• Jean Schoenen, Bart Vandersmissen, Sandrine Jeangette, Luc Herroelen, Michel Vandenheede, Pascale Gérard, and Delphine Magis.
• From the Headache Research Unit, Department of Neurology & GIGA-Neurosciences, Liège University, Citadelle Hospital, Liege, Belgium. jschoenen@ulg.ac.be
• Neurology. 2013 Feb 19;80(8):697-704.

ObjectiveTo assess efficacy and safety of trigeminal neurostimulation with a supraorbital transcutaneous stimulator (Cefaly, STX-Med., Herstal, Belgium) in migraine prevention.MethodsThis was a double-blinded, randomized, sham-controlled trial conducted at 5 Belgian tertiary headache clinics. After a 1-month run-in, patients with at least 2 migraine attacks/month were randomized 1:1 to verum or sham stimulation, and applied the stimulator daily for 20 minutes during 3 months. Primary outcome measures were change in monthly migraine days and 50% responder rate.ResultsSixty-seven patients were randomized and included in the intention-to-treat analysis. Between run-in and third month of treatment, the mean number of migraine days decreased significantly in the verum (6.94 vs 4.88; p = 0.023), but not in the sham group (6.54 vs 6.22; p = 0.608). The 50% responder rate was significantly greater (p = 0.023) in the verum (38.1%) than in the sham group (12.1%). Monthly migraine attacks (p = 0.044), monthly headache days (p = 0.041), and monthly acute antimigraine drug intake (p = 0.007) were also significantly reduced in the verum but not in the sham group. There were no adverse events in either group.ConclusionsSupraorbital transcutaneous stimulation with the device used in this trial is effective and safe as a preventive therapy for migraine. The therapeutic gain (26%) is within the range of those reported for other preventive drug and nondrug antimigraine treatments.Classification Of EvidenceThis study provides Class III evidence that treatment with a supraorbital transcutaneous stimulator is effective and safe as a preventive therapy for migraine.

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