2016 News Briefs - International Neuromodulation Society

 
 

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January 2016


Article Explains Goal of Using Implant to Stabilize Back and Relieve Chronic Pain

Jan. 31, 2016 - Dublin-based Mainstay Medical has applied for CE Mark approval of a novel investigational neurostimulation device for back pain. The implant induces contractions of the multifidus muscle to stabilize the back. The company would like to offer the device later this year in Europe as an option when treatments such as physiotherapy have failed. An article says the application includes data from a clinical trial involving 45 patients in Belgium, Australia, and England. The coverage mentions International Neuromodulation Society member Sam Eldabe, MBBS, FRCA of Middlesbrough, England, who implanted four enrollees. (Daily Mail)

Neurostimulation for Spine-Injury Patients Receives Research Funding in Minnesota

Jan. 28, 2016 - The state of Minnesota has given a grant to the University of Minnesota and Hennepin County Medical Center to study epidural spinal cord stimulation as a way to potentially restore some function in spine-injured patients. A summary in Becker Spine Review says clinical trials in other states resulted in patients moving paralyzed muscles and that once the stimulator has been implanted for some time, the patients should experience some improved function even when it is inactive. (WCCO)

Study: External Device Improved Post Traumatic Stress Disorder Symptoms

Jan. 28, 2016 - A proof-of-concept clinical trial of adjunctive treatment with external trigeminal nerve stimulation in 12 patients who have post traumatic stress disorder (PTSD) and major depressive disorder showed that eight weeks of nightly stimulation led to significant improvements in symptom severity. The research institution, the University of California, Los Angeles, is seeking military veterans with PTSD for additional clinical research with the modality. (Neuromodulation: Technology at the Neural Interface)

Agency Seeks Proposals for Neural Interface Technology

Jan. 26, 2016 - The U.S. Defense Advanced Research Projects Agency (DARPA) announced a Neural Engineering System Design program, and invites proposals for modular, compact hardware that can record from more than 1 million neurons and stimulate more than 100,000 neurons. (TechNewsWorld)

Analysis Compares Healthcare Utilization and Payments for Cancer-Pain Patients Who Receive Intrathecal Drug Delivery or Conventional Medical Management

Jan. 27, 2016 - Healthcare costs of conventional medical management vs. intrathecal drug delivery (IDD) were compared in 73 matched pairs of patients who had cancer-related pain. In the first year after IDD implant, the IDD patients had a consistent trend of lower medical utilization, and total payments were $3,195 mower. The analysis by International Neuromodulation Society member Lisa Stearns, MD and colleagues suggests that despite the high initial cost of IDD, those patients incur lower medical utilization and payments over the first year post-implant. (Neuromodulation: Technology at the Neural Interface)

Media Cover Use of Deep Brain Stimulation for Focal Hand Disorder

Jan. 27, 2016 - A Chinese citizen with focal hand disorder was reported to receive deep brain stimulation (DBS) surgery while playing guitar, which he had had to give up due to his condition. His surgeon said this was the seventh known case where DBS was used for this disorder, a condition that was said to not be uncommon among athletes and musicians. The article described DBS therapy, noting that "it is thought that it will remain the main surgical therapy for Parkinson's for the next 30 years." (Daily Mail)

European Researchers Examine Neuroendocrine Changes in Deep Brain Stimulation for Obsessive Compulsive Disorder

Jan. 26, 2016 - Researchers report that resuming deep brain stimulation (DBS) in patients with treatment-resistant obsessive compulsive disorder led to rapid release of the neuroendocrine factors prolactin and thyroid-stimulating hormone (TSH). The authors say the findings suggest that DBS is capable of inducing rapid psychiatric symptom changes through an alternative or additional underlying mechanism. For instance, seeing the increase in prolactin and TSH leads them to believe the observed acute mood elevation may be due to stimulation of hypothalamic thyrotropin-releasing hormone. They add that one patient who had previously become a DBS non-responder found some relief of his affective symptoms during the day by switching the DBS off at night and resuming it in the morning, thereby recreating a short-term acute stimulation effect. (Nature Translational Psychiatry)

Company Looks to Gain More Capital for Its Visual Prosthesis Pipeline

Jan. 25, 2016 - Second Sight Medical Products, Inc. filed a proposed rights offering with the Securities and Exchange Commission for its existing companies. The company would use the proceeds for an ongoing safety and efficacy trial of its Argus® II Retinal Prosthesis System for the treatment of age-related macular degeneration and development of a visual cortical prosthesis to potentially treat nearly all forms of blindness. (Business Wire)

