A Randomized, Multicenter, Study for the prEvention and Acute Treatment of Migraine (REAL)

A randomized study for the prevention and acute treatment of migraine using open label nVNS and standard of care versus standard of care. Eligible subjects will participate in a 4 week run-in period after which they will be randomized (1:1) to either nVNS and standard of care (nVNS group) or standard of care (SOC group) for 12 weeks. The nVNS group will use the nVNS device preventatively and acutely for the treatment of migraine. The SOC group will continue to use their regular standard of care migraine treatment medications for the duration of the 12 week randomized period.