Guidelines of the International Headache Society for clinical trials with neuromodulation devices for the treatment of migraine

ORCID
0000-0003-1513-2113
Affiliation
Headache Science & Neurorehabilitation Centre, IRCCS C. Mondino Foundation, Pavia, Italy
Tassorelli, Cristina;
GND
11811901X
ORCID
0000-0002-6556-8612
LSF
13450
Affiliation
Institute for Medical Informatics, Biometry and Epidemiology, University Duisburg-Essen, Essen, Germany
Diener, Hans-Christoph;
ORCID
0000-0001-9467-5567
Affiliation
Jefferson Headache Center, Thomas Jefferson University, Philadelphia, PA, USA
Silberstein, Stephen D.;
Affiliation
Department of Neurology, Mayo Clinic, Phoenix, AZ, USA
Dodick, David W.;
ORCID
0000-0003-3260-5904
Affiliation
National Institute for Health Research-Wellcome Trust King’s Clinical Research Facility, King’s College London, UK
Goadsby, Peter J.;
Affiliation
Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark
Jensen, Rigmor H.;
ORCID
0000-0002-4392-9413
Affiliation
Headache and Pain Clinic, CHR East Belgium, 4800 Verviers, Belgium
Magis, Delphine;
Affiliation
Headache Unit, Neurology Department, Vall d’Hebron University Hospital & Headache Research Group, Vall d’Hebron Research Institute, Universitat Autonoma de Barcelona, Barcelona, Spain
Pozo-Rosich, Patricia;
Affiliation
Jefferson Headache Center, Thomas Jefferson University, Philadelphia, PA, USA
Yuan, Hsiangkuo;
ORCID
0000-0001-6355-7947
Affiliation
Headache Science & Neurorehabilitation Centre, IRCCS C. Mondino Foundation, Pavia, Italy
Martinelli, Daniele;
Affiliation
Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands
Hoek, Thomas van den;
ORCID
0000-0001-7818-9841
Affiliation
Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark
Deen, Marie;
Affiliation
Danish Headache Center, Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Sciences, University of Copenhagen, Glostrup, Denmark
Ashina, Messoud;
Affiliation
Department of Neurology, Leiden University Medical Center, Leiden, the Netherlands
Terwindt, Gisela M

Background: Although the European Medicines Agency and the US Food and Drug Administration have cleared several devices that use neuromodulation to provide clinical benefits in the acute or preventive treatment of migraine, the Clinical Trials Committee of the International Headache Society has not developed guidelines specifically for clinical trials of neuromodulation devices. In recognition of the distinct needs and challenges associated with their assessment in controlled trials, the Committee provides these recommendations for optimizing the design and conduct of controlled trials of neuromodulation devices for the acute and/or preventive treatment of migraine.

Methods: An international group of headache scientists and clinicians with expertise in neuromodulation evaluated clinical trials involving neuromodulation devices that have been published since 2000. The Clinical Trials Committee incorporated findings from this expert analysis into a new guideline for clinical trials of neuromodulation devices for the treatment of migraine.

Results: Key terms were defined and recommendations provided relative to the assessment of neuromodulation devices for acute treatment in adults, preventive treatment in adults, and acute and preventive treatment in children and adolescents. Ethical and administrative responsibilities were outlined, and a bibliography of previous research involving neuromodulation devices was created.

Conclusions: Adoption of these recommendations will improve the quality of evidence regarding this important area in migraine treatment.

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© International Headache Society 2021

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