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Neurology. 2018 Jul 24;91(4):e364-e373. doi: 10.1212/WNL.0000000000005857. Epub 2018 Jun 15.

Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study.

Author information

1
From the Headache Science Centre (C.T.), IRCCS C. Mondino Foundation, Pavia; University of Pavia (C.T.); Headache Center (L.G.), Carlo Besta Neurological Institute and Foundation, Milan; Neurophysiology and Pain Unit (M.d.T.), University of Bari Aldo Moro; Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) (G.P.), Istituto delle Scienze Neurologiche di Bologna; Department of Clinical and Molecular Medicine (P.M.), Sapienza University, Rome; Department of Neuroscience (I.R.), University of Turin, Italy; MedLogix Communications, LLC (S.D.), Itasca IL; Headache Centre (P.G.), University Hospital of Careggi, Florence; IRCCS Neuromed (A.A.), Pozzilli (IS); Neurologic Clinic (P.S.), Santa Maria della Misericordia Hospital, Perugia, Italy; electroCore, LLC (E.L.), Basking Ridge, NJ; and Headache and Pain Unit (P.B.), IRCCS San Raffaele Pisana, Rome, Italy. cristina.tassorelli@mondino.it.
2
From the Headache Science Centre (C.T.), IRCCS C. Mondino Foundation, Pavia; University of Pavia (C.T.); Headache Center (L.G.), Carlo Besta Neurological Institute and Foundation, Milan; Neurophysiology and Pain Unit (M.d.T.), University of Bari Aldo Moro; Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS) (G.P.), Istituto delle Scienze Neurologiche di Bologna; Department of Clinical and Molecular Medicine (P.M.), Sapienza University, Rome; Department of Neuroscience (I.R.), University of Turin, Italy; MedLogix Communications, LLC (S.D.), Itasca IL; Headache Centre (P.G.), University Hospital of Careggi, Florence; IRCCS Neuromed (A.A.), Pozzilli (IS); Neurologic Clinic (P.S.), Santa Maria della Misericordia Hospital, Perugia, Italy; electroCore, LLC (E.L.), Basking Ridge, NJ; and Headache and Pain Unit (P.B.), IRCCS San Raffaele Pisana, Rome, Italy.

Abstract

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 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.

CONCLUSION:

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.

CLINICALTRIALSGOV IDENTIFIER:

NCT02686034.

CLASSIFICATION OF EVIDENCE:

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%).

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