus (STN) deep brain stimulation (DBS) in Parkinson’s disease patients. Comparing off- and on-stimulation in 68 patients with DBS and contrasting that with 40 patients who were treated with medical therapy alone showed the STN DBS was associated with abnormal laryngeal muscle contraction, with more widespread voice impairment occurring in women. A related paper in the same issue about the Netherlands Subthalamic and Pallidal Stimulation trial provides Class I evidence that there is no large difference in neuropsychological outcome between globus pallidus pars interna DBS and subthalamic nucleus DBS after 12 months in patients with advanced Parkinson's disease. (European Parkinson's Disease Association)

Company Eyes Overactive Bladder Application, and Is Expanding to Germany

Feb. 27, 2015 - nUro, Inc. is adapting its CE Marked Synapse™ system to a wireless neurostimulation system for the treatment of overactive bladder. The company plans to begin trading on the US OTC Markets QB Stock Exchange by Aug. 1, 2015. It is opening a German subsidiary in the Erlangen Medical Valley Center, and plans to also begin trading in 2015 on a German stock exchange. (PR Web)

Experts Present Neuromodulation Interventions in Overactive Bladder

Feb. 26, 2015 - Sacral neuromodulation (SNM) and pudendal nerve stimulation were discussed by panelists addressing refractory overactive bladder. SNM was recommended after botulinum toxin fails to relieve symptoms; reprogramming or a revision may restore efficacy in some patients. An experienced clinician said pudendal nerve stimulation (off-label in the U.S.) was effective in 93.8% of patients who had failed SNM. (Uro Today)

Review Article Considers an Emerging Brain-Stimulation Target in Behavioral Disorders

February 2015 - International Neuromodulation Society member Michael Kaplitt, MD, PhD co-authored a review of nucleus accumbens, an emerging target of interest for focal modulation with deep brain stimulation or novel biological therapies such as gene therapy or cell transplantation. The article states that this component of the ventral striatum has been "implicated in numerous neurological and psychiatric disorders, including depression, obsessive-compulsive disorder, bipolar disorder, anxiety disorders, Parkinson's disease, Alzheimer's disease, Huntington's disease, obesity, and in drug abuse and addiction." The review appears in the February issue of Stereotactic and Functional Neurosurgery, where in a position statement, the Psychiatric Neurosurgery Committee and Board of Directors of the American Society for Stereotactic and Functional Neurosurgery "express their enthusiastic and unwavering commitment to research exploring the neuromodulatory treatment of psychiatric disease." (Stereotactic and Functional Neurosurgery)

Company Receives CE Mark for Vagus Nerve Stimulation System in Heart Failure

Feb. 26, 2015 - Cyberonics, Inc. announced it has received CE mark approval of its vagus nerve stimulation for use as adjunctive therapy in treatment-resistant patients with heart failure with left ventricular dysfunction. The company's Vitaria system delivers autonomic regulation therapy, which was shown in the open-label ANTHEM-HF clinical study to improve a number of symptoms at six months of treatment. (Pharmabiz.com)

Neuromodulation Company to Merge with Global Device Company

Feb. 26, 2015 - Cyberonics Inc. plans to merge with create a new company domiciled in the UK by buying* Italian medical device company Sorin SpA in an all-stock deal to create a new company with a combined equity of $2.7 billion. The new company will apply for dual-listing on the Nasdaq and the London Stock Exchange, the companies said in a statement. The newly formed company will include a portfolio addressing heart failure and sleep apnea, according to a news release by Sorin Group. *Note: Reuters later ran an updated story to clarify that this is a merger: http://www.reuters.com/article/2015/02/26/us-sorin-m-a-cyberonics-idUSKBN0LU0QE20150226 (Reuters)

Hospital Anticipates Being First Government Facility in Its State to Offer Deep Brain Stimulation

Feb. 26, 2015 - The Rajiv Gandhi Government General Hospital in Chennai will begin offering deep brain stimulation when new equipment is procured in five months, with the services being covered under the Chief Minister’s Comprehensive Health Insurance Scheme. The government recently supplied the hospital a stereotactic capability, which has already allowed neurosurgeons there to perform brain-tumor biopsies more easily. (New India Express)

