A study has found that twice-daily stimulation of the vagus nerve with the hand-held gammaCore non-Invasive Nerve Stimulation (nVNS) device has reduced the number of headaches days per month from 14.7 to 8.9 (p<0.001) days per patient. The number of monthly migraine attacks observed was reduced from 7.3 to 4.5 (p<0.0001).
All patients in this study, which was published in the Journal of Headache and Pain, were identified as treatment-refractory, with 50% falling into the class of chronic migraineurs (migraines on 15 or more days per month), with the remaining being episodic (
Thomas Kinfe, the lead author and a member of the Division of Functional Neurosurgery and Neuromodulation at the University Hospital Bonn, comments, “We found a clinically meaningful response to the three months of prophylactic non-invasive vagus nerve stimulation, with significant reductions both in pain intensity and the number of headache days.”
The open-label trial enrolled twenty refractory patients who were defined by a failure to respond to at least four other classes of preventative medication, and treated them for three months. Treatment consisted of self-administration of nVNS using the gammaCore device, which was placed on the neck, over the vagus nerve, and activated for two minutes twice per day.
In this study, patients were also asked to report the intensity of their migraine attacks before and after treatment with nVNS. The median pain intensity, measured using the validated VAS scoring system, dropped from baseline by 50% (8.0–4.0, p<0.001) at the end of the study.
The study also examined other important migraine-related symptoms, including sleep disturbance and depression. The results showed that there were clinically meaningful improvements in migraine-associated disability, depression and sleep quality.