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Cephalalgia. 2016 May;36(6):534-46. doi: 10.1177/0333102415607070. Epub 2015 Sep 21.

Non-invasive vagus nerve stimulation for PREVention and Acute treatment of chronic cluster headache (PREVA): A randomised controlled study.

Author information

1
Migraine and Headache Clinic, Königstein, Germany c.gaul@migraene-klinik.de.
2
Department of Neurology, University Hospital-Essen, Essen, Germany.
3
Walton Centre for Neurology and Neurosurgery, Liverpool, UK.
4
Liège University, Liège, Belgium.
5
Department of Neurology, Charité University Hospital, Berlin, Germany.
6
electroCore GMBH, Gothenburg, Sweden.
7
electroCore, LLC, Basking Ridge, NJ, USA.
8
Ludwig Maximilian University of Munich, Munich, Germany.

Abstract

BACKGROUND:

Chronic cluster headache (CH) is a debilitating disorder for which few well-controlled studies demon.strate effectiveness of available therapies. Non-invasive vagus nerve stimulation (nVNS) was examined as adjunctive prophylactic treatment of chronic CH.

METHODS:

PREVA was a prospective, open-label, randomised study that compared adjunctive prophylactic nVNS (n = 48) with standard of care (SoC) alone (control (n = 49)). A two-week baseline phase was followed by a four-week randomised phase (SoC plus nVNS vs control) and a four-week extension phase (SoC plus nVNS). The primary end point was the reduction in the mean number of CH attacks per week. Response rate, abortive medication use and safety/tolerability were also assessed.

RESULTS:

During the randomised phase, individuals in the intent-to-treat population treated with SoC plus nVNS (n = 45) had a significantly greater reduction in the number of attacks per week vs controls (n = 48) (-5.9 vs -2.1, respectively) for a mean therapeutic gain of 3.9 fewer attacks per week (95% CI: 0.5, 7.2; p = 0.02). Higher ≥50% response rates were also observed with SoC plus nVNS (40% (18/45)) vs controls (8.3% (4/48); p < 0.001). No serious treatment-related adverse events occurred.

CONCLUSION:

Adjunctive prophylactic nVNS is a well-tolerated novel treatment for chronic CH, offering clinical benefits beyond those with SoC.

KEYWORDS:

Neuromodulation; adjunctive prophylaxis; cluster headache; vagus nerve

PMID:
26391457
PMCID:
PMC4853813
DOI:
10.1177/0333102415607070
[Indexed for MEDLINE]
Free PMC Article

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