July 21, 2016 - International Neuromodulation Society members Paul Eldridge, MD and Rod Taylor, PhD and colleagues co-authored an analysis of the cost-effectiveness, over a 15-year time frame, of deep brain stimulation (DBS) for Parkinson's disease with early motor complications. They conclude that DBS is cost-effective compared to existing interventions, and offers additional health benefits at acceptable incremental cost. (PLoS ONE)
July 19, 2016 - A review of 11 studies of noninvasive brain stimulation of the dorsolateral prefrontal cortex indicated that repetitive transcranial magnetic stimulation (rTNS) has a significant, moderate effect on food cravings. Studies that looked at actual food consumption had results that, while inconsistent, did suggest a possible effect on the intake of carbohydrates through treatment with rTMS. By contrast, studies did not show a significant effect of transcranial direct current stimulation on food cravings. (EurekAlert)
July 19, 2016 - A guest columnist describes using cranial electrotherapy stimulation to help with his anxiety for the past six years. He supports viewing electrical stimulation of the brain as a good alternative for many people, especially those who have not responded to other therapies. (Scientific American)
July 19, 2016 - An article describes repetitive transcranial magnetic stimulation (rTMS) services coming to Nigeria. The article included comments by physicians who appreciated the chance to add to existing treatment options for mental health conditions and pointed out the technology also has applications for diagnostic purposes and motor recovery following strike, pain and seizure. The article said previously in Africa, rTMS was only available in South Africa and Egypt. The article characterized the extent of unmet need, saying 20 to 40% of patients are resistant to pharmacological antidepressant treatments while another 33% show poor response. (All Africa)
July 18, 2016 - Researchers working with a mouse model of Alzheimer's disease found that increased neuronal activity enhances the propagation and pathology of the tau protein responsible for the disease. The senior author said the findings suggest that investigative treatments for the disease that increase brain activity should be monitored carefully. (EurkeAlert)
July 18, 2016 - Allergan announced it is applying for FDA approval of a handheld intranasal neuromodulation device to stimulate tear production in people who have dry eye disease due to decreased tear production. (MPR)
July 18, 2016 - Cefaly Technology is releasing the next version of its external trigeminal nerve stimulation device for the prevention of frequent episodic migraine attacks. The Cefaly® II device is available in the U.S. and will be available next in Europe in September. (PR Newswire)
July 14, 2016 - Researchers in Helsinki published a proof-of-principle study in which transcranial magnetic stimulation, synchronized to electrical peripheral nerve stimulation, helped two patients with partial spinal cord injuries regain some voluntary muscle control after six months. (UPI)
July 14, 2016 - International Neuromodulation Society member Paul Verrills, MD, and co-authors have prepared a review concerning spinal cord stimulation (SCS) for chronic pain. The review in the Journal of Pain Research states, "A number of variables have been identified that can affect SCS efficacy: implanter experience, appropriate patient selection, etiologies of patient pain, existence of comorbidities, including psychiatric illness, smoking status, and delay to SCS implant following pain onset." It concludes that SCS is a safe, effective, and drug-free treatment for many types of chronic pain. (MD Magazine)
July 14, 2016 - A team of researchers created a computer model that predicts that delivering deep brain stimulation in bursts at select phases of brain oscillation may be most efficient. Their paper, "Phasic Burst Stimulation: A Closed-Loop Approach to Tuning Deep Brain Stimulation Parameters for Parkinson’s Disease," was published in PLoS Computational Biology. (Medical Xpress)
July 11, 2016 - Endonovo Therapeutics, Inc. announced it intends to acquire Rio Grande Neurosciences, Inc. for $21.5 million following execution of a definitive purchase agreement, shareholder approvals, and raising more capital. Privately held Rio Grande Neurosciences develops non-invasive technology for the treatment of neuro-inflammation and central nervous system diseases and disorders. The company's devices include an FDA-cleared device for treating pain and edema, a proprietary multi-coil repetitive transcranial magnetic stimulation system with pending 510(k) application, which is currently being adapted for the treatment of neuro-inflammatory conditions, including traumatic brain injury, acute concussion, post concussion syndrome and multiple sclerosis; and targeted pulsed electromagnetic field therapy for the treatment of post surgical neuroinflammation. The deal is expected to be completed by Sept. 30 and entails $15 million in Endonovo common stock, $5 million in Endonovo warrants and $1.5 million in cash. (Fierce Biotech)
