反復性電気前庭神経刺激は中等症から重症の不安症患者の不安を軽減する：ランダム化、シャム対照試験：Modius Anxiety Study

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.

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).

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.

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).

VeNS is a low-risk, noninvasive therapy that has the potential to alleviate the symptoms of moderate-to-severe GAD.

The Clinicaltrials.gov registration number for the study is NCT05907967.