2017 News Briefs - International Neuromodulation Society

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Later News:

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January - December 2017

Company Acquires Neuroscience Startup's Intellectual Property and Assets

Dec. 27, 2017 - Endonovo Therapeutics bought intellectual property and assets from Rio Grande Neurosciences for $3 million cash and a $1.5 million promissory note due Nov. 30, 2018. Rio Grande's device to treat pain and edema using pulsed electromagnetic fields (PEMF) has been CE marked and received FDA approval. The company also has a multi-coil repetitive transcranial magnetic stimulation device that is pending FDA marketing clearance. Endonovo said it will pursue clinical trials of PEMF in traumatic brain injury, post-concussion syndrome, stroke, and multiple sclerosis. (Mass Device)

Article Highlights Neuromodulation as an Option That Is an Alternative to Opioids

Dec. 26, 2017 - In an article that calls neurostimulation a once-overlooked option for people with debilitating nerve pain, International Neuromodulation Society member Timothy Deer, MD, was quoted about spinal cord stimulation as an alternative to opioids. He said neuromodulation reduces the need to go on opioids and the risk of opioid dependence. (Bloomberg)

Journal Publishes Updated Guidelines About Bleeding Risk From Regional Anesthesia Procedures

Dec. 22, 2017 - International Neuromodulation Society members David Provenzano, MD; José De Andres, MD; Timothy Deer, MD; Richard Rauck, MD; Marc A. Huntoon, MD; and colleagues published joint anticoagulation guidelines from the American Society of Regional Anesthesia and Pain Medicine, the European Society of Regional Anaesthesia and Pain Therapy, the American Academy of Pain Medicine, the International Neuromodulation Society, the North American Neuromodulation Society, and the World Institute of Pain that stratify the risk of bleeding during regional anesthesia procedures, such as neurostimulator implantation. (Regional Anesthesia & Pain Medicine)

Researchers Investigate Possible Brain "Switch" for Impulsive Behavior

Dec. 19, 2017 - International Neuromodulation Society member Casey Halpern, MD and colleagues published deep brain stimulation research in Proceedings of the National Academy of Sciences that suggests responsive stimulation might be developed to avert risky impulsive behavior. They report they identified a "high-delta" electrical signature in the nucleus accumbens that precedes impulsive behavior, such as mice binge-eating fatty food, or a patient performing computerized tasks that yielded a cash reward. The human subject consented to participate in the study while undergoing implantation of the deep brain stimulation system for obsessive compulsive disorder. The authors demonstrated that pulsed stimulation to the mice's nucleus accumbens when an electrode array sensed an increase in delta intensity reduced the binge-feeding behavior. (Medical Xpress)

Study: Amygdala Stimulation Enhanced Memory Recall 24 Hours Later

Dec. 18, 2017 - A memory study in 14 patients with epilepsy showed that stimulation of the amygdala helped convert short-term memories to long-term ones. (IEEE Spectrum)

Clinical Trial: Brain Stimulation Target Showed Promise in Reducing Hallucinations in Parkinson's Disease Dementia

Dec. 18, 2017 - A short interview summarizes a recent double-blind, crossover trial in which six patients with Parkinson's disease dementia received low frequency stimulation of the nucleus basalis of Meynert. In the trial, there was little evidence of benefit in global cognition, but visual hallucinations reduced. The study was published in JAMA Neurology. (MedicalResearch.com)

U.S.University Participates in Neuromodulation Forum in Central China

Dec. 18, 2017 - The University of Kentucky announced that a group from its Brain Restoration center concluded a conference series at a number of Chinese university hospitals by performing the first deep brain stimulation surgery for a Parkinson's disease patient that was carried out at the First Affiliated Hospital of Zhengzhou University in Henan, China. (University of Kentucky)

Article Highlights Devices as Potentially Helping Combat the Opioid Crisis

Dec. 18, 2017 - Three of seven devices in an article about combating the opioid crisis are implanted neurostimulation systems. (Medical Design and Outsourcing)

Article Calls for Moving Non-Opioid Treatments Earlier in the Pain Therapy Continuum

Dec. 18, 2017 - International Neuromodulation Society member Peter Staats, MD, offers a perspective on factors leading to overprescribing of opioids in the United States. He stresses the importance of including interventional strategies in a pain treatment algorithm before problems develop. (Pain Medicine News)

A Bioelectric Medicine Approach Will Be Explored for Reducing Pain from Lupus

Dec. 17, 2017 - Researchers announced a pilot study to treat the pain of lupus by administering five minutes of electrical stimulation through the ear daily for four days. The stimulation is intended to inhibit the inflammatory reflex. (Patch.com)

One-Year Results Published in the Use of Neurostimulation to Address Chronic Mechanical Low Back Pain

Dec. 15, 2017 - Investigators conducted an international, prospective, single-arm trial of a new neurostimulation approach for chronic mechanical low back pain, designed to periodically contract the lumbar multifidus that helps to stabilize the lower spine. The authors reported one-year results on 53 subjects in the study. They conclude the data showed "clinically important, statistically significant, and lasting improvement" in pain, disability, and quality of life. Meanwhile, a new review presents evidence for the role of the lumbar multifidus muscle in chronic low back pain. (Neuromodulation: Technology at the Neural Interface)

Researchers Give Interviews about Presentations Concerning High Frequency Stimulation for Abdominal and Other Pain

Dec. 14, 2017 -  International Neuromodulation Society member Leonardo Kapural, MD, PhD, was interviewed by an industry publication about his presentation of a feasibility study about high frequency spinal cord stimulation for treating chronic abdominal pain. He presented the study at the annual meeting of the American Society of Regional Anesthesia and Pain Medicine. At the same meeting, INS member Kasha Amirdelfan, MD, was interviewed about presenting preliminary 12-month results of a single-arm study of high frequency stimulation in upper limb and axial neck pain. (SmartTRAK)

Researchers Compare Neural Deficits in Autism and a Mouse Model, and Show Brain Stimulation Partially Reverses Behavioral Symptoms in the Mice

Dec. 13, 2017 - Researchers used neuromodulation to show that people and mice have similar connections between the Right Crus I domain of the cerebellum and the inferior parietal lobule of the cortex. In brain imaging, they said, those connections are disrupted in a mouse model of autism and in a cohort of autistic children. Brain stimulation in the mice reversed aspects of the abnormal behavior that arose when the connection was disrupted. The work was published in Nature Neuroscience. (NewsMedical.net)

Pain Management Experts Provide Perspectives on Neuromodulation

Dec. 14, 2017 - In a health awareness article that appears in the Guardian, International Neuromodulation Society President Timothy Deer, MD, describes growing excitement about neuromodulation therapy for managing symptoms of long-term disease, and new and more tailored forms of neuromodulation therapy. Due to the potential of neuromodulation to improve quality of life, he said, awareness should grow among patients and their clinicians. In the same news supplement, INS member Tacson Fernandez, MBBS, FRCA, FIPP, described a case in which spinal cord stimulation provided pain relief to a patient who had suffered brachial plexus injury in a motorcycle accident years before. (Media Planet)

Device Company Targeting Chronic Low Back Pain Passes Early Milestone of U.S. Clinical Trial

Dec. 11, 2017 - Mainstay Medical plc announced an interim analysis of the first 58 patients to complete its U.S. clinical trial showed no safety concerns with the company's implantable device for chronic low back pain. The analysis was carried out by an independent data committee that also recommended achieving a final sample size of 168 evaluable patients. The company expects to reach full enrollment by the second quarter of 2018. (Irish Times)

Technology Publication Recognizes a Company for Developing a Sacral Neuromodulation System

Dec. 11, 2017 - Axonics Modulation Technologies is one of 15 companies named a "Fierce 15" by the publication Fierce Biotech for 2017. The company is developing a rechargeable, miniaturized implantable device to provide sacral neuromodulation for overactive bladder. A U.S. clinical trial is beginning enrollment this month. (Fierce Biotech)

FDA Approves Rechargeable Deep Brain Stimulation System with Independent Current Control

Dec. 11, 2017 - Boston Scientific Corp. announced FDA approval of its deep brain stimulation system to address symptoms of Parkinson's disease with electrodes that have independent current control. U.S. approval was based on a multi-center, randomized, controlled, prospective, double-blind study of 292 Parkinson's disease patients at 23 sites in the United States. Data from the Intrepid study are expected to be released in 2018. The filing included additional safety data from an earlier study in Europe, where the rechargeable system launched in 2012. (PR Newswire)

FDA Permits Clinical Trial of Vagus Nerve Stimulation in Rheumatoid Arthritis

Dec. 11, 2017 - Setpoint Medical Corp. received FDA approval to start a clinical trial of 15 subjects at seven U.S. centers to evaluate its implantable vagus nerve stimulator in medication-resistant rheumatoid arthritis. The stimulation is intended to activate an anti-inflammatory pathway. (Mass Device)

Trancranial Magnetic Stimulation Device Maker Raises $8.5 Million

Dec. 11, 2017 - Brainsway Ltd. has raised $8.5 million from financial institutions in Israel. The company produces transcranial magnetic stimulation devices for the treatment of depression. Brainsway is awaiting a decision from the U.S. FDA about potentially marketing its device for treatment of obsessive compulsive disorder. The company is also anticipating results in late 2018 of a smoking cessation study. (Globes)

Company Receives Recognition from a Biotechnology Industry Publication

Dec. 11, 2017 - An article describes Saluda Medical's spinal cord stimulator, a closed-loop device, as moving toward personalized, precision-based medicine. The company was one of 15 named as a "Fierce 15" for 2017 by the publication Fierce Biotech. (Fierce Biotech)

Man with a Metabolic Condition that Impaired Motor Function Undergoes Deep Brain Stimulation

Dec. 11, 2017 - A television segment describes the gradual improvement of a young man with a rare genetic condition, Pank 2, that causes iron accumulation in the brain, disrupting motor function. Nine months ago, about five years after his symptoms began, he became one of about two dozen people with the disorder to try deep brain stimulation. (Fox 5 Atlanta)

Researchers Study the Effect of Epidural Spinal Cord Stimulation in Patients with Spinal Cord Injury

Dec. 11, 2017 - An article describes a feasibility study at the University of Louisville School of Medicine to "measure the extent to which epidural stimulation will improve cardiovascular function as well as facilitate the ability to stand and voluntarily control leg movements" in people with spinal cord injury. (SurfKY)

A Multicenter Randomized Controlled Trial Compared Pulse Rate Outcomes in Spinal Cord Stimulation for Back Pain

Dec. 8, 2017 - International Neuromodulation Society members Simon Thomson, MBBS; Moein Tavakkolizadeh, MD; Sarah Love-Jones, MBBS; and colleagues published results of a randomized, crossover study of spinal cord stimulation (SCS) for back pain, Evaluation of Spinal Cord Stimulation Pulse Rate On Clinical Outcomes (PROCO). They found that, with appropriate titration of pulse width and amplitude, there is Level I evidence of equivalent pain relief from SCS at frequencies from 1 to 10 kHz. Stimulation at 1kHz required 60-70% less charge than higher frequencies. (Neuromodulation: Technology at the Neural Interface)

U.S. Centers for Medicare & Medicaid Service Will Increase Reimbursement in January for Peripheral Nerve Stimulator Implantation

Dec. 7, 2017 - Bioness, Inc. announced that starting Jan. 1, 2018, the U.S. Centers for Medicare & Medicaid Service has approved increased payments for implantation of its percutaneous neurostimulator that addresses chronic pain of peripheral nerve origin. The increased reimbursement will be 11% at outpatient hospitals, 3% at ambulatory surgery centers, and 124% at physician offices. (PR Newswire)

 Article Considers Non-Invasive Neurostimulation to Potentially Address Organ Function

Dec. 7, 2017 - An article touches upon preclinical studies that may lead to treating diabetes through stimulating the pancreas via the vagus nerve. The article cites a review in Trends in Molecular Medicine about transdermal nerve stimulation to potentially control immune and organ functions. (Healthline)

In a Sham-Controlled Study, Neurostimulation Reduced Abdominal Pain in Adolescents and Teens

Dec. 6, 2017 - International Neuromodulation Society member Timothy Deer, MD, commented in Pain Medicine News on a study of percutaneous electrical nerve field stimulation to treat pain from functional gastrointestinal disorders in children aged 11 - 18. The sham-controlled study of 115 children, reported in The Lancet, found that the treatment group sustained improvement in pain scores, compared to sham, during four weeks of treatment. Dr. Deer said basic science work may help elucidate underlying mechanisms, while identifying subsets of responders could increase therapeutic efficiency. (Pain Medicine News)

Brain-Stimulation Study Implicates Bromann Area 25 in Blood Pressure Control

Dec. 6, 2017 - A case series of 12 patients undergoing epilepsy and blood-pressure monitoring at the University Hospitals Cleveland Medical Center found decreased systolic blood pressure associated with electrical stimulation of Brodmann area 25, the rostral subcallosal neocortex. Researchers would like to identify the brain site involved in maintaining blood pressure since it may be inhibited during seizures. Hypotension from peri-octal autonomic dysregulation is thought to be a factor in sudden unexpected death in epilepsy. (2 Minute Medicine)

Long-Term Data Presented About Responsive Neurostimulation in Epilepsy

Dec. 5, 2017 - Adjunctive neurostimulation with a device that monitors and responds to brain activity led to sustained seizure reduction at eight years in three-fourths of the epilepsy patients who use it, according to data presented at the American Epilepsy Society annual meeting. The device was approved by the FDA for adults with refractory partial-onset seizures who have one or two epileptogenic foci. In addition, almost one-third of the recipients had one or more 6-month-long seizure-free periods. (Medscape)

Television Segment Presents Spinal Cord Stimulation as an Alternative to Pain Medication

Dec. 6, 2017 - A news segment features a woman in chronic pain from a leg injury, who describes how spinal cord stimulation improved her function and quality of life. She says she would like people to know that prescription medication is not the only answer. In the segment, an explanation of the system was provided by International Neuromodulation Society member Youssef Josephson, DO. (CBS News)

Article Summarizes Study of Neuromodulation for Painful Neuropathy from Leprosy

Dec. 5, 2017 - An article summarizes a report in Neuromodulation: Technology at the Neural Interface, in which International Neuromodulation Society member Tiago Freitas and colleagues provide 12-month follow-up data on 10 patients in a prospective case series who received spinal cord stimulation to treat painful mononeuropathy, secondary to leprosy, which was refractive to conservative treatment. In addition to experiencing reductions in baseline pain scores, the patients reduced their pain medication by 40% from preoperative levels. (Clinical Pain Advisor)

Device Maker Announces Acquisition

Dec. 5, 2017 - LivaNova, PLC has agreed to acquire ImTherra Medical and its implantable sleep apnea treatment in a transaction valued at $225 million. The sleep apnea device is available in Europe and the FDA has granted permission for a U.S. pivotal trial. (Mass Device)

Neurostimulation Findings Presented at Annual Epilepsy Meeting

Dec. 5, 2017 - NeuroPace, Inc., issued a news release announcing five poster presentations at the American Epilepsy Society annual meeting. The prospective data being presented came from 256 neurostimulation patients with an average follow-up of eight years. The company noted that its responsive neurostimulation system has accumulated more than 1.5 million stored brain recordings, which could potentially provide clinical insight into the condition and its treatment. (Business Wire)

Researchers to Explore Infrared Stimulation to Potentially Modulate Autonomic Nervous System Conditions

