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The Journal of Headache and Pain reports that electroCore’s gammaCore® (nVNS) treatment is effective in the acute treatment of high frequency and chronic migraine

65% of the study participants reported pain relief1 by 2 hours after treatment, with 56% already reporting pain relief by one hour, and 35% were pain free by one hour

Authors stated that nVNS was safe, well tolerated and effective in many patients and may reduce medication overuse and medication associated adverse events

The study, in the July 2015 edition of The Journal of Headache and Pain2, reports that electroCore’s gammaCore non-invasive Vagus Nerve Stimulation (nVNS) treatment was effective in reducing pain levels in more than 65 percent of the patients after two hours – the primary endpoint. Furthermore 65 percent achieved at least a 50 percent reduction in pain.

Migraine is a highly disabling condition with many of the treatments having both unpleasant side effects and a risk of generating medication overuse headache, which is a paradoxical increase in headache frequency and severity as a result of overuse of pain medication. GammaCore is seen as a new, easy to use treatment that patients self-administer with very few side effects. This study is one of a series, including double blind, sham controlled trials, demonstrating that nVNS is effective for many patients in both the treatment and prevention of cluster and migraine headaches.

This European multicentre study involved 48 patients (34 chronic and 14 high-frequency migraneurs) who experienced mild to moderate attacks.  The patients self-treated a total of 131 attacks. Pain relief was reported for 51 percent of these attacks after two hours.

Professor Barbanti, an author of the study, commented “This trial continues to reinforce the results from previous studies which show that gammaCore appears effective for the acute treatment of migraine. Because it is well tolerated and is easy to use we hope that use of this therapy will help to decrease: patient’s reliance on medications that can cause side effects; safety concerns for some patients; and medication overuse complications.”

GammaCore is available through specialist headache and pain clinics across Canada, the EU and Australia. It is not yet available in the US.

1 Pain relief defined as more than 50 percent reduction in visual analog scale (VAS)
2 Barbanti et al. The Journal of Headache and Pain, 30th June 2015


About SeaKa Products Inc.  SeaKa is a Canadian importer and distributor of medical products based in Parksville, BC and the exclusive Canadian importer of the gammaCore non-invasive Vagus Nerve Stimulator.

gammaCore is available for sale to Canadian residents only on the written recommendation of Canadian clinicians familiar with and trained on the application of gammaCore therapy.

Please note that we are unable to provide gammaCore directly to patients who have not first been recommended by a healthcare provider.

Please use our Contact Form to request more information concerning gammaCore.

® of ElectroCore Medical LLC.

Posted in: Clinical Trials, Headache Articles, Journal Article, Migraines

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Presentation at International Headache Congress shows gammaCore nVNS treatment for chronic cluster headache to be cost-effective

electroCore’s gammaCore non-invasive vagus nerve stimulation (nVNS) therapy improves quality of life when added to standard of care (SOC)
gammaCore is cost-effective compared to other treatment options
gammaCore reduces acute medication usage, resulting in a 30% decrease in cost.

 18th May, 2015, Valencia, Spain; A poster at the International Headache Society meeting in Valencia, Spain1 demonstrated that treatment with electroCore’s nVNS treatment for chronic cluster headache, gammaCore®, was both clinically and cost-effective when used with standard of care. Cluster headache is one of the worst pain conditions known to medical science and has few preventative treatment options, many of which have severe side effects.

The poster presentation was based on the successful PREVA2 study, which involved 97 patients at ten sites across Europe. The patients were randomised into two arms – one using the gammaCore device plus the standard of care, and the other the standard of care alone. Patients using gammaCore had a 45% reduction in the number of weekly cluster headache attacks compared with 13% (p=0.0025) in patients treated with the best available standard of care.

The poster shows a 30% reduction in costs associated with acute treatments such as zolmitriptan, sumatriptan and inhaled oxygen, a saving in medication usage of approximately €2,383 per patient per year. Average total cost savings for nVNS treatment were €2,799 per patient per year (the per dose costs for the gammaCore device are now 28% lower as the company has launched a newer model containing a higher number of doses). This study did not look at the significant cost reduction potential associated resulting from fewer clinic visits by cluster headache patients.

