Non invasive vagus nerve stimulation for PREVention and Acute treatment of chronic cluster headache (PREVA) A randomised controlled study
Background Chronic cluster headache (CH) is a debilitating disorder for which few well controlled studies demonstrate 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.
Cephalalgia an international journal of headache