1. Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study
- Author
-
Tassorelli, C, Grazzi, L, de Tommaso, M, Pierangeli, G, Martelletti, P, Rainero, I, Dorlas, S, Geppetti, P, Ambrosini, A, Sarchielli, P, Liebler, E, Barbanti, P, PRESTO Study Group (Tassorelli, C, Bitetto, V, De Icco, R, Martinelli, D, Sances, Giuseppe, Bianchi, M, Padovan, Anna Maria, Ricci, Katia Ivana, Vecchio, E, Cortelli, Pietro, Cevoli, S, Terlizzi, R, Negro, A, Chiariello, Ga, De Martino, P, Gai, A, Govone, F, Masuzzo, Federica, Rubino, E, Torrieri, MARIA CLAUDIA, Vacca, A, Chiarugi, A, De Cesaris, F, Puma, Sl, Lupi, C, Marone, Isabella, Perrotta, A, Bernetti, L, Corbelli, I, Romoli, M, Simoni, S, Verzina, A, Aurilia, C, Egeo, G, Fofi, L, Andersson, A, Spitzer, L, MARIN ACUNA, JANET MILAGROS, Mcclure, C, Thackerey, L, Baldi, Mg, Di Maro, D. )., Tassorelli, Cristina, Grazzi, Licia, de Tommaso, Marina, Pierangeli, Giulia, Martelletti, Paolo, Rainero, Innocenzo, Dorlas, Stefanie, Geppetti, Pierangelo, Ambrosini, Anna, Sarchielli, Paola, Liebler, Eric, Barbanti, Piero, and Cortelli, Pietro
- Subjects
Male ,Aura ,triptans serotonin ,medicine.medical_treatment ,diclofenac potassium ,efficacy ,law.invention ,0302 clinical medicine ,Randomized controlled trial ,law ,Clinical endpoint ,Medicine ,migraine ,030212 general & internal medicine ,Prospective Studies ,Prospective cohort study ,5-ht1b/1d agonists ,Pain Measurement ,Middle Aged ,Treatment Outcome ,Tolerability ,controlled-trial ,Anesthesia ,Female ,double-blind ,headache ,Vagus nerve stimulation ,Adult ,Vagus Nerve Stimulation ,Migraine Disorders ,open-label ,Article ,03 medical and health sciences ,Double-Blind Method ,prevention ampp ,vagus nerve ,Humans ,tolerability ,migraine therapy ,neurology (clinical) ,business.industry ,Odds ratio ,medicine.disease ,Migraine ,Neurology (clinical) ,business ,030217 neurology & neurosurgery - Abstract
ObjectiveTo 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.MethodsA 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.ResultsnVNS (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.ConclusionThis 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.ClinicalTrials.gov identifierNCT02686034.Classification of evidenceThis 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%).
- Published
- 2018