Chronic migraine headache prevention with noninvasive vagus nerve stimulation: The EVENT study

• Published in: Neurology Vol. 87; no. 5; p. 529
• Main Authors: Silberstein, Stephen D, Calhoun, Anne H, Lipton, Richard B, Grosberg, Brian M, Cady, Roger K, Dorlas, Stefanie, Simmons, Kristy A, Mullin, Chris, Liebler, Eric J, Goadsby, Peter J, Saper, Joel R
• Format: Journal Article
• Language: English
• Published: United States 02.08.2016
• Subjects: Adolescent; Adult; Aged; Double-Blind Method; Female; Headache Disorders - prevention & control; Humans; Male; Middle Aged; Migraine Disorders - prevention & control; Pilot Projects; Treatment Outcome; Vagus Nerve Stimulation - adverse effects; Young Adult
• ISSN: 1526-632X
• DOI: 10.1212/WNL.0000000000002918

To evaluate the feasibility, safety, and tolerability of noninvasive vagus nerve stimulation (nVNS) for the prevention of chronic migraine (CM) attacks. In this first prospective, multicenter, double-blind, sham-controlled pilot study of nVNS in CM prophylaxis, adults with CM (≥15 headache d/mo) entered the baseline phase (1 month) and were subsequently randomized to nVNS or sham treatment (2 months) before receiving open-label nVNS treatment (6 months). The primary endpoints were safety and tolerability. Efficacy endpoints in the intent-to-treat population included change in the number of headache days per 28 days and acute medication use. Fifty-nine participants (mean age, 39.2 years; mean headache frequency, 21.5 d/mo) were enrolled. During the randomized phase, tolerability was similar for nVNS (n = 30) and sham treatment (n = 29). Most adverse events were mild/moderate and transient. Mean changes in the number of headache days were -1.4 (nVNS) and -0.2 (sham) (Δ = 1.2; p = 0.56). Twenty-seven participants completed the open-label phase. For the 15 completers initially assigned to nVNS, the mean change from baseline in headache days after 8 months of treatment was -7.9 (95% confidence interval -11.9 to -3.8; p < 0.01). Therapy with nVNS was well-tolerated with no safety issues. Persistent prophylactic use may reduce the number of headache days in CM; larger sham-controlled studies are needed. NCT01667250. This study provides Class II evidence that for patients with CM, nVNS is safe, is well-tolerated, and did not significantly change the number of headache days. This pilot study lacked the precision to exclude important safety issues or benefits of nVNS.