July 11, 2016 - Lynn’s Queen Elizabeth Hospital's Brancaster Outpatients Unit has been awarded a Centre of Excellence for its high standard of care in a dedicated clinical room used for percutaneous tibial nerve stimulation services for treatment of voiding conditions. (Lynn News)
July 11, 2016 - Sunshine Heart announced its device to augment cardiac function will focus on neuromodulation via baroreceptors rather than its originally envisioned approach of counterpulsation to reduce left-ventricle load in heart failure patients. A clinical trial had shown that the counterpulsation device on the ascending aorta was activating baroreceptors, so the observed positive effect had a neuromodulatory basis. The new approach may be more cost-effective to develop, the company said, in describing anticipated upcoming studies, which start with a current physician-led five-patient study of the device looking at sympathetic nerve activity. (Mass Device)
July 8, 2016 - A reporter observes deep brain stimulation surgery on a Parkinson's disease patient, performed by International Neuromodulation Society member Ali Rezai, MD, in Ohio. (Columbus Business First)
July 7, 2016 - Nyxoah, of Israel and Belgium, raised €18 million ($20 million) for development of its neurostimulation system for obstructive sleep apnea. Its implant is powered by a disposable patch placed on the patient's skin. (Fierce Biotech)
June 29, 2016 - The potential of neurostimulation in perioperative pain control was described in a presentation of a five-patient prospective feasibility study of ultrasound-guided percutaneous peripheral nerve stimulation following primary unilateral total knee arthroplasty. (Anesthesiology News)
June 28, 2016 - The neurostimulation company Nuvectra Corporation was added June 24 to the Russell Microcap® Index. Membership in the index lasts for one year. Indexes are used for investment or benchmarking purposes by fund managers. (Nasdaq)
June 28, 2016 - Nexstim Plc announced it received a U.S. patent for its way of estimating motor threshold when delivering transcranial magnetic stimulation to targets below the cortex. The method involves a scan of 60 - 90 seconds combined with an electromyography measurement. (Nasdaq)
June 28, 2016 - A review looks at vagus nerve stimulation in heart failure and obesity, and concludes that results may be improved through advanced stimulation delivery, with most findings from animal studies still to be shown in clinical investigations. (Journal of Neural Engineering)
June 28, 2016 - International Neuromodulation Society member Andre Machado, MD, PhD, is quoted in an article about an upcoming clinical study of deep brain stimulation after ischemic stroke. It is hoped the brain stimulation will augment physical training by increasing neuroplasticity. (Time)
May/June 2016 - A case report describes the effect of dual stimulation in a woman with complex regional pain syndrome whose response to spinal cord stimulation decreased. She received an additional motor cortex implant that was connected to the same pulse generator. The two targets were stimulated in cycling mode with independent parameters. The authors say their encouraging results suggest motor cortex stimulation may be an add-on possible rescue therapy in managing this pain condition. (Pain Physician)
June 26, 2016 - Of six medical technologies a news column calls "worth watching," two involve neuromodulation. One is a collaboration with Battelle involving International Neuromodulation Society member Ali Rezai, MD, to use a device to bypass a damaged spinal cord and send brain signals directly to a paralyzed limb to allow a spinal-cord injury patient to regain some use of his hand. Another is SetPoint Medical's work on a small neuromodulation implant to potentially treat inflammatory conditions such as rheumatoid arthritis and Crohn's disease. (Wall Street Journal)
June 24, 2016 - International Neuromodulation Society member Magdy Hassouna, MD, PhD, is helping design and conduct clinical trials of peripheral nerve-stimulation technology, developed at the University of Toronto, to potentially treat overactive bladder. The device developers recently received a commercialization grant. (U of T Engineering News)
June 24, 2016 - An article describes how sphenopalatine ganglion stimulators are being implanted in some cluster headache sufferers at two U.K. centers. (Daily Mail)
June 24, 2016 - A six-person study presented at the 2016 Annual Meeting of the Consortium of Multiple Sclerosis Centers was subject to a news release by Helius Medical Technologies. The study involved use of the company's noninvasive portable nerve stimulation system, PoNS, in combination with physical training. At the end of the trial, the company said, all patients could be considered improved, with those who had better functional status at the start making the most gains. (Mass Device)
June 24, 2016 - New Jersey-based electroCore LLC issued a news release summarizing three clinical studies and two preclinical studies regarding the mode of action of noninvasive vagus nerve stimulation in primary headache. The studies were presented at the annual meeting of the American Headache Society. (BioSpace)
June 23, 2016 - A review looks at the experience of 116 patients with advanced Parkinson's disease, and nine spouses, and their expectations before and after initiating treatment with deep brain stimulation. (BMJ Open)
June 22, 2016 - A meta-analysis of 13 studies comprising 1,148 patients with Parkinson's disease compared deep brain stimulation that targeted the subthalamic nucleus or the globus pallidus internus to treat advanced Parkinson's disease. (Neuropsychiatric Disease and Treatment)
June 20, 2016 - A review of treatment for medication-refractory schizophrenia explores the evidence from published literature concerning co-administration of electrical brain stimulation, such as repetitive transcranial magnetic stimulation or transcranial direct current stimulation, with the antipsychotic clozapine. (Expert Review of Clinical Pharmacology)
June 20, 2016 - Axonics Modulation Technologies, Inc. announced its small, rechargeable sacral nerve stimulation system has been implanted in the first patients as part of a post-market follow-up study in overactive bladder. The study is being conducted in England, Belgium, the Netherlands and France. (Business Wire)
June 20, 2016 - International Neuromodulation Society (INS) member David Provenzano, MD mentions a randomized controlled clinical trial by INS member Leonardo Kapural, MD, PhD and colleagues in remarks published in an article about letters written by the American Society of Regional Anesthesia (ASRA) to Blue Cross Blue Shield of Tennessee and Highmark Blue Cross Blue Shield of Pennsylvania regarding classification of high-frequency spinal cord stimulation (SCS) for chronic pain. In an April 2016 medical policy, the insurers classified this type of SCS, which is approved by the FDA, to be experimental and investigational. The letters say beneficiaries should be provided access to this "evidence-based therapy when deemed medically necessary." ASRA pointed out the importance of patient access to non-drug options for chronic pain in light of the U.S. opioid epidemic. (News-medical.net)
June 18, 2016 - CVRx has raised $46 million for development of its potential heart-failure intervention, an implantable neurostimulator that targets the baroreflex to restore autonomic balance through lowering sympathetic activity and raising parasympathetic activity. A pivotal clinical trial involving 310 patients is expected to conclude in September 2017. (Med City News)
June 18, 2016 - Coverage of a pilot study of a wireless neurostimulator for pain relief describes how it can be injected into the epidural space, or into "clusters of spinal nerves." (The pilot study concerned dorsal root ganglion stimulation.) (Daily Mail)
June 17, 2016 - An article summarizes research into deep brain stimulation for central pain syndrome and says the authors hypothesize that relief may be obtained through tailoring deep brain stimulation frequencies to suppress theta oscillations in the thalamus and the periventricular gray/periaqueductal gray. Dysrhythmia and alterations of burst firing in the thalamus have been associated with neuropathic pain. During the dysrhythmia, theta oscillations trigger cortical dysfunction, leading to dysfunction of the thalamocortical circuit, which causes neuropathic pain. (Neurology Advisor)
June 17, 2016 - Mainstay Medical has raised €30 million through placing shares that represent roughly one-third of all the company's shares. As part of the placement, KCK, a family investment group, is taking ownership of half the shares. The company is addressing certain types of lower back pain through commercialization of an implantable device that stimulates nerves to strengthen muscles that stabilize the lower back. (Irish Times)
June 16, 2016 - St. Jude Medical has launched a deep brain stimulation system in Europe that has stimulation leads designed to steer current. The system also allows commercial handheld wireless devices to be used as controllers by patients and physicians. (Mass Device)
June 15, 2016 - BlueWind Medical received CE mark approval for a wirelessly powered tibial nerve stimulator to treat overactive bladder. (Fierce Medical Devices)
June 15, 2016 - Soterix Medical, Inc. announced the company has received a $2.5 million grant from the National Institute of Neurological Disorders and Stroke to support a Phase II clinical trial of non-invasive brain stimulation for post-stroke aphasia. The company plans to test transcranial direct current nerve stimulation as an adjunctive treatment for aphasia patients. Stimulation will be individualized based on functional MRI results. (Business Wire)
June 15, 2016 - Physicians who placed vibratory devices on the hand and foot of premature babies to stimulate limb movement say it encouraged reflexive breathing. They called it a low-cost neuromodulataory way to reduce apnea that is common at less than 34 weeks gestation. (PLoS ONE)
June 14, 2016 - International Neuromodulation Society member Ali Rezai, MD, is interviewed about the emergence, and basic concepts, of deep brain stimulation in a science-column video. (Huffington Post)
