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

NCT05242367 | Completed

• 1 other identifier: MS003
• Study Type: interventional
• Target: 383
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Posttraumatic Stress Disorder Checklist PCL-5 score

  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 Outcomes (3)

• 36-Item Short Form Survey (SF-36) score

  12 weeks

• Generalised Anxiety Disorder (GAD-7) score

  12 weeks

• Insomnia Severity Index (ISI) score

  12 weeks

Study Arms (2)

Active VeNS

ACTIVE COMPARATOR

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

Sham VeNS

SHAM COMPARATOR

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

Interventions

Modius Spero active device DEVICE

Battery powered non-invasive neurostimulation device

Active VeNS

Sham device DEVICE

Placebo comparator sham device (no active stimulation)

Sham VeNS

Eligibility Criteria

• Age: 22 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Neurovalens Ltd.: lead
• University of California, San Diego: collaborator
• Clinical Trial Mentors: collaborator

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Peter Colvonen, MD

  UC San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2022
• First Posted: February 16, 2022
• Study Start: February 13, 2023
• Primary Completion: December 2, 2024
• Study Completion: December 2, 2024
• Last Updated: June 4, 2025

Record last verified: 2025-05

Locations

US (1)