US-based healthcare company ElectroCore has begun enrolling patients in a clinical trial of its non-invasive device designed for preventing chronic migraine.
The portable GammaCore nVNS device, which enables self-administration of therapy without a surgical procedure, stimulates cervical branches of the vagus nerve for treating chronic migraines, cluster headaches and medication-overuse headaches.
The sham-controlled study will randomise 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, as well as against their own baseline data gathered prior to the initiation of the treatment protocol.
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."