Patients in France Begin to Receive Retinal Prosthesis Implants

Feb. 25, 2015 - Second Sight Medical said the first implants of its Argus II Retinal Prosthesis System have taken place in France. Up to 35 patients with retinitis pigmentosa will receive the implants through the government reimbursement program Forfait Innovation. (Mass Device)

Neuromodulation Supplier Reports Increased Earnings

Feb. 25, 2015 - Greatbatch Inc. reported adjusted earnings per share of 65 cents in the fourth quarter of 2014, up 18.2% from one year ago. Revenues from QiG Group, which includes sales from the recently acquired implantable-pulse-generator-maker CCC Medical Devices, rose to $5.5 million from $0.9 million the previous year. (Nasdaq)

Study Confirms Effectiveness of Percutaneous Tibial Nerve Stimulation

Feb. 24, 2015 - In a study at the Department of Urology, China Rehabilitation Research Center in  Beijing, 100 patients with neurogenic detrusor overactivity secondary to spinal cord injury underwent a four-week randomized controlled trial that compared percutaneous tibial nerve stimulation (PTNS) with medical treatment with solifenacin succinate. Both treatment groups improved, with no significant difference between them. The author concludes that PTNS is effective, noninvasive, and easily managed by patients. (Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction)

Insurer Adds Coverage of Overactive Bladder Treatment

Feb. 24, 2015 - Uroplasty, Inc. announced its percutaneous tibial nerve stimulation therapy for overactive bladder is now covered by Cigna, which wrote a positive coverage policy that applies to some 14 million people and became effective Feb. 15, 2015. (CNN Money)

Researchers Identify Emotion-Sensing Neurons in Deep Brain Stimulation Target

Feb. 23, 2015 - Researchers at Prague's Charles University reported in the Proceedings of the National Academy of Sciences direct evidence of the emotional role of the subthalamic nucleus (STN). Patients undergoing deep brain stimulation (DBS) were shown visual images considered pleasant, unpleasant or neutral. Populations of neurons that were spatially and functionally separate responded either to the emotional valence (positive or negative) or the intensity of the emotional effect. A radio report said 17% of the STN neurons were involved in the response, and that more selective stimulation might improve DBS therapy. (Prague Daily Monitor)

Optogenetics Researcher to Receive $100,000 Prize

February 2015 - The Foundation for the National Institutes of Health selected Karl Deisseroth, MD, PhD., for the 2015 Lurie Prize in Biomedical Sciences, to recognize his outstanding achievement, as a scientist under age 52, in the development of optogenetics and the brain-imaging tool CLARITY. The award, which began three years ago, will be presented in May in Washington, D.C. and includes a $100,000 honorarium. (Foundation for the National Institutes of Health)

Peripheral Nerve Stimulation Device Receives FDA Clearance

Feb. 24, 2015 - Bioness, Inc. announced FDA clearance of its minimally invasive neuromodulation device for peripheral nerve pain, StimRouter®, which consists of an implanted lead, external pulse transmitter and conductive electrode, and is controlled by a small hand-held wireless control unit. Electrical signals travel from the pulse generator to the electrode and down the lead to the origin of pain. (Business Wire)

Obesity Device Startup Announces Fourth Quarter Earnings

Feb. 23, 2015 - An earnings report for EnteroMedics, Inc., whose vagus nerve stimulation therapy for certain types of obesity received FDA approval in January, shows that as the company completed U.S. regulatory approval and geared up for commercialization, its losses totaled nearly $6.2 million in the fourth quarter of 2014. The loss of $0.09 per basic and diluted share was a slight improvement losses in the same quarter a year ago of $0.11 per basic/diluted share. For the year, EnteroMedics lost $26.1 million, and had $11.6 million on hand. (Mass Device)

Poster Covers Infection-Control Practices for Spinal Cord Stimulation

February 2015 - International Neuromodulation Society (INS) member David Provenzano, MD presented results of a survey of infection-control practices for spinal cord stimulation procedures at the American Society of Regional Anesthesia and Pain Medicine's 13th annual pain medicine meeting in San Francisco in November. A summary of the e-poster now appears in Anesthesiology News. INS was among the societies where the survey had been circulated. (Anesthesiology News)

Company Developing Closed-Loop Spinal Cord Stimulation Announces $10 Million Investment

Feb. 23, 2015 - Saluda Medical announced it received $10 million in Series B financing in a funding round led by new investor Biosciences Managers, in which existing investors also participated. The Australian-based company plans to use the funds to support clinical trials and commercialization plans for its Evoke™ closed-loop spinal cord stimulation system that is intended to treat chronic pain of the trunk and limbs, automatically adjusting stimulation levels for optimal pain relief. (Send2Press Newswire)

Company Acquires Developer of Overactive Bladder Treatment

Feb. 23, 2015 - Medtronic plc has acquired Advanced Uro-Solutions, a Tennessee-based developer of a percutaneous tibial nerve stimulation system, which consists of a small external stimulator and a single, reusable lead to provide temporary stimulation to the tibial nerve, NURO(TM). The device has FDA clearance for patients with overactive bladder and associated symptoms, and Medtronic plans U.S. commercialization within the next 12 months. (Fierce Medical Devices)

Article Presents Bioelectric Medicine

Feb. 17, 2015 - A column discusses the prospects of vagus nerve stimulation to treat inflammatory disease; in a related article, targets in the spleen, liver, and pelvic organs are presented as potential future applications of "bioelectric medicine". (Scientific American)

Study: Deep Brain Stimulation More Effective Over Time in Refractory Epilepsy

Feb. 20, 2015 - Five-year results of the SANTE (stimulation of the anterior nucleus of the thalamus in epilepsy) clinical trial showed an increase in efficacy over time of deep brain stimulation to treat adults with refractory epilepsy characterized by partial-onset seizures, according to a paper in Neurology. International Neuromodulation Society members Douglas Labar, MD, Jaimie Henderson, MD, and Ashwini Sharan, MD, were among the co-authors of the multi-center clinical trial report. SANTE (stimulation of the anterior nucleus of the thalamus in epilepsy) showed an increase in efficacy over time. The median rate of seizure reduction was 69%, compared to 41% at 12 months. Patients who seizures reduced in frequency by more than half, was 68% at 5 years, up from 43%. The rate of serious, but reversible, adverse events was 34% with infection at the implant site, at 10%, being the most common. The paper concluded that longterm followup indicated this intervention showed sustained efficacy and safety in a treatment-resistant population. (Fierce Medical Devices)

Montreal Clinical Trial Examines Non-Invasive Neurostimulation in Multiple Sclerosis

Feb. 19, 2015 - Helius Medical Technologies has enrolled the first three subjects in its multiple sclerosis feasibility study of a portable neurostimulation device, PoNS™, to reduce multiple sclerosis symptoms by stimulating the cranial nerves found in the tongue. In the double-blind, sham-controlled study, a total of 14 subjects will receive stimulation combined with physical therapy to improve balance and gait for 14 weeks at the Montreal Neurological Institute and Hospital and Concordia University’s PERFORM Center. (Business Wire)

Neuromodulation to Be Subject of Pain Meeting Preconference in March

February 2014 - International Neuromodulation Society members Timothy Deer, MD, Tim Lamer, MD, Robert Levy, MD, PhD, and Nagy Mekhail, MD, PhD, will present a preconference on neuromodulation prior to the American Academy of Pain Medicine meeting on March 18 in National Harbor, MD. The program will cover future targets and waveforms, clinician views of the best-practice recommendations, and discrepancies between current practices and the consensus recommendations. (American Academy of Pain Medicine)

Company Announces Patent for Neurostimulator-Lead Technology

Feb. 17, 2015 - AdvaStim, Inc. announced it received a U.S. patient for an integrated switching circuit and pulse generator for its neurostimulator lead. The company's technology is intended to provide compact multi-channel switching and electrode programming. (Business Wire)

Show Features Journalist Trying Out Advanced Prosthetic Arm

Feb. 12, 2015 - Science correspondent Miles O'Brien, whose left arm was amputated after an injury last year, tried out a modular prosthetic limb that uses an array of electrodes to sense muscle firing in the stump and move the artificial limb. The limb is under development at the Johns Hopkins Applied Physics Laboratory with funding from the Defense Advanced Projects Research Agency. (PBS News Hour)

