Study: Non-invasive Vagus Nerve Stimulation (nVNS) as mini-prophylaxis for menstrual related migraine

The Journal of Headache and Pain published an open label study – Non-invasive Vagus Nerve Stimulation (nVNS) as mini-prophylaxis for menstrual/menstrually related migraine.

Abstract

Background

Menstrual migraine and menstrually related migraine attacks are typically longer, more disabling, and less responsive to medications than non-menstrual attacks. The aim of this study was to evaluate the efficacy, safety, and tolerability of non-invasive vagus nerve stimulation for the prophylactic treatment of menstrual migraine/menstrually related migraine.

Methods

Fifty-six enrolled subjects (menstrual migraine, 9 %; menstrually related migraine, 91 %), 33 (59 %) of whom were receiving other prophylactic therapies, entered a 12-week baseline period. Fifty-one subjects subsequently entered a 12-week treatment period to receive open-label prophylactic non-invasive vagus nerve stimulation adjunctively (31/51; 61 %) or as monotherapy (20/51; 39 %) on day −3 before estimated onset of menses through day +3 after the end of menses.

Results

The number of menstrual migraine/menstrually related migraine days per month was significantly reduced from baseline (mean ± standard error, 7.2 ± 0.7 days) to the end of treatment (mean ± standard error, 4.7 ± 0.5 days; P < 0.001) (primary end point). Of all subjects, 39 % (95 % confidence interval: 26 %, 54 %) (20/51) had a ≥ 50 % reduction (secondary end point). For the other secondary end points, clinically meaningful reductions in analgesic use (mean change ± standard error, −3.3 ± 0.6 times per month; P < 0.001), 6-item Headache Impact Test score (mean change ± standard error, −3.1 ± 0.7; P < 0.001), and Migraine Disability Assessment score (mean change ± standard error, −11.9 ± 3.4; P < 0.001) were observed, along with a modest reduction in pain intensity (mean change ± standard error, −0.5 ± 0.2; P = 0.002). There were no safety/tolerability concerns.

Conclusions

These findings suggest that non-invasive vagus nerve stimulation is an effective treatment that reduces the number of menstrual migraine/menstrually related migraine days and analgesic use without safety/tolerability concerns in subjects with menstrual migraine/menstrually related migraine. Randomised controlled studies are warranted.

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Medtronic Receives CE Mark for Deep Brain Stimulation Therapy

Medtronic announced it has received CE (Conformité Européenne) Mark for SureTune2(TM) software, which provides patient-specific visualization to help physicians make decisions on how to program – or tune – their patient’s deep brain stimulation (DBS) therapy. SureTune2 is currently not approved in the United States.

DBS therapy applies mild electrical stimulation to precise targets in the brain in order to modulate specific symptom control. The brain targets are stimulated through lead(s) inserted into the brain and connected to an implantable neurostimulator through extensions running under the skin. A medical professional uses an external programmer to set and adjust stimulation settings.

Today DBS patient programming can be an interactive process, which can be time- consuming for the hospital and the patient. SureTune2 is designed for Medtronic DBS therapy and other DBS therapy delivery systems to help physicians more efficiently select the optimal stimulation settings on their programmer by visualizing patient-specific information in one comprehensive view including anatomy, physiology, and calculated stimulation field. Users can segment structures using a greyscale threshold within a region of interest, or by outlining shapes of interest from a patient image.

“SureTune will have an important impact on the care of patients with deep brain stimulation because it allows me for the first time to visualize activation patterns of DBS within the individual segmented patient anatomy,” said Professor Jens Volkmann, MD, PhD, FEAN, chairman and professor of neurology in the University Clinic of Würzburg. “It simplifies the trial and error process associated with DBS programming by helping me identify the best contacts, which saves me time.”

“Medtronic is committed to providing advanced technology to the multidisciplinary teams who are helping DBS patients, and I’m convinced that SureTune will provide them with easy-to-use tools to aid in optimizing therapy outcomes,” said Lothar Krinke, PhD, vice president and general manager of the Brain Modulation business in Medtronic’s Restorative Therapies Group. “SureTune is a key aspect of Medtronic’s commitment to providing integrated solutions for improving accuracy and confidence from surgery to post-operative DBS patient management.”

