作者
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, PRESTO Study Group, PRESTO Study Group
发表日期
2018/7/24
期刊
Neurology
卷号
91
期号
4
页码范围
e364-e373
出版商
Lippincott Williams & Wilkins
简介
Objective
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.
Methods
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.
Results
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 …
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C Tassorelli, L Grazzi, M De Tommaso, G Pierangeli… - Neurology, 2018
