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 - 2021/10
Y1 - 2021/10
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 - Migraine
KW - devices
KW - neuromodulation
KW - recommendations
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U2 - 10.1177/03331024211010413
DO - 10.1177/03331024211010413
M3 - Article
C2 - 33990161
AN - SCOPUS:85105921587
SN - 0333-1024
VL - 41
SP - 1135
EP - 1151
JO - Cephalalgia
JF - Cephalalgia
IS - 11-12
ER -