Dec. 5, 2017 - Researchers from Case Western Reserve University's School of Medicine, Vanderbilt University, and the University of Pittsburgh received a $9 million grant from the National Institutes of Health to develop enhanced infrared neuromodulation to potentially treat conditions of the autonomic nervous system. The researchers will study the effects of this stimulation on such nerve structures as the nodose ganglion, which connects through the vagus nerve to a number of organs to manage their physiological function. (Photonics Media)

Visual Prostheses Company Begins Implantations in Iran

Dec. 5, 2017 - In Iran, Second Sight Medical has launched its second-generation retinal prosthesis system, which has already been implanted in two patients there. (Mass Device)

Company Releases Its Next Transcranial Magnetic Stimulation Platform

Dec. 5, 2017 - The Magstim Company Ltd. announced release of a next-generation transcranial magnetic stimulation platform for treatment medication-resistant major depressive disorder. (PR Newswire)

Publisher Provides INS Members Access to an Enhanced Database of Neuromodulation Products

November 2017 - Neurotech Reports announced it is enhancing its Database of Neuromodulation Products, which is available to members of the International Neuromodulation Society through their website member portal. The database contains information on existing and forthcoming products in a number of product categories, including spinal cord stimulation, deep brain stimulation, leads, power supplies, and many others. Users can search by product category, company name, or medical condition. The database reports details such as approval status, reimbursement, and product description. (Neurotech Reports)

New U.S. Patents Announced by Sacral Neuromodulation Device Maker

Dec. 4, 2017 - Axonics Modulation Technologies, Inc. announced seven new U.S. patents for its sacral neuromodulation system, adding to its more than 100 granted, and 80 pending, patent applications in various worldwide jurisdictions. (Business Wire)

Company Announces Singapore Approvals for Non-Invasive Device

Dec. 4, 2017 - Soterix Medical, Inc. announced it has received approval by Singapore’s Health Sciences Authority (HSA) for its non-invasive transcranial direct current stimulation (tDCS) device for fibromyalgia-related migraines and other chronic pain. It also announced HSA approval for its tDCS device for symptoms associated with major depression. Their office-based therapist entail using a cap to position the electrodes. (Fibromyalgia News Today)

Team Plans a Study to Potentially Restore Some Movement After Spinal Cord Injury

Dec. 4, 2017 - An anticipated study in Australia will to try to restore hand function in patients with quadriplegia. The new project begins in January. A researcher who led similar research in the U.S., Prof. Reggie Edgerton of the University of California, Los Angeles, will join the effort part-time. Upon receiving ethics approval, the team anticipates enrolling spinal cord injury patients in July. (Sydney Morning Herald)

Responsive Neurostimulation Company Combines Device Data Management and Programming in One Tablet

Dec. 1, 2017 - NeuroPace, Inc. has launched a tablet that, in one interface, integrates its online patient data management system and the programmer for its responsive neurostimulation system. The company's responsive neurostimulation system was approved by the FDA in 2013 as adjunctive therapy in adults with certain types of epilepsy that have not responded to two or more medications. (MPR)

CE Mark Announced for Spinal Cord Stimulation System

Nov. 30, 2017 - Nevro Corp. announced it received CE mark approval for its next-generation spinal cord stimulation system, permitting its sale in European Economic Area countries. (PR Newswire)

Company Changes Intrathecal Drug Delivery Device Design to Decrease Motor Stall

Nov. 29, 2017 - Medtronic plc issued a letter to physicians saying it has received approval to address motor stall and shaft wear issues in its intrathecal drug delivery pump. While new pumps are made with this design change, the company said quantities are limited, and so pumps manufactured before the latest change will remain available until there is sufficient inventory of pumps with the new design. (Drug Delivery Business News)

Development of a Sub-Millimeter Scale Wireless Neural Stimulator

Nov. 27, 2017 - A team has published data about a proof-of-concept, sub-millimeter-scale stimulator that might enable nerve-cuff peripheral nerve stimulation or wireless deep brain stimulation. The paper covers analytical and computational modeling, and use of a working prototype to elicit a motor response in the sciatic nerve of a rat. The authors say their device, with a compact polymer-based encapsulation, "consists only of an antenna to receive inductive power, a diode for rectification, and two electrodes" to deliver current to neurons. (Frontiers in Neuroscience)

Data in Animals Showed Heart Rate Variability Reversibly Suppressed by Optogenetic Means

December 2017 - An optogenetic study in beagles showed that illumination with a laser-emitting diode led to decreased indices of heart rate variability weeks after an inhibitory light-sensitive opsin was delivered to neurons in the left stellate ganglion, whose suppression protects against ventricular arrhyhimias. A 14-minute audio file describes the study. (Journal of the American College of Cardiology)

Small Study Demonstrates Pain Relief From Posterior Tibial Nerve Stimulation for Peripheral Neuropathic Pain

Nov. 29, 2017 - In an open-label study of patients with peripheral neuropathic pain from polyneuropathy, posterior tibial nerve stimulation was evaluated for pain relief. Eight patients had six stimulation sessions spaced about three or four days apart. Their pain was reduced by 85.5% at the end of the period. Six of the patients had more than 50% decrease after the first stimulation session and 99.2% after the final session. (Journal of Pain Research)

Analysis: Suspending Anticoagulant Use Did Not Increase Risk of Adverse Events from Spinal Cord Stimulation Implantation or Revision

Nov. 27, 2017 - International Neuromodulation Society members Julie Pilitis, MD, PhD, Vishad Sukul, MD, and colleagues published a retrospective analysis of a prospectively collected database of 225 spinal cord stimulation patients. The analysis included 43 patients who had been on at least one anticoagulant, and assessed the safety of implanting or revising spinal cord stimulators after anticoagulant medication was suspended. Suspension had been recommended by the 2017 guidelines of the Neurostimulation Appropriateness Consensus Committee. The analysis found that anticoagulant use "as a whole" had no significant relationship to 13 adverse events recorded within 90 days of surgery. The authors conclude suspension did not comparatively increase risk of bleeding or blood clots. (Pain Medicine)

Neurostimulator Anchor Receives Clearance from the FDA

Nov. 28, 2017 - Stimwave LLC announced receiving FDA clearance for its pain-relief neurostimulator anchor systems. They are deployed through a needle puncture used to implant the neurostimulator leads. (Business Wire)

Study: Low-Frequency Stimulation in Parkinson's Disease May Improve Cognitive Deficit

Nov. 28, 2017 - Simple cognitive tests performed during deep brain stimulation surgery, and after recovery, indicate that cognitive deficits in Parkinson's disease may be lessened with low frequency stimulation to the subthalamic nucleus at 4 Hz, which researchers say restores delta wave activity in the medial prefrontal cortex. A published study that involved evoked responses and functional mapping indicates there may be a single, direct synaptic connection between these regions. (Medical Express)

Bioelectronic Medicine Researchers Investigate Delaying Preterm Labor

Nov. 21, 2017 - A research team won $500,000 to investigate potentially delaying preterm delivery by delivering electrical stimulation through a belt-like device. The concept also calls for administering antenatal steroids to enhance the infant's lung maturity. (Innovate Long Island)

Study Evaluates Outcomes of Combining Psychotherapy and Brain Stimulation

Nov. 17, 2017 - A study in the Netherlands of 196 patients with major depressive disorder found that combining cognitive behavioral therapy and 10 sessions of repetitive transcranial magnetic stimulation resulted in a 66% response rate and a 56% remission rate at the end of treatment, with 60% sustained remission at follow-up. (Vision)

Company's Neurostimulator Receives CE Mark for MRI-Conditional Body Scans

Nov. 16, 2017 - Nevro Corp. announced receiving CE mark approval for MRI conditional use of its high-frequency spinal cord stimulator for chronic pain. Previously the device had CE mark for head and extremity MRI scans. The new approval applies retroactively to patients already implanted with the device. (Mass Device)

Startup Focuses on Advancing Neuroprosthetic Capabilities

Nov. 16, 2017 - An article describes the efforts of the startup Kernel to develop ambitious neuroprosthetic capabilities to sense and stimulate through brain-computer interfaces. (Wired)

FDA Approves Percutaneous Nerve Field Stimulation Device for Opioid Addiction Withdrawal Treatment

Nov. 15, 2017 - A noninvasive percutaneous nerve field device worn behind the ear and previously cleared by the U.S. FDA for acupuncture indications in 2014 has received approval for use by prescription to treat acute symptoms of opioid withdrawal. The treatment is intended to be a transitional aid for medically assisted weaning from opioid addiction. The electro auricular device was studied in 73 patients, who reported a 31% reduction in such symptoms as sweating, gastrointestinal upset, agitation, insomnia and joint pain after 30 minutes of stimulation. In a news release, the device developer, Innovative Health Solutions, Inc., said withdrawal symptoms were reduced by 84.6% in at least 60 minutes of treatment with the single-use device. The company posted a brief video explaining the function of their NSS-2 Bridge device. (MD Magazine)

Presentation: Neurostimulation for Dry Eye Disease Improved All Tear Layers Over Time

Nov. 14, 2017 - Electrical stimulation of the intranasal tear reflex for dry eye disease was studied in two large pivotal multicenter clinical studies. The studies of the hand-held prototype showed gradual production of all three layers of tear film that results in healing of the eye surface, according to a presenter at the American Academy of Ophthalmology meeting. (Medpage Today)

Brain Stimulation Study Reveals Brain-Inhibition Imbalance in Genetic Condition

Nov. 14, 2017 - Brain-stimulation research showing an imbalance in inhibition and excitation in people with fragile X syndrome, which often has some features of autism, lends support to the idea that autism and related conditions may be associated with decreased inhibition in the brain. (Spectrum)

Study: Stimulation Via Capsaicin Swab of Ear Canal Improved Dysphagia in Elderly

Nov. 13, 2017 - In a randomized, placebo-controlled, double-blind, comparative study of 20 elderly patients with difficulty swallowing, swallowing scores improved in the10 who received 0.025% capsaicin ointment swabbed on the external auditory canal. The authors say capsaicin is an agonist of the transient receptor potential vanilloid 1, and that improvement in glottal closure and cough reflexes especially may be due to that receptor mediating aural stimulation of the vagal Arnold's nerve. (Clinical Interventions in Aging)

Researchers Present Work to Address Dyskinesia Using Closed-Loop Deep Brain Stimulation With Motor Cortex Electrocorticography

Nov. 12, 2017 - In two Parkinson's disease patients, the feasibility of closed-loop adjustment of deep brain stimulation to address dyskinesia, using motor cortex electrocorticography, was demonstrated during adjustment sessions of 10-60 minutes. The study was mentioned in a news release that summarized several presentations at the Society for Neuroscience meeting concerning brain stimulation treatment and research. (Society for Neuroscience)

Transcranial Magnetic Stimulation Improved Gait and Balance in Multiple Sclerosis Patients

Nov. 7, 2017 - A randomized, single-blind pilot study in 43 patients with relapsing-remitting multiple sclerosis showed improvements in gait and balance, compared to sham, in patients who received 12 sessions of repetitive transcranial magnetic stimulation over four weeks along with intensive rehabilitation. (Medscape)

Noninvasive Brain Stimulation System Receives FDA Clearance for Depression Treatment

Nov. 13, 2017 - The FDA has cleared Nexstim plc's noninvasive, navigated transcranial magnetic stimulation system for the treatment of major depressive disorder, the company announced. (Fierce Medical Devices)

In Small Study, Optic Nerve Electrical Stimulation Stopped or Reversed Glaucoma in Most Patients

Nov. 13, 2017 - A yearlong study in Germany of 13 patients with glaucoma, presented at the Deutsche Ophthalmologische Gesellschaft Congress in Berlin, found that electrical stimulation of the optic nerve cells aided 75% of patients by stopping profession of the disease or improving vision, according to the device maker, EBS Technologies. (PR Newswire)

Academic Medical Center in West Virginia Plans to Add Brain Stimulation to Addiction Treatment

Nov. 13, 2017 - International Neuromodulation Society member Ali Rezai, MD, was featured in a news item from the Associated Press that says addictions treatment will be expanded next year to include brain stimulation techniques at West Virginia University Medicine. He is the new director of the university's Rockefeller Neurosciences Institute. (U.S. News & World Report)

Neuroscience Meeting Sees a Rise in Research Presentations About Mental Health Applications 

Nov. 12, 2017 - A radio interview from the Society for Neuroscience discusses how the fields of brain science and mental health are merging through new insights and capabilities to understand circuit disorders and the underlying science. (NPR)

Noninvasive Neurostimulation Startup Featured in Article About Combating the Opioid Epidemic

Nov. 9, 2017 - An article about small businesses that address the opioid epidemic describes a noninvasive neurostimulation therapy for phantom pain that the startup SPR Therapeutics, Inc. offers. (Inc.)

Study Confirms Usefulness of Telemedicine for Remote Deep Brain Stimulation Patients

Nov. 9, 2017 - A retrospective study of deep brain stimulation patients and candidates who used the Ontario Telemedicine Network due to living far from services confirmed it is a feasible and useful approach for assessing patients. The authors suggest combining it with in-person visits, such as for battery replacement and surgery. (Movement Disorders)

Research Project Involves Using Optogenetics for a Visual Prosthesis

Nov. 9, 2017 - A program of the U.S. Defense Advanced Projects Research Agency, DARPA, involves the French research laboratory Leti, which is developing a wireless, implantable system called CorticalSight to stimulate ontogenetically modified neurons in the visual cortex using light. (Electronics Weekly)

Company Says Study Shows Noninvasive Stimulation Improved Balance in Head-Injury Patients

Nov. 9, 2017 - Helius Medical Technologies, Inc. said a double-blind, randomized, sham-controlled clinical study of its cranial nerve noninvasive neuromodulation system to improve balance in 122 subjects with mild to moderate traumatic brain injury showed improvements from baseline that averaged more than three times the clinically significant amount. The company plans to file for device clearance from the FDA in 2018. (Nasdaq)

FDA Reportedly Fast-Tracks Review of a Visual Prosthetic

Nov. 8, 2017 - Second Sight Medical announced the FDA gave its next-generation visual prosthesis a expedited review pathway. This device bypasses the optic nerve by using a cortical implant connected to a camera. (Mass Device)

Clinicians Report Use of a 3D Printed Guiding Device to Facilitate Sacral Neuromodulation Implantation

Nov. 7, 2017 - Clinicians in China report on creation of a customized novel 3D printed guiding device for electrode implantation of sacral neuromodulation. They say it allowed placing the test needle successfully on the first attempt, and that implanting a tined electrode took less than 20 minutes with no complications. The two patients, who had intractable constipation, experienced symptom improvement of more than 50% during the screening phase, and received a permanent implant. (Colorectal Disease)

Comparative Study in Back-Pain Patients Finds Conventional or High-Frequency Stimulation Yielded Similar Scores at One Year Followup

Nov. 4, 2017 - International Neuromodulation Society member Jose De Andres, MD, PhD, and colleagues published a comparative prospective, randomized, blind effect-on-outcome study comparing conventional and high-frequency spinal cord stimulation. After one year, assessments in 55 patients showed similar, significant global average reduction in scores. (Pain Medicine)

Lifetime Analysis of Transcranial Magnetic Stimulation for Depression Finds It Cost-Effective After One Medication Failure

Oct. 26, 2017 - An analysis concludes that repetitive transcranial magnetic stimulation provides lower costs with better outcomes, with direct costs and quality adjusted life years ranging from $2,952/0.32 to $11,140/0.43 for younger patients. The authors say their results support the use of the therapy after a single failed antidepressant medication trial. (PLoS ONE)

