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

Abstract

BackgroundEvidence 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.MethodsWe 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.ResultsThe 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.ConclusionsSignificant 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.Electronic supplementary materialThe online version of this article (10.1186/s10194-018-0936-1) contains supplementary material, which is available to authorized users.

Non-invasive vagus nerve stimulation (nVNS) for the preventive treatment of episodic migraine: The multicentre, double-blind, randomised, sham-controlled PREMIUM trial

“…In a previous open-label pilot study of 20 patients with migraine who received preventive and acute nVNS therapy for 3 months, the reduction in headache days per month was −5.8 days (15), which compares favourably with the headache day reduction in this study (−2.7 days) in which patients received preventive nVNS only. These clinical data are consistent with the mechanistic evidence supporting the potential synergy of acute and preventive nVNS treatment in migraine (15,22–24,34). The ability of nVNS to provide acute and preventive benefits would represent a novel clinical option, as pharmacologic migraine therapies are indicated only as either preventive or acute treatment.…”

Non-invasive vagus nerve stimulation for the acute treatment of episodic and chronic cluster headache: A randomized, double-blind, sham-controlled ACT2 study

“…No differences in the efficacy of nVNS as acute or preventive therapy were apparent between eCH and cCH subtypes, although not all treatment outcomes were formally compared between the CH subtypes. Benefits of individually adjusted dosing in patients with cCH are also supported by findings from a retrospective review of nVNS in patients with treatment-refractory CH ( 34 ). Such results are from open-label studies, but are nevertheless pertinent given that sustained improvements were noted in several patients with CH that had been refractory to treatment.…”

Non-invasive neuromodulation for migraine and cluster headache: a systematic review of clinical trials

“…The PREVA24 study indicated a significantly greater reduction in the number of attacks per week versus controls (−5.9 vs −2.1, respectively) for a mean therapeutic gain of 3.9 fewer attacks per week (p=0.02). Marin et al ’s25 study demonstrated a decrease in mean attack frequency from 26.6 attacks per week before initiation of nVNS treatment to 9.5 attacks per week (p<0.01) afterward.…”