MedTrace Logo

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

NCT05242367 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 383

Last updated 2025-06-04

No results posted yet for this study

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

DEVICE

Modius Spero active device

Battery powered non-invasive neurostimulation device

DEVICE

Sham device

Placebo comparator sham device (no active stimulation)

Sponsors & Collaborators

Principal Investigators

  • Peter Colvonen, MD · UC San Diego

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-13
Primary Completion
2024-12-02
Completion
2024-12-02

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05242367 on ClinicalTrials.gov