Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial
Keywords: 
Neuromodulation
Preventive therapy
RCT
Migraine prophylaxis
Non-pharmacologic treatment
Vagal activation
Issue Date: 
2019
Publisher: 
SAGE Publications
OpenAIRE: 
info:eu-repo/grantAgreement/UKRI/MRC/MR%2FK015184%2F1/GB/MICA: Assessing the therapeutic efficacy of 11beta-hydroxysteroid dehydrogenase type 1 inhibitor (AZD4017) in idiopathic intracranial hypertension//
ISSN: 
0333-1024
Note: 
This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (http://www.creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access pages (https://us.sagepub.com/en-us/nam/open-access-at-sage)
Citation: 
Diener, H.C. (Hans Christoph); Goadsby, P.J. (Peter J.); Ashina, M. (Messoud); et al. "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), 2019, 1475 - 1487
Abstract
Introduction: Non-invasive vagus nerve stimulation (nVNS; gammaCore) has the potential to prevent migraine days in patients with migraine on the basis of mechanistic rationale and pilot clinical data. Methods: This multicentre study included a 4-week run-in period, a 12-week double-blind period of randomised treatment with nVNS or sham, and a 24-week open-label period of nVNS. Patients were to administer two 120-second stimulations bilaterally to the neck three times daily (6–8 hours apart). Results: Of 477 enrolled patients, 332 comprised the intent-to-treat (ITT) population. Mean reductions in migraine days per month (primary outcome) were 2.26 for nVNS (n ¼ 165; baseline, 7.9 days) and 1.80 for sham (n ¼ 167; baseline, 8.1 days) (p ¼ 0.15). Results were similar across other outcomes. Upon observation of suboptimal adherence rates, post hoc analysis of patients with 67% adherence per month demonstrated significant differences between nVNS (n ¼ 138) and sham (n ¼ 140) for outcomes including reduction in migraine days (2.27 vs. 1.53; p ¼ 0.043); therapeutic gains were greater in patients with aura than in those without aura. Most nVNS device-related adverse events were mild and transient, with application site discomfort being the most common. Conclusions: 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.

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