The presentation also analysed the quality of life data using the EQ-5D™3– showing that standard of care plus gammaCore provided an average 16.5% improvement in patient’s quality of life.

Peter May of OUCH4 (the UK patient group for cluster patients) said “This data is very important in establishing that, not only is gammaCore’s nVNS treatment effective in preventing cluster attacks, but that it also reduces costs. We need this information so that we can encourage payors and doctors to use this new treatment particularly as our members have so few options and especially as gammaCore has no serious side effects.”

1 17th Congress of the International Headache Society, Valencia, Spain, 14th-17th May 2015
2 Prevention and Acute Treatment of Chronic Cluster Headache (PREVA); Authors: Charly Gaul, MD; Hans-Christoph Diener, MD, PhD; Kasja Solbach, MD; Andreas Straube, MD; Ozan Eren, MD; Uwe Reuter, MD, MBA; Stefan Evers, MD, PhD; Annelie Andersson; Eric J. Liebler
3 EQ-5D™ is a standardised instrument for use as a measure of health outcome.
4 Organization for Understanding Cluster Headaches (OUCH)


About SeaKa Products Inc.  SeaKa is a Canadian importer and distributor of medical products based in Parksville, BC and the exclusive Canadian importer of the gammaCore non-invasive Vagus Nerve Stimulator.

gammaCore is available for sale to Canadian residents only on the written recommendation of Canadian clinicians familiar with and trained on the application of gammaCore therapy.

Please note that we are unable to provide gammaCore directly to patients who have not first been recommended by a healthcare provider.

Please use our Contact Form to request more information concerning gammaCore.

® of ElectroCore Medical LLC.

Posted in: Clinical Trials, Cluster Headaches, GammaCore, Uncategorized

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Experts to discuss the science behind stimulating the body’s ‘superhighway’ – the vagus nerve

At the American Headache Society (AHS) annual meeting next week in Washington, DC, a panel of experts will explore groundbreaking research regarding the role of non-invasive stimulation of the vagus nerve (nVNS) in pain pathways.

The vagus nerve is a main conduit between the brain and the body’s major organs and the latest ground breaking research shows that non-invasive stimulation causes a broad range of physiologic effects that could be effective in treating a range of chronic disorders.

The panel, chaired by Dr Stephen Silberstein of Thomas Jefferson University, includes Dr Michael Oshinsky of the National Institute of Neurological Disorders and Stroke, Dr Cenk Ayata of the Massachusetts General Hospital, Harvard Medical School, and Dr Adam Farmer of Barts and the Royal London School of Medicine.

The topics covered will be the role of nVNS in headache physiology and beyond, the biological rationale and possible effect of VNS on neurotransmitter expression, the inhibitory effects of VNS on cortical spreading depression, and the potential role of VNS in reducing inflammation.

Surgically implanted vagus nerve stimulation has been an approved treatment for refractory epilepsy and depression for many years, but due to the cost – around $30,000 – it has been relegated to the end of the continuum of care. The cost and surgical procedures involved have also limited clinical research even though there are many reports in the literature of the beneficial effects VNS has on other conditions. electroCore’s development of non-invasive VNS has led to extensive research programs across a number of conditions in neurology, psychiatry, gastroenterology, and respiratory fields.

The symposium will take place at the Grand Hyatt Hotel in Washington, DC on Thursday June 18th from 12.45 to 2.00pm. The symposium is sponsored by electroCore. Anyone wishing to register should do so at www.vagussymposium.com


 

Posted in: Conference News, Uncategorized

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Researchers establish that vagus nerve stimulation is effective in suppressing cortical spreading depression, a trigger for migraine

Both non-invasive and surgically implanted vagus nerve stimulation (VNS) are equally effective in reducing cortical spreading depression (CSD), a trigger for headache.

A brief VNS reduces CSD in less than 30 minutes and lasts for more than three hours, much quicker than traditional, pharmaceutical, prophylactic migraine treatments.

