Journal of affective disorders · 2025
A randomized, double-blind, sham controlled clinical trial to evaluate the efficacy of electrical vestibular stimulation (VeNS) for major depressive disorder.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Goothy Sai Sailesh Kumar, Singh Rohit, Reel Joseph, Robinson Rachel, Ratajczak Wiktoria, Watson Sinead, McKeown Jason
Аннотация
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.
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.