Opinion Piece Says It's Time to Embrace New Pain Treatments

Nov. 4, 2017 - International Neuromodulation Society member Peter Staats, MD, wrote an opinion article that says interventional pain therapies, by targeting the parts of the body that generate chronic pain, could help to eliminate patients' desire for opioids. (Newsweek)

Authors Conclude Sacral Neuromodulation in Teen-Agers and Adolescents May Be Cost-Effective for Chronic, Refractory Constipation

Nov. 1, 2017 - A modeling study based on data from 27 patients followed for a median of 22 months concluded that in children and adolescents aged 10 18 years old who have chronic refractory constipation, sacral neuromodulation can be a cost-effective option compared to continued conservative management. (Colorectal Disease)

CE Mark Announced for Neurostimulation System

Nov. 6, 2017 - Medtronic pls announced it received CE marking for its spinal cord stimulator that is managed through a tablet interface. The designation applies to both spinal cord stimulation and peripheral nerve stimulation, the company said. (Globe Newswire)

Study Explores Transcranial Magnetic Stimulation to Address Chronic Pain

Nov. 5, 2017 - An article describes a clinical trial of transcranial magnetic stimulation for chronic pain at the Medical University of South Carolina. (Post and Courier)

Australian Clinical Trial Will Explore Thalamic Deep Brain Stimulation in Patients Who Have Daily Epilepsy Attacks

Nov. 5, 2017 - A double-blinded clinical trial at the University of Melbourne will explore deep brain stimulation to the thalamus in up to 20 patients who have a type of epilepsy called Lennox-Gastaut syndrome. The childhood-onset condition causes daily attacks, and interferes with learning. The study is supported through a $1 million grant from Australia's National Health and Medical Research Council. (Herald Sun)

Article Describes Possible Advantages of Asleep Deep Brain Stimulation

Nov. 3, 2017 - A clinical trial of 69 deep brain stimulation (DBS) patients at Oregon Health & Science University compared awake vs. asleep DBS was reported to show better outcomes in communication, cognition and speech -- possibly because the asleep approach relies on imaging and so does not require using multiple probes to map the trajectory and target location through microelectrode recordings. (Portland Business Journal)

News Release Expresses Concern About Reduced Access to Pain Treatment for Injured Workers

Nov. 2, 2017 - The North American Neuromodulation Society issued a news release expressing concern about upcoming regulations from the California Department of Workers Compensation. The news release says that when the department's updated treatment schedule goes into effect Dec. 1, 2017, injured workers would no longer have access to non-addictive, FDA-approved neuromodulation treatment that the release says is covered for patients in 48 other states.

Pediatric Patients With Obstructive Sleep Apnea Receive Hypoglossal Nerve Stimulator

Nov. 2, 2017 - A case series of six adolescents who have Down syndrome and obstructive sleep apnea showed implantation of hypoglossal nerve stimulators was well tolerated and effective. The article says the pediatric patients, aged 12 - 18, were the first children to have the implant. (The JAMA Network)

Research Collaboration Will Explore Nerve Block Technology for Autonomic Nervous System

Nov. 2, 2017 - An article says that a stimulation method currently being used by Neuros Medical Inc. to block pain, which relies on a combined waveform of AC/DC currents across different time frames, may also help treat asthma and heart failure through research at Case Western Reserve University, with collaborators from the University of California at Los Angeles and Johns Hopkins University. A news release says the project received a four-year, $2 million grant from the National Institutes of Health. (Medical Design & Outsourcing)

In Clinical Trial, Spinal Cord Stimulation at Different Frequencies Delivered Equivalent Pain Relief

Nov. 2, 2017 - International Neuromodulation Society members Simon Thomson, MBBS, and Timothy Deer, MD, were quoted in an article about the presentation of research results from Dr. Thomson's PROCO (Evaluation of Spinal Cord Stimulation Pulse Rate On Clinical Outcomes) clinical trial at the INS 13th World Congress in June 2017. Results of the double-blind, crossover study in 20 pain patients showed equivalent pain relief using spinal cord stimulation frequencies from 1 kHz to 10 kHz. Commentators called for additional, expanded study, and Dr. Deer pointed out neurostimulation can lower the need for opioid medication. (Pain Medicine News)

National Institutes of Health Seeks Clinician, Industry Input on Studies of Peripheral or Spinal Cord Neuromodulation of Organ Function

Nov. 2, 2017 - The National Institutes of Health program SPARC (Stimulating Peripheral Activity to Relieve Conditions) seeks input from clinicians and industry, through two requests for information, by Dec. 1st, regarding potential ways to improve the therapeutic potential and scientific impact of studies of peripheral or spinal cord stimulation to modulate organ function. Clinician perspectives are needed on topics such as surgical planning and access tools, device design and functionality, and the potential collection of physiology data for research in clinical settings. Clinician input may be submitted via the request for information NOT-RM-17-023. Input from industry scientists and engineers is sought on ways to establish effective public-private partnerships around clinical studies, to pursue new therapeutic opportunities using existing technology, and to explore the use of devices with expanded research capabilities to maximize data yield from clinical device-based studies. Industry perspectives may be submitted via the request NOT-RM-17-015.

As explained in the requests, responses can be submitted via email [email protected], through teleconference meetings with the SPARC team requested at http://nihsparc.setmore.com, or through voicemail messages left at the provided telephone number. Responses must be submitted by Dec. 1, 2017

Research into Deep Brain Stimulation for Depression Discussed at National Institutes of Health Workshop

Oct. 31, 2017 - At a meeting on ethical dilemmas of brain stimulation research, experts discussed issues such as the 44 patients from a clinical trial of deep brain stimulation for depression who opted to leave their implants in place, but must cover the costs of maintaining the device or surgery to replace the pulse generator. (Science)

Australian Healthcare System Will Add Coverage for Vagus Nerve Stimulation for Epilepsy

Oct. 31, 2017 - The Australian government approved recommendations from the independent Medical Services Advisory Committee which include access to six vagus nerve stimulation items for epilepsy patients. (Brisbane Times)

Epidural Spinal Cord Stimulation Aided Physical Rehabilitation After Paralysis

Oct. 30, 2017 - A paraplegic man who combined epidural spinal cord stimulation with intensive rehabilitation therapy twice a day regained his ability to stand independently for periods of time, despite the loss of motor function in his legs following his injury. (Daily Mail)

Review Summarizes Evidence for Sacral Nerve Stimulation Following Surgery for Colon Disorders

Oct. 30, 2017 - A systematic review covers three papers about sacral nerve stimulation for fecal incontinence in patients who have had ileal pouch anal anastomosis for inflammatory bowel disease or other disorders. (Updates in Surgery)

Article Summarizes Brain-Computer Interface Development

Oct. 24, 2017 - International Neuromodulation Society member Jaimie Henderson, MD, is mentioned in an article about the potential therapeutic promise of brain-machine interfaces that can essentially listen to, and "speak," the brain's language. (Parkinson's News Today)

Grant Enables Research Into Neuroethics of Closed-Loop Brain Stimulation Therapies

Oct. 24, 2017 - A four-year, $1.9 million grant from the NIH BRAIN Initiative will support research into neuroethical implications of adaptive deep brain stimulation technologies, which use signals from the brain to adjust stimulation in real time. The researchers will follow 10 patients from five collaborating research studies. (Baylor College of Medicine)

Stimulation Study Pinpoints Area Linked to Recall of Distinct Memory

Oct. 24, 2017 - Memory tests on 13 people who were undergoing epilepsy monitoring monitoring showed that stimulating the right side of the brain’s entorhinal area, but not the left, improved subjects' ability to recognize specific faces and ignore similar ones. (UCLA)

Responsive Neurostimulation Company Raises $74 Million

Oct. 24, 2017 - NeuroPace, Inc. announced it has closed a $74 million financing round to expand marketing of its responsive neurostimulation system to treat epilepsy. The investors commented about the potential to apply the technology to other conditions. (Fierce Biotech)

Company Rebrands As Its Portfolio Expands to Address Obesity-Related Conditions

Oct. 23, 2017 - EnteroMedics, Inc. is following its acquisition of ReShape Medical, Inc. with rebranding itself with the name ReShape Lifesciences, updating its NASDAQ ticker to RSLS. (Mass Device)

Vestibular Nerve Stimulation Targets Balance Impairment

Oct. 20, 2017 - A safety and efficacy clinical trial of a vestibular nerve stimulator to restore balance has shown good preliminary results, according to an investigator at Johns Hopkins. Results are available from the first three of five eventual enrollees. Their balance issues stem from inner ear damage that developed during a course of life-saving antibiotics. In the trial, stimulation is delivered in one ear through a modified cochlear implant that responds to data from an externally worn gyroscope. The developers anticipate potentially commercializing the device later through the spinoff company Labyrinth Devices. (IEEE Spectrum)

Interagency Working Group Produces U.S. Federal Pain Research Strategy

Oct. 20, 2017 - The NIH Office of Pain Policy has released a Federal Pain Research Strategy. The strategy prioritizes research recommendations concerning both acute and chronic pain. (NIH)

Article Advises Emergency Medicine Providers About Issues That Deep Brain Stimulation Patients May Present

October 2017 - An article alerts emergency medicine providers to be alert to potential complications involving deep brain stimulation implants. (Emergency Medicine News)

French Authorities Permit Pilot Study of Visual Prosthesis

Oct. 19, 2017 - Pixium Vision announced approval from the French regulatory agency to recruit five patients for a feasibility study of the company's next-generation retinal implant. The three-year study will explore tolerance of the system and its evoked central vision perception in people with dry age-related macular degeneration. (Mass Device)

Company Receives Grant for Asthma Treatment

Oct. 19, 2017 - Nexeon MedSystems Inc. received a Phase I Small Business Research Innovation grant from the U.S. National Heart, Lung, and Blood Institute to develop a neurostimulation therapy for asthma with Oregon Health Sciences University. The vagus nerve stimulation treatment would be a second-line defense to open airways. (PR Web)

Team Studies Effect of Non-Invasive Brain Stimulation on Appetite

Oct. 18, 2017 - A study of 21 people with obesity found that longer periods of transcranial direct current stimulation reduced hunger and snack food intake, but shorter term stimulation, such as 3 sessions, had no effect relative to sham. In the study, active-treatment subjects received anodal stimulation of the left dorsolateral prefrontal cortex for a maximum of 15 sessions. (American Journal of Clinical Nutrition)

Device Company Raises $61 Million

Oct. 18, 2017 - EnteroMedics, Inc. raised $61 million in a new round of equity financing. The fundraising followed an announcement that the company will pay about $38 million to acquire ReShape Medical, which developed a balloon device for weight loss. (Mass Device)

Newly Approved Study in Germany Will Test Retinal Prosthetic in Better-Sighted Patients

Oct. 17, 2017 - Second Sight Medical said it received approval in Germany to study its retinal prosthetic in 10 better-sighted individuals who have retinitis pigmentosa and tunnel vision. The device is supposed to improve the visual field, to enhance functional vision. (Mass Device)

Start-Up Surpasses Fundraising Goal for Neurostimulator Device Intended to Aid Weight Loss

Oct. 17, 2017 - The start-up Neurovalens has raised $1.5 million, which was reportedly more than 3,000% of its goal, for research and development of its non-invasive vestibular nerve stimulator that the company aims to apply to weight loss. (MobiHealthNews)

Article Profiles Research Into Brain-Computer Interfaces

Oct. 17, 2017 - An article about brain-computer interfaces discusses research into applications for prosthetics, vision, gait, and potentially epilepsy or stroke. Among the people interviewed is International Neuromodulation Society member Jaimie Henderson, MD, a professor of neurosurgery at Stanford University who is collaborating on neural prosthetics. (Stanford)

Neurostimulator Sales Launched in the United States of Wirelessly Controlled Device Addressing Complex Regional Pain Syndrome

Oct. 16, 2017 - Abbott launched U.S. sales of a Bluetooth-enabled dorsal root ganglion stimulation system designed to treat complex regional pain syndrome of the lower limbs. (Mass Device)

Study in Australia Examines Impact of Non-Invasive Stimulation on Balance of Stroke Survivors

Oct. 15, 2017 - A two-week controlled pilot study in Australia in 10 stroke survivors showed that non-invasive stimulation through a device placed on the tongue improved balance when combined with physical rehabilitation therapy. (Herald Sun)

Clinical Research Abstract Raises Possibility of Mitigating Stimulation Tolerance Through Closed-Loop Paradigm

Oct. 3, 2017 - A scientific abstract by International Neuromodulation Society member Marc Russo, MD presents six-month data on 36 patients who were implanted with a closed-loop spinal cord stimulation system. The system uses evoked compound action potentials to measure the response to stimulus. Through longer term follow-up, the abstract concludes, it may be determined whether this stimulation paradigm helps mitigate the development of stimulation tolerance. (NeuroNews)

Review Analyzes Spinal Cord Stimulation in Refractory Angina

October 2017 - An analysis of nine randomized controlled trials comprising 364 patients with refractory angina concluded that compared to groups that did not receive spinal cord stimulation (SCS), SCS decreased use of nitrate drugs and increased several indicators of health-related quality of life. The analysis found SCS outcomes compared to those of bypass surgery or revascularization. (Translational Perioperative and Pain Medicine)

Researchers Seek to Predict Response to Occipital Nerve Stimulation

Oct. 10, 2017 -  An article summarizes research published in Cephalalgia in which investigators studied response to occipital nerve stimulation in 100 patients who had migraine and/or headache attacks. They found a greater chance for therapy response among patients with short-lasting unilateral neuralgiform headache attacks, as well as among patients who had responded previously to a greater occipital nerve block. (Clinical Pain Advisor)

Trade Publication Column Highlights an Interview with a Neurostimulation Company CEO

Oct. 9, 2017 - An editor speaks to Maria Bennett, founder and CEO of SPR Therapeutics, about the company's transition from R&D to a commercial focus now its peripheral nerve stimulator has received FDA clearance. In addition, she pointed to the challenge of health insurance reimbursement. The column also discusses recognition of the need for better pain management options in light of the opioid crisis. (Med Device Online)

Project Will Use Non-Invasive Brain Stimulation to Explore the Basis of Inner Speech

October 2017 - A project at the University of Manchester will use non-invasive brain stimulation to study relationships between the right superior temporal sulcus and the experience of inner speech (which is described as "an audible speech-like experience without hearing actual sounds"). The principal investigator anticipates potential therapeutic applications. (FindAPhD)

Researcher Shows Effects on Adaptive Decision-Making

Oct. 9, 2017 - A study among 90 test subjects, published in the Proceedings of the National Academy of Sciences, showed the influence of functional connectivity between the medial frontal cortex and lateral prefrontal cortex on executive function. Study subjects improved their adaptive behavior when they received in-phase, theta-frequency, high-definition transcranial alternating current stimulation. With anti-phase stimulation, the performance temporarily worsened. The author said there may be applications in conditions that are associated with less than, or more than, normal connectivity. (Inverse)

Company Developing Directional Leads for Deep Brain Stimulation Raises Capital

Oct. 4, 2017 - Aleva Neurotherapeutics, which was spun out of the Swiss Federal Institute of Technology in Lausanne (EPFL), and is developing directional leads for deep brain stimulation, raised $13 million in a Series D financing round. The proceeds are expected to be applied toward seeking CE mark approval. (Startup Ticker)

FDA Approves Vagus Nerve Stimulation System for Drug-Resistant Epilepsy

Oct. 9, 2017 - LivaNova PLC announced FDA approval for a vagus nerve stimulation system for adjunctive therapy in patients aged four years old or older who have drug-resistant epilepsy. The operation includes a detect-and-respond mode. (Business Wire)

