TY - JOUR

T1 - Guidelines of the International Headache Society for clinical trials with neuromodulation devices for the treatment of migraine

AU - Tassorelli, Cristina

AU - Diener, Hans Christoph

AU - Silberstein, Stephen D.

AU - Dodick, David W.

AU - Goadsby, Peter J.

AU - Jensen, Rigmor H.

AU - Magis, Delphine

AU - Pozo-Rosich, Patricia

AU - Yuan, Hsiangkuo

AU - Martinelli, Daniele

AU - Hoek, Thomas van den

AU - Deen, Marie

AU - Ashina, Messoud

AU - Terwindt, Gisela M.

N1 - Publisher Copyright: © International Headache Society 2021.

PY - 2021

Y1 - 2021

N2 - 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.

AB - 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.

KW - devices

KW - Migraine

KW - neuromodulation

KW - recommendations

U2 - 10.1177/03331024211010413

DO - 10.1177/03331024211010413

M3 - Journal article

C2 - 33990161

AN - SCOPUS:85105921587

VL - 41

SP - 1135

EP - 1151

JO - Cephalalgia

JF - Cephalalgia

SN - 0800-1952

IS - 11-12

ER -