Medtronic helped pioneer DBS, and more than 140,000 patients worldwide have received Medtronic DBS Therapy, which is approved in many locations around the world, including Europe and the United States, for the treatment of the disabling symptoms of essential tremor, Parkinson’s disease and dystonia, the latter for which approval in the United States is under a Humanitarian Device Exemption (HDE). In Europe, Canada and Australia, Medtronic DBS therapy is approved for the treatment of refractory epilepsy. Medtronic DBS therapy is also approved for the treatment of severe, treatment-resistant obsessive-compulsive disorder in Europe and Australia, and in the United States under an HDE.

A press release can be found from Medtroic website.

St. Jude Medical Launches New Deep Brain Stimulation System and Directional Lead

St. Jude Medical announced the European launch of the St. Jude Medical Infinity™ Deep Brain Stimulation (DBS) System and directional DBS lead. The system, which received CE Mark approval late in 2015, will support the treatment of patients with the three most common movement disorders in the world: Parkinson’s disease, tremor and dystonia, a disorder which causes involuntary muscle contractions.

Movement disorders are neurologic conditions caused by a communication breakdown throughout the central nervous system that can result in a debilitating loss of muscle control, involuntary movement and reduced coordination. There are currently no proven cures for movement disorders, which means treatment options focus on alleviating symptoms to improve quality of life. St. Jude Medical designed the Infinity system to improve the experience of patients who rely on DBS therapy to manage their symptoms. The company also developed the St. Jude Medical directional lead to help physicians more accurately tailor DBS therapy to their patient’s specific needs while reducing side effects.

The first physician to implant the new Infinity system and the St. Jude Medical directional lead was Prof. Jan Vesper, a professor of functional neurosurgery and stereotaxy at the University Hospital in Düsseldorf, Germany, and president of the German Neuromodulation Society.

“The Infinity system is the first DBS system I’ve encountered that adjusts to the patient’s individual needs, rather than forcing the patient to adjust to the system,” said Prof. Vesper. “Offering my patients a DBS system with exceptional ease of use and smooth manageability is an exciting step in the treatment of debilitating movement disorders.”

A DBS system, like the St. Jude Medical Infinity DBS system, delivers mild electrical pulses to specific targets in the brain to stimulate the structures involved in motor control. With the launch of the Infinity system, St. Jude Medical aims to empower physicians to more accurately deliver stimulation with a DBS system. The new St. Jude Medical directional lead can deliver stimulation more precisely through eight independent electrodes that allow physicians to specifically direct current to targeted structures and areas of the brain. This advance will allow physicians to tailor the therapy to a patient’s specific needs while avoiding unnecessary stimulation to areas that may create side effects.

The Infinity system also offers new, distinct patient advantages. For patient comfort, the system is available in two different sizes, offers a maintenance-free and long-lasting recharge-free system, and uses Bluetooth® wireless technology and Apple™ digital devices for its patient controller and physician programmers. In addition, the St. Jude Medical Infinity system is also upgradeable, which provides patients the potential to access new therapy advances as they’re approved without the need for repeat surgery.

“The Infinity DBS system and directional lead design was designed to meet the needs of physicians who confirmed that they needed a system that prioritized improved stimulation targeting, device longevity and improved patient ease of use,” said Dr. Allen Burton, medical director of neuromodulation and vice president of medical affairs at St. Jude Medical. “The Infinity DBS system is our answer for these previously unmet needs, demonstrating St. Jude Medical’s commitment to patient-centric solutions that help alleviate the debilitating effects of movement disorders.”

A press release can be found from St. Jude website.

Brain stimulation may reduce anorexia symptoms

Core symptoms of anorexia nervosa, including the urge to restrict food intake and feeling fat, are reduced after just one session of a non-invasive brain stimulation technique, according to King’s College London Research.

This new study is the first randomised control trial to assess whether repetitive transcranial stimulation (rTMS), already an approved treatment for depression, is also effective in reducing symptoms of anorexia.

Up to 20 per cent of people with anorexia die prematurely from the disorder and treatments in adults are moderately effective, with only 20-30 per cent of people recovering from the best available talking therapies.

Given the urgent need to improve treatments, researchers are increasingly looking towards emerging neuroscience-based technologies that could target the underlying neural basis of anorexia.

In the study, 49 people completed food exposure and decision-making tasks, both before and after a session of either real or placebo rTMS. Symptoms of anorexia were measured immediately prior to and following rTMS, as well as 20 minutes and 24 hours after the session.

This study represents independent research part-funded by the National Institute for Health Research (NIHR) Biomedical Research Centre (BRC) at South London and Maudsley NHS Foundation Trust and King’s College London.