June 15, 2016 - The Italian startup Newronika has raised €1.7 million in venture financing to help support development of an adaptive, closed-loop, deep brain stimulation system for Parkinson's disease. The company spun out of the Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico in Milan and Università degli Studi di Milano. (FINSMES)
June 13, 2016 - Authors of a case report published in Neuromodulation: Technology at the Neural Interface describe treating a woman who developed urinary retention after cancer surgery removed part of her sacral nerve. They report the woman's voiding symptoms resolved following implantation of a sacral nerve stimulation system. (Uro Today)
June 13, 2016 - French neurosurgeon Alim-Louis Benabid received a 2016 European Inventor Award from the European Patent Office for bringing into clinical practice the application of high-frequency deep brain stimulation help control motor symptoms of movement disorders such as Parkinson's disease. (Quartz)
June 14, 2016 - Researchers in Iran have been working for two years to develop deep brain stimulation electrodes. In March, they implanted the electrodes in monkeys after tests in mice. The electrodes might eventually be used to treat Parkinson's disease and possibly addiction, according to an interview with one of the researchers. (MEHR News Agency)
June 11, 2016 - An interim analysis of registry data concerning a neurostimulation device for cluster headaches was presented in a poster session at the 58th Annual Scientific Meeting of the American Headache Society. Sphenopalatine ganglion stimulation received CE mark for cluster headache in 2012. A post-market registry study showed that 68% of 85 patients with the device experienced either 50% fewer cluster headache attacks or decreased symptoms in at least half of their attacks, or both. The population also had a 52% reduction in acute medication usage. (PR Newswire)
June 10, 2016 - International Neuromodulation Society member Tariq Al-Shaiji, MD and colleagues reviewed literature related to sacral nerve modulation and related modes of neuromodulation during pregnancy. Based on case reports and studies reported in animals, they conclude there were no significant reports of negative effects on the fetus, mother, or device. They say hypothesized effects have limited its use although women of childbearing age and pregnant women constitute a fair number of sufferers of overactive bladder and nonobstructive urinary retention. They add that expanded data may move the therapy toward being considered safe during pregnancy. (Neuromodulation: Technology at the Neural Interface)
June 10, 2016 - An article summarizing an interview by Bloomberg says GlaxoSmithKline plans three clinical trials that combine drugs and other companies' electrical stimulation devices, and aims to develop an implant of its own in 2019. The article said the company's overall investment would be "on par" with the amount that is often seen quoted for "molecular" medicines, that is, in the billions of dollars. It adds that determining how to modulate individual neurons will be a challenge, but it is hoped that ensuing generations of devices can be modified slightly to treat other diseases, making those versions less costly to produce than a medication. The company is limiting its focus to systems that treat the peripheral nervous system. (Mass Device)
June 10, 2016 - An abstract from the University of Pennsylvania about hypoglossal nerve stimulation system indicates the device yields similar outcomes in a general clinical population with obstructive sleep apnea as it did in a controlled clinical study prior to its approval in 2014. The neurostimulation treatment received approval for individuals who have moderate-to-severe obstructive sleep apnea and cannot tolerate using a continuous positive airway pressure (CPAP) system. The abstract, being presented at the 30th annual meeting of the Associated Professional Sleep Societies LLC, concerns results from 20 patients who received the implant between January 2015 and March 2016. (Medical Xpress)
June 10, 2016 - A review article summarizes research into the influence of repetitive transcranial magnetic stimulation or transcranial direct current stimulation on emotional regulation and decision making. (Neuropsychiatric Electrophysiology)
June 9, 2016 - International Neuromodulation Society member Thierry Vancaillie, MD, a clinical professor and gynecologist in Australia, co-authored a case report about a woman with a complex pelvic neuropathy. Her diagnoses included interstitial cystitis and persistent genital arousal disorder. The symptoms responded to an intervention that combined decompression of the pudendal nerves along with implantation of a sacral and pudendal nerve neuromodulation device. (BMJ Case Reports)
June 2, 2016 - An article about the future psychiatric potential of noninvasive brain stimulation for some conditions in some patients describes two emerging electrical-based therapies, external trigeminal nerve stimulation, and transcutaneous vagus nerve stimulation. (Psychiatric News)
May 26, 2016 - An article profiles development by Neuros Medical of emerging electrical devices to block post-amputation pain. (Tech Ohio)
June 8, 2016 - Nevro Corp. announced its public offering of convertible senior notes will pay an interest rate of 1.75% a year. In addition, the company revised the amount it expected to raise from $125 million to $150 million. (Mass Device)
June 1, 2016 - News coverage of transcranial magnetic stimulation for depression calls the therapy "a sort of depression fighting helmet" and features one patient describing how she has benefited from the treatment. (KING5)
June 7, 2016 - Nevro Corp. announced it plans to offer $125 million in convertible senior notes to support repayment of a term loan agreement, general corporate purposes, and continued commercialization of its high-frequency spinal cord stimulation system. (Mass Device)
June 6, 2016 - The Black Dog Institute in Australia is recruiting patients for a clinical trial of transcranial direct current stimulation in depression. (Newsmaker)
June 6, 2016 - Axonics Modulation Technologies, Inc. announced it has received CE mark approval for its rechargeable sacral nerve stimulation (SNS) system. The system is designed to treat overactive bladder, urinary retention, and fecal incontinence. The company also announced publication of a study in Neurology and Urodynamics in April that modeled comparative costs of a rechargeable SNS system versus a non-rechargeable one. (Mass Device)
June 1, 2016 - Second Sight Medical Products, Inc. said it netted about $19.4 million in a rights offering that was oversubscribed. The company will use the proceeds on the research and development of its visual prosthetics. (Business Wire)
June 1, 2016 - Medtronic said its restorative therapies group, which includes neuromodulation, posted a 1% gain over the previous year. This was the smallest growth margin of the company's four divisions. The restorative therapies group will be reorganized into a general-manager model and the focus will shift to diseases and conditions over technology. The company will focus its pain stimulation strategies toward the opioid epidemic. (Twin Cities Business)
To see select neuromodulation news by category, as well as news about the INS in particular, please visit the Newsroom. To see archived news briefs dating back to January 2011, visit the News Archive.
How Has Neuromodulation Been Developed and Used?
Conventional medicine has typically had four modes of treating diseases or disorders: counseling or “talk therapy”; physical therapy involving manipulation and strengthening of muscles and range of motion; pharmaceuticals that act on a chemical level; and altering or augmenting tissue through surgery, injections, or filtering methods like dialysis. The growing field of neuromodulation is a new class of therapies that involves directly treating the nervous system itself, often through small implanted devices that target a specific area, to rebalance the activity of neural circuits and manage symptoms.
Progress has been spurred by advances in our understanding of the nervous system, as well as new technologies and clinical experience, enabling treatments to modify nerve cell activity in brain, spinal cord and periphery to restore function, minimize pain, and treat disease symptoms. Developed over the last 45 years, neuromodulation has grown rapidly into a family of therapies that applies stimulation or agents directly to the nervous system, often using small implanted medical devices that are powered in a similar fashion to a cardiac pacemaker. By delivering electrical or chemical stimulation, neuromodulation has increasingly been used to treat motor disorders such as Parkinson’s disease, refractory chronic pain ranging from neuropathy to cancer related pain to severe headaches, spasticity, epilepsy, and incontinence. It is also under study for conditions ranging from gastroparesis to medically refractory depression. Providers of such therapies include neurosurgeons, pain physician specialists and rehabilitation physicians. They may often work with other specialists such as neurologists, psychiatrists, psychologists, gastrointestinal or colorectal specialists, urologists, primary care physicians, and physical therapists to achieve best outcomes.
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Clinical trials that involve a wide range of emerging neuromodulation approaches are listed on our Resources and Research pages. Neuromodulator trials address symptom control through nerve stimulation in such condition categories as:
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The International Neuromodulation Society (INS) is a non-profit group of clinicians, scientists and engineers dedicated to the scientific development and awareness of neuromodulation - the alteration of nerve activity through the delivery of electrical stimulation or chemical agents to targeted sites of the body. Founded in 1989 and based in San Francisco, CA, the INS educates and promotes the field through meetings, its peer-reviewed journal Neuromodulation: Technology at the Neural Interface, explanatory content, and chapter websites.
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