Prevention of migraine by supraorbital transcutaneous neurostimulation using the Cefaly® device (PREMICE): a multi-centre, randomized, sham-controlled trial

Abstract

Introduction: Subjects who have frequent migraine attacks (> 2 / month) are in need of a preventive anti‐migraine treatment. Available preventive drugs have incomplete efficacy and/or unpleasant side effects. Purpose: Supraorbital transcutaneous neurostimulation (STNS) has shown encouraging results for migraine prevention in pilot studies and has no side effects [1‐3]. We assessed efficacy and safety of STNS in migraine prophylaxis with the Cefaly device in a multicentre, double‐blind, randomized, sham‐controlled trial. Methods: Five Belgian tertiary headache clinics participated to the study. After a 1‐month run‐in, patients with > 2 migraine attacks/month were randomized to verum or sham stimulation, and applied the Cefaly device daily for 20 minutes during 3 months. Primary outcome measures were change in monthly migraine days and 50% responder rate, i.e. the percentage of subjects having a > 50% reduction of monthly migraine days. Patients and enrolling neurologists were blinded from the randomization. Results: Sixty‐seven patients were randomized and included in the intention‐to‐treat analysis. Between run‐in and 3rd month of treatment the mean number of migraine days decreased significantly in the verum (4.88 vs 6.94; p=0.023), but not in the sham group (6.22 vs 6.54; 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 anti‐migraine 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. Conclusions: STNS with the Cefaly device is effective as a preventive therapy for migraine. The therapeutic gain (26%) is within the range of those reported for other preventive drug and non‐drug anti‐migraine treatments [45], and the safety profile is excellent.