Neurostimulator Receives FDA Approval for Central Sleep Apnea

Oct. 6, 2017 - The FDA approved an implant for moderate to severe central sleep apnea that stimulates the phrenic nerve through a vein. The system has been developed by Respicardia, Inc. (FDA)

Study Compares Awake and Asleep Deep Brain Stimulation Implantation in Parkinson's Disease

Oct. 6, 2017 - A single-center comparative six-month study compared outcomes in 30 Parkinson's disease patients who received asleep deep brain stimulation with outcomes of 39 patients who previously underwent awake deep brain stimulation (DBS) by the same surgeon. The authors conclude that motor outcomes of asleep DBS were on par or better than awake DBS and that asleep DBS was associated with superior fluency and quality of life. (Neurology)

In Study, Non-Invasive Stimulation Showed Promise for Migraine

Oct. 6, 2017 - A comparative study of 110 migraineurs who received transcutaneous occipital nerve stimulation, or medication, or sham stimulation, found that the treatment groups had a significantly higher 50% responder rate and lower headache intensity. (Medical News Bulletin)

Group in Finland Examines Incidence of Spinal Cord Stimulation Among Back-Surgery Patients

Oct. 5, 2017 - A team of authors from Finland who sought to estimate the incidence and predictive factors concerning spinal cord stimulation (SCS) in the lower-back surgery cohort at their facility surveyed 814 patients who had received non-traumatic back surgery between 2005 and 2008. Of that group, 21 had received SCS by 2015. The mean waiting time to receive SCS was 65 months (26-93 months). They conclude, "In our region, the SCS treatment is used only for very serious pain conditions. Waiting time is too long and it may be the reason why this treatment option is not offered to all candidates." (Journal of Pain Research)

Newspaper Article Describes Woman's Success Relieving Pain Through Burst Spinal Cord Stimulation

Oct. 5, 2017 - An article describes how a chronic pain patient injured in a horseback riding fall found relief through a burst mode of spinal cord stimulation. Her care was delivered by International Neuromodulation Society member Ganesan Baranidharan, MBBS FRCA FCARCSI, at the Leeds Teaching Hospital NHS Trust in the UK. (Yorkshire Post)

Clinical Trial Compares Transcranial Direct Current Stimulation to Anti-Depressant Medication

Oct. 5, 2017 - A single-center, double-blind noninferiority trial in 245 adults with unipolar depression compared transcranial direct current stimulation (tDCS) plus oral placebo to tDCS alone, sham tDCS plus the selective serotonin-reuptake inhibitor escitalopram, or sham tDCS and oral placebo. In this trial tDCS did not show noninferiority compared to the antidepressant medication over a 10-week period, and was associated with more adverse events, such as skin redness or tinnitus. (Clinical Pharmacist)

Experts Publish Standardized Procedure for Sacral Nerve Stimulation

Oct. 4, 2017 - International Neuromodulation Society member Charles Knowles, PhD was among an international multidisciplinary working party of 10 highly experienced practitioners of sacral neuromodulation (sacral nerve stimulation) who convened two meetings, including a live operating one, to prepare a publication about standardization of the implant procedure to optimize outcomes. (Neuromodulation: Technology at the Neural Interface)

Company Says Autonomic Nervous System Stimulation Lowered Autoimmune Disease Symptoms in Pilot Trial

Oct. 4, 2017 - The bioelectronics company Thync Global Inc. announced results of a single-blind study of its non-invasive device that stimulates the autonomic nervous system. The device is worn on the neck. In the 28-person study, the company said that symptoms of plaque psoriasis decreased by at least 50% in 15 of 18 people who used the device daily for four weeks. By contrast, only 2 of 10 people in the control group saw their symptoms lowered by at least 50%. (Mass Device)

Researchers Report Promising Results of Augmentative Non-Invasive Brain Stimulation During Rehabilitation for Treatment-Resistant Hemispatial Neglect

Oct. 4, 2017 - Researchers plan a larger study after seeing that transcranial direct current stimulation augmented rehabilitation of treatment-resistant stroke patients undergoing therapy for hemispatial neglect. (Medical Xpress)

Article Describes Peripheral Nerve Stimulation as an Alternative to Opioids or Surgery for Pain Relief

Oct. 2, 2017 - An article presents a percutaneous peripheral nerve stimulation device by SPR Therapeutics as a therapy meant to help control pain without the risks or side effects of opiates or invasive surgery. (R&D Magazine)

In Study, Transcranial Direct Current Stimulation Linked to Lower Fatigue in Patients With Multiple Sclerosis

Oct. 2, 2017 - A controlled study of transcranial direct current stimulation indicates that treatments reduced fatigue experienced by people with multiple sclerosis. The study had 27 subjects who received up to 20 sessions of stimulation over four weeks, for 20 minutes a day, five days a week. (Medical Xpress)

Authors Review Evidence for "Asleep" Deep Brain Stimulation in Movement Disorder

September 2017 - A review of nine studies of 237 patients who have Parkinson's disease or essential tremor and received "asleep" deep brain stimulation without microelectrode recording or intraoperative test stimulation suggests this approach can be performed safely with good outcomes although the authors say the initial findings should be further validated. (World Neurosurgery)

Clinical Team Devises Responsive Deep Brain Stimulation for an Individual with Medically Refractory Tourette Syndrome

Sept. 29, 2017 - International Neuromodulation Society member Aysegul Gunduz, PhD and colleagues report on designing and implanting a responsive deep brain stimulation system in a patient with medically refractory Tourette syndrome. The stimulating leads were implanted in the centromedian-parafascicular region of the thalamus. After 12 months, the patient's symptoms improved in two scales by 64% and 48%, while the projected mean battery life improved 63.3%. For the device's control signal, the team used a spectral feature in the 5- to 15-Hz band. (Journal of Neurosurgery)

Review Examines Experimental Approach for Axial Symptoms of Parkinson's Disease

Sept. 28, 2017 - Pedunculopontine nucleus deep brain stimulation (PPN DBS)  in Parkinson's disease has emerged as an experimental therapy for addressing axial motor deficits of Parkinson's disease that contribute to quality of life and safety issues, such as gait freezing and postural instability. A review by the Movement Disorders Society PPN DBS Working Group, in collaboration with the World Society for Stereotactic and Functional Neurosurgery, found that less than 100 cases of this intervention have been published. Due to variable and unpredictable results, the authors recommend a multicenter database to track agreed-upon measures, clinical application, and outcomes. (Movement Disorders)

UK News Article Describes Research Into and Access to Vagus Nerve Stimulation for Depression

Oct. 2, 2017 - An article about vagus nerve stimulation (VNS) for depression cites five-year findings in the American Journal of Psychiatry from a registry that showed adjunctive VNS had enhanced antidepressant effects compared with treatment as usual. The article adds that VNS is difficult to get in the UK since funding can only be arranged if the specialist appeals to a panel that funds individual requests. (The Guardian)

Neuromodulation Practitioners Join Conversation About Opioid Epidemic

Oct. 1, 2017 - International Neuromodulation Society member Rudy Malayil, MD is quoted in an article about pain treatment beyond opioids. The article says officials have written to insurers to ask for greater access to non-opioid pain management alternatives. West Virginia Sen. Joe Manchin wrote an open letter to two of the largest U.S. health insurers, and a coalition of 37 U.S. attorneys general also wrote to the head of a U.S. health insurance trade association, citing an article that quotes INS President Timothy Deer, MD about long-term cost savings from more advanced, non-opioid, therapies. (Herald Dispatch)

Parkinson's Disease Patient Gives First-Hand Account of His Deep Brain Stimulation in National News Outlet

Oct. 1, 2017 - A Parkinson's disease patient writes about his decade-long satisfaction with using deep brain stimulation to limit motor symptoms of the disease, as well as challenges from battery depletion, and brings up his earlier appeal for major spending in seeking disease cures. (Washington Post)

Study: Multi-Modal Neurostimulation Is Safe, Effective

Sept. 29, 2017 - International Neuromodulation Society member Timothy Deer, MD and colleagues have published the results of a multicenter, randomized, unblinded, crossover study that followed 100 chronic pain patients for one year to assess the safety and efficacy of a spinal cord stimulation device that offers a choice of tonic or burst stimulation modes. Patients received one or the other mode for 12 weeks, and then crossed over to the other mode for another 12 weeks. For the remainder of the study period they continued on the mode of their choice. At one year, 68.2% of patients preferred burst stimulation, 23.9% preferred tonic, and 8% had no preference. (Neuromodulation: Technology at the Neural Interface)

Study Explores Using Non-Invasive Brain Stimulation for Recovery From Traumatic Brain Injury

Sept. 28, 2017 - A pilot study of low-intensity transcranial electrical stimulation in six patients with mild traumatic brain injury used magnetoencephalography to investigate neuronal changes after the participants received a passive neurofeedback-based treatment program. The authors say the patients' persistent post-concussive symptoms, and abnormal slow-waves, reduced significantly from the pre-treatment baseline. (Medical Xpress)

Analysis Assesses Non-Invasive Brain Stimulation in Essential Tremor

Sept. 28, 2017 - Authors of a systematic review and meta-analysis of non-invasive brain stimulation in essential tremor say the technique yielded positive treatment effects. (PLoS ONE)

Neurostimulation Device Developer Announces Its Over-the-Counter Trading

Sept. 29, 2017 - The neurostimulation company Nexeon MedSystems, which is developing a deep brain stimulation system, has begun "regular way" trading on the OTC Market (OTC:QB) as NXNN. (BioSpace)

Authors Assess Long-Term Benefits of Deep Brain Stimulation in Dystonia

Sept. 28, 2017 - Clinicians in Europe published data on deep brain stimulation to the globus pallidus internus (GPi DBS) for disabling isolated idiopathic, inherited, or acquired dystonia. In their report, 61 patients were followed for a median of about 8 years (from one year to more than 20). The authors conclude that GPi DBS is safe and effective for most patients with dystonia. (Journal of Neurology, Neurosurgery & Psychiatry)

Video Interview Summarizes Stroke Research

Sept. 26, 2017 - International Neuromodulation Society member Jesse Dawson, MD, was interviewed during the INS 13th World Congress about a double-blind pilot study of vagus nerve stimulation paired with physical rehabilitation for arm weakness following stroke. (SmartTRAK)

Woman's Deafness is Reversed Through Neurostimulation

Sept. 27, 2017 - A woman in Kentucky received an auditory brainstem implant, first recommended in 2009 when type 2 neurofibromatosis tumors damaged her auditory nerves. With treatment now covered by insurance, she received a cochlear implant on her right ear, followed by the auditory brainstem implant, which addresses the auditory nerve damage affecting her left ear. (Winchester Sun)

Patient Recounts Her Satisfaction With a Sacral Nerve Stimulation Implant

Sept. 25, 2017 - A woman in the UK describes receiving sacral nerve stimulation for fecal incontinance. (Daily Mail)

Study Looks at Longitudinal Costs of Spinal Cord Stimulation

Sept. 20, 2017 - International Neuromodulation Society members Nandan Lad, MD, PhD, and Aladine Elsamadicy, MD and colleagues published a retrospective health economics analysis of 5,328 U.S. patients who received spinal cord stimulation for failed back surgery syndrome. The recipients represented 4.34% of the 122,827 patients who were identified with this indication from 2000 to 2012. Their longitudinal analysis showed that although costs climbed the year of implantation, they fell 68% compared to conventional medical management the next year, and an average of 40% annually after that, at 1, 3, 6 and 9 years. (Pain Physician)

Article Says Vagus Nerve Stimulation Helped Patient Gain Minimally Conscious State

Sept. 25, 2017 - A patient in France was brought to a minimally conscious state by use of vagus nerve stimulation after entering a vegetative state following an accident. (New Scientist)

FDA Clears Non-Invasive Stimulation System for Use During Migraine

Sept. 21, 2017 - Cefaly Technology announced the FDA has cleared its external trigeminal nerve stimulator for use during a migraine attack. It had been previously cleared for use to prevent an attack. (MPR)

FDA Approves Spinal Cord Stimulator

Sept. 18, 2017 - Medtronic plc has received FDA approval for a rechargeable spinal cord stimulation system that can be controlled by a tablet device. An article about the development discusses neurostimulation as an alternative to addictive opioid drugs. (Star Tribune)

Study: Non-Invasive Stimulation Reduced Pain After Migraines Began

Sept. 18, 2017 - A presentation at the 18th Congress of the International Headache Society on 57 patients who have participated in a randomized, sham-controlled clinical trial for acute migraine suggests that external trigeminal nerve stimulation can reduce pain of the attacks even three or more hours after an attack began. (Medscape)

Non-Invasive Stimulation Augmented Anxiety Disorder Therapy in Study

Sept. 18, 2017 - A placebo-controlled study showed that 20 minutes of transcranial magnetic stimulation prior to a desensitization exercise, using virtual reality, for study subjects who were afraid of heights had an effect that lasted three months. The active stimulation to the frontal lobe was described as accelerating the therapy to help overcome the anxiety. (Deccan Chronicle)

Initial Data Published on Closed-Loop Spinal Cord Stimulation

Sept. 18, 2017 - An Early View article presents data from six months of study of closed-loop spinal cord stimulation for chronic back and/or leg pain. Of 36 patients who received implants, the proportion experiencing more than 50% relief at three and six months was more than 90% and 80% respectively. For more than half of the recipients, pain relief surpassed 80% at three and six months (Neuromodulation: Technology at the Neural Interface)

Clinicians: Twenty Sessions of Non-Invasive Brain Stimulation Reduced Youths' Autism Symptoms

Sept. 17, 2017 - Clinicians from Cuba report that in a partial cross-over trial of 24 children (mean age 12), 20 sessions of non-invasive brain stimulation to the left dorsolateral prefrontal cortex improved autistic symptoms for six months. Children 10 and younger received transcranial direct current stimulation, while children aged 10 years, 11 months and older received repetitive transcranial magnetic stimulation, which requires more collaboration for targeting. (Behavioral Science)

Article Summarizes Electrical Stimulation Methods to Address Paralysis

Sept. 15, 2017 - The journal Physiology has published an overview of electrical stimulation to improve function after spinal cord injury. (Medical Xpress)

Research Review Explores Publications on the Clinical Use of Transcranial Direct Current Stimulation

Sept. 14, 2017 - An article reviews nearly 17 years of published research into transcranial direct current stimulation (tDCS) to augment cognitive or physical therapy. The authors comment, "Although tDCS is a safe and easy technique, it is only safe and easy in the hands of trained persons." Still, they conclude that remotely controlled and supervised tDCS for home has promise as a potentially widespread clinical use of noninvasive brain stimulation. (Neuromodulation: Technology at the Neural Interface)

Review Surveys Evidence Regarding Neuromodulation for Trigeminal Neuralgia

Sept. 14, 2017 - Commenting that neuromodulation represents "some of the most exciting new technologies in neurology today," a neurologist reviews several less-invasive and more-invasive forms of neuromodulation that have been explored to relieve trigeminal neuralgia that is not effectively treated with conventional surgery and/or medication. (Headache Currents)

Interview About International Neuromodulation Society 13th World Congress Recaps Progress in the Field

