Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for PTSD
NCT ID: NCT05242367
Last Updated: 2025-06-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
383 participants
INTERVENTIONAL
2023-02-13
2024-12-02
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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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.
Modius Spero active device
Battery powered non-invasive neurostimulation device
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.
Sham device
Placebo comparator sham device (no active stimulation)
Interventions
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Modius Spero active device
Battery powered non-invasive neurostimulation device
Sham device
Placebo comparator sham device (no active stimulation)
Eligibility Criteria
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Inclusion Criteria
* 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 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.
22 Years
80 Years
ALL
No
Sponsors
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University of California, San Diego
OTHER
Clinical Trial Mentors
INDUSTRY
Neurovalens Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Peter Colvonen, MD
Role: PRINCIPAL_INVESTIGATOR
UC San Diego
Locations
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VA San Diego Healthcare System
San Diego, California, United States
Countries
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Other Identifiers
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MS003
Identifier Type: -
Identifier Source: org_study_id
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