Pharmacy Publication Features Bioelectronic Medicine

January 2016 - An article about bioelectronic medicine defines it as "the use of neurostimulation to modulate disease pathways." For now, the article says, vagus nerve stimulation is receiving the most attention for potentially treating disease conditions. (PharmaTimes)

Researchers Publish Results of Prospective Peripheral Nerve Stimulation Clinical Trial

Jan. 22, 2016 - International Neuromodulation Society members Timothy Deer, MD; Jason Pope, MD; Ramsin Benyamin, MD; Richardo Vallejo, MD, PhD; David Caraway, MD, PhD; Peter Staats, MD; Eric Grigsby, MD; Porter McRoberts, MD; Tory McJunkin, MD; Robert Levy, MD; Leonardo Kapural, MD, PhD; and Nagy Mekhail, MD, PhD and colleagues have published Early View results of a partial crossover trial of a novel peripheral nerve stimulation device. They conclude the implantable device is safe and effective for treating neuropathic pain of peripheral nerve origin. In the safety and efficacy trial, 94 patients were randomized in control and active stimulation groups. The results showed that three months of active stimulation led to a 38% response rate (vs. 10% in the control group); and the mean pain reduction in the treatment group was 27.2% vs. 2.3% in the control group. (Neuromodulation: Technology at the Neural Interface) 

Hospital in India Announces Implantation of a Vagus Nerve Stimulation System in a Patient with Heart Failure

Jan. 20, 2016 - A cardiac care hospital in India has implanted a vagus nerve stimulation system in a patient who has heart failure, in an effort to increase tone of the parasympathetic nervous system and improve her symptoms. (Equity Bulls)

Review Evaluates Evidence for Spinal Cord Stimulation

January 2016 - International Neuromodulation Society members Jay Grider, DO, PhD; Laxmaiah Manchikanti, MD; Alexios Carayannopoulos, DO, MPH; Carl Balog, MD; Michael E. Harned, MD; Salim M. Hayek, MD, PhD; Ricardo Vallejo, MD, PhD; and Paul Christo, MD, along with other co-authors, have published a systematic review of spinal cord stimulation (SCS) in spinal pain. They found there was significant evidence -- Level I to II -- of the efficacy of SCS in lower-back failed back surgery syndrome. In addition, they found moderate Level II to III evidence for the efficacy of high frequency stimulation based on one randomized controlled clinical trial. They conclude more studies are needed and said that based on a lack of high quality studies, there was limited evidence for adaptive stimulation and burst stimulation. (Pain Physician)

Observational Study Suggests Percutaneous Electrical Nerve Stimulation is Effective and Feasible in Neuropathic Pain

January 2016 - International Neuromodulation Society members Giuliano De Carolis, MD; Goffredo Liberatoscioli, MD; Paola Nosella, MD; and Luigi F. Nardi, MD and co-authors published results of a multi-center observational study of percutaneous electrical nerve stimulation (PENS) in neuropathic pain. There were 76 patients who had a variety of conditions, such as post-herpetic pain and occipital neuralgia. The authors concluded that the intervention produced significant pain relief and is safe and feasible. (Pain Physician)

Study Shows Headache Reduction from Non-invasive Vagus Nerve Stimulation

Jan. 19, 2016 - International Neuromodulation Society member Thomas Kinfe and colleagues published data in the Journal of Headache and Pain that showed cervical non-invasive vagus nerve stimulation twice daily reduced the number of headache days per month from 14.7 to 8.9, and the number of monthly migraine attacks from 7.3 to 4.5. (Business Wire)

Analysis Finds Spinal Cord Stimulation Lowers Amputation Rate in Chronic Critical Limb Ischemia

Jan. 18, 2016 - A meta-analysis of 13 studies comprising 595 patients concludes that spinal cord stimulation is better than medical management alone in preventing limb amputation for patients who have chronic critical limb ischemia, particularly in patients with less severe disease. The findings were presented in a poster at the Annual Pain Medicine Meeting of the American Society of Regional Anesthesia and Pain Medicine. (Pain Medicine)

Authors Present an Overview for Pharmacists of Medical and Surgical Treatment for Parkinson's Disease

