Status:
COMPLETED
Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for PTSD
Lead Sponsor:
Neurovalens Ltd.
Collaborating Sponsors:
University of California, San Diego
Clinical Trial Mentors
Conditions:
Post Traumatic Stress Disorder
Eligibility:
All Genders
22-80 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 13 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2024
Estimated Enrollment :
383 Patients enrolled
Trial Details
Trial ID
NCT05242367
Start Date
February 13 2023
End Date
December 2 2024
Last Update
June 4 2025
Active Locations (1)
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1
VA San Diego Healthcare System
San Diego, California, United States, 92161