Article Describes Research Into Vagus Nerve Stimulation for Cluster Headache

Feb. 16, 2015 - An article profiles a participant in a 19-patient study who found relief from cluster headaches through use of electroCore's external vagus nerve stimulator (VNS), gammaCore®. The article also touches upon other emerging uses of VNS therapy, such as appetite suppression to control obesity. (Daily Mail)

Researchers Discuss Pediatric Clinical Trial of Auditory Brainstem Implants

Feb. 14, 2015 - Researchers presented a clinical trial of auditory brainstem implants in pediatric patients at the annual meeting of the American Association for the Advancement of Science. Funded by the National Institutes of Health, the safety-and-feasibility study led by the Keck School of Medicine at the University of Southern California has enrolled five of 10 patients aged 2 - 5 years old who are not able to benefit from hearing aids or cochlear implants. After the device is implanted the children receive intensive speech-and-language therapy to learn to use and decipher speech. (domain-b.com)

Article Focuses on Thought-Leadership in Neuromodulation

Feb. 9, 2015 - NeuroNews published online an interview with four members of the International Neuromodulation Society board who were selected to speak as thought-leaders on neuromodulation "research priorities, challenges and potential areas for growth": Drs. Timothy Deer, Ali Rezai, Marc Russo, and Konstantin Slavin, (NeuroNews)

First Implants Announced in Clinical Trial of Vagus Nerve Stimulation in Heart Failure

Feb. 11, 2015 - Milan-based Sorin Group announced the first successful vagus nerve stimulation (VNS) implants in the first clinical trial under its New Ventures organization that will explore a number of potential VNS therapies. The clinical trial of VNS in heart failure, Vanguard (Vagal Nerve Stimulation Safeguarding Heart Failure Patients), uses the he Equilia(TM) system initially developed by the Israeli startup Enopace Biomedical. (Business Wire)

Hospital in Pakistan Admits Patients for Deep Brain Stimulation

Feb. 10, 2015 - Lahore General Hospital, which has begun offering deep brain stimulation (DBS) for Parkinson's disease and other movement disorders, announced at least six cases have been admitted to the hospital. A Parkinson's disease patient who was operated on there expressed gratitude for the government bearing the DBS expenses and was quoted as saying the facility is a great blessing for the poor. (The News International)

Analysis Anticipates Growth in Spinal Cord Stimulator Market Penetration

Feb. 10, 2015 - An article in a pain publication says the publication plans to cover spinal cord stimulation (SCS) more and quotes a recent market research study that says less than 10% of the people who might benefit from SCS for chronic pain use it. The report mentions Nevro Corp. as the new player in the market; its Senza SCS system received an "approvable" letter from the FDA. Meanwhile, the market research study by iData Research says Boston Scientific has grown market share and is a leading competitor in SCS for back pain and failed back surgery syndrome, while Medtronic still has the largest client base in SCS, and all three major players, including St. Jude Medical, have run public awareness campaigns. (National Pain Report)

Business Profile Features Borough's Neuromodulation Center

Feb. 8, 2015 - A business feature profiles the Greenville Neuromodulation Center, which opened 10 years ago in Greenville, a borough of about 5,000 people, 80 miles from Pittsburgh and Cleveland, which is home to Thiel College. Eighteen months ago the center added a neurologist experienced in deep brain stimulation. (Sharon Herald)

Company Settles False Claims Allegation

Feb. 7, 2015 - The U.S. Department of Justice announced that Medtronic, Inc. agreed to pay $2.8 million to resolve allegations made by a former company sales representative, that the company caused some physicians to submit false reimbursement claims to federal health programs using a code for peripheral nerve stimulation when an investigational subcutaneous nerve field stimulation implant was performed. The settlement states that the "claims resolved by this settlement are allegations only, and there has been no determination of liability." (Sputnik News)

Investigators Say Pilot Study of Spinal Cord Stimulation Showed Promise in Heart Failure Patients

Feb. 6, 2015 - A pilot study of spinal cord stimulation in 17 heart-failure patients from Australia, Hong Kong, and Japan showed that 15 improved their composite score and 11 had improved efficacy parameters after six months, according to the Hong Kong-based investigators. (The Standard)

