Summary

Eligibility
for people ages 22-80 (full criteria)
Healthy Volunteers
healthy people welcome
Dates
study started
estimated completion
Principal Investigator
by Peter Colvonen, MD
Headshot of Peter Colvonen
Peter Colvonen

Description

Summary

Trial tile: 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 100 participants. The study will last 12 weeks in total for each subject.

Official 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 Post- Traumatic Stress Disorder (PTSD)

Keywords

Post Traumatic Stress Disorder Stress Disorders, Traumatic Stress Disorders, Post-Traumatic Modius Spero active device

Eligibility

You can join if…

Open to people ages 22-80

  • Signed informed consent
  • Diagnosed PTSD by a medical practitioner
  • Post-Traumatic Checklist (PCL-5) score or 31 or above
  • Insomnia Severity Index (ISI) score of 15 or above
  • 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
  • No change to PTSD, mental health or insomnia medication within the past 3 months (regimen should be stable)
  • Agreement not to change usage of prescription or over the counter PTSD, mental health or insomnia medications for the duration of the trial
  • 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 CAN'T join if...

  • History of skin breakdown, eczema, or other dermatological condition (e.g., psoriasis) affecting the skin behind the ears
  • Previous diagnosis of HIV infection or AIDS (HIV is known to cause vestibular neuropathy which would prevent VeNS from working)
  • Use of beta-blockers within 1 month of starting the study
  • 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)
  • 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 sleep or 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
  • History of vestibular dysfunction or other inner ear disease
  • Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.

Lead Scientist at UCSD

  • Peter Colvonen, MD
    Dr. Colvonen received his B.A. from Wesleyan University and his Ph.D. from University of Illinois, Chicago. He completed his pre-doctoral internship at the University of California, San Diego/V.A. San Diego Healthcare System. After receiving his Ph.D., Dr. Colvonen completed a postdoctoral fellowship at UCSD focusing on PTSD treatments and Alcohol use disorder.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
Neurovalens Ltd.
ID
NCT05242367
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated