Resum
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 = 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. 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. Study identification and registration: PREMIUM; NCT02378844; https://clinicaltrials.gov/ct2/show/NCT02378844.
Idioma original | Anglès |
---|---|
Pàgines (de-a) | 1475-1487 |
Nombre de pàgines | 13 |
Revista | Cephalalgia |
Volum | 39 |
Número | 12 |
DOIs | |
Estat de la publicació | Publicada - 1 d’oct. 2019 |
Fingerprint
Navegar pels temes de recerca de 'Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial'. Junts formen un fingerprint únic.Conjunts de dades
-
Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial
Diener, H.-C. (Col·laborador), Goadsby, P. J. (Creador), Ashina, M. (Col·laborador), Al-Karagholi, M.A.-M. (Creador), Sinclair, A. (Creador), Mitsikostas, D. (Creador), Magis, D. (Creador), Pozo-Rosich, P. (Creador), Irimia Sieira, P. (Col·laborador), Làinez, M. J. (Creador), Gaul, C. (Creador), Silver, N. (Creador), Hoffmann, J. (Creador), Marin, J. (Creador), Liebler, E. (Creador) & Ferrari, M. D. (Creador), SAGE Journals, 17 de set. 2019
DOI: 10.25384/sage.c.4668374.v1, https://sage.figshare.com/collections/Non-invasive_vagus_nerve_stimulation_nVNS_for_the_preventive_treatment_of_episodic_migraine_The_multicentre_double-blind_randomised_sham-controlled_PREMIUM_trial/4668374/1
Conjunt de dades