14th May, 2015, Valencia, Spain; A poster presentation at the International Headache Congress1 in Valencia, Spain reports that VNS inhibits CSD, which is known to be the cause of migraine aura and a trigger for headache.

CSD is a local disturbance in the occipital cortex (a region of the brain), which is caused by a slowly propagating wave of depolarisation – suppression of electrical activity – spreading across the cortex.

The researchers determined that both surgically implanted and non-invasive VNS were just as effective at reducing CSD. They also found that VNS reduced CSD in 20 to 30 minutes as against the standard migraine prophylactic drugs, which took weeks to have a similar effect. (more…)

Posted in: Cortical Spreading Depression (CSD), GammaCore, Headache Articles, Migraines, Pre-clinical

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gammaCore® nVNS therapy shown to be safe and to produce no meaningful cardiac adverse effects

At the 67th American Academy of Neurology meeting in Washington, DC, last week a poster presentation showed that electroCore’s gammaCore non-invasive vagus nerve stimulation (nVNS) therapy does not cause any meaningful cardiovascular adverse effects in patients with asthma. The poster presentation, reported on the cardiac effects of nVNS in asthma patients using nVNS to treat acute bronchospasm. This study further reinforces the safety of nVNS shown in other clinical trials1 and experience with more than 1500 patients.

The open-label trial which was carried out at four centers across the US2 involved 284 ECGs being performed on 29 patients with a history of mild-to-moderate asthma. Each patient had a 12-lead electrocardiograms (ECGs) performed at 3 study visits: baseline, stimulation, and follow-up. During the stimulation visit, ECGs were performed prior to, during, and ≤90 minutes after administration of a single 120-second VNS stimulation.

The results showed that there were no clinically significant ECG changes, either in isolated readings or in comparison to baseline. Treatment with nVNS had no meaningful effect on heart rate, PR interval, corrected QT interval, or QRS duration. These findings were reviewed by an independent cardiologist. (more…)

Posted in: Cardiac Effects, Clinical Trials, Conference News, GammaCore, Safety

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Clinical study published in Neurology finds gammaCore® nVNS is effective in treating cluster headaches

Preventative use reduced mean attack frequency from 4.5 attacks every 24 hours to 2.6 after treatment

A twelve-month open-label study in the March issue of the journal Neurology reports that electroCore’s non-invasive Vagus Nerve stimulation (nVNS) device, gammaCore, is practical and effective as an acute and preventative treatment in cluster headache. Seventy-nine percent of patients who completed the trial (15 out of 19) reported an overall improvement in their condition.

The study into cluster headache, which is considered to be one of the most painful conditions known to medical science, was led by Professor Peter Goadsby1 and was conducted at the Royal Free Hospital in London and the Beaumont Hospital in Dublin.

Of the 25 patients enrolled 19 patients completed the study; 11 of whom had chronic cluster headache, and eight were classified as episodic. Seven of the chronic cluster patients were drug refractory – having previously failed to respond to at least five different preventative agents. Of all acute attacks treated, 47% were aborted within an average of 11 minutes. Ten patients reduced their acute use of high flow oxygen by 55% with nine reducing triptan use by 48%. Preventative use of the gammaCore device resulted in a substantial reduction in estimated mean attack frequency from 4.5 attacks every twenty-four hours to 2.6 after treatment.

Professor Peter Goadsby who is lead author of the paper commented:

“Cluster headache is a dreadful, extremely painful and disabling condition that can be very complex to manage. Given the unmet need for effective and safe treatments, we were excited to see the outcomes in these patients of an approach offering very considerable promise for future development.” (more…)

Posted in: Clinical Trials, Cluster Headaches, GammaCore, Journal Article

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A review in the European Journal of Neurology confirms that electroCore’s gammaCore® nVNS therapy is not only safe but could be effective across a wide range of conditions

Non-invasive vagus nerve stimulation (nVNS) ‘improves the safety and tolerability of VNS making it more accessible and facilitating further investigations across a wide range of uses when compared with surgically implanted VNS’1 according to a review in the European Journal of Neurology. The review then went on to look at the efficacy of both surgically implanted VNS and non-invasive VNS including electroCore’s gammaCore device.

