NCT05242367

Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for PTSD

A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control for Treatment of Post- Traumatic Stress Disorder (PTSD)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 383 (actual)
• Sponsor: Neurovalens Ltd. · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Trial title: A Randomized, Double Blind Sham Controlled Clinical Trial to Evaluate the Efficacy of Electrical Vestibular Nerve Stimulation (VeNS), Compared to a Sham Control for Treatment of PTSD The aim of this study: To better evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS) as a method of treating PTSD, as compared to a sham control. Allocation: Randomized to either active device or control device usage. Endpoint classification: Efficacy Study Intervention Model: Parallel Assignment in 1:1 active to control allocation Sample size: The aim is to recruit a total of up to 400 participants. The study will last 12 weeks in total for each subject.

Conditions

• Post Traumatic Stress Disorder

Interventions

Type	Name	Description
DEVICE	Modius Spero active device	Battery powered non-invasive neurostimulation device
DEVICE	Sham device	Placebo comparator sham device (no active stimulation)

Timeline

• Start date: 2023-02-13
• Primary completion: 2024-12-02
• Completion: 2024-12-02
• First posted: 2022-02-16
• Last updated: 2025-06-04

Locations

1 site across 1 country: United States