Jan. 18, 2016 - An article summarizes Parkinson's disease treatment and informs pharmacists they may see a Parkinson's patient more often after deep brain stimulation surgery, as medication dosages are adjusted. (Pharmacy Times)

Non-invasive Stimulation for Fibromyalgia Studied

Jan. 17, 2016 - A Phase II open-label study of high-definition transcranial direct current stimulation in 14 fibromyalgia patients, published in the Journal of Pain, explored dosing regimens for pain reduction. (National Pain Report)

Column Presents Transcranial Magnetic Stimulation Options for Depression

Jan. 17, 2016 - An article about transcranial magnetic stimulation (TMS) for depression describes deep TMS as a newer option for treatment-resistant depression. (New York Daily News)

Pair Exhibit a Consumer Device in Development for Vagus Nerve Stimulation through Earbuds

Jan. 15, 2016 - International Neuromodulation Society member Daniel Cartledge, MD, and his brother, a cardiac and thoracic surgeon, have co-developed a vagus nerve stimulation device that was voted a top new digital health device at the Consumer Electronics Show. The product is an earbud device designed to be used with music and improve mood, although the product has no medical claims. The device is expected to enter the market in the next few months. (Palm Beach Post)

Column Asks If More Will Be Done For Patients in a Minimally Conscious State

Jan. 14, 2016 - A newspaper column mentions motor cortex stimulation and describes the ability to distinguish and partially rehabilitate patients who are in a minimally conscious state in which they retain some awareness and ability to respond. The writer asks if society will more fully restore the lives of people who may currently only receive custodial care. (Houston Chronicle)

Company Announces New Head of Neuromodulation Business Unit

Jan. 14, 20i6 - LivaNova, PLC has named former Cyberonics, Inc. executive Jason Richey president of LivaNova's neuromodulation business unit and a member of the executive team. He was previously vice president of global sales and marketing for neuromodulation. (Street Insider)

Device Maker Announces Sales Growth

Jan. 13, 2016 - St. Jude Medical, Inc. expected to report consolidated net sales of approximately $1.447 billion for the fourth quarter of 2015. That is an increase of 7% on a constant currency basis. Sales of its neuromodulation products in the fourth quarter amounted to approximately $128 million, an increase of 9% on a constant currency basis over the fourth quarter of 2014. (Business Wire)

Vagus Nerve Stimulation System Developer Raises $11 Million

Jan. 13, 2016 - Minnesota-based EnteroMedics Inc. brought in $11 million in the 2nd tranche of a $25 million offering, announced in November, of senior amortizing convertible notes. The company received $1.5 million at the initial offering in November 2015. In 45 days, a 3rd tranche of $12.5 million is scheduled. The company has developed a vagus nerve stimulation system to treat metabolic diseases and other gastrointestinal disorders. (Mass Device)

Company Describes Pursuing a Potentially Therapeutic Brain-Stimulation Headset

Jan. 13, 2016 - A U.K. company founded in 2014, Cerestim, says it has demonstrated a proof-of-concept for an alternating transcranial direct-current stimulation device to be remotely monitored by physicians. The company is initially targeting the product for depression and pending regulatory approval, would expect to market the home-use device in three to five years. An article explains that the headset is intended to identify dysfunctional neural activity and reset that through stimulation via electrodes tailored for each individual. (International Business Times)

Singapore Initiative is Working to Create a Wireless Neurostimulator

Jan. 13, 2016 - An initiative in Singapore is developing a wireless implantable chronic pain management device that is anticipated to be about as small as a grain of rice. The neurostimulator is being developed by the Institute of Microelectronics of the Agency for Science, Technology and Research (A*STAR) and the local biotechnology firm Biospark Technologies. (Today Online)

Patient Enrollment is Complete in Tibial Nerve Stimulation Study

Jan. 11, 2016 - Israel-based BlueWind Medical announced it has completed enrollment of 36 patients with overactive bladder in a clinical trial of its wireless neurostimulation device. The patients in the U.K. and Netherlands will have the device implanted in their lower leg to stimulate the tibial nerve. The company expects to present initial results in February 2016, and is gathering the data to support a CE Mark application. (PR Newswire) 

Research Indicates Non-Invasive Stimulation Can Potentially Help Suppress Migraine Onset

