Summary

Eligibility
for people ages 18-80 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
completion around
Principal Investigator
by Peter Colvonen
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 Major Depressive Disorder (MDD) - Modius Mood Study

The aim of this study: To better evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS) as a method of treating major depressive disorder(MDD) , 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 170 participants. The study will last 10 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 Major Depressive Disorder (MDD) - Modius Mood Study

Keywords

Major Depressive Disorder \(MDD, Depressive Disorder, Major, VeNS, Depression, MDD, Vestibular stimulation, Depressive Disorder, Major Depressive Disorder, Active VeNS Device

Eligibility

You can join if…

Open to people ages 18-80

  1. Signed Informed Consent
  2. Adults, (US ≥ 22 years and ≤ 80 years, UK ≥ 18 years and ≤ 80 years) male or female at the time of signing informed consent
  3. Beck's Depression Inventory-ll (BDI-ll) score of ≥ 14 at Screening
  4. Established diagnosis of depression as confirmed at the time of screening by the Mini-International Neuropsychiatric Interview (MINI)
  5. A Generalized Anxiety Disorder (GAD-7) score <10 at screening
  6. On anti-depressant medication to treat depression (participant must only be on one Selective Serotonin or Norepinephrine Reuptake Inhibitor (SSRI/SNRI) for at least 1 year prior to baseline visit, and no longer than 5 years)
  7. Stable dose of current prescribed antidepressant (SSRI/SNRI) medication to treat depression, 3 months prior to baseline appointment
  8. Maintain a stable prescribed medication and/or treatment regime to treat depression for the duration of the trial
  9. No change in regular medication for the duration of the trial (unless directed by a health care provider).
  10. Can speak / read English
  11. Ability and willingness to complete all study visits and procedures; in particular an agreement to engage with trying to use the device per the study protocol
  12. Ability and willingness to adhere to 30 minutes usage of the device daily for the duration of the trial
  13. Access to Wi-Fi for the duration of the study
  14. Access to a computer, laptop, iPad, tablet or smartphone (to complete study visits and complete online study questionnaires)
  15. Willingness to use a video calling platform to conduct remote study visits
  16. Agree not to undergo any extreme lifestyle changes during the duration of the study that could impact mood e.g. dietary , exercise changes
  17. Agree not to begin any complimentary or alternative therapies that may affect your mood during the time on the study e.g use of mental health apps, CBT

You CAN'T join if...

  1. Risk of persistent self-harm or suicide as confirmed by the Columbia Suicide Severity Rating Scale (CSSRS)
  2. Diagnosis or history of bipolar disorder
  3. History of or a current psychotic disorder such as schizophrenia or other non-mood disorder psychosis
  4. Diagnosis of substance use disorder within the past 12 months or current substance use dependence
  5. Use of recreational drugs (e.g nalgesics, depressants, stimulants, and hallucinogens). Subject can enrol after a washout period of 30 days
  6. Female who is pregnant or breast-feeding
  7. History of diagnosed cognitive impairment / disorder such as delirium or dementia
  8. Previous or current diagnosis of a chronic viral infection, for example hepatitis or HIV (potential damage to vestibular system, known as vestibular neuropathy).
  9. History of stroke or head injury requiring intensive care or neurosurgery (potential damage to neurological pathways affected by vestibular stimulation)
  10. Presence of permanently implanted batterypowered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator, etc.)
  11. History of epilepsy
  12. History of severe tinnitus or vertigo
  13. History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
  14. History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)
  15. History of vestibular dysfunction or another inner ear disease
  16. Regular use (more than twice a month) of antihistamine medication within the last 6 months. The subject can opt to switch to Fexofenadine (non-drowsy) and may enrol after a wash-out period of 2 weeks
  17. Diagnosis of active migraines
  18. Previous use of Modius device or any VeNS device
  19. Participation in other clinical trials sponsored by Neurovalens
  20. Participation in any other depression studies at the time of enrolment and throughout this study duration
  21. Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.
  22. Failure to use device daily during trial participation (no more than 14 consecutive days usage drop without reasonable explanation)
  23. Persistent failure to comply with study protocol and procedures

Locations

  • VA San Diego Healthcare System
    San Diego California 92161 United States
  • Biomedical Science Research University of Ulster
    Belfast Co.Antrim BT52 1SA United Kingdom

Lead Scientist at UCSD

  • Peter Colvonen
    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
NCT06470035
Study Type
Interventional
Participants
Expecting 170 study participants
Last Updated