Skip to main content

EHMTI-0364. Non-invasive vagus nerve stimulation using gammacore® for prevention and acute treatment of chronic cluster headache: report from the randomized phase of the preva study

Introduction

Cluster headache (CH) is a painful and debilitating disorder for which non-invasive vagus nerve stimulation (nVNS) may be a treatment option.

Aim

Compare the efficacy of gammaCore®, a handheld nVNS device, with the standard of care (SoC) in chronic CH subjects in the randomized phase of the Prevention and Acute (PREVA) Treatment of Chronic Cluster Headache study.

Methods

PREVA was a multicenter study comprised of 3 phases: 2-week run-in, 4-week randomized (1:1; nVNS vs SoC), and 4-week extension. Subjects randomized to nVNS delivered stimulations prophylactically twice daily (mandatory) and optionally for the rescue treatment of CH attack. The primary efficacy end point was the reduction in number of CH attacks/week during the last 2 weeks of the randomized phase versus the run-in phase. Additional end points included the proportion of subjects with >50% reduction in CH attacks/week (response rate) and rescue medication use; safety was assessed by monitoring the frequency of adverse events.

Results

Ninety-seven subjects were randomized; data from 93 subjects (n=45 nVNS; n=48 SoC) were included in the intention-to-treat population. Number of CH attacks/week was significantly reduced in subjects treated with nVNS compared with patients treated with SoC only (-7.6 vs -2.0; P=.002). Further, significantly more nVNS- than SoC-treated subjects were considered treatment responders (34.4% vs 7.1%; P=.003). nVNS was associated with less use of rescue medications and demonstrated a favorable safety/tolerability profile.

Conclusion

Prophylactic treatment of chronic CH with nVNS is safe and, compared with SoC, reduces frequency of CH attacks/week. Sham-controlled studies are warranted and underway to confirm these data.

Abstract submitted on behalf of the PREVA Study Investigators.

Author information

Affiliations

Authors

Corresponding author

Correspondence to C Gaul.

Rights and permissions

Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (https://creativecommons.org/licenses/by/4.0), which permits use, duplication, adaptation, distribution, and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.

Reprints and Permissions

About this article

Verify currency and authenticity via CrossMark

Cite this article

Gaul, C., Diener, H., Solbach, K. et al. EHMTI-0364. Non-invasive vagus nerve stimulation using gammacore® for prevention and acute treatment of chronic cluster headache: report from the randomized phase of the preva study. J Headache Pain 15, I7 (2014). https://doi.org/10.1186/1129-2377-15-S1-I7

Download citation

Keywords

  • Cluster Headache
  • PREVA Study
  • Rescue Medication
  • Rescue Treatment
  • Headache Study