Sept. 7, 2017 - International Neuromodulation Society member Timothy Deer, MD, gave an 8-minute videotaped interview at the start of the INS 13th World Congress about exciting presentations, emerging trends and impacts, and research results and potential market growth that are on the horizon. The interview touched upon growing access based on reimbursement, patient demand for alternatives, the need to avoid or minimize opioid use, and advancing technology. Technology advances include smaller, smarter devices with new waveforms, frequencies, pulse trains and targets, and closed-loop adjustment of stimulation for devices addressing pain or interventions targeting brain centers or bladder function. He also mentioned impressive research permitting paralyzed persons to move or use a cursor. (SmartTRAK)

Abstract Presents 12-Month Results in Post-Market Study of Dorsal Root Ganglion Stimulation

Sept. 14, 2017 - An article covers an abstract presented at the International Neuromodulation Society 13th World Congress by INS member Sam Eldabe, MBBS, FRCA on a prospective, observational, post-market study of dorsal root ganglion stimulation for chronic intractable pain, PREDICT. The study followed 100 implanted patients for up to 12 months. The data suggest patients with complex regional pain syndrome or peripheral nerve injury respond particularly well, especially in the lower extremities, according to the abstract. (NeuroNews)

Development Agreement is Extended for Non-Invasive Neuromodulation Device

Sept. 13, 2017 - Helius Medical Technologies, Inc. announced its wholly owned subsidiary NeuroHabilitation Corporation extended a development agreement with the U.S. Army Medical Research and Materiel Command through 2018, and extended the deadline for commercialization of the Portable Neuromodulation Stimulator device to Dec. 31, 2021. Helius anticipates FDA clearance of the non-invasive device in 2018. The device is initially being developed to treat chronic balance disorder in patients with mild to moderate traumatic brain injury. (Globe Newswire)

Long-term Data Presented About Neuromodulation for Obstructive Sleep Apnea

Sept. 13, 2017 - Hypoglossal nerve stimulation led to significant improvements in moderate to severe obstructive sleep apnea at one and five years, according to a study presented at the annual meeting of the American Academy of Otolaryngology-Head and Neck Surgery. (Business Wire)

Article Discusses Bioelectronic Medicine Challenges and Potential

Sept. 8, 2017 - An article about early research into bioelectronic medicine says that it may not be necessary to develop smaller electrodes to target individual nerve fibers to treat inflammatory disease. That's because a low current from a cuff electrode around the vagus nerve should preferentially stimulate low-threshold fibers that link to the spleen. In principle, this stimulation would in turn down-regulate release of inflammatory factors. (The Guardian)

Maker of Non-Invasive Vagus Nerve Stimulation System Raises $36 Million, Seeks and Additional $29 Million

Sept. 8, 2017 - Vagus nerve stimulation device company electroCore has raised $36 million in a round of equity and options financing, with the intent to raise $29 million more for a total of $65 million. In July, the company launched an FDA-approved non-invasive vagus nerve stimulation system to address pain of episodic cluster headache in adults. (Mass Device)

Article Details Randomized Controlled Clinical Trial of Kilohertz Frequency Spinal Cord Stimulation

Sept. 5, 2017 - International Neuromodulation Society member Simon Thomson, MBBS, FRCA, FIPP, FFPMRCA, was interviewed about the PROCO (Effects of Pulse Rate On Clinical Outcomes in Kilohertz Frequency Spinal Cord Stimulation) randomized controlled trial, whose results he presented at the INS 13th World Congress. The results showed no clinical difference in pain relief using frequencies from 1–10kHz. In the study, targeting was optimized at 10kHz. During randomization, both amplitude and pulse width were optimized at each of four frequencies tested -- 1kHz, 4kHz, 7kHz and 10kHz. In the interview, Dr. Thomson discussed using a minimal electrical neural dose, adding that automation might facilitate targeting and neural dose optimization. (NeuroNews)

Article Calls Neurostimulation a Technology-Based Alternative to Opioids

Aug. 31, 2017 - An article that asks "are we doing all we can to stop the opioid crisis?" calls spinal cord stimulation "an underutilized pain management alternative for patients struggling with chronic pain." (U.S. News)

Study Examined Frequency-Specific Neuromodulation of Local and Distant Connectivity in Memory

Aug. 28, 2017 - In a pre-print, Duke University researchers say that in 15 healthy volunteers, they gathered evidence of network interactions that are associated with successful memory encoding in older adults. The investigation combined transcranial magnetic stimulation to the dorsolateral prefrontal cortex, fMRI, and diffusion weighted imaging. (BioRxiv)

Company Developing Neurostimulation for Inflammatory Disease Raises $30 Million in a New Funding Round

Aug. 28, 2017 - SetPoint Medical, which is developing bioelectronic medicine for chronic inflammatory disease, raised $30 million in Series D financing from existing investors. An article notes the investors include Medtronic and Boston Scientific Corp. (Mass Device)

Pain-Device Company Approaching Commercial Stage Names New President and CEO

Aug. 28, 2017 - Neuros Medical Inc.'s founder Jon Snyder will become chief business officer as Tom Wilder, who has been an executive of neurovascular companies, becomes president and CEO. The company will open an operational center in the San Francisco Bay Area. The company is completing a pivotal clinical trial of its neurostimulation device in patients with post-amputation pain. (Trains Cleveland Business)

Visual Prosthesis Company Announces Conditional Approval of Clinical Study

Aug. 28, 2017 - Second Sight Medical Products said it received conditional FDA approval to start a human feasibility clinical study of its cortical visual prosthesis system. Up to five patients would be enrolled. (Healio)

Clinicians Report on Noninvasive Vagus Nerve Stimulation to Address Pain of Trigeminal Autonomic Cephalalgia

Aug. 28, 2017 - A research letter describes using noninvasive vagus nerve stimulation in the headache disorders paroxysmal hemicranial and hemicranial continua in which medical treatment with indomethacin is not tolerated. (JAMA Neurology)

Article Forecasts Aspects of Future Bioelectronic Medicine Devices

Aug. 28, 2017 - An article says bioelectronic medicine devices to stimulate peripheral nerves for chronic conditions may appear by the mid-2020s and at first may be the size of a pill or pen. The article said the treatments would modulate organ function, such as hormone production or airway constriction. (Guardian)

Magazine Presents the Science of Neural Circuits and Addiction

September 2017 - A cover story about addiction and neural reward circuitry describes, in part, using transcranial magnetic stimulation to treat the disorder. (National Geographic)

Article: Device Company May Seek Additional Investment as Clinical Trial Nears Completion

Aug. 24, 2017 - Mainstay Medical anticipates seeking expanded funding as the company completes its U.S. clinical trial of its implant for chronic disabling back pain. The clinical trial is reported to be expected to be completed by the end of 2017. (Irish Times)

Neurosurgeons in China Report Deep Brain Stimulation Reduced Symptoms of Tardive Dystonia

Aug. 23, 2017 - International Neuromodulation Society member Bomin Sun, MD and colleagues reported in Parkinsonism and Related Disorders about long-term followup in 10 patients who received deep brain stimulation for refractory tardive dystonia. The patients' movement and disability scores improved 87% and 84% respectively by six months, and continued, after plateauing. Follow-up lasted as long as 8.75 years. (MD Magazine)

State Hospital Brings Deep Brain Stimulation for Adults to a New Area of South Africa

Aug. 22, 2017 - A man with tardive dystonia became the first adult to receive deep brain stimulation at a state hospital in the Western Cape in South Africa. (Bizcommunity)

Case Report: Wireless Peripheral Nerve Stimulator Reduced Pain of Post-Herpetic Neuralgia

Aug. 18, 2017 - International Neuromodulation Society member Bart Billet, MD, and colleagues report in PAIN Practice on a case of a 78-year-old man with postherpetic neuralgia whose pain was relieved by a wireless peripheral nerve stimulator. (Clinical Pain Advisor)

Article Recounts Progress in Spinal Cord Stimulation

Aug. 18, 2017 - International Neuromodulation Society President Timothy Deer, MD, is quoted in an article about spinal cord stimulation (SCS). The article notes drawbacks of longterm opioid treatment, and says that with its technical advancements, SCS is poised to become a mainstay in chronic pain treatment. (Pain Medicine News)

Company Raises $18 Million in Public Offering

Aug. 17, 2017 - EnteroMedics, Inc. raised $18.1 million in a recent public preferred stock offering. (Mass Device)

Study of Deep Brain Stimulation in Post-Stroke Pain Showed Some Modulation of Mood

Aug. 16, 2017 - International Neuromodulation Society member Andre Machado, MD, PhD, presented results of a 10-patient prospective study of deep brain stimulation for post-stroke pain at the 2017 annual meeting of the American Association of Neurological Surgeons. Stimulation that targeted the affective, emotional aspect of pain led to a change in perception and emotion but disability associated with pain remained unchanged. (Pain Medicine News)

Company Raises Funds to Study Low-Energy Transcranial Magnetic Stimulation for Treatment-Resistant Depression

Aug. 11, 2017 - NeoSync, Inc. has closed a $23 million Series D round of funding to finance a trial of its transcranial magnetic stimulation technology in treatment-resistant depression. The company's home-use device delivers low-energy, alternating magnetic field stimulation. (Fierce Biotech)

Device Company Plans Public Offering

Aug. 11, 2017 - EnteroMedics, Inc. has priced a preferred stock offering of $20 million that is expected to close Aug. 16, to support commercialization and product development. (Mass Device)

First Enrollee Shows Continued Progress in Clinical Study of Deep Brain Stimulation in Stroke Recovery

Aug. 10, 2017 - An article describes progress made by the first enrollee in a clinical study of deep brain stimulation to augment stroke recovery. International Neuromodulation Society member Andre Machado, MD, PhD, the investigator, will work with the FDA to change the study protocol so the patient can continue to receive stimulation after four months because she has continued to make progress, without a plateau as had initially been anticipated by the original study design. (Time)

Neurostimulator Receives Conditional MRI Clearance in the U.S.

Aug. 9, 2017 - Stimwave LLC announced its peripheral neurostimulation pain-relief device has received FDA 510(k) clearance for full-body MRI scans under certain conditions. (Business Wire)

Neuromodulation Company Closes $20 Million Round of Venture Financing

Aug. 7, 2017 - Neuros Medical, Inc. announced it raised $20 million to help fund a pivotal trial of its peripheral nerve stimulator for post-amputation pain. The company anticipates enrolling up to 130 individuals at 15 institutions. (Fierce Biotech)

Neuromodulation Research Winner to be Honored at Chinese Neuromodulation Society Meeting

Aug. 4, 2017 - The International Neuromodulation Society Chinese chapter will honor the first winner of the Science & PINS Prize for Neuromodulation on Sept. 2 at the 2017 Annual Meeting of Chinese Neuromodulation Society & The 8th Neuromodulation Congress of China in Jinan, Shandong Province, China. The winner of the $25,000 prize, University of Maryland Assistant Professor Meaghan Creed, PhD, submitted an essay for publication in the journal about her work showing a reversal of addictive symptoms in mice exposed to cocaine through deep brain stimulation (DBS) plus a drug to inhibit dopamine D1 receptors. In the mouse model of cocaine addiction, combining neurostimulation and a receptor antagonist showed an effect similar to the reversal seen in mice treated with optogenetics. Ontogenetic tools initially provided insight into how the plasticity of the brain's reward system is altered by exposure to addictive drugs. DBS alone was ineffective in addressing the symptoms in the mice. She explained in her essay that using a precise circuit-based intervention was key: "One acute, 10-min session of optogenetically inspired DBS . . . reversed cocaine-evoked plasticity and abolished drug-adaptive behavior for more than a week after its application." (AAAS)

FDA Provides Clearance for TENS Device With Novel Waveform

Aug. 2, 2017 - A South African company, Xavant Technology, received FDA clearance to sell a transcutaneous electrical nerve stimulation (TENS) system in the U.S. for pain relief. The company said its device combines a monophonic square wave with a patented hybrid pulsed radio frequency waveform. (Fierce Biotech)

Vagus Nerve Stimulation Systems Receive CE Mark for Expanded MRI Labeling

Aug. 1, 2017 - LivaNova PLC announced its latest vagus nerve stimulation systems, for adjunctive treatment of medication-resistant epilepsy, have received CE Mark for expanded MRI labeling. The systems received similar expanded labeling approval a month ago from the FDA. (Business Wire)

Study: Non-Invasive Brain Stimulation Improved Cognitive Task Scores for Schizophrenic Patients After 24 Hours

Aug. 1, 2017 - A study of 49 people with schizophrenia in the journal Brain explored whether transcranial direct current stimulation might address problems with working memory and executive function that impair daily function for people with the condition. The double-blind, sham-controlled study found significant improvement in working memory 24 hours after stimulation. Twenty-eight subjects also had a functional MRI exam, and the study tracked improvements in an executive function task with changes in activity in the anterior cingulate cortex, task-related brain regions, and more distal nodes. (Psychiatric Times)

Article Presents Neuromodulation Alternatives to Opioids for Managing Chronic Pain

July 31, 2017 - International Neuromodulation Society member Michael Leong, MD, is quoted in a news feature that describes how neurostimulation for chronic pain presents an alternative to reliance on opioid medication. (Technology Review)

Deal Calls for Modified Vagus Nerve Stimulation System for Preclinical Research

July 26, 2017 - EnteroMedics, Inc. entered a collaboration agreement with Galvani Bioelectronics Limited to modify its vagus nerve stimulation implant for use in preclinical research by Galvani. In the agreement, EnteroMedics will receive development payments and retain rights to the new device, licensing it to Galvani. The abdominal implant was FDA approved in 2015 for addressing obesity by limiting feelings of hunger. (Fierce Biotech)

Data Show Increased Adoption of Sacral Neuromodulation for Overactive Bladder

June 27, 2017 - Case logs from the American Board of Urology show that from 2003 to 2012, the number of sacral neuromodulation procedures for overactive bladder increased from 48 to 2068. By contrast, the number of augmentation cystoplasty procedures remained stable, with 14 to 38 cases reported annually. Proportionally, the augmentation procedure dropped from 25% to less than 1% of cases. (Female Pelvic Medicine & Reconstructive Surgery)

Company Launches U.S. Sales and Registry of Non-invasive Vagus Nerve Stimulator for Episodic Cluster Headache

July 18, 2017 - A hand-held vagus nerve stimulation device is being launched in the U.S. for acute treatment of pain from episodic cluster headaches in adults by the device company electroCore, following FDA approval in April. The company is also launching a device registry to gather patient experience and self-reported quality-of-life information. (PR Newswire)

Study Reports Five-Year Follow-up Results of Sacral Neuromodulation in Overactive Bladder

July 17, 2017 - A five -year follow-up study in the Journal of Urology concludes that sacral neuromodulation has sustained efficacy and quality-of-life improvements, and an acceptable safety profile. The prospective multi-center study enrolled 340 patients with overactive bladder. In the study, 68 patients received standard drug therapy, and the remainder received a sacral nerve stimulation implant. (Mass Device)

International Neuromodulation Society Member Studies Peripheral Nerve Field Stimulation for Pain Relief

July 17, 2017 - A retrospective study presented by International Neuromodulation Society member Sylvine Cottin, PhD, showed that peripheral nerve field stimulation improved chronic pain by more than 50% in 30 patients who were followed for 24 months. One-third of the patients also received spinal cord stimulation simultaneously. The patients primarily had failed back surgery syndrome or low back pain. (Pain Medicine News)

Medical Center in India Begins Providing Deep Brain Stimulation for Movement Disorders

July 16, 2017 - A Parkinson's disease patient received a deep brain stimulation implant last week at a medical center in the state of Andhra Pradesh in India. An article says that previously the state did not have a dedicated, multi-disciplinary program to address movement disorders in a comprehensive way. The new treatment program is expected to integrate complementary medicine and yoga. (The Hans India)

