The study presented at the AAN meeting in Vancouver1 this week reported success in an open label study of 56 patients with menstrual migraine using nVNS. Menstrual migraine is one the most common causes of migraine in women and their attacks are typically longer lasting, more disabling, and less responsive to medications than non-menstrual migraine attacks. GammaCore not only reduced the average number of monthly migraine days by 35% (average of 7.2 per monthly cycle to 4.7), but also reduced the average pain intensity experienced, and thus also reduced the average use of rescue/analgesic medications used to treat the attacks per month by 38%.
“nVNS is an effective, safe, and well-tolerated treatment that reduced the number of headache days and use of acute rescue medication in women with menstrual and menstrually-related migraine in our study. GammaCore, which is self-administered by the patient, is portable, easy to use, and without any of the significant side effects of existing medications” commented Dr. Grazzi from the Headache Centre at the Carlo Besta Neurological Institute in Milan, Italy, who presented the study.
The other study, which was carried out in twelve healthy subjects, was presented by Professor Jean Schoenen of the Headache Research Unit at the University of Liege in Belgium, and showed that the targeted fibers in the vagus nerve presumed to be stimulated by the gammaCore nVNS device are in fact activated as previously expected. Prof. Schoenen commented, “This study provides strong evidence that nVNS stimulates afferent vagus nerve fibers [those going to the brain] non-invasively in humans.”
This research furthers the ongoing exploration of the benefits of treatment with nVNS, which has a well-established safety and tolerability profile. This is especially valuable in menstrual and menstrually-related migraine, as studies of pharmaceutical products have produced concerns regarding side effects in women of child-bearing years, drug-drug interactions, and acute medication overuse, which can exacerbate the frequency of migraine attacks. Since gammaCore is convenient and portable it removes two major barriers to the adoption of current VNS delivery devices: the expense (around $30,000) and the requirement to undergo a surgical procedure with the associated risks and side effects of surgery.
1 The 68th American Academy of Neurology Annual Meeting in Vancouver – 15th to 21st April.