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



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 300 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)


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


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.


  • 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.


accepting new patients
Start Date
Completion Date
Neurovalens Ltd.
Study Type
Expecting 300 study participants
Last Updated