title: Safety and patients' satisfaction of transcutaneous supraorbital neurostimulation (tSNS) with the Cefaly® device in headache treatment: a survey of 2,313 headache sufferers in the general population.
abstract: BACKGROUND
  Transcutaneous supraorbital nerve stimulation (tSNS) with the Cefaly® device was recently found superior to sham stimulation for episodic migraine prevention in a randomized trial. Its safety and efficiency in larger cohorts of headache sufferers in the general population remain to be determined.The objective of this study was to assess the satisfaction with the Cefaly® device in 2,313 headache sufferers who rented the device for a 40-day trial period via Internet.
  
  
  METHODS
  Only subjects using specific anti-migraine drugs, and thus most likely suffering from migraine, were included in the survey. Adverse events (AEs) and willingness to continue tSNS were monitored via phone interviews after the trial period. A built-in software allowed monitoring the total duration of use and hence compliance in subjects who returned the device to the manufacturer after the trial period.
  
  
  RESULTS
  After a testing period of 58.2 days on average, 46.6% of the 2,313 renters were not satisfied and returned the device, but the compliance check showed that they used it only for 48.6% of the recommended time. The remaining 54.4% of subjects were satisfied with the tSNS treatment and willing to purchase the device. Ninety-nine subjects out of the 2,313 (4.3%) reported one or more AEs, but none of them was serious. The most frequent AEs were local pain/intolerance to paresthesia (47 subjects, i.e. 2.03%), arousal changes (mostly sleepiness/fatigue, sometimes insomnia, 19 subjects, i.e. 0.82%), headache after the stimulation (12 subjects, i.e. 0.52%). A transient local skin allergy was seen in 2 subjects, i.e. 0.09%.
  
  
  CONCLUSIONS
  This survey of 2,313 headache sufferers in the general population confirms that tSNS with is a safe and well-tolerated treatment for migraine headaches that provides satisfaction to a majority of patients who tested it for 40 days. Only 4.3% of subjects reported AEs, all of them were minor and fully reversible.
authors.affiliation: Headache Research Unit, University Department of Neurology, CHR Citadelle, Boulevard du 12eme de Ligne 1, 4000 Liege, Belgium. dmagis@chu.ulg.ac.be.
authors.forename: Delphine
authors.initials: D
authors.lastname: Magis
authors.forename: Simona
authors.initials: S
authors.lastname: Sava
authors.forename: Tullia Sasso
authors.initials: TS
authors.lastname: d'Elia
authors.forename: Roberta
authors.initials: R
authors.lastname: Baschi
authors.forename: Jean
authors.initials: J
authors.lastname: Schoenen
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004599:Electric Stimulation Therapy / Q000009:adverse effects* / Q000379:methods*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000517:prevention & control*; D010349:Patient Compliance / Q000706:statistics & numerical data; D017060:Patient Satisfaction / Q000706:statistics & numerical data*; D055815:Young Adult