Professor Stephen Silberstein of Thomas Jefferson University – one of the authors of the paper – commented “This review confirms that nVNS is safe and effective and because there is no surgery involved and because the costs are very competitive we believe it could open up a whole variety of conditions which have responded to vagus nerve stimulation.”
(more…)

Posted in: ElectroCore, GammaCore, Journal Article

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Trial reported in Headache and Pain journal further confirms the effectiveness of electroCore’s gammaCore® nVNS treatment for headache

Preliminary results of an open-label trial carried in the journal of Headache and Pain reported that a single treatment with electroCore’s hand held non-invasive vagus nerve stimulation (nVNS) device gammaCore, completely resolved 44.8% of migraines within 30 minutes, with an additional 11.4% experiencing moderate benefits (incomplete resolution of their headaches) by 2 hours.

This result follows two presentations at the International headache meeting in Copenhagen (EHMTIC) in September showing that patients using gammaCore plus standard of care achieved a 43.4% reduction in the number of weekly cluster headache attacks compared with 12.5% (p=0.002) in patients treated with the best available standard of care. It also found that patients experienced a greater reduction in number of attacks the longer they stayed on treatment. (more…)

Posted in: Clinical Trials, GammaCore, Headache Articles, Migraines

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Randomized data presented at international Headache Meeting (EHMTICi) shows gammaCore® nVNS significantly reduces cluster headache attack frequency – ‘the worst pain known to medical scienceii’

Basking Ridge, New Jersey: The biannual European Headache and Migraine Trust International Conference (EHMTIC) meeting concluded yesterday in Copenhagen, where more than 900 neurologists and other headache specialists came to hear about the latest advances in managing severe headache conditions, including electroCore’s gammaCore therapy. The attendees heard that a large scale randomized clinical trial of gammaCore therapy for treatment of chronic cluster headache both significantly reduced the number of cluster headache attacks beyond the best available standard of care and reduced the number of headache attacks the longer patients continued gammaCore therapy.

Treatment with gammaCore also resulted in meaningful improvements in quality of life and a reduction in the use of traditional rescue medications such as injectable sumatriptan and oxygen.

Cluster headache is a condition that affects approximately the same number of people as multiple sclerosis, and is considered by experts to be one of the most painful medical conditions known to medicine. gammaCore’s demonstrated effects represent a significant breakthrough in the care of patients with this debilitating condition. (more…)

Posted in: Clinical Trials, Cluster Headaches, Conference News, GammaCore

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Sham controlled pilot study shows electroCore’s gammaCore® nVNS therapy for the prevention of migraine is safe and reduces the number of headache days.

June 26, 2014, at the American Headache Society (AHS) meeting in California two poster presentations reported the results of the sham controlled pilot study that examined the use of electroCore’s gammaCore non invasive vagus nerve stimulation therapy (nVNS) to prevent chronic migraine. The study met its endpoint of safety, and also demonstrated a reduction in the number of headache days per month for patients using the active device. The study further suggests that patients who remained on therapy for longer periods of time, may enjoy progressively larger decreases in headache days over the period they are on therapy.

Professor Stephen Silberstein, Professor of Neurology at the Jefferson Medical College and Director of the Jefferson Headache Center commented: “In this pilot study we showed that nVNS was able to demonstrate an increasingly meaningful decrease in headache days in those patients who were treated with nVNS for a number of months. Our trial suggests that nVNS is a safe and effective alternative to drug therapies. I look forward to participating in larger studies in migraine to further confirm and expand on these findings.” The study which ran over nine months at six sites across the US comprised a run-in period of one month, a double-blind comparison period of two months, and an open-label phase of six months during which all patients used electroCore’s gammaCore device on daily basis to reduce the occurrence of their chronic migraines. The 59 adult migraine patients who were enrolled in the study had to have had more than 15 headache days per month in the three months preceding the trial, in accordance with the ICHD definition of Chronic Migraine. (more…)

Posted in: Clinical Trials, GammaCore, Migraines

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