Ricerc@Sapienza

Besides having incomplete efficacy, acute and preventive migraine drug treatments have minor and major contraindications and side effects, frequently leading to patients’ dissatisfaction and treatment discontinuation. There is thus a need to explore new therapeutic approaches that have a better efficacy over side effect profile. Targeting different pathophysiological aspects, many nondrug treatments have been tested in migraine. Among them, noninvasive peripheral neurostimulation of the first division of the trigeminal nerve—central cornerstone to the initiation and maintenance of migraine pain and associated symptoms—has attracted much attention recently.

A transcutaneous external trigeminal nerve stimulation (eTNS) device called Cefaly®, developed and marketed by Cefaly Technology (Seraing, Liège, Belgium), has been approved for the acute and preventive treatment of migraine by the American Food and Drug Administration.

In a sham-controlled, double-blind randomized trial (the PREMICE trial), the efficacy of eTNS with Cefaly® was found to be comparable to that of prophylactic pharmacotherapies. More recently, eTNS was also proven to be effective as abortive therapy.

Possible mechanisms of action through which the device induces clinical improvement in migraine include short-term effects on the peripheral and long-term effects the central nervous system.