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

PRESTO Study Group

Research output: Contribution to journalArticle

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%).

Original languageEnglish
Pages (from-to)e364-e373
JournalNeurology
Volume91
Issue number4
DOIs
Publication statusPublished - Jul 24 2018

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Vagus Nerve Stimulation
Migraine Disorders
Pain
Therapeutics
Randomized Controlled Trials
Migraine without Aura
Migraine with Aura
Logistic Models
Odds Ratio
Confidence Intervals
Safety

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

In: Neurology, Vol. 91, No. 4, 24.07.2018, p. e364-e373.

Research output: Contribution to journalArticle

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title = "Noninvasive vagus nerve stimulation as acute therapy for migraine: The randomized PRESTO study",
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{\%}).",
author = "{PRESTO Study Group} and Cristina Tassorelli and Licia Grazzi and {de Tommaso}, Marina and Giulia Pierangeli and Paolo Martelletti and Innocenzo Rainero and Stefanie Dorlas and Pierangelo Geppetti and Anna Ambrosini and Paola Sarchielli and Eric Liebler and Piero Barbanti",
note = "{\circledC} 2018 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.",
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T1 - Noninvasive vagus nerve stimulation as acute therapy for migraine

T2 - The randomized PRESTO study

AU - PRESTO Study Group

AU - Tassorelli, Cristina

AU - Grazzi, Licia

AU - de Tommaso, Marina

AU - Pierangeli, Giulia

AU - Martelletti, Paolo

AU - Rainero, Innocenzo

AU - Dorlas, Stefanie

AU - Geppetti, Pierangelo

AU - Ambrosini, Anna

AU - Sarchielli, Paola

AU - Liebler, Eric

AU - Barbanti, Piero

N1 - © 2018 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the American Academy of Neurology.

PY - 2018/7/24

Y1 - 2018/7/24

N2 - 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%).

AB - 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%).

U2 - 10.1212/WNL.0000000000005857

DO - 10.1212/WNL.0000000000005857

M3 - Article

C2 - 29907608

VL - 91

SP - e364-e373

JO - Neurology

JF - Neurology

SN - 0028-3878

IS - 4

ER -