Al-Mahdi-Al-Karagholi, M. (Mohammad)

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    Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial
    (SAGE Publications, 2019) Silver, N. (Nicholas); Goadsby, P.J. (Peter J.); Ashina, M. (Messoud); Pozo-Rosich, P. (Patricia); Irimia, P. (Pablo); Diener, H.C. (Hans Christoph); Mitsikostas, D. (Dimos); Marin, J. (Juana); Hoffmann, J. (Jan); Liebler, E. (Eric); Ferrari, M.D. (Michel D.); Al-Mahdi-Al-Karagholi, M. (Mohammad); Sinclair, A. (Alexandra); Láinez, J.M. (J.M); Gaul, C. (Charly); Magis, D. (Delphine)
    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.