Care-Home Residents in the United Kingdom to Participate in a Clinical Trial of Transcutaneous Tibial Nerve Stimulation for Urinary Incontinence

July 14, 2017 - A three-year controlled clinical trial of transcutaneous tibial nerve stimulation will be  carried out in the UK in 500 patients living in care homes who have urinary incontinence. The study is being funded by the National Institute for Health Research. (Chartered Society of Physiotherapy)

Report Summarizes Seizure Reduction in Epilepsy Patients who Received Responsive Neurostimulation Systems

June 2017 - Responsive neurostimulation in epilepsy patients was shown to reduce seizures over two to six years after implantation in 126 patients. (Epilepsia)

Six Research Teams Receive Federal Grants for Brain-Computer Research

July 10, 2017 - The Defense Advanced Research Projects Agency will fund six research teams for four years to develop prototype technology to transmit data between the brain and computers. The work may address blindness, paralysis and speech disorders through such means as light-emitting diodes, sensors linked to systems designed to decode speech, and detecting neural activity with holographic microscopes. Engadget reported that the lead organizations are Brown University, Columbia University, The Seeing and Hearing Foundation, the John B. Pierce Laboratory, Paradromics Inc. and the University of California, Berkeley. (Gizmodo)

Foundation Gives $1 Million for Research into Nerve Stimulation as a Potential Therapy for Diabetes

July 10, 2017 - The Feinstein Institute for Medical Research received a $1 million gift from the Knapp Family Foundation for research into developing a bioelectronic nerve-stimulation system to regulate glucose metabolism in diabetes patients, functioning as a sort of "electronic pancreas" in lieu of having the patients rely on insulin injections. (Innovate Long Island)

Agency Grants $19 Million for Brain-Computer Interface Development

July 10, 2017 - The Defense Advanced Projects Research Agency (DARPA) has eight organizations, led by Brown University, up to $19 million over four years to develop a fully implantable wireless brain interface system to record and stimulate neural activity. The award came through DARPA's new Neural System Engineering Design program. (EurekAlert)

International Neuromodulation Society Members Reflect on the Past and Future of Spinal Cord Stimulation

July 5, 2017 - NeuroNews published a feature about the 50th anniversary of spinal cord stimulation therapy. The article includes perspectives from International Neuromodulation Society members Giancarlo Baronet, MD; Christophe Perruchoud, MD; and Simon Thomson, MD. (NeuroNews)

Sacral Neuromodulation Device Company Raises $20.5 Million

July 6, 2017 - Axonics Modulation Technologies, Inc. announced it raised an additional $20.5 million in a second closing of its Series C financing, bringing the total raised in this series to $35 million. The proceeds will be used to fund a pivotal study in the U.S. of its rechargeable sacral neuromodulation system in overactive bladder. (Business Wire)

Neuromodulation Device Outsourcing Company to Receive an Investment of About $136 Million

July 5, 2017 - The investment firm 3i Group plc announced it will provide about $136 million to Cirtec Medical, a provider of outsourced design, development, and manufacture of neuromodulation devices and other medical devices. (PE Hub)

Neurostimulator Company Announces First Implants of Its Wireless Devices for Chronic Pain in Brazil

July 5, 2017 - Stimwave LLC announced plans for the first chronic pain patients in Brazil to receive implants of the company's wireless neurostimulators. (Business Wire)

Bioelectronics Company That is Targeting Migraine Treatment Raises $6 Million

July 4, 2017 - Israel-based medical device company Theranica Bio-electronics raised $6 million in Series A financing, which it will use on the regulatory process for its first product, an acute treatment for migraine. The company said its device is in a pivotal study in eight hospitals and clinics in the U.S. and Israel. The company was founded in 2016 to develop wireless neuromodulation approaches. (Globes)

More States Will Provide Medicaid Reimbursement for Retinal Prosthesis

July 3, 2017 - Second Sight Medical said its retinal prosthesis has received expanded reimbursement coverage from the Centers for Medicare and Medicaid Services in 11 states (beyond the previous 17) and the District of Columbia. (Mass Device)

FDA Approves Implanted Vagus Nerve Stimulation System for Epilepsy Patients as Young as 4 Years Old

June 30, 2017 - LivaNova announced its implanted vagus nerve stimulation system received FDA approval for adjunctive treatment in patients aged 4 and older who have medically refractory partial-onset seizures. Previously, the device was approved for patients aged 12 and older. Earlier in June, the company announced its device had received expanded MRI labeling from the FDA. (Medscape)

Three Patients Receive an Investigational Closed-Loop Deep Brain Stimulation System for Essential Tremor

June 30, 2017 - Under an investigational device exemption, researchers have implanted a closed-loop deep brain stimulation system in three patients with essential tremor, and say the system provides a 50% savings in battery life. (R&D Magazine)

Article Recaps Brain-Computer Interface Progress

June 19, 2017 - A feature article summarizes the state of brain-computer interface research projects, noting that while devices are far from everyday use, they are beginning to help people who are paralyzed, and include attempts to include sensory input. (Paste Magazine)

Neuromodulation Research Database Registrants Surge After INS Congress

June 2017 - The collective database of primary neuromodulation research data, WIKISTIM, reported the largest monthly increase in registrants -- a one-month increase of more than 7% -- since the online resource was created in 2013. Its editor, International Neuromodulation Society member Jane Shipley, attributes that growth to her presentations made at the INS 13th World Congress. In the monthly newsletter, she acknowledged INS Director-at-Large Konstantin Slavin for mentioning the resource during his presentations as well. With an additional 37 registrants since May, the registered users now number 510. (WIKISTIM)

Deep Brain Stimulation Clinical Trial Addresses Affective Component of Neuropathic Pain

June 14, 2017 - International Neuromodulation Society member Andre Machado, MD, PhD, was mentioned in an article about the first prospective, randomized, controlled trial of DBS for neuropathic pain. The work was published in May 2017 in the Annals of Neurology. Co-authors included fellow INS members Scott Lempke, PhD and Kenneth Baker, PhD. In the nine patients in the cross-over trial, active stimulation did not produce at least a 50% improvement in pain disability compared to sham, but the stimulation to the ventral striatum did improve indices of the affective component of pain, such as depression, anxiety and quality of life. (Cleveland Clinic)

Spinal Cord Stimulation Improved Gait in Patients with Advanced Parkinson's Disease

June 6, 2017 - A pilot study of spinal cord stimulation in advanced Parkinson's disease, reported at the International Congress of Parkinson's Disease and Movement Disorders (MDS) 2017, showed the intervention improved freezing of gait in five patients whose gait dysfunction did not respond to levodopa. Up to 25 patients may eventually be included in the study. (Medscape)

Vagus Nerve Stimulation in Stroke Rehabilitation: Pilot Data Presented, Pivotal Clinical Trial Announced

May 31, 2017 - At the International Neuromodulation Society 13th World Congress, results of a randomized controlled pilot study were presented regarding 20 patients undergoing physical rehabilitation for stroke. Nine of the 20 patients received six weeks of vagus nerve stimulation in conjunction with intensive physical rehabilitation. The combination led to improvement in 75% of patients, compared to improvement in 33% of the 11 patients who only received physical rehabilitation. The response to the combined intervention increased to 88% at 90 days, and scores continued to increase through 9 months. At the same meeting, MicroTransponder, Inc. announced a 120-patient pivotal clinical trial of this intervention will begin enrollment this summer in the U.S. and U.K. (military-technologies.net)

Startup Plans Clinical Trial of Contact Lenses for Glaucoma

May 31, 2017 - Bionode, a Purdue University affiliated startup, plans to start a clinical trial of a contact lens designed to decrease pressure within the eye to treat glaucoma. The device includes a gold loop that receives an electromagnetic field from a special pair of glasses, which is converted into a current and delivered to a part of the eye that helps drain fluid build-up. (Journal & Courier)

Company Announces Positive Interim Results of Rechargeable Neurostimulator for Overactive Bladder

May 30, 2017 - Axonics Modulation Technologies, Inc. announced interim results of a prospective multi-center clinical study of its rechargeable sacral neuromodulation system for the treatment of overactive bladder. Of 33 patients who reached the three-month mark, 71% experienced at least a 50% decrease in symptoms, according to the results presented at the International Neuromodulation Society 13th World Congress. (Business Wire)

Company Announces $40 Million Pre-Commercial Investment

May 29, 2017 - Saluda Medical Pty Limited announced it received $40 million in a series D round of financing led by new investor Action Potential Venture Capital, a GSK fund, with previous investors participating. The funding should support clinical development of an intelligent, closed-loop spinal cord stimulation system that is undergoing a prospective, randomized, controlled, double-blinded clinical study by pain specialists at up to 20 U.S. sites. The funding will also allow the company to commercialize the therapy in Europe and Australia. (PR Newswire)

INS Announces Six Best Abstracts at the 13th World Congress

May 29, 2017 - The International Neuromodulation Society announced six best abstract awards at its 13th World Congress in Edinburgh, Scotland. The abstracts about pain and movement disorder were presented in a plenary session during the opening day of the congress. (EurekAlert)

Company Announces CE Marking for Peripheral Nerve Stimulation Anchoring System

May 26, 2017 - Freedom Neuro BV, a medical device distributor for Stimwave Technologies, announced CE mark approval for a percutaneous injectable anchor system used with Stimwave's neurostimulation devices designed to address chronic pain. (Business Wire)

Company Announces Financing for Clinical Validation of Its Stretchable Neuromodulation Lead

May 25, 2017 - WISE Srl announced EUR 6.5 million in series B financing to clinically validate its flexible, stretchable implantable neuromodulation leads for brain monitoring and spinal cord stimulation. Based on Italy with an office in Berlin, the company opened a production plant in Milan in 2016, where the leads' electrode functionality is impregnated into a polymer substrate using supersonic cluster beam implantation. (Gruenderfonds)

Small Study Suggests Transcranial Direct Current Stimulation Can Help Relieve Chronic Knee Pain

May 22, 2017 - A double-blind, randomized clinical study of 40 adults aged 50 -70 with osteoarthritis indicated that five daily sessions of transcranial direct Current stimulation lessened their pain severity. (tDCS) (Medscape)

Article Highlights Acceleration of Neuromodulation Progress

May 18, 2017 - An interview with International Neuromodulation Society President Timothy Deer, MD, prior to the INS 13th World Congress, touches upon the accelerating progress made in the field of neuromodulation. (Medtech Insight)

Company Receives $6 Million to Develop Peripheral Nerve Stimulation for Pain Relief

May 15, 2017 - SPR Therapeutics has received a second contract from the U.S. Department of Defense to use its peripheral nerve stimulation system for relief of chronic pain. Including an previous grant, the company has received nearly $9 million for research and commercialization of the therapy. (P&T Community)

Interview Surveys the Future of Neuromodulation

May 2017 - International Neuromodulation Society President Timothy Deer, MD, is interviewed about the future of neuromodulation in a publication's "Spotlight on neuromodulation". He describes devices becoming smarter so they can evaluate the response of the body and make changes in real time, as well as work in the brain to find new targets to treat diseases and conditions that are not optimally treated by pharmaceutical options. (Neuro Central)

Company Announces Its Neurostimulator's First Use in Ireland

May 9, 2017 - Mainstay Medical International plc announces its first sale and implant of its neurostimulation system to treat disabling chronic low back pain in Ireland. (Business Wire)

Long-Term Evidence Published Regarding Closed-Loop Neurostimulation in Epilepsy

May 3, 2017 - An article summarizes two recently published studies that offer long-term perspective on responsive, closed-loop, neurostimulation for the reduction of epileptic seizures. (Practical Neurology)

Sacral Neuromodulation Device Maker Raises $14.5 Million

May 2, 2017 - Axonics Modulation Technologies has raised $14.5 million toward its goal of $30 million for a series C round of financing for a pivotal study of its rechargeable sacral nerve stimulation system in overactive bladder. The clinical trial is anticipated to start in the second half of 2017 at medical centers in the U.S. and Europe. (Fierce Biotech)

Company Plans Clinical Study of Neurostimulator for Weight Loss

May 2, 2017 - According to an SEC filing, EnteroMedics Inc. will fund a clinical study of its vagus nerve stimulation implant by the Southern California Permanente Medical Group, to investigate the device as an aid for weight loss in patients who have Type 2 diabetes and obesity. (Mass Device)

International Neuromodulation Society Innovations Day Will Present 12 Emerging Companies and Organizations

April 27, 2017 - Twelve emerging companies and organizations will present their innovative therapeutic strategies at the International Neuromodulation Society's Innovations Day preconference on May 28, 2017 in Edinburgh. They are endeavoring to address such conditions as paralysis, autism, and challenging persistent pain. (International Neuromodulation Society)

Grant Supports Research into Combining Transcranial Magnetic Stimulation with Monitoring of Brain-Network Activation

April 26, 2017 - Aalto University and the University of Eastern Finland  have received a grant of €1M from the Jane and Aatos Erkko Foundation to produce a new kind of multi-channel transcranial magnetic stimulator that is compatible with fMRI and EEG methods to measure stimulation-induced neural network activation. The intent is to develop approaches to conditions such as Parkinson's disease, chronic pain, and potentially also stroke or depression. (Science Business)

U.S. Agency Announces Research Grants for Brain-Plasticity Studies

April 26, 2017 - The U.S. Department of Defense's Advanced Research Program Agency, DARPA, is funding eight projects at seven U.S. universities to study ways to potentially use peripheral nerve stimulation to facilitate brain plasticity and learning, through the Targeted Neuroplasticity Training (TNT) program. (DARPA)

Study: Transcutaneous Occipital Nerve Stimulation Lowered Migraine Intensity

April 17, 2017 - A randomized controlled clinical trial of transcutaneous occipital nerve stimulation in 110 patients with migraine found that one month of neurostimulation plus treatment with topiramate resulted in reduced headache intensity, regardless of frequency -- which was either 2 Hz, 100 Hz, or 2/100 Hz. The group that received 100 Hz stimulation plus topiramate had significant decreases in headache duration. (Pain)

FDA Approves Neurostimulator to Treat Dry Eye

April 25, 2017 - The FDA granted marketing authorization to Allergen plc for its stimulator to temporarily increase tear production in adults with dry eye. The handheld device is designed for intranasal use with disposable tips. (PR Newswire)

Non-invasive Brain Stimulation Aided Some Memory Training in Study

April 24, 2017 Researchers investigating the effects of transcranial direct current stimulation (tDCS) report that tDCS to the right dorsolateral prefrontal cortex in 12 subjects significantly improved performance on a verbal memory-training task and a related task, as well as a reasoning test. The overall research explored combinations of working memory training in groups of 70 volunteers total, with some tDCS administered to the left dorsolateral prefrontal cortex, and some to the right. Results appeared in the journal Neuropsychologia. (Science Daily)

Case Series Indicates Sacral Nerve Stimulation Shows Promise for Refractory Constipation in Pediatric Patients

April 24, 2017 - The author of an abstract presented at the 2016 World Congress of Pediatric Gastroenterology, Hepatology and Nutrition concluded that sacral nerve stimulation is promising for children who have constipation that is refractory to conventional treatment. The study involved 25 patients with a mean age of 14. Despite a 25% complication rate, all patients said they would recommend the therapy to patients with similar symptoms. (Gastroenterology & Endoscopy News)

Review Summarizes Studies of Non-invasive Brain Stimulation in Spasticity Management

