title: Migraine prevention with a supraorbital transcutaneous stimulator: a randomized controlled trial.
abstract: OBJECTIVE
  To assess efficacy and safety of trigeminal neurostimulation with a supraorbital transcutaneous stimulator (Cefaly, STX-Med., Herstal, Belgium) in migraine prevention.
  
  
  METHODS
  This 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.
  
  
  RESULTS
  Sixty-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.
  
  
  CONCLUSIONS
  Supraorbital 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.
  
  
  METHODS
  This study provides Class III evidence that treatment with a supraorbital transcutaneous stimulator is effective and safe as a preventive therapy for migraine.
authors: From the Headache Research Unit, Department of Neurology & GIGA-Neurosciences, Liège University, Citadelle Hospital, Liege, Belgium. jschoenen@ulg.ac.be
authors: Jean
authors: J
authors: Schoenen
authors: Bart
authors: B
authors: Vandersmissen
authors: Sandrine
authors: S
authors: Jeangette
authors: Luc
authors: L
authors: Herroelen
authors: Michel
authors: M
authors: Vandenheede
authors: Pascale
authors: P
authors: Gérard
authors: Delphine
authors: D
authors: Magis
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008881:Migraine Disorders / Q000517:prevention & control*; D050781:Transcranial Magnetic Stimulation; D016896:Treatment Outcome