Non-invasive vagus nerve stimulation for treatment of cluster headache: early UK clinical experience

J Headache Pain. 2018 Nov 23;19(1):114. doi: 10.1186/s10194-018-0936-1.


Background: Evidence supports the use of non-invasive vagus nerve stimulation (nVNS; gammaCore®) as a promising therapeutic option for patients with cluster headache (CH). We conducted this audit of real-world data from patients with CH, the majority of whom were treatment refractory, to explore early UK clinical experience with nVNS used acutely, preventively, or both.

Methods: We retrospectively analysed data from 30 patients with CH (29 chronic, 1 episodic) who submitted individual funding requests for nVNS to the National Health Service. All patients had responded to adjunctive nVNS therapy during an evaluation period (typical duration, 3-6 months). Data collected from patient interviews, treatment diaries, and physician notes were summarised with descriptive statistics. Paired t tests were used to examine statistical significance.

Results: The mean (SD) CH attack frequency decreased from 26.6 (17.1) attacks/wk. before initiation of nVNS therapy to 9.5 (11.0) attacks/wk. (P < 0.01) afterward. Mean (SD) attack duration decreased from 51.9 (36.7) minutes to 29.4 (28.5) minutes (P < 0.01), and mean (SD) attack severity (rated on a 10-point scale) decreased from 7.8 (2.3) to 6.0 (2.6) (P < 0.01). Use of abortive treatments also decreased. Favourable changes in the use of preventive medication were also observed. No serious device-related adverse events were reported.

Conclusions: Significant decreases in attack frequency, severity, and duration were observed in these patients with CH who did not respond to or were intolerant of multiple preventive and/or acute treatments. These real-world findings complement evidence from clinical trials demonstrating the efficacy and safety of nVNS in CH.

Keywords: Acute treatment; Chronic cluster headache; Neuromodulation; Non-invasive vagus nerve stimulation; Preventive therapy; Real-world data; Refractory.

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Analgesics / administration & dosage
  • Cluster Headache / diagnosis
  • Cluster Headache / epidemiology*
  • Cluster Headache / therapy*
  • Combined Modality Therapy / methods
  • Female
  • Humans
  • Male
  • Middle Aged
  • Retrospective Studies
  • Treatment Outcome
  • United Kingdom / epidemiology
  • Vagus Nerve Stimulation / economics
  • Vagus Nerve Stimulation / methods*
  • Young Adult


  • Analgesics