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March 24, 2015; 84 (12) Article

Initial use of a novel noninvasive vagus nerve stimulator for cluster headache treatment

Alexander D. Nesbitt, Juana C.A. Marin, Esther Tompkins, Martin H. Ruttledge, Peter J. Goadsby
First published February 20, 2015, DOI: https://doi.org/10.1212/WNL.0000000000001394
Alexander D. Nesbitt
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.
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Juana C.A. Marin
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.
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Esther Tompkins
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.
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Martin H. Ruttledge
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.
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Peter J. Goadsby
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.
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Citation
Initial use of a novel noninvasive vagus nerve stimulator for cluster headache treatment
Alexander D. Nesbitt, Juana C.A. Marin, Esther Tompkins, Martin H. Ruttledge, Peter J. Goadsby
Neurology Mar 2015, 84 (12) 1249-1253; DOI: 10.1212/WNL.0000000000001394

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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.

Conclusion: 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.

Classification of evidence: 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.

GLOSSARY

nVNS=
noninvasive vagus nerve stimulation

Footnotes

  • Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.

  • Received July 8, 2014.
  • Accepted in final form December 3, 2014.
  • © 2015 American Academy of Neurology
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