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Noninvasive vagus nerve stimulation as acute therapy for migraine

2018; Lippincott Williams & Wilkins; Volume: 91; Issue: 4 Linguagem: Inglês

10.1212/wnl.0000000000005857

1526-632X

Cristina Tassorelli, Licia Grazzi, Marina de Tommaso, Giulia Pierangeli, Paolo Martelletti, Innocenzo Rainero, Stefanie Dorlas, Pierangelo Geppetti, Anna Ambrosini, Paola Sarchielli, Eric Liebler, Piero Barbanti, Cristina Tassorelli, Vito Bitetto, Roberto De Icco, Daniele Martinelli, Grazia Sances, Monica Bianchi, Licia Grazzi, Anna Maria Padovan, Marina de Tommaso, Katia Ricci, Eleonora Vecchio, Pietro Cortelli, Sabina Cevoli, Giulia Pierangeli, Rossana Terlizzi, Paolo Martelletti, Andrea Negro, Gabriella Addolorata Chiariello, Innocenzo Rainero, Paola Martino, Annalisa Gai, Flora Govone, Federica Masuzzo, Elisa Rubino, Maria Claudia Torrieri, Alessandro Vacca, Pierangelo Geppetti, Alberto Chiarugi, Francesco De Cesaris, Simone Li Puma, Chiara Lupi, Ilaria M. Marone, Anna Ambrosini, Armando Perrotta, Paola Sarchielli, Laura Bernetti, Ilenia Corbelli, Michele Romoli, Simone Simoni, Angela Verzina, Piero Barbanti, Cinzia Aurilia, Gabriella Egeo, Luisa Fofi, Eric Liebler, Annelie Andersson, Lia Spitzer, Juana Marin, Candace K. McClure, Lisa Thackerey, Maria Giovanna Baldi, Daniela Di Maro,

Trigeminal Neuralgia and Treatments

To evaluate the efficacy, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS; gammaCore; electroCore, LLC, Basking Ridge, NJ) for the acute treatment of migraine in a multicenter, double-blind, randomized, sham-controlled trial.A total of 248 participants with episodic migraine with/without aura were randomized to receive nVNS or sham within 20 minutes from pain onset. Participants were to repeat treatment if pain had not improved in 15 minutes.nVNS (n = 120) was superior to sham (n = 123) for pain freedom at 30 minutes (12.7% vs 4.2%; p = 0.012) and 60 minutes (21.0% vs 10.0%; p = 0.023) but not at 120 minutes (30.4% vs 19.7%; p = 0.067; primary endpoint; logistic regression) after the first treated attack. A post hoc repeated-measures test provided further insight into the therapeutic benefit of nVNS through 30, 60, and 120 minutes (odds ratio 2.3; 95% confidence interval 1.2, 4.4; p = 0.012). nVNS demonstrated benefits across other endpoints including pain relief at 120 minutes and was safe and well-tolerated.This randomized sham-controlled trial supports the abortive efficacy of nVNS as early as 30 minutes and up to 60 minutes after an attack. Findings also suggest effective pain relief, tolerability, and practicality of nVNS for the acute treatment of episodic migraine.NCT02686034.This study provides Class I evidence that for patients with an episodic migraine, nVNS significantly increases the probability of having mild pain or being pain-free 2 hours poststimulation (absolute difference 13.2%).