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dc.creatorDiener, H.C. (Hans Christoph)-
dc.creatorGoadsby, P.J. (Peter J.)-
dc.creatorAshina, M. (Messoud)-
dc.creatorAl-Mahdi-Al-Karagholi, M. (Mohammad)-
dc.creatorSinclair, A. (Alexandra)-
dc.creatorMitsikostas, D. (Dimos)-
dc.creatorMagis, D. (Delphine)-
dc.creatorPozo-Rosich, P. (P.)-
dc.creatorIrimia-Sieira, P. (P.)-
dc.creatorLàinez, M.J. (Miguel J.)-
dc.creatorGaul, C. (Charly)-
dc.creatorSilver, N. (Nicholas)-
dc.creatorHoffmann, J. (Jan)-
dc.creatorMarin, J. (Juana)-
dc.creatorLiebler, E. (Eric)-
dc.creatorFerrari, M.D. (Michel D.)-
dc.identifier.citationDiener, 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 - 1487es
dc.description.abstractIntroduction: 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.es_ES
dc.description.sponsorshipThe authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: This study was sponsored by electroCore, Inc. Employees of the sponsor were involved in study design, data collection, analysis, and interpretation. All authors, including an employee of the study sponsor, drafted and/or revised the manuscript and approved the final version for submission. Statistical analysis for the study conducted by North American Science Associates Inc. (Minneapolis, MN, USA) and editorial support from MedLogix Communications, LLC (Itasca, IL, USA) were funded by electroCore, Inc.es_ES
dc.publisherSAGE Publicationses_ES
dc.subjectPreventive therapyes_ES
dc.subjectMigraine prophylaxises_ES
dc.subjectNon-pharmacologic treatmentes_ES
dc.subjectVagal activationes_ES
dc.titleNon-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM triales_ES
dc.description.noteThis 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)es_ES

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