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Papers: 15 May 2021 - 21 May 2021


2021 May 14


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


Tassorelli C, Diener H-C, Silberstein SD, Dodick DW, Goadsby PJ, Jensen RH, Magis D, Pozo-Rosich P, Yuan H, Martinelli D, van den Hoek T, Deen M, Ashina M, Terwindt GM
Cephalalgia. 2021 May 14:3331024211010413.
PMID: 33990161.


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.