Repeated Electrical Vestibular Nerve Stimulation Reduces Anxiety in People With Moderate-to-Severe Anxiety: A Randomized, Sham-Controlled Trial: The Modius Anxiety Study

BACKGROUND: Generalized anxiety disorder (GAD) affects approximately 4% of the global population. Current treatment methods, for example, pharmacology and psychotherapy, are insufficient owing to side effects and a lack of efficacy and accessibility, highlighting the need for better therapeutic options. Studies have identified electrical vestibular nerve stimulation (VeNS) as a potential novel treatment method. OBJECTIVES/HYPOTHESIS: Participants using a VeNS device will show superior improvement in GAD (GAD-7) score after 28 days of use to those receiving sham stimulation. Secondary outcomes were change in Insomnia Severity Index (ISI) and the 36-Item Short Form Health Survey (SF-36) scores (eight components). MATERIALS AND METHODS: In this double-blind, randomized, sham-controlled study, N = 87 participants with a GAD-7 score ≥10 were allocated a VeNS or sham device (1:1 ratio). Participants were asked to complete daily 30-minute stimulation sessions at home for 28 days. Data were statistically analyzed using an intention-to-treat approach. RESULTS: The change in GAD-7 score from baseline to day 28 in those who presented at baseline with a GAD-7 score ≥5 was not statistically significant between the sham and treatment groups (3.90 ± 4.09 and 4.95 ± 4.32, sham and treatment groups, respectively; p = 0.269). Subgroup analysis of participants with moderate/severe GAD (GAD-7 score ≥10) showed a significantly greater improvement in GAD-7 score in the treatment group than in the sham group (intention to treat p = 0.045). There was no significant difference between intervention groups in improvement in either ISI score or SF-36 components in the moderate/severe anxiety group (GAD-7 score ≥10). CONCLUSIONS: VeNS is a low-risk, noninvasive therapy that has the potential to alleviate the symptoms of moderate-to-severe GAD. CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT05907967.