April 19, 2017 - Authors of a literature review about repetitive transcranial magnetic stimulation or transcranial direct current stimulation for spasticity management say most studies have been heterogenous. However, they write that published findings indicate "low-frequency rTMS and cathodal-tDCS over the unaffected hemisphere are more effective in reducing spasticity than high-frequency rTMS and anodal-tDCS over the affected hemisphere in chronic post-stroke." (PM & R)

Company Receives a Five-Year Contract to Supply its Wireless Neurostimulation System to the U.S. Department of the Defense

April 21, 2017 - Stimwave Technologies announced it received a five-year contract from the Department of Defense to supply its spinal cord stimulation system. (Mass Device)

Facing Unusual Spinal Anatomy, Physicians Use Three-Dimensional Printing to Plan a Spinal Cord Stimulation Case

April 20, 2017 - A case report in Neuromodulation: Technology at the Neural Interface describes using 3D printing to plan spinal cord stimulation for a patient whose distorted spinal anatomy had previously made access to the target location difficult. (News-Medical.net)

Researchers Predict Electrical Stimulation Aids Memory Most When Recall Wanes

April 20, 2017 - Researchers published results of a study in which they analyzed brain activity during memory tests and then developed and tested a predictive algorithm that indicates memory recall is enhanced when a stimulus is applied at a time it is faltering. The study in Current Biology was funded by the U.S. Department of Defense, through the DARPA Restoring Active Memory (RAM) program. The data were obtained during intracranial monitoring of 102 people who were undergoing epilepsy evaluation. (IEEE Spectrum)

INS Member Discusses Data Showing Patient Satisfaction Over 7.5 Years With Spinal Cord Stimulation

April 18, 2017 - International Neuromodulation Society member Simon Thomson, MD, was interviewed about a single-center case series of 321 patients in Neuromodulation: Technology at the Neural Interface that suggests the cost-effectiveness of spinal cord stimulation may become increasingly favorable. The interview also covered a comparatively low infection rate, accomplished through meeting the recent infection-control guidelines published by the Neuromodulation Appropriateness Consensus Committee. (NeuroNews)

Portable, Hand-Held Device Receives FDA Approval to Treat Cluster Headache

April 18, 2017 - The FDA has approved a non-invasive vagus nerve stimulation device to treat episodic cluster headaches. The manufacturer, electroCore LLC, said the condition affects about 350,000 people in the U.S. (NBC)

Clinical Trial Participant with ALS Uses Her Thoughts to Type Via a Brain-Computer Interface

March 29, 2017 - International Neuromodulation Society member Jamie Henderson, MD, of Stanford University was interviewed about an ALS patient who is using the BrainGate2 interface to mentally control a cursor and type out her thoughts despite her immobility due to her condition. His university is among the collaborating institutions that work on BrainGate research. (ABC7news.com)

Company Will Present Results of Clinical Trial of Rechargeable Sacral Neuromodulation in Overactive Bladder

April 18, 2017 - Axonics Modulation Technologies, Inc. will present initial results of its  prospective, multicenter clinical study of its rechargeable sacral neuromodulation system in 51 patients with overactive bladder at the International Neuromodulation Society 13th World Congress on May 30, 2017. (Yahoo Finance)

Analysis Tracks Infection Rates in Spinal Cord Stimulation Implants

April 14, 2017 - In an analysis of two U.S. payor databases, International Neuromodulation Society member David Provenzano, MD, found infection rates for spinal cord stimulation of 3.11% within one year of implant, which is approximately 1% higher than the rate for cardiac pacemaker implants. He called for identifying and evaluating common risk factors in a prospective manner. (Pain Medicine News)

Company Announces Brazilian Approval for Its Non-Invasive Brain Stimulation Products

April 13, 2017 - Soterix Medical said it has received regulatory approval in Brazil for its transcranial direct current stimulation products intended to address pain or depression. (P&T Community)

Company Announces FDA Approval for its Transcranial Magnetic Stimulation Device

April 12, 2017 - NeuroStar announced it has received FDA clearance for its most recent transcranial magnetic stimulation device, which provides treatment in 19 minutes, for use in major depressive disorder. (Mass Device)

Article Reports Tractography Aided Targeting in Deep Brain Stimulation for Depression

April 12, 2017 - Researchers prospectively planned surgical targeting of deep brain stimulation to the subcallosal cingulate in 11 patients with treatment-resistant depression, using diffusion tractography and 3-D modeling to guide individualized targeting. In Molecular Psychiatry, https://www.ncbi.nlm.nih.gov/pubmed/28397839 they report that after 12 months, nine of the patients were responders, with six in remission. (Medical Xpress)

FDA Nominee at Hearing: Devices May Aid Fight Against Opioid Crisis

April 6, 2017 - The nominee for FDA commissioner said at his confirmation hearing that a partial solution for the opioid abuse epidemic may be found in alternatives that include devices for pain control and drug-delivery devices. (Medtech Insight)

Experiments Explore Impact of Non-Invasive Brain Stimulation on Honesty

April 10, 2017 - Researchers found non-invasive brain stimulation increased honesty in experiments involving 300 university students. They report that transcranial direct current stimulation over the right dorsolateral prefrontal cortex made study subjects less likely to cheat for financial incentive on a die-rolling experiment, compared to controls. The study appeared in the Proceedings of the National Academy of Sciences.

Article Explores Genesis and Possibilities for Brain-Computer Interfaces

April 9, 2017 - Engineers at the University of Washington produced an overview about the state of brain-computer interfaces, and their inherent limitations and possibilities. They claim the brain may adjust to an interface just as people learn to drive a car or use a touchscreen. (The Conversation)

Researchers Publish Findings on Deep Brain Stimulation in Tourette Syndrome

April 7, 2017 - International Neuromodulation Society member Alon Mogilner, MD, PhD was quoted in an article about a study he published with colleagues in the Journal of Neurosurgery. In it, they report on 13 patients with refractory Tourette Syndrome who received deep brain stimulation over the past seven years, with at least six months of follow-up. On average, the patients achieved a 50% reduction in tic severity. The average position of the active contact was the the junction of the posterior ventralis oralis internus and the centromedian-parafascicular nuclei. (Washington Post)

Company Launches Neurostimulator in Australia

April 7, 2017 - Stimwave LLC has received regulatory approval from the Australian Therapeutic Goods Administration for its wireless spinal cord stimulation system. The company launched the product at the 12th annual meeting of the Neuromodulation Society of Australia and New Zealand. (Business Wire)

Article Announces the International Neuromodulation Society 13th World Congress

March 30, 2017 - An article that announces the International Neuromodulation Society's 13th World Congress, in Edinburgh May 27 - June 1, 2017, quotes International Neuromodulation Society President Timothy Deer, MD, about recent growth in the field and developments to be presented. (News-medical.net)

Review Examines Studies of Non-invasive Brain Stimulation in Post-Stroke Therapy for Dysphagia

March 28, 2017 - Two researchers review studies about post-stroke rehabilitation for swallowing difficulty and conclude that clinical trials of motor recovery that includes use of non-invasive brain stimulation -- such as transcranial magnetic stimulation or transcranial direct current stimulation -- offer early signs of promise for treatment of dysphagia. (Dysphagia)

Entrepreneur Finances a Brain-Computer Interface Startup

March 28, 2017 - Technology entrepreneur Elon Musk has started a California firm called Neuralink to develop a brain-computer interface. He confirmed reports of the company he is funding and indicated more information will come out in a week. (Newsweek)

Neural Prosthesis Allows Paralyzed Man to Eat Using Robotic Arm

March 28, 2017 - A man paralyzed for eight years has demonstrated an ability to feed himself mashed potatoes by using his thoughts to move his arm, attached to a brain-computer interface, as part of the BrainGate research project. (Reuters)

Article Describes Development of a Custom Neural Prosthesis

March 27, 2017 - An article highlights the journey taken by one man who has received a custom neural prosthetic that allows him some use of his hand, bypassing the spinal cord injury that left him paralyzed seven years ago. (Daily Mail)

Company Reports Insurance Coverage for Peripheral Nerve Stimulation System

March 27, 2017 - Bioness, Inc. reported that its peripheral nerve stimulator received insurance coverage from Aetna, Inc. to treat chronic pain of peripheral nerve origin. (Yahoo Finance)

Device Company That is Focused on Chronic Low Back Pain Releases 2016 Annual Report

March 23, 2017 - Mainstay Medical International plc announced publication of its 2016 annual report. The company received CE mark approval for its neurostimulator for chronic low back pain in 2016 and initiated commercial sales in Germany earlier in 2017. In preparation for filing for pre-market approval in the U.S., the company has selected 27 clinical trial sites, where 18 are already enrolling patients. Enrollment completion is anticipated by the end of 2017 with data expected to be available in 2018. (Business Wire)

Study Suggests Spinal Cord Stimulation Curbs Opioid Use

March 22, 2017 - A study presented at the 2017 annual meeting of the North American Neuromodulation Society analyzed data for more than 5,400 patients between January 2010 and December 2014, finding that 70% of patients who received spinal cord stimulation reported declined or stabilized opioid use. (Pain Medicine News)

Physicians Report Two Cases of Peripheral Nerve Stimulation for Lower Back Pain

March 20, 2017 - International Neuromodulation Society members Leonardo Kapural, MD, PhD, John Chae, MD, Richard Rauck, MD, Michael Saulino, MD, Joseph Boggs, PhD and colleagues report in Pain Practice on two patients who received one month of peripheral nerve stimulation for chronic low back pain. They say the use of pain relievers dropped and the patient who had been taking opioids stopped, and the pain relief continued at least four months after therapy began. (Medical Xpress)

Journal Publishes a Long-Term Followup of Eight Patients with Depression who Received Deep Brain Stimulation

March 20, 2017 - Researchers in Germany report that seven of eight patients who received deep brain stimulation to the medial forebrain bundle for severe depression showed lasting improvements up to four years into treatment. The report appeared in the journal Brain Stimulation. (News-Medical.net)

Venture Capital Firm Invests in Early Stage Neuromodulation Company

March 20, 2017 - SetPoint Medical announced it has received an investment from the venture capital firm New Enterprise Associates (NEA), and NEA general partner Dr. Josh Makower has joined its board of directors. (Mass Device)

Updated Intrathecal Drug Delivery Guidelines are Featured

March 16, 2017 - International Neuromodulation Society member Peter Staats, MD, was interviewed for an article about the updated guidelines published in Neuromodulation: Technology at the Neural Interface by the Polyanalgesic Consensus Conference. The update ranks evidence and lists 32 consensus points. INS member Todd Sitzman, MD was quoted in the article as noting that the guidelines recommend lower medication concentrations and potentially safer daily dosages of many medications. Dr. Staats said he anticipates a resurgence of interest in intrathecal therapy for patients whose conditions are otherwise hard to manage. (Pain Medicine News)

Noninvasive Brain Stimulation Studied in Australia for Mild to Moderate Alzheimer's Disease

March 15, 2017 - An article profiles a patient with early stage Alzheimer's disease who participated in a small placebo-controlled clinical trial of repetitive transcranial magnetic stimulation for cognition, attention, memory and concentration. The treatment consisted of six weeks of treatments with theta-burst stimulation, which can target four sections of the brain in 12 minutes. She said her symptoms have not worsened and in some cases her memory has been helped. (Sydney Morning Herald)

Patient's Tourette Syndrome Symptoms Improve After Deep Brain Stimulation

March 14, 2017 - International Neuromodulation Society member Joohi Jimenez-Shahed, MD, an assistant professor of neurology at Baylor College of Medicine, was interviewed for a television segment about a patient with Tourette Syndrome whose symptoms improved after Dr. Jimenez-Shahed implanted a deep brain stimulation system. The patient is a high school girl's club lacrosse team coach who said she had been drained by trying to control her symptoms and thinking of taking a medical leave before the successful procedure 10 months ago. (Click2Houston)

Authors Report Six Months' Follow-Up of Pain Control Using Tibial Nerve Microstimulator

March 15, 2017 - International Neuromodulation Society members Pawel Sokal, PhD; Marek Harat, MD, PhD, and colleagues published a case series of six patients with peripheral neuropathic pain and complex regional pain syndrome who were treated with a wirelessly controlled microstimulator to provide tibial nerve stimulation. The authors report that pain relief was immediate and sustained for six months. They write that intermittent tibial nerve stimulation with such a device is safe and effective as well as minimally invasive. (Dove Press)

Publication Profiles Alzheimer's Patient Who Is Participating in a Deep Brain Stimulation Study

March 15, 2017 - A woman who received deep brain stimulation (DBS) a year ago in a small clinical trial of DBS for mild to moderate Alzheimer's disease is profiled in an ongoing series. (Vancouver Courier)

Updated Intrathecal Drug Delivery Guidelines are Featured

March 16, 2017 - International Neuromodulation Society member Peter Staats, MD, was interviewed for an article about the updated guidelines published in Neuromodulation: Technology at the Neural Interface by the Polyanalgesic Consensus Conference. The update ranks evidence and lists 32 consensus points. INS member Todd Sitzman, MD was quoted in the article as noting that the guidelines recommend lower medication concentrations and potentially safer daily dosages of many medications. Dr. Staats said he anticipates a resurgence of interest in intrathecal therapy for patients whose conditions are otherwise hard to manage. (Pain Medicine News)

Noninvasive Brain Stimulation Studied in Australia for Mild to Moderate Alzheimer's Disease

March 15, 2017 - An article profiles a patient with early stage Alzheimer's disease who participated in a small placebo-controlled clinical trial of repetitive transcranial magnetic stimulation for cognition, attention, memory and concentration. The treatment consisted of six weeks of treatments with theta-burst stimulation, which can target four sections of the brain in 12 minutes. She said her symptoms have not worsened and in some cases her memory has been helped. (Sydney Morning Herald)

Patient's Tourette Syndrome Symptoms Improve After Deep Brain Stimulation

March 14, 2017 - International Neuromodulation Society member Joohi Jimenez-Shahed, MD, an assistant professor of neurology at Baylor College of Medicine, was interviewed for a television segment about a patient with Tourette Syndrome whose symptoms improved after Dr. Jimenez-Shahed implanted a deep brain stimulation system. The patient is a high school girl's club lacrosse team coach who said she had been drained by trying to control her symptoms and thinking of taking a medical leave before the successful procedure 10 months ago. (Click2Houston)

Brain Stimulation to Improve Synchronization Aids Working Memory, Investigated as a Potential Therapy Tool

March 14, 2017 - In two experiments, with 10 or 20 healthy volunteers each, a research team determined that applying transcranial alternating current stimulation to induce frontoparietal synchronization enhanced performance on working memory tests, as tracked in brain-activity imaging via functional magnetic resonance stimulation. The researchers say they would like to later apply these methods to patients who have brain injury or epilepsy. The work was published in the journal eLife. (Medical Xpress)

Scientist Exploring Brain Stimulation for Stroke Rehabilitation Receives a Research Award

March 14, 2017 - A researcher studying transcranial brain stimulation as a potential treatment for stroke-induced aphasia has received an early career recognition from the American Academy of Neurology. (News-Medical.net)

Show Features Investigational Uses of Deep Brain Stimulation

March 13, 2017 - An online radio program about novel uses of deep brain stimulation (DBS) includes a research study by International Neuromodulation Society (INS) member Andre Machaco, MD, PhD, of DBS in stroke recovery, as well as research by INS member Jennifer Sweet, MD, into DBS for chronic pain or memory. (WKSU)

Television Show Profiles Sisters Who Received Deep Brain Stimulation for Obsessive Compulsive Disorder

