Results of a patient survey for an implantable neurostimulator to treat migraine headaches

Koen Paemeleire, Amy M. Goodman

Migraine attacks are believed to involve activation of the trigeminovascular system and trigeminal-parasympathetic reflex, which is mediated through the sphenopalatine ganglion (SPG). An implantable SPG neurostimulator has been developed to apply on-demand SPG stimulation for the treatment of severe primary headache. The neurostimulator is implanted via an oral incision and placed along the maxilla, with the lead placed at the SPG. The neurostimulator contains no battery and is powered and controlled via a handheld remote controller. The potential interest of patients with high-frequency, high-disability migraine in having a SPG neurostimulator implanted to treat migraine is unknown. We aimed to evaluate patient interest to undergo such an implantation procedure and to participate in a clinical investigation of on-demand SPG stimulation for migraine by conducting a survey at the Ghent University Hospital in 41 migraineurs. Seventy-seven percent (77%) of subjects expressed an interest in participating in a clinical investigation requiring implantation of a SPG neurostimulator when headache frequency and severity were considered and 69% when pain relief experienced with current migraine treatment was considered. Preventive and acute medications were used in 64 and 95% of the subjects, respectively, and provided a reported reduction of headache frequency, duration and pain. However, acute medications were frequently associated with headache recurrence and bothersome side effects. Results indicate that a majority of high-frequency, high-disability migraineurs, many of whom achieve pain relief with their current medications, have an interest in participating in a clinical investigation of an implantable SPG neurostimulator for the treatment of migraine headache.