A randomized, double-blind, sham controlled clinical trial to evaluate the efficacy of electrical vestibular stimulation (VeNS) for major depressive disorder

Aims and objectives

Stimulating the vestibular nerve may influence neurological processes such as prefrontal cortex functions, aiding cognitive flexibility and emotional regulation, important aspects of addressing depressive patterns. This randomized, double-blind, sham-controlled trial aimed to determine the efficacy and safety of a non-invasive electrical vestibular nerve stimulation (VeNS) device as a treatment for major depressive disorder (MDD).

Materials and methods

62 adults (mean age = 43.1 ± 5.0 years) with MDD were randomized to receive an active VeNS device (n = 31) or a sham device (n = 31). Both groups attended the clinic for stimulation sessions (30 min) 5 days per week. The primary outcome was change in Beck's Depression Inventory (BDI-II) score from baseline to week 8. Secondary outcomes were change in Insomnia Severity Index (ISI), Generalized Anxiety Disorder, 7-item (GAD-7), and the EQ-5D-5L Health Utility Index (HUI) scores from baseline to week 8. A post-intervention follow-up was at week 12.

Results

After 8 weeks, the active group showed a mean BDI-II score reduction of 6.39 points greater than the sham group (P < 0.001), with scores remaining low during the 4-week post-intervention follow-up. Additionally, the active group, compared with the sham group, showed a significant improvement in ISI (−6.29 vs. 2.23, p < 0.001), GAD-7 (−4.45 vs. -0.32, p < 0.001) and HUI (0.51 vs 0.11, p < 0.001) One minor Adverse Event was reported in the sham group. Formal blinding assessment demonstrated a successful level of blinding was achieved throughout the study.

Conclusion

VeNS, when delivered over 8-weeks, appears to have a clinically meaningful benefit as an intervention for major depressive disorder.