title: Treatment of chronic migraine with transcutaneous stimulation of the auricular branch of the vagal nerve (auricular t-VNS): a randomized, monocentric clinical trial.
abstract: BACKGROUND
  Aim of the study was assessment of efficacy and safety of transcutaneous stimulation of the auricular branch of the vagal nerve (t-VNS) in the treatment of chronic migraine.
  
  
  METHODS
  A monocentric, randomized, controlled, double-blind study was conducted. After one month of baseline, chronic migraine patients were randomized to receive 25 Hz or 1 Hz stimulation of the sensory vagal area at the left ear by a handhold battery driven stimulator for 4 h/day during 3 months. Headache days per 28 days were compared between baseline and the last month of treatment and the number of days with acute medication was recorded The Headache Impact Test (HIT-6) and the Migraine Disability Assessment (MIDAS) questionnaires were used to assess headache-related disability.
  
  
  RESULTS
  Of 46 randomized patients, 40 finished the study (per protocol). In the per protocol analysis, patients in the 1 Hz group had a significantly larger reduction in headache days per 28 days than patients in the 25 Hz group (-7.0 ± 4.6 vs. -3.3 ± 5.4 days, p = 0.035). 29.4 % of the patients in the 1 Hz group had a ≥50 % reduction in headache days vs. 13.3 % in the 25 Hz group. HIT-6 and MIDAS scores were significantly improved in both groups, without group differences. There were no serious treatment-related adverse events.
  
  
  CONCLUSIONS
  Treatment of chronic migraine by t-VNS at 1 Hz was safe and effective. The mean reduction of headache days after 12 weeks of treatment exceeded that reported for other nerve stimulating procedures.
authors.affiliation: Klinik und Poliklinik für Neurologie, Oberbayerisches Kopfschmerzzentrum, Klinikum Großhadern, Ludwig-Maximilians-Universität München, Marchioninistr. 15, 81377, Munich, Germany, Andreas.Straube@med.uni-muenchen.de.
authors.forename: Andreas
authors.initials: A
authors.lastname: Straube
authors.forename: J
authors.initials: J
authors.lastname: Ellrich
authors.forename: O
authors.initials: O
authors.lastname: Eren
authors.forename: B
authors.initials: B
authors.lastname: Blum
authors.forename: R
authors.initials: R
authors.lastname: Ruscheweyh
mesh_terms: D000328:Adult; D002908:Chronic Disease; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008881:Migraine Disorders / Q000175:diagnosis* / Q000628:therapy*; D059408:Pain Management / Q000379:methods*; D011446:Prospective Studies; D011795:Surveys and Questionnaires; D004561:Transcutaneous Electric Nerve Stimulation / Q000295:instrumentation / Q000379:methods*; D016896:Treatment Outcome; D014630:Vagus Nerve / Q000502:physiology*