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

Hans-Christoph DienerPeter J GoadsbyMessoud AshinaMohammad Al-Mahdi Al-KaragholiAlexandra SinclairDimos MitsikostasDelphine MagisPatricia Pozo-RosichPablo Irimia SieiraMiguel Ja LàinezCharly GaulNicholas SilverJan HoffmannJuana MarinEric LieblerMichel D Ferrari

Published in: Cephalalgia : an international journal of headache (2019)

Preventive nVNS treatment in episodic migraine was not superior to sham stimulation in the ITT population. The "sham" device inadvertently provided a level of active vagus nerve stimulation. Post hoc analysis showed significant effects of nVNS in treatment-adherent patients. Study identification and registration: PREMIUM; NCT02378844; https://clinicaltrials.gov/ct2/show/NCT02378844.

Keyphrases

double blind
clinical trial
study protocol
placebo controlled
newly diagnosed
computed tomography
randomized controlled trial
magnetic resonance imaging
ejection fraction
phase ii
replacement therapy