March 12, 2017 - Twin sisters who received deep brain stimulation for obsessive compulsive disorder are featured on a segment of The Doctors. The young women's neurosurgeon, International Neuromodulation Society member David Vansickle, MD, explains the procedure in the program. (Yahoo News)

Patient From Noninvasive Brain Stimulation Study Describes Her Anorexia Symptoms

March 10, 2017 - An article profiles an anorexia patient who says she temporarily responded to a single dose of noninvasive electrical brain stimulation in a pilot trial for a graduate student's doctoral thesis in London. The stimulation targeted the dorsolateral prefrontal cortex, which is associated with impulsivity or self-control. (BBC News)

Group Calls For Comment on Proposed Workers' Compensation Revision

March 10, 2017 - The North American Neuromodulation Society, NANS, issued a news release asking for physician and patient comment on proposed revised rules by the California Division of Workers' Compensation that do not address coverage for neuromodulation for chronic pain. International Neuromodulation Society members Lawrence Poree, MD, PhD, and Nathan Miller, MD, have submitted published comments. (Business Wire)

Retinal Prosthesis Maker Raises About $20 Million

March 9, 2017 - Second Sight Medical closed a rights offering that raised approximately $20 million to support continued development and improvement of its retinal prosthesis. (Mass Device)

Bioelectronics Research Institute Enters Partnership to Address Cardiovascular Issues

March 9, 2017 - The Feinstein Institute for Medical Research entered a partnership with United Therapeutics Corp. to apply bioelectronics and cell-therapy technologies to cardiology and hypertension cases. (Innovate)

Neurostimulator Company Receives Expanded CE Mark for Disabling Migraine

March 9, 2017 - Autonomic Technologies, Inc. announced it received an expanded CE mark indication for its sphenopalatine ganglion stimulator for patients with highly disabling migraine. (PR Newswire)

Case Series: Patients Would Have Wanted Spinal Cord Stimulation as an Earlier Option

Feb. 27, 2017 - International Neuromodulation Society members Simon Thomson, MBBS; Dmitry Kruglov, MD, PhD; and Rui Duarte, PhD report data about 321 patients who had spinal cord stimulation trials at a single center from January 2008 until July 2015. Among their findings, they project a mean gain of 6.2 quality of life years. They add that 96.4% of the patients would have wanted SCS as an earlier treatment option. (Neuromodulation: Technology at the Neural Interface)

Deep Brain Stimulation Lowers Woman's Hypertension

Feb. 27, 2017 - International Neuromodulation Society member Nik Patel, MD has published a case in the journal Hypertension of a woman who is said to the the first to receive deep brain stimulation (DBS) to treat her high blood pressure. He had previously published a report of high blood pressure resolving in a patient who received DBS for neuropathic pain. (University of Bristol)

Pilot Study Investigates Vagus Nerve Stimulation in Stroke Recovery

Feb. 27, 2017 - At the International Stroke Conference, International Neuromodulation Society member Jesse Dawson, MD, presented results of a sham-controlled pilot trial of vagus nerve stimulation during rehabilitation for upper limb mobility following stroke. Treatment consisted of six weeks of stimulation. He said that 90 days after treatment ended, scores in the treatment group diverged from those of the sham group, and indicated significant improvement. (MedPage Today)

Survey Authors Conclude that Drug Delivery System Refilling Training Should be Standardized

Feb. 24, 2017 - International Neuromodulation Society member Gail McGlothen, DNP, RN has co-authored a U.S. survey of 65 healthcare professionals who refill intraspinal drug delivery systems. The article, in available online in Early View, concludes the high variability in methods calls for the need for standardized training to minimize risk of human error. (Neuromodulation: Technology at the Neural Interface)

Study Investigates Deep Brain Stimulation for Anorexia Nervosa

Feb. 24, 2017 - A study of 16 patients with anorexia nervosa who had deep brain stimulation to their subcallosal cingulate showed the intervention was safe and might help improve their symptoms, according to data published in The Lancet Psychiatry. (Medical Xpress)

Chronic Pain Patients Simulation Preferences Varied in Neurostimulation Clinical Trial

Feb. 23, 2017 - International Neuromodulation Society member Frank Huygen, MD, PhD and colleagues report in the European Journal of Pain that a multi-center, cross-over trial of five different types of stimulation in 29 patients with complex regional pain syndrome showed 48% preferred the standard frequency of stimulation and 54% preferred a non-standard one. (Neuro News)

Company Announces U.S. Patents for Its Sacral Neuromodulation System

Feb. 23, 2017 - Axionics Modulation Technologies, Inc. announced issuance of four U.S. patents related to the company's implantable sacral nerve stimulation technology. (Yahoo Finance)

Company Announces First European Implants of Its Neurostimulator for Peripheral Neuralgias

Feb. 22, 2017 - Bioness, Inc. announced a series of the first implantations of its percutaneous peripheral nerve stimulation system at medical centers in the Netherlands, Ireland, and Belgium. (Yahoo Finance)

Cognitive Training Improved Slightly with Transcranial Direct Current Stimulation in Home Study of Multiple Sclerosis Patients

Feb. 22, 2017 - A feasibility study of multiple sclerosis patients showed modest improvements from receiving transcranial direct current stimulation during 10 sessions of computer-based cognitive-training at home, while they were remotely monitored through video-conferencing. Compared to 20 patients who only received cognitive training, 25 patients who received simultaneous stimulation improved modestly in performance scores for complex attention tasks and reaction times. The results were published in Neuromodulation: Technology at the Neural Interface. (Mass Device)

Bioelectric Medicine Center Receives $25 Million Donation

Feb. 21, 2017 - The Feinstein Institute for Medical Research, which pursues research in bioelectric medicine, received A $25 million donation from philanthropists Leonard and Susan Feinstein, whose donation follows a $25 million donation in 2005 that led to the institute's renaming in their honor. (Innovate LI)

Review Examines Studies of Non-Invasive Stimulation in Stroke

Feb. 21, 2017 - A review about the safety of transcranial direct current stimulation (tDCS) in stroke rehabilitation says studies should describe exclusion criteria and induced adverse effects, in order to facilitate examination of factors that may induce side effects. Less than 12% of papers published between 1998 and 2015 reported adverse effects of tDCS in stroke patients. (Neuromodulation: Technology at the Neural Interface)

Column Highlights Research and Industry Developments Presented at Neuromodulation Meeting

February 2017 - A business column summarizes highlights from the 2017 annual meeting of the North American Neuromodulation Society, held in January. (Neurotech Reports)

Company Developing a Non-invasive Neurostimulator Raises Nearly $10 million

Feb. 16, 2017 - Helius Medical Technologies raised nearly $10 million in a public offering. The company plans to complete a clinical trial of its portable neurostimulator in treating mild to moderate traumatic brain injury. In addition, the company plans new clinical trials in multiple sclerosis and cognition, and to submit an FDA application. (Mass Device)

Startup Would Use Ultrasound to Non-Invasively Stimulate Vagus Nerve

Feb. 11, 2017 - A doctor and an engineer have begun investigating non-invasive stimulation of the vagus nerve through their startup company, Acuta Technologies. An article describes their interest in applying the technology to potentially address diabetes, or control appetite or inflammation. (Minneapolis Star Tribune)

Researchers Build Computer Model of Motor Circuits to Optimize Deep Brain Stimulation

Feb. 10, 2017 - In a research project at University College Dublin, a team is modeling the brain-to-muscle pathway as a way to develop smarter, closed-loop deep brain stimulation devices for Parkinson's disease. The article says there are some 2 million possible stimulation parameters, and the research is intended to help select optimal ones. (Silicon Republic)

Clinical Trial Will Examine Effect of Transcranial Magnetic Stimulation on Fear and Anxiety

Jan 24, 2017 - The National Institute of Mental Health is recruiting up to 126 healthy volunteers for a clinical trial to explore whether transcranial magnetic stimulation to the dorsolateral prefrontal cortex can reduce fear and anxiety. (Clinicaltrials.gov)

Marketing Clearance Received for Device to Improve Gait

Feb. 8, 2017 - A Bioness system that provides stimulation to assist with gait received FDA clearance. The system includes feedback and a learning algorithm to correct gait as a patient moves. (FDA News)

Brain-Computer Interface Research Attempts to Help Patients with Locked-In Syndrome Communicate

Feb. 7, 2017 - A researcher at the Wyss Center for Bio and Neuroengineering in Geneva is developing an EEG monitoring system for otherwise uncommunicative patients who have locked-in syndrome to respond to yes-or-no questions. (Extreme Tech)

Visual Prosthesis Research Explores Magnetic Stimulation

Feb. 7, 2017 - A magnetic micro-coil developer, PARC, announced unspecified funding from the National Institutes of Health through the U.S. BRAIN Initiative to develop a visual prosthetic in collaboration with the Massachusetts General Hospital, Harvard Medical School, and the University of Florida. The announcement said the funding is "a multi-year, multi-million dollar award". (Globe Newswire)

Article Highlights Importance of Data Analytics for Devices That Employ Neurosensing

Feb. 7, 2017 - An article says data analytics can help neurosensing applications to improve devices to address a number of conditions, such as helping store limb motion after spinal injury. (Healthcare IT)

Retinal Prosthesis Company Raises Funds

Feb. 6, 2017 - Second Sight Medical announced plans for a rights offering to raise additional funds to further develop its retinal prosthesis and expand the market to better-sighted patients who have retinitis pigmentosa. The company announced a decision by the German Institute for the Hospital Renumeration System last week that allows approved hospitals to negotiate for reimbursement by insurers for treatment of patients with advanced retitinitis pigmentosa. (Mass Device)

Company Seeks Regulatory Approval for Sacral Nerve Stimulation System

Feb. 1, 2017 - Nuvectra Corporation filed regulatory submissions with the FDA and CE mark authorities for its sacral nerve stimulation system to treat chronic urinary retention or overactive bladder symptoms. (Nasdaq)

Germany's First Patient Receives First Implant for Disabling Chronic Low Back Pain

Jan. 31, 2017 - Mainstay Medical International plc announced the first sale and implant of its neurostimulation system for disabling chronic low back pain in Germany. (Business Wire)

Cleveland Starts a Brain Health Initiative

Jan. 27, 2017 - The Cleveland Foundation is awarding $15. million grant to Case Western Reserve University to start a multi-institution Cleveland Brain Health Initiative. An article about the grant mentions a federal grant for stroke research by International Neuromodulation Society member Andre Machado, MD, PhD, chair of the Cleveland Clinic Neurological Institute.  (Cleveland Business)

Proof-of-Principle Study Explores Non-invasive Brain Stimulation for Bulimia Patients

Jan. 25, 2017 - A proof-of-principle clinical trial of transcranial direct current stimulation showed effects on bulimia symptoms the day after active stimulation, compared to sham, according to results in 39 patients. The results were reported in PLoS ONE. (Healio)

Study: Most Spinal Cord Stimulation Recipients Do Not Increase Opioid Use

Jan. 24, 2017 - An analysis of medical claims from 5,476 patients who received a spinal cord stimulator showed opioid use declined or stabilized in 70% of them, according to a study sponsored by Abbott and presented at the North American Neuromodulation Society annual meeting. (Pain News Network)

Physician Investigating Potential Benefits of Vagus Nerve Stimulation in Head Injury Patients

Jan. 24, 2017 - A physician has started a clinical trial for up to 30 patients who have had a traumatic brain injury or concussion, in order to investigate transcutaneous vagus nerve stimulation (VNS). Daily VNS sessions address cognitive or functional symptoms ascribed to "abnormal electrical currents in the brain," a news article says. (Minnesota Daily)

Company Prepares to Test Non-invasive Neuromodulation Device in Neuromotor Spasticity

Jan. 23, 2017 - PathMaker Neurosystems Inc. announced it will start a clinical trial in Paris of a non-invasive neuromodulation device to treat neuromotor spasticity. (Business Wire)

Peripheral Neurostimulation Studied in Post-Stroke Shoulder Pain

Jan. 21, 2017 - In a poster presentation at the annual meeting of the North American Neuromodulation Society, data on seven patients with post-stroke shoulder pain were presented. The data showed an average 70% reduction in the patients' pain, as rated in a visual analogue scale, following treatment with a peripheral neurostimulator. (National Pain Report)

Device Company Targeting Weight Loss Raises $19 Million

Jan. 19, 2017 - The company EnteroMedics Inc. announced it raised $19 million in an oversubscribed public offering. The company is commercializing a vagus nerve stimulation system for weight loss. (Mass Device)

Company Makes a Dorsal Root Ganglion Stimulator Available in Europe

Jan. 18, 2017 - St. Jude Medical, which is now part of Abbott, announced it is releasing a dorsal root ganglion stimulation system in Europe. (Medgadget)

New Prize in Neuromodulation Announced

January 2017 - A Science & PINS Prize for Neuromodulation was established in 2016 to honor contributions to neuromodulation research. Recipients will be honored annually for outstanding research as described in an essay based on research performed in the past three years. The award carries a prize of $25,000 and publication of the essay in Science Online, which is published by the nonprofit American Association for the Advancement of Science. Beijing PINS Medical Equipment Co. Ltd. develops nerve stimulation technologies. (Science)

Health Canada Approves a Rechargeable Sacral Neuromodulation System

Jan. 5, 2017 - Axonics Modulation Technologies, Inc. announced it received medical device approval  from Health Canada for its rechargeable sacral neuromodulation system to treat overactive bladder, fecal incontinence and urinary retention. (Yahoo Finance)

Vagus Nerve Stimulation Approach Blocks Unwanted Nerve Conduction

Jan. 5, 2017 - Biomedical engineers at Georgia Tech have designed a pair of vagus nerve stimulation electrodes that block stimulation in an afferent direction and force stimulation to only go in an efferent direction in order to lower inflammatory effects. The blocking electrode uses kilohertz frequency to block unwanted nerve conduction. (Medical Xpress)

First Patient Receives Implant in Clinical Trial of Deep Brain Stimulation for Motor Recovery After Stroke

Jan. 5, 2017 - International Neuromodulation Society member Andre Machado, MD, PhD, is interviewed for a news story about the first stroke patient to be implanted with a deep brain stimulation (DBS) system in his clinical trial of DBS in stroke recovery. The study will investigate if DBS and physical therapy combined help regain motor function. (WOIO)

Review: Non-invasive Neuromodulation is Useful for Migraine Management

January 2017 - A review of non-invasive stimulation in migraine treatment concludes, "Noninvasive neuromodulation is an exciting and useful method that is being increasingly recognised as a valid strategy for migraine management." (touch Neurology)

Small Study Shows Positive Results for Treating Depression in Elderly with Transcranial Magnetic Stimulation

Jan. 3, 2017 - A placebo-controlled study of 52 patients over the age of 60 who have treatment-resistant depression showed that deep transcranial magnetic stimulation led to half the patients achieving full remission, compared to only 16% of the sham-treated patients. (Nasdaq)

Journal Publishes New Consensus on Neuromodulation Therapy

Jan. 2, 2017 - The International Neuromodulation Society journal, Neuromodulation: Technology at the Neural Interface, has published updated guidelines for neurostimulation implants and intrathecal drug delivery. The six articles appear in Early View, and were authored by the Polyanalgesic Consensus Conference and the Neurostimulation Appropriateness Consensus Committee. These more than 60 international experts were convened by the INS Executive Board to provide guidance for improving safety and efficacy of these therapies that can help reduce opioid use. The authors reviewed publications that appeared in the scientific literature by 2014 to issue the updated guidance. (News-Medical.net)