Summary

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

Description

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 200 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, Traumatic Stress Disorders, Post-Traumatic Stress Disorders, 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
  • 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)

You CAN'T join 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
  • 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.

Location

  • VA San Diego Healthcare System accepting new patients
    San Diego California 92161 United States

Lead Scientist at University of California Health

  • Peter Colvonen, MD (ucsd)
    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
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Neurovalens Ltd.
ID
NCT05242367
Study Type
Interventional
Participants
Expecting 200 study participants
Last Updated