Jan. 11, 2016 - In preclinical studies reported in Pain non-invasive vagus nerve stimulation (VNS) was found as effective as surgically implanted VNS in suppressing, by up to 40%, cortical spreading depression that is associated with pre-migraine aura. (PR Rocket)

Reprogramming Helped Restore Efficacy of Spinal Cord Stimulation

Jan. 8, 2016 - At the combined annual scientific meeting in London of the Neuromodulation Society of the United Kingdom and Ireland and the International Neuromodulation Society (INS) chapters from Germany and Switzerland, INS member Frank Wille, MD presented results gathered between 2010 - 2011 in the Netherlands that showed that reprogramming existing spinal cord stimulation (SCS) devices could restore efficacy in managing back pain. He said that in this high-density mode, the leads were implanted as close as possible to the T9 - T10 target, and the devices were operated at maximum frequency, with the pulse width as broad as possible and amplitude adjusted for continuous stimulation. Rather than have devices explanted, 65% of the patients continued to use their SCS systems one year later. (NeuroNews)

Neurostimulation Device Maker Receives Regional Government Grant in Belgium

Jan. 8, 2016 - Neurostimulation device maker Nuviant Medical received a research grant of €3.4 million from the Walloon Region government and plans to expand manufacturing operations there in a program that incorporates digital healthcare in collaboration with regional innovators. (Fierce Medical Devices)

Researchers Report Long-term Data on Deep Brain Stimulation in Dystonia

Jan. 8, 2016 - A group of Korean researchers published long-term data on 36 patients with several types of dystonia that compares outcomes of deep brain stimulation to the globus pallidus interna. Their results suggest a favorable outcome is expected for patients with DYT-1 dystonia and isolated dystonia without a known genetic cause. (PLoS ONE)

Optogenetics Study Examines Role of Hippocampus in Social Memory

Jan. 5, 2016 - Laboratory researchers used optogenetics in mice to excite a part of the hippocampus involved in memory formation and found the stimulation enhanced social memory if applied during memory formation, but not during retrieval. (Molecular Psychiatry)

Post-Market Surveillance: External Trigeminal Nerve Stimulation Compliance Rate is Twice That of Medical Management for Chronic Migraine

Jan. 7, 2016 - CEFALY Technology released data about patient compliance among 14,745 migraine patients who acquired the Belgium-based company's trigeminal nerve stimulation device between March 2014 and October 2015. The external device was FDA-approved in March 2014 to reduce the frequency and intensity of migraines. Full compliance would entail replacing the electrode every month. Based on recurrent orders of electrodes, the company reported a 72.4% compliance rate, twice that of oral preventive migraine medication. (Fierce Medical Devices)

Company Sets Up Distribution Agreement in Germany for Non-Invasive Treatment for Chronic Headache

Jan. 6, 2016 - The pan-European pharmaceutical company Desitin, a distributor of treatments for Parkinson's disease and epilepsy, entered an agreement Jan. 1 to distribute ElectroCore's non-invasive vagus nerve stimulation device, gammaCore, to neurologists in Germany who treat migraine and cluster headache. (Business Wire)

Medical Society Plans Movement Disorders Registry in India

Jan. 5, 2016 - The Movement Disorders Society of India announced it is planning to create a registry of Parkinson's and movement disorder cases in the interests of optimizing treatment. Besides deep brain stimulation, the society is interested in potential novel treatments and planned a conference on Jan. 8 to discuss those. (Times of India)

Case Reports Detail Considerations for Intrathecal Drug Delivery

Jan. 1, 2016 - Since intrathecal drug delivery systems have been in use for more than two decades, the need to manage patients at the end of the device life is increasingly common, note International Neuromodulation Society members Jason Pope, MD and Timothy Deer, MD in a case report about a patient who experienced a decrease in analgesia and needed a replacement infusion pump. The authors also report about a novel delivery system for ziconotide, in a separate case report on Dec. 30, 2015. (Pain Medicine News)

Authors Examine Growth of Emerging Indications for Deep Brain Stimulation

Jan. 1, 2016 - There was rapid growth in the percentage of deep brain stimulation patients in the U.S. who were treated for indications under a humanitarian device exemption or other emerging indication in the last decade, according to analysis of hospital discharge records. The newer indications were associated with greater costs, so the authors of this study conclude that "additional costs should be anticipated as surgeons gain experience with new patient populations and targets." (Journal of Neurosurgery)

Last Updated on Tuesday, March 22, 2016 11:24 AM
 
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