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February 19, 2013; 80 (8) Article

Migraine prevention with a supraorbital transcutaneous stimulator

A randomized controlled trial

Jean Schoenen, Bart Vandersmissen, Sandrine Jeangette, Luc Herroelen, Michel Vandenheede, Pascale Gérard, Delphine Magis
First published February 6, 2013, DOI: https://doi.org/10.1212/WNL.0b013e3182825055
Jean Schoenen
From the Headache Research Unit (J.S., P.G., D.M.), Department of Neurology & GIGA–Neurosciences, Liège University, Citadelle Hospital, Liege; Department of Neurology (B.V.), CHU Erasme, University of Brussels & Clinique de l'Europe, Brussels; Department of Neurology (S.J.), CHU Charleroi, Charleroi; Department of Neurology (L.H.), AZ Gasthuisberg, Catholic University of Leuven, Leuven; and CHC Espérance Liège (M.V.), Montegnee, Belgium.
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Bart Vandersmissen
From the Headache Research Unit (J.S., P.G., D.M.), Department of Neurology & GIGA–Neurosciences, Liège University, Citadelle Hospital, Liege; Department of Neurology (B.V.), CHU Erasme, University of Brussels & Clinique de l'Europe, Brussels; Department of Neurology (S.J.), CHU Charleroi, Charleroi; Department of Neurology (L.H.), AZ Gasthuisberg, Catholic University of Leuven, Leuven; and CHC Espérance Liège (M.V.), Montegnee, Belgium.
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Sandrine Jeangette
From the Headache Research Unit (J.S., P.G., D.M.), Department of Neurology & GIGA–Neurosciences, Liège University, Citadelle Hospital, Liege; Department of Neurology (B.V.), CHU Erasme, University of Brussels & Clinique de l'Europe, Brussels; Department of Neurology (S.J.), CHU Charleroi, Charleroi; Department of Neurology (L.H.), AZ Gasthuisberg, Catholic University of Leuven, Leuven; and CHC Espérance Liège (M.V.), Montegnee, Belgium.
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Luc Herroelen
From the Headache Research Unit (J.S., P.G., D.M.), Department of Neurology & GIGA–Neurosciences, Liège University, Citadelle Hospital, Liege; Department of Neurology (B.V.), CHU Erasme, University of Brussels & Clinique de l'Europe, Brussels; Department of Neurology (S.J.), CHU Charleroi, Charleroi; Department of Neurology (L.H.), AZ Gasthuisberg, Catholic University of Leuven, Leuven; and CHC Espérance Liège (M.V.), Montegnee, Belgium.
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Michel Vandenheede
From the Headache Research Unit (J.S., P.G., D.M.), Department of Neurology & GIGA–Neurosciences, Liège University, Citadelle Hospital, Liege; Department of Neurology (B.V.), CHU Erasme, University of Brussels & Clinique de l'Europe, Brussels; Department of Neurology (S.J.), CHU Charleroi, Charleroi; Department of Neurology (L.H.), AZ Gasthuisberg, Catholic University of Leuven, Leuven; and CHC Espérance Liège (M.V.), Montegnee, Belgium.
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Pascale Gérard
From the Headache Research Unit (J.S., P.G., D.M.), Department of Neurology & GIGA–Neurosciences, Liège University, Citadelle Hospital, Liege; Department of Neurology (B.V.), CHU Erasme, University of Brussels & Clinique de l'Europe, Brussels; Department of Neurology (S.J.), CHU Charleroi, Charleroi; Department of Neurology (L.H.), AZ Gasthuisberg, Catholic University of Leuven, Leuven; and CHC Espérance Liège (M.V.), Montegnee, Belgium.
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Delphine Magis
From the Headache Research Unit (J.S., P.G., D.M.), Department of Neurology & GIGA–Neurosciences, Liège University, Citadelle Hospital, Liege; Department of Neurology (B.V.), CHU Erasme, University of Brussels & Clinique de l'Europe, Brussels; Department of Neurology (S.J.), CHU Charleroi, Charleroi; Department of Neurology (L.H.), AZ Gasthuisberg, Catholic University of Leuven, Leuven; and CHC Espérance Liège (M.V.), Montegnee, Belgium.
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Citation
Migraine prevention with a supraorbital transcutaneous stimulator
Jean Schoenen, Bart Vandersmissen, Sandrine Jeangette, Luc Herroelen, Michel Vandenheede, Pascale Gérard, Delphine Magis
Neurology Feb 2013, 80 (8) 697-704; DOI: 10.1212/WNL.0b013e3182825055

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This article has a correction. Please see:

  • Migraine prevention with a supraorbital transcutaneous stimulator: A randomized controlled trial - December 01, 2015
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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.

Classification of evidence: This study provides Class III evidence that treatment with a supraorbital transcutaneous stimulator is effective and safe as a preventive therapy for migraine.

GLOSSARY

ICHD=
International Classification of Headache Disorders;
ONS=
occipital nerve stimulation;
PREMICE=
PREvention of MIgraine using the STS Cefaly study;
STS=
supraorbital transcutaneous stimulator

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.

  • Editorial, page 694

  • Received April 23, 2012.
  • Accepted October 4, 2012.
  • © 2013 American Academy of Neurology
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Disputes & Debates: Rapid online correspondence

  • Addendum to "Migraine prevention with a supraorbital transcutaneous stimulator: a randomized controlled trial"
    • Jean E Schoenen, Co-Director Headache Research Unit
    Published October 01, 2015
  • Re:Do we need a method to pre-operatively predict the efficacy of STS?
    • Jean Schoenen, Professor
    • Jean Schoenen, Liege,BE; Bart Vandersmissen, Brussels, BE; Sandrine Jeangette, Charleroi,BE; Luc Herroelen, Leuven, BE; Michel Vandenheede, Liege, BE; Pascale Gerard, Liege, BE; Delphine Magis, Liege, BE.
    Published May 15, 2013
  • Do we need a method to pre-operatively predict the efficacy of STS?
    • Fan-gang Meng, Vice Director
    • Jian-guo Zhang
    Published March 07, 2013
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