Electrical Vestibular Nerve Stimulation (VeNS) As a Treatment for PTSD
Purpose
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.
Condition
- Post Traumatic Stress Disorder
Eligibility
- Eligible Ages
- Between 22 Years and 80 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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 Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
|
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. |
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Recruiting Locations
More Details
- NCT ID
- NCT05242367
- Status
- Completed
- Sponsor
- Neurovalens Ltd.