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Transcutaneous supraorbital neurostimulation for the prevention of chronic migraine: a prospective, open-label preliminary trial

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Abstract

Since chronic migraine is difficult to treat and often associated with medication overuse, non-invasive neurostimulation approaches are worth investigating. Transcutaneous supraorbital neurostimulation using the Cefaly® device is promising as a non-invasive preventive treatment for episodic migraine, but no data are available for chronic migraine. Our aim was to perform a preliminary evaluation of the efficacy of the Cefaly® device for the prophylaxis of chronic migraine with or without medication overuse. Primary endpoints were 50% reduction in monthly migraine days and 50% reduction in monthly medication use over 4 months. In an open-label study, twenty-three consecutive headache center patients with chronic migraine, diagnosed according to International Headache Society criteria, were recruited prospectively. After informed consent, patients were trained to use Cefaly® and instructed to use it for 20 min daily over 4 months. All patients received active neurostimulation. Thirty-five percent of the patients enrolled in the study achieved the study endpoints. Over half the patients had a greater than 50% reduction in acute medication consumption.

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Authors and Affiliations

  1. Neurological and Stroke Unit Department, Headache Center, ASST Santi Paolo e Carlo, San Carlo Borromeo Hospital, Via Pio II, 3, 20153, Milan, Italy

    Paola Di Fiore, Alberto Galli & Fabio Frediani

  2. C. Besta Neurological Institute IRCCS Foundation and Igea Healthcare Institute, Milan, Italy

    Gennaro Bussone

  3. Maxillo-Facial and Dental Unit, Dental and Oral Surgery, Headache and Facial Pain Center, IRCCS Foundation Ca’ Granda, Ospedale Maggiore Policlinico, University of Milan, Milan, Italy

    Henri Didier

  4. LIMPE-DISMOV Academy, University La Sapienza, Rome, Italy

    Cesare Peccarisi

  5. Headache Center, Carlo Besta Neurological Institute and Foundation, Milan, Italy

    Domenico D’Amico

Authors
  1. Paola Di Fiore
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  2. Gennaro Bussone
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  3. Alberto Galli
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  4. Henri Didier
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  5. Cesare Peccarisi
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  6. Domenico D’Amico
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  7. Fabio Frediani
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Corresponding author

Correspondence to Paola Di Fiore.

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Funding

This study had no external funding source. Cefaly® devices were made available by the manufacturer (Cefaly Technology, Liège, Belgium) free of charge, for use in the study, Cefaly® Technology had no role in the design or conduct of the study

Conflict of interest

The authors certify that there is no actual or potential conflict of interest in relation to this article.

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Di Fiore, P., Bussone, G., Galli, A. et al. Transcutaneous supraorbital neurostimulation for the prevention of chronic migraine: a prospective, open-label preliminary trial. Neurol Sci 38 (Suppl 1), 201–206 (2017). https://doi.org/10.1007/s10072-017-2916-7

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  • DOI: https://doi.org/10.1007/s10072-017-2916-7

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