ElectroCore has initiated enrolling patients in a clinical trial of its GammaCore nVNS therapy, designed for preventing chronic migraine.
The easy-to-use, non-invasive device, which enables self-administration of therapy, stimulates cervical branches of the vagus nerve and treats chronic migraine, cluster headache and medication overuse headache.
The sham-controlled study will randomize 60 patients to undergo three 180-second GammaCore treatments per day for two months.
The study will compare the frequency, duration, and severity of the migraines against a control group using a sham device, and against their own baseline data gathered prior to the initiation of the treatment protocol, according to the company.
Following the completion of the study’s initial phase, subjects will continue to use the prophylactic therapy for six additional months.
The study is expected to provide initial results during the first half of 2013.
ElectroCore CEO JP Errico said, "Positive results from this study will bring us one step closer to providing an important new treatment option to the more than seven million Americans who suffer from chronic migraine."