Nerve stimulation studies for migraine sufferers
Bioelectric pharma company electroCore is running two new trials of its gammaCore non-invasive vagus nerve stimulation (nVNS) therapy in episodic migraine. The first trial is focused on the prevention of migraine, while the second examines the efficacy of nVNS for the acute treatment of migraine attacks.
electroCore’s nVNS therapy is delivered by placing the gammaCore device against the neck over the vagus nerve, where the carotid pulse is located. When the active device stimulates the afferent fibres of the vagus nerve, which project into the brain stem, there is a rapid and sustained change in brain chemistry characterised by the release of inhibitory neurotransmitters and a decrease in the over-expression of the excitatory neurotransmitter glutamate. These sustained changes are believed to reduce the susceptibility of the individual to migraine attacks and also to provide pain relief from migraines, if present.
The migraine prevention study, which is being run at 22 sites in six countries across Europe, has so far enrolled over 200 of up to 400 patients. The primary objective of the trial is to compare the change in the number of migraine days experienced by those using the gammaCore treatment from the change experienced by patients using a sham therapy, specifically focusing on the change during the last four weeks of the 12-week randomised period as compared to the four-week run-in period.
The acute trial is recruiting at 10 sites across Italy, with the first patient of up to 250 having been enrolled in January. The primary outcome measure for this study is the pain-free rate for patients’ first migraine attacks, measured two hours after treatment.
Both trials are randomised, double-blind, parallel-group, sham-controlled studies. They are due to be completed in 2017.
“These studies are a continuation of our extensive scientific and clinical investigation of the effects of nVNS in headache,” said electroCore CEO JP Errico, referring to the company’s three recent studies of nVNS for the prevention and treatment of cluster headache. “We believe that the studies will confirm both the results of previous trials into the effectiveness of nVNS in treating migraine and clinical experiences already seen among patients using the therapy regularly.”
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