title: Initial use of a novel noninvasive vagus nerve stimulator for cluster headache treatment.
abstract: OBJECTIVE
  To report our initial experience with a novel device, designed to provide portable, noninvasive, transcutaneous stimulation of the vagus nerve, both acutely and preventively, as a treatment for cluster headache.
  
  
  METHODS
  Patients with cluster headache (11 chronic, 8 episodic), from 2 centers, including 7 who were refractory to drug treatment, had sufficient data available for analysis in this open-label observational cohort study. The device, known as the gammaCore, was used acutely to treat individual attacks as well as to provide prevention. Patient-estimated efficacy data were collected by systematic inquiry during follow-up appointments up to a period of 52 weeks of continuous use.
  
  
  RESULTS
  Fifteen patients reported an overall improvement in their condition, with 4 reporting no change, providing a mean overall estimated improvement of 48%. Of all attacks treated, 47% were aborted within an average of 11 ± 1 minutes of commencing stimulation. Ten patients reduced their acute use of high-flow oxygen by 55% with 9 reducing triptan use by 48%. Prophylactic use of the device resulted in a substantial reduction in estimated mean attack frequency from 4.5/24 hours to 2.6/24 hours (p < 0.0005) posttreatment.
  
  
  CONCLUSIONS
  These data suggest that noninvasive vagus nerve stimulation may be practical and effective as an acute and preventive treatment in chronic cluster headache. Further evaluation of this treatment using randomized sham-controlled trials is thus warranted.
  
  
  METHODS
  This study provides Class IV evidence that for patients with cluster headache, transcutaneous stimulation of the vagus nerve aborts acute attacks and reduces the frequency of attacks.
authors.affiliation: From NIHR-Wellcome Trust Clinical Research Facility (A.D.N., J.C.A.M., P.J.G.), King's College London; Neurosciences Directorate (J.C.A.M.), Royal Free London NHS Foundation Trust; Surrey Sleep Research Centre (A.D.N.), University of Surrey, Guildford, UK; and Beaumont Hospital (E.T., M.H.R.), Dublin, Republic of Ireland.
authors.forename: Alexander D
authors.initials: AD
authors.lastname: Nesbitt
authors.affiliation: From NIHR-Wellcome Trust Clinical Research Facility (A.D.N., J.C.A.M., P.J.G.), King's College London; Neurosciences Directorate (J.C.A.M.), Royal Free London NHS Foundation Trust; Surrey Sleep Research Centre (A.D.N.), University of Surrey, Guildford, UK; and Beaumont Hospital (E.T., M.H.R.), Dublin, Republic of Ireland.
authors.forename: Juana C A
authors.initials: JC
authors.lastname: Marin
authors.affiliation: From NIHR-Wellcome Trust Clinical Research Facility (A.D.N., J.C.A.M., P.J.G.), King's College London; Neurosciences Directorate (J.C.A.M.), Royal Free London NHS Foundation Trust; Surrey Sleep Research Centre (A.D.N.), University of Surrey, Guildford, UK; and Beaumont Hospital (E.T., M.H.R.), Dublin, Republic of Ireland.
authors.forename: Esther
authors.initials: E
authors.lastname: Tompkins
authors.affiliation: From NIHR-Wellcome Trust Clinical Research Facility (A.D.N., J.C.A.M., P.J.G.), King's College London; Neurosciences Directorate (J.C.A.M.), Royal Free London NHS Foundation Trust; Surrey Sleep Research Centre (A.D.N.), University of Surrey, Guildford, UK; and Beaumont Hospital (E.T., M.H.R.), Dublin, Republic of Ireland.
authors.forename: Martin H
authors.initials: MH
authors.lastname: Ruttledge
authors.affiliation: From NIHR-Wellcome Trust Clinical Research Facility (A.D.N., J.C.A.M., P.J.G.), King's College London; Neurosciences Directorate (J.C.A.M.), Royal Free London NHS Foundation Trust; Surrey Sleep Research Centre (A.D.N.), University of Surrey, Guildford, UK; and Beaumont Hospital (E.T., M.H.R.), Dublin, Republic of Ireland. peter.goadsby@kcl.ac.uk.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Goadsby
mesh_terms: D000293:Adolescent; D000328:Adult; D000369:Aged, 80 and over; D003027:Cluster Headache / Q000517:prevention & control / Q000628:therapy*; D015331:Cohort Studies; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D063868:Patient Outcome Assessment; D016896:Treatment Outcome; D055536:Vagus Nerve Stimulation / Q000295:instrumentation* / Q000379:methods