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.
Highlights
Evidence supports the use of non-invasive vagus nerve stimulation as a promising therapeutic option for patients with cluster headache (CH)
The decision to pursue Individual funding request (IFR) submission for these subjects was at the discretion of physicians and patients, but submission was not encouraged for patients who did not achieve a ≥ 25% decrease in weekly attack frequency
Additional observations and outcomes In addition to the objective findings, some patients spontaneously reported subjective benefits of non-invasive vagus nerve stimulation (nVNS) that they considered meaningful. These included decreased interictal headache pain (n = 6), no longer being housebound (n = 6), the ability to return to work or school (n = 4), improved sleep (n = 4), decreased absenteeism (n = 4), avoidance of surgery intended to treat CH (n = 3), and improved quality of life (n = 3). In these patients with CH, headache burden as measured by attack frequency, duration, and severity significantly improved with nVNS therapy
Summary
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. A non-invasive vagus nerve stimulation (nVNS) device (gammaCore®) has demonstrated safety and efficacy for prevention and acute treatment of CH attacks in clinical trials [4,5,6]. The device is CE marked and indicated for acute and preventive therapy in CH and for treatment of migraine, hemicrania continua, and medication overuse headache in adults. The use of novel treatments in practice can provide data to complement those from clinical trials by documenting qualitative details that are not typically captured during such trials, enabling a real-world view of patient- and
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