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

May 29, 2025 updated by: Neurovalens Ltd.

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

383

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161
        • VA San Diego Healthcare System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed informed consent
  • Diagnosed PTSD by a medical practitioner
  • Post-Traumatic Checklist (PCL-5) score or 31 or above
  • Eligibility confirmed via the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
  • Male or female, age ≥ 22 years and ≤ 80 years at the time of signing informed consent
  • Ability and willingness to complete all study visits and procedures, including completion of mental health questionnaires
  • Ability and willingness to adhere to 30 minutes usage of the device daily for the duration of the trial
  • Agreement not to start any new PTSD, mental health, or insomnia medications for the duration of the trial and/or to inform the study team if intending on starting any new PTSD, mental health, or insomnia medications
  • Agreement not to change any PTSD specific treatments for the duration of the trial e.g cognitive processing therapy
  • Agreement not to undergo any significant lifestyle changes that may affect sleep (e.g. excessive exercise, sleep interventions etc.) for the duration of the trial
  • Agreement not to use sleep trackers (e.g. Fitbit) for the duration of the trial
  • Agreement not to travel across different time zones for the duration of the trial
  • Access to Wi-Fi (for app to be able to upload usage data)
  • Access to computer, laptop, iPad or tablet (to conduct remote study visits and complete study questionnaires remotely)
  • Screening review by PTSD physician (study PI)
  • Willingness to download and use a video platform (e.g Zoom) to conduct remote study visits
  • Willingness to engage weekly with your Clinical Trial Mentor (CTM)

Exclusion Criteria:

  • History of skin breakdown, eczema, or other dermatological condition (e.g., psoriasis) affecting the skin behind the ears
  • History of severe tinnitus or vertigo
  • History or presence of malignancy within the last year
  • Use of beta-blockers within 1 month of starting the study
  • History of chronic viral infection that causes vestibular neuropathy (e.g., hepatitis or HIV)
  • Use of antihistamines
  • A history of stroke or severe head injury as defined by a head injury that required a craniotomy or endotracheal intubation (in case this damaged the neurological pathways involved in vestibular stimulation)
  • Taking H2-receptor antagonist medication
  • Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.)
  • Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method
  • Diagnosis of epilepsy
  • Diagnosis of active migraines
  • Previous use of Modius device
  • Participation in other research studies sponsored by Neurovalens
  • Participation in any other PTSD studies
  • Not fluent in English language
  • Have a member of the same household who is currently participating in this study
  • Failure to agree to use of device daily during study participation
  • Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active VeNS
The active device utilizes a technology termed vestibular nerve stimulation (VeNS). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day.
Device: Modius Spero active device
Battery powered non-invasive neurostimulation device
Sham Comparator: Sham VeNS
The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. It will apply some stimulation to a user for a limited period of time (30 seconds), before tapering down to zero over a further 20 seconds, thus creating the impression of an active device. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day.
Device: Sham device
Placebo comparator sham device (no active stimulation)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Posttraumatic Stress Disorder Checklist PCL-5 score
Time Frame: 12 weeks
To evaluate the effect of the Modius Sleep device, relative to control group, on the symptoms of PTSD, quantified by change in the PCL-5 Score.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
36-Item Short Form Survey (SF-36) score
Time Frame: 12 weeks
To evaluate the effect of the Modius Spero device, relative to control group, on quality of life quantified by change in SF-36 score.
12 weeks
Generalised Anxiety Disorder (GAD-7) score
Time Frame: 12 weeks
To evaluate the effect of the Modius Spero device, relative to control group, on anxiety, quantified by change in the GAD-7 score. GAD-7 is a self-report rating scale assessing the severity of anxiety (range 0-21), with higher score indicating more severe anxiety.
12 weeks
Insomnia Severity Index (ISI) score
Time Frame: 12 weeks
To evaluate the effect of the Modius Spero device, relative to control group, on participants with insomnia. ISI is a self-report rating scale assessing the severity of insomnia symptoms (range 0-28) with higher scores indicating a more severe insomnia.
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Neurovalens Ltd.

Collaborators

University of California, San Diego
Clinical Trial Mentors

Investigators

  • Principal Investigator: Peter Colvonen, MD, UC San Diego

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 13, 2023

Primary Completion (Actual)

December 2, 2024

Study Completion (Actual)

December 2, 2024

Study Registration Dates

First Submitted

February 9, 2022

First Submitted That Met QC Criteria

February 9, 2022

First Posted (Actual)

February 16, 2022

Study Record Updates

Last Update Posted (Actual)

June 4, 2025

Last Update Submitted That Met QC Criteria

May 29, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post Traumatic Stress Disorder

Clinical Trials on Modius Spero active device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Paraguay

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe