Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine : The multicentre, double-blind, randomised, sham-controlled PREMIUM trial
Diener, Hans-Christoph (University Duisburg-Essen)
Goadsby, Peter J. (King's College London)
Ashina, Messoud (Glostrup University Hospital Copenhagen)
Al-Karagholi, Mohammad Al-Mahdi (Glostrup University Hospital Copenhagen)
Sinclair, Alexandra J. (Metabolic Neurology, Institute of Metabolism and Systems Research, University of Birmingham)
Mitsikostas, Dimos (1st National and Kapodistrian University of Athens)
Magis, Delphine (CHR East Belgium)
Pozo-Rosich, Patricia (Hospital Universitari Vall d'Hebron. Institut de Recerca)
Irimia Sieira, Pablo (Clínica Universidad de Navarra)
Làinez, Miguel J. A. (Universidad Católica de Valencia)
Gaul, Charly (Migraine and Headache Clinic)
Silver, Nicholas (The Walton Centre)
Hoffmann, Jan (King's College London)
Marin, Juana (King's College London)
Liebler, Eric (electroCore, Inc., Basking Ridge)
Ferrari, Michel D.. (Leiden University Medical Center)
Universitat Autònoma de Barcelona

Date:	2019
Abstract:	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. 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). 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 = 165; baseline, 7. 9 days) and 1. 80 for sham (n = 167; baseline, 8. 1 days) (p = 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 = 138) and sham (n = 140) for outcomes including reduction in migraine days (2. 27 vs. 1. 53; p = 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. 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;.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Neuromodulation ; Preventive therapy ; RCT ; Migraine prophylaxis ; Non-pharmacologic treatment ; Vagal activation
Published in:	Cephalalgia, Vol. 39 (september 2019) , p. 1475-1487, ISSN 1468-2982

DOI: 10.1177/0333102419876920
PMID: 31522546

13 p, 823.6 KB

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