A new sham-controlled pilot study on non-invasive vagus nerve stimulation (nVNS), recently published in Neurology, has found that nVNS therapy can reduce the number of headache days per month for chronic migraine patients. The study also found that patients who remained on nVNS therapy for longer periods of time enjoy progressively larger decreases in headache. Given the need for novel preventative therapies and the high cost of the currently approved medication for chronic migraine, nVNS may be a safe, well-tolerated, and cost-effective treatment for chronic migraine patients (p.7-8 Neurology).
In the initial two month comparative phase of the study, where patients using gammaCore nVNS were compared to patients using a sham device, there was a decrease of 1.9 headache days per 28 days with three nVNS treated patients having more than a 50% decrease, and one having a 75% decrease in headache days. No sham control patients achieved a significant reduction. During the next phase the drop in headache days continued to grow, with patients originally randomized to the active therapy, and remaining on therapy through the full six-month open label phase, experiencing nearly an eight day drop in headache days per month. Among the entire group of patients remaining on therapy for the defined six months, 88.5% were satisfied with the treatment, and 38% experienced a more than 50% reduction in headache days per month.
Migraine is a disabling neurological headache disorder with symptoms including nausea, vomiting, and increased sensitivity to light and sound. Patients who suffer from chronic migraine have 15 or more headache days per month, compared to the far more common condition of episodic migraine, where patients have <15 headache days a month. Chronic migraine patients experience greater disability and reduced productivity in comparison to episodic migraine patients. There are currently very few effective treatment options to prevent chronic migraine, and many of them are expensive, painful, and/or risk serious side effects. By comparison, electroCore’s gammaCore nVNS therapy is more cost-effective and safer. Chronic migraine is estimated to affect about 2% of Americans, roughly 7 million people.
The lead author of the EVENT study, 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 progressively more 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 with the gammaCore nVNS therapy to further confirm and expand on these findings.” Since the completion of this study electroCore has begun two new large studies into the effects of nVNS at preventing and treating migraine.
• electroCore LLC was founded in 2005 and is based in New Jersey, USA.
• ElectroCore’s gammaCore device is approved for the treatment of multiple conditions in neurology, psychiatry, respiratory, and other fields. Initial focus is on primary headache (migraine and cluster headache), with trials continuing in gastric motility disorders and inflammation.