The safety and preventive effects of a supraorbital transcutaneous stimulator in Japanese migraine patients.

Cefaly (Cefaly Technology, Seraing, Belgium) is a device that stimulates the bilateral supraorbital nerve transcutaneously. A previous study in Europe proved that Cefaly was an effective and safe device as a preventive therapy for migraine. However, there have been no studies on this device in Asia. We examined the safety and preventive effect of Cefaly for migraine. One-hundred patients were prospectively collected from four headache units in Japan. The inclusion criteria were as follows: 18-75 years of age, migraine with and without aura, and at least 2 attacks per month. A 4-week baseline period was followed by 12-week treatment period. The primary end point was the change from baseline in the number of migraine days at 12 weeks. The secondary end points include the changes of the number of migraine attacks, all headache days, acute medicine consumption days and headache severity. After treatment, a questionnaire survey on the satisfaction of the treatment was administered to the patients. The Friedmann test was used to assess the changes between baseline period and after treatment, and Mann-Whitney U test was used for the comparison of efficacy between chronic migraine and episodic migraine, with and without prophylactic treatment or medication overuse. After 12 weeks of treatment, Cefaly use significantly decreased the number of migraine days (8.16 vs. 6.84; p = 0.0036). Only three subjects (3.0%) dropped out due to the adverse effects; however, no serious adverse events were observed. The compliance of this study was very high at 90.0%. Furthermore, a significant decrease was observed in the number of migraine attacks (5.33 vs. 3.94; p = 0.0002) and the intake of acute antimigraine drugs (8.75 vs. 7.83; p = 0.0166). Cefaly is considered to be a safe and highly tolerable effective device for Japanese patients. Trial registration: This study was retrospectively registered to UMIN-CTR(UMIN000033333) on 10 July 2018.