Randomised Controlled TrialtcVNSn = 477

Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial

Diener HC, Goadsby PJ, Ashina M, Al-Karagholi MAM, Sinclair A, Mitsikostas D, Magis D, Pozo-Rosich P, Irimia Sieira P, Làinez MJ, et al.

Cephalalgia · 2019

Key finding

Though the primary endpoint was not met, post hoc analysis of adherent patients showed significant benefit of nVNS for migraine prevention, with sham device inadvertently found to have parasympathetic activity.

Condition
Migraine
Stimulation
tcVNS
Evidence tier
Randomised Controlled Trial
Participants
477
View on DOI

Cite this study

Diener, H. C., Goadsby, P. J., Ashina, M., Al-Karagholi, M. A. M., Sinclair, A., Mitsikostas, D., Magis, D., Pozo-Rosich, P., Irimia Sieira, P., Làinez, M. J., Gaul, C., Silver, N., Hoffmann, J., Marin, J., Liebler, E., & Ferrari, M. D. (2019). Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial. Cephalalgia, 39(12), 1475-1487. https://doi.org/10.1177/0333102419876920

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