Spinal Cord Stimulation System Receives Expanded Labeling for MRI Scans

Feb. 4, 2015 -  Nevro Corp. announced its Senza® spinal cord stimulation system has received approval for expanded labeling in Europe and Australia. The expanded labeling now permits scans of the head and extremities with both 1.5 and 3 Tesla MRI machines under specified conditions for existing and future patients. (Market Watch)

Company Presents Vagus Nerve Stimulation Results in Stroke Patients and Plans U.S. Clinical Trial

Feb. 4, 2015 - Microtransponder, Inc. plans a 20-person clinical trial in the U.S. of its Vivistim® System for stroke patients who are undergoing rehabilitation to improve upper limb mobility. On Feb. 12, its findings in a 20-person clinical trial in the United Kingdom will be presented at the International Stroke Conference in Nashville. The U.S. trial will take place in Dallas, Houston, and Minneapolis, and enrollment information is available at http://www.vnsstroketrial.com. (PR Web)

Interim Results Show Long-term Benefits of Closed-Loop Neurostimulation in Epilepsy

Feb. 3, 2015 - NeuroPace, Inc. published interim results of its long-term study of its responsive neurostimulation system in adults with medication-resistant epilepsy. The data from 230 adults show that after three years, the median seizure frequency reduced by 60%, and after six years, by 66%. (Business Wire)

Vagus Nerve Stimulation Reviewed in Neurology Journal

Jan. 29, 2015 - A review in the European Journal of Neurology compares invasive and non-invasive vagus nerve stimulation (VNS), saying the non-invasive option "improves the safety and tolerability of VNS making it more accessible and facilitating further investigations across a wide range of uses when compared with surgically implanted VNS." (News-Medical.net)

Company Plans a U.S. Clinical Trial of Its Neurostimulation Device to Treat Chronic Lower Back Pain

Jan. 26, 2015 - Mainstay Medical International plc has applied for an FDA Investigational Device Exemption to begin a clinical trial of its ReActiv8® implantable neurostimulation device to treat people with disabling chronic low back pain for whom conventional therapy has not been successful and for whom surgery is not indicated. (Mainstay Medical)

Company Announces FDA Allows Gastroparesis Device Therapy

Jan. 23, 2015 - Medtronic announced a Humanitarian Device Exemption for its Enterra II neurostimulation implant for treating gastroparesis. (Mass Device)

Neuromodulation Device in Clinical Trials Targets Ophthalmologic Issue of Dry Eye

Jan. 23, 2015 - A former biomedical engineer with Boston Scientific Corporation has created a small implanted device to stimulate nerves in the lacrimal gland to treat dry eye. After four years of work, the device is now a product-candidate undergoing clinical trials through the new company Occuleve. (Stanford Medicine)

Price Index Tracks Hospital Costs for Spinal Cord Stimulators

Jan. 23, 2015 - According to the Modern Healthcare/ECRI Institute Technology Price Index, the average cost of spinal cord stimulators is now $16,957, up 8% from this time last year. The article mentions that advanced versions released in 2013 by Boston Scientific Corp. and Medtronic cost on average $19,000 while older models cost hospitals on average $13,000, although more hospitals are choosing to buy the newer devices. (Modern Healthcare)

Company Plans to Release Cochlear Implant on U.S. Market That Permits 3.0 Tesla Imaging

Jan. 23, 2015 - MED-EL USA says it will launch its Synchrony cochlear implant in the U.S. following FDA approval for this model, which the company says is the only U.S.-approved one that can be used with 3.0 Tesla magnetic resonance imaging devices without surgical removal of the internal magnet. (FDA News)

Company Announces FDA "Approvability" Letter for New Spinal Cord Stimulator

Jan. 22, 2015 - Nevro Corp. announced the FDA has written to say that, subject to check-off on a number of inspection, audit, labeling, and similar compliance issues, its Senza spinal cord stimulation system is approvable under the premarket approval application, based on the application's supporting data. (PR Newswire)

FDA Approves Intrathecal Device With Safety Valve to Facilitate MRI Procedures

Jan. 19, 2015 - Flownix Medical Inc. announced a PMA-Supplement approval from the FDA for is intrathecal Prometra® II system with a flow-activated safety valve that allows an MRI without the need to remove the drug from the reservoir in advance. (PR Newswire)

