Electrical vestibular system stimulation versus sham for treatment of post-traumatic stress disorder: a double-blind, randomized clinical trial

Abstract

In-home electrical vestibular system stimulation (VSS) represents a promising and underexplored approach to address core physiological dysregulation and arousal symptoms in post-traumatic stress disorder (PTSD). We conducted a fully remote, double-blind, placebo-controlled, nationally recruited 12-week superiority trial investigating the effects of a noninvasive VSS headset compared with a sham control headset in reducing PTSD symptoms. Participants were ≥22 years and ≤74 years old, diagnosed with PTSD and had at least current moderate severity of PTSD. The primary outcome was the PTSD Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5; mean 51.83, s.d. 12.91). Secondary outcomes were insomnia severity, quality of life and generalized anxiety. Overall, 383 participants were consented and randomized to an active VSS headset or sham (mean age 45.88 years, s.d. 10.67 years; 56.70% female). Both groups were advised to use the headset at home for 30 min per day for 12 weeks. The headsets are like headphones, with two self-adhesive electrode pads placed over the mastoid processes (VSS headset delivers participant-controlled 0.0–1.5 mA; sham delivers a 1-min ramp-up to 1.0 mA and back down to 0.0 mA). Mixed-effects models showed that the VSS group at 12 weeks had a larger decrease in PCL-5, with a 23.5-point decrease (12-week PCL-5 mean 27.3, s.d. 5.7), while the sham group had a 12.1-point decrease on the PCL-5 (12-week PCL-5 mean 35.7, s.d. 5.7). The VSS group had larger gains across all secondary outcomes. There were equal discontinuation rates between groups. There were minimal adverse events reported (9% had mild dizziness) with no differences between groups. Together, 12 weeks of in-home VSS is effective and safe, and shows strong potential as an accessible intervention that may reach a broad population seeking support for PTSD. ClinicalTrials.gov NCT05242367 . In-home electrical vestibular system stimulation offers a novel approach to mitigate physiological dysregulation and arousal symptoms in post-traumatic stress disorder (PTSD). Here the authors demonstrate that a 12-week regimen of noninvasive vestibular system stimulation significantly reduces PTSD symptoms and improves secondary outcomes, highlighting its potential as a safe, accessible intervention for widespread PTSD treatment.