A Randomized, Double Blind, Sham-Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control for Generalized Anxiety Disorder.

Abstract

Aims and Objectives: It has been hypothesised that vestibular stimulation may have a modulatory effect on anxiety. The aim of this randomised, double blind, sham-controlled trial was to determine the efficacy and safety of a non-invasive electrical vestibular nerve stimulation (VeNS) device as a treatment for anxiety compared to a sham stimulation device. Materials and methods: A total of 60 participants (mean age [SD]: 35.6 [8.1]) with a generalized anxiety disorder assessment (GAD-7) score of ≥10 were randomised to receive either an active VeNS device (n = 34) or a sham control device (n = 26). Both groups were asked to complete 20 stimulation sessions (30 min duration) at a rate of 3-5 sessions per week at a research clinic. The primary outcome was change in GAD-7 score from baseline to the end of study (when each participant finished their 20 stimulation sessions). Secondary outcomes were change in Insomnia Severity Index (ISI), and the Short Form 36 Health Survey (SF-36) scores (8 domains). Results: One participant allocated to the sham group withdrew from the study. The mean (SD) number of weeks it took to complete the 20 stimulation sessions was 5.8. The active group had a statistically greater reduction in GAD-7 score compared to the sham group (-7.4 versus -2.2, P < .001; respectively). A total of 97% (n = 33) of the active group achieved a clinically meaningful reduction (defined as ≥4-point reduction) in GAD-7 from baseline to the follow up visit compared to 24% (n = 6) of the sham group (P < .001). Additionally, the active group showed a significant improvement in ISI (-4.9 versus 2.2, P < .001) and greater improvements on all eight SF36 domains (P < .001) compared with the sham group. There was no device related reported adverse events. Conclusion: Regular non-invasive electrical vestibular nerve stimulation appears to have a clinically meaningful benefit when used as an intervention for Generalized Anxiety Disorder.