New Release Announces the International Neuromodulation Society 12th World Congress

Jan. 21, 2015 - The International Neuromodulation Society 12th World Congress "Neuromodulation: Medicine Evolving Through Technology" will feature traditional and cutting-edge ways to address chronic disease through interfacing with the body’s nervous system, according to a news announcement. The event takes place June 6-11, 2015 in Montreal, Canada. (Newswise)

Publication Recaps Neuromodulation Appropriateness Guidelines

January 2015 - International Neuromodulation Society member Timothy Deer, MD, is quoted in an article about the Neuromodulation Appropriateness Consensus Committee guidelines that appeared in the August 2014 issue of Neuromodulation: Technology at the Neural Interface. (Anesthesiology News)

Infection Survey Results Presented

January 2015 - International Neuromodulation Society member David Provenzano, MD presented an international survey of infection-control practices during spinal cord stimulation implantation and trials. The survey was filled out by 506 respondents. In the presentation in a poster at the American Society of Regional Anesthesia and Pain Medicine 13th annual pain medicine meeting, the responses showed best practices and also areas for improvement, such as the responsibility for deep infection up to one year after implant, according to the Centers for Disease Control and Prevention definition. (Pain Medicine News)

Researchers Investigate Vestibular Stimulation to Address Balance Problems in Parkinson's Disease

January 20, 2015 - Ten patients with Parkinson's disease have undergone a test period of so called "noisy" electric stimulation of their balance organs (stochastic vestibular galvanic stimulation) to smooth out the effects of dopamine shortage and improve their motor skills and balance, after the concept was demonstrated in preclinical studies. The investigation in Sweden was published in the Journal Brain Stimulation. (Medical Express)

Database Expands to Add Deep Brain Stimulation Citations

January 2015 - With volunteer effort, the collaborative neuromodulation literature database WIKISTIM is expanding to include deep brain stimulation citations as well as spinal cord stimulation citations, according to the January issue of the nonprofit organization's newsletter. (WIKISTIM)

The FDA Approves a Neurostimulation Device for Obesity

Jan. 14, 2015 - EnteroMedics, Inc. received FDA approval for its vagus nerve stimulation therapy, VBLOC®, delivered through the Maestro® System. In an announcement, the FDA called it "the first FDA-approved obesity device since 2007," saying the device is approved for adults with a body mass index of 35 to 45 who have not been able to lose weight with a weight loss program and have at least one other obesity-related condition, such as type 2 diabetes. The approval requires a five-year post-market study of safety and effectiveness in 100 patients. (IEEE Spectrum)

Shareholders Pave Way for Merger to Close

Jan. 7, 2015 - Medtronic, Inc. said shareholders who have more than 75% of the stock voted in favor of its merger with Ireland-based Covidien, whose shareholders approved the deal hours earlier. The $43 billion merger should close in two weeks, turning Medtronic into an Irish-based entity, Medtronic PLC. (Mass Device)

External Trigeminal Nerve Stimulation to be Studied in Attention-Deficit/Hyperactivity Disorder

Jan. 5, 2015 - NeuroSigma®, Inc. announced its external trigeminal nerve stimulation will be subject to a Phase II clinical trial of up to 90 children, aged 8-12, who have Attention-Deficit/Hyperactivity Disorder. The double-blind controlled trial will be supported by the U.S. National Institute of Mental Health (NIMH) and collect data on mechanism of action in alignment with the NIMH's Research Domain Criteria that emphasizes behavioral dimensions and neurobiological measures. The clinical trial will be carried out at the Semel Institute for Neuroscience and Human Behavior, located at the University of California, Los Angeles. (PR Newswire)

Cross-Continental Merger Faces Shareholder Vote Tomorrow

Jan. 4, 2015 - After a shareholder vote tomorrow on the $48 billion merger of Medtronic, Inc. and Covidien, an article in the Minneapolis Star Tribune says, Medtronic would become a new Irish-domiciled, multinational conglomerate called Medtronic PLC. Top executives will remain based in Fridley, MN. The New York Stock Exchange ticker will remain MDT, with the new shares expected to begin trading at the same price as the closing price from the day before. (Star Tribune)