Skip to main page content
Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
, 91 (4), e364-e373

Noninvasive Vagus Nerve Stimulation as Acute Therapy for Migraine: The Randomized PRESTO Study

Collaborators, Affiliations
Randomized Controlled Trial

Noninvasive Vagus Nerve Stimulation as Acute Therapy for Migraine: The Randomized PRESTO Study

Cristina Tassorelli et al. Neurology.

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%).

Figures

Figure 1
Figure 1. Participant disposition
AE = adverse event; ITT = intent-to-treat; nVNS = noninvasive vagus nerve stimulation. *Other reasons for discontinuation included inability to fulfill visits because of injury, inability to continue the study because of family commitments, dissatisfaction with or discontinued/lack of use of the device, and noncompliance with study procedures.
Figure 2
Figure 2. Responder rates after the first treated attack during the double-blind period
(A) Pain freedom and (B) pain relief. CI = confidence interval; nVNS = noninvasive vagus nerve stimulation. Data for no. of participants in (A) are unadjusted numbers. *Statistically significant. **Primary endpoint.
Figure 3
Figure 3. Mean percentage pain score reductions
Changes are from baseline for the first treated attack in the double-blind period; post hoc analysis. CI = confidence interval; nVNS = noninvasive vagus nerve stimulation. *Statistically significant.
Figure 4
Figure 4. ≥50% responder rates at 120 minutes during the double-blind period
CI = confidence interval; nVNS = noninvasive vagus nerve stimulation. *Statistically significant. **Post hoc analysis.
Figure 5
Figure 5. Blinding
nVNS = noninvasive vagus nerve stimulation. *Inclusion of zero in the 95% confidence interval (CI) indicates successful blinding.

Similar articles

See all similar articles

Cited by 21 PubMed Central articles

See all "Cited by" articles

References

    1. Buse DC, Serrano D, Reed ML, et al. Adding additional acute medications to a triptan regimen for migraine and observed changes in headache-related disability: results from the American Migraine Prevalence and Prevention (AMPP) study. Headache 2015;55:825–839. - PubMed
    1. Puledda F, Goadsby PJ. An update on non-pharmacological neuromodulation for the acute and preventive treatment of migraine. Headache 2017;57:685–691. - PubMed
    1. Serrano D, Buse DC, Kori SH, et al. Effects of switching acute treatment on disability in migraine patients using triptans. Headache 2013;53:1415–1429. - PubMed
    1. Ferrari MD, Goadsby PJ, Roon KI, Lipton RB. Triptans (serotonin, 5-HT1B/1D agonists) in migraine: detailed results and methods of a meta-analysis of 53 trials. Cephalalgia 2002;22:633–658. - PubMed
    1. Lipton RB, Buse DC, Serrano D, Holland S, Reed ML. Examination of unmet treatment needs among persons with episodic migraine: results of the American Migraine Prevalence and Prevention (AMPP) study. Headache 2013;53:1300–1311. - PubMed

Publication types

Associated data

Feedback