Electrical Vestibular Nerve Stimulation (VeNS) as a Treatment for Major Depressive Disorder (MDD)

NCT06470035 | Not Yet Recruiting FDA Device

• 1 other identifier: MMS002
• Study Type: interventional
• Target: 170
• Locations: 2 countries
• Sites: 2

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 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

Conditions

Major Depressive Disorder \(MDD; Depressive Disorder, Major

Keywords

VeNS; Depression; MDD; Vestibular stimulation

Outcome Measures

Primary Outcomes (2)

• Hamilton Depression Rating Scale (HDRS-17)

  The HDRS (also known as the HAM-D) is the most widely used clinician-administered depression assessment scale. The original version contains 17 items (HDRS-17) pertaining to symptoms of depression experienced over the past week. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale. The HDRS-17 scoring shall be the Primary Outcome of the study and will be completed at baseline and each study visit.

  Change in score from baseline to 6 weeks

• Hamilton Depression Rating Scale (HDRS-17)

  The HDRS (also known as the HAM-D) is the most widely used clinician-administered depression assessment scale. The original version contains 17 items (HDRS-17) pertaining to symptoms of depression experienced over the past week. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale. The HDRS-17 scoring shall be the Primary Outcome of the study and will be completed at baseline and each study visit. The proportion (%) of participants achieving the HDRS-17 minimal clinically important difference (≥3 point reduction) by the 6-week time point between the active and sham groups.

  6 weeks

Secondary Outcomes (5)

• WHO Disability Assessment Schedule 2.0 (WHODAS2)

  Change in score from baseline to 6 weeks

• Insomnia Severity Index (ISI)

  Change in score from baseline to 6 weeks

• Quality of Life (EQ-5D-5L)

  Change in score from baseline to 6 weeks

• Hamilton Depression Rating Scale (HDRS-17)

  Change in score at 4 week post-intervention timepoint

• WHO Disability Assessment Schedule 2.0 (WHODAS2)

  Change in score at 4 week post-intervention timepoint

Study Arms (2)

Active VeNS

EXPERIMENTAL

The active device utilizes a technology termed vestibular nerve stimulation (VeNS). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day.

Device: Active VeNS Device

Sham VeNS

SHAM COMPARATOR

The sham device looks identical to the active device and interacts with the app in a similar manner to the active device. The device will be placed on the head in a manner analogous to headphones with hydrogel electrodes placed over the mastoid processes. Participants will be advised to use the device at home for 30 minutes per day.

Device: Sham VeNS Device

Interventions

Active VeNS Device DEVICE

Battery powered non-invasive neurostimulation device

Also known as: Modius Mood

Active VeNS

Sham VeNS Device DEVICE

Placebo comparator sham device (no active stimulation)

Sham VeNS

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent
• Adults, (US ≥ 22 years and ≤ 80 years, UK ≥ 18 years and ≤ 80 years) male or female at the time of signing informed consent
• Beck's Depression Inventory-ll (BDI-ll) score of ≥ 14 at Screening
• Established diagnosis of depression as confirmed at the time of screening by the Mini-International Neuropsychiatric Interview (MINI)
• A Generalized Anxiety Disorder (GAD-7) score \<10 at screening
• 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)
• Stable dose of current prescribed antidepressant (SSRI/SNRI) medication to treat depression, 3 months prior to baseline appointment
• Maintain a stable prescribed medication and/or treatment regime to treat depression for the duration of the trial
• No change in regular medication for the duration of the trial (unless directed by a health care provider).
• Can speak / read English
• 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
• Ability and willingness to adhere to 30 minutes usage of the device daily for the duration of the trial
• Access to Wi-Fi for the duration of the study
• Access to a computer, laptop, iPad, tablet or smartphone (to complete study visits and complete online study questionnaires)
• Willingness to use a video calling platform to conduct remote study visits

You may not qualify if:

• Risk of persistent self-harm or suicide as confirmed by the Columbia Suicide Severity Rating Scale (CSSRS)
• Diagnosis or history of bipolar disorder
• History of or a current psychotic disorder such as schizophrenia or other non-mood disorder psychosis
• Diagnosis of substance use disorder within the past 12 months or current substance use dependence
• Use of recreational drugs (e.g nalgesics, depressants, stimulants, and hallucinogens). Subject can enrol after a washout period of 30 days
• Female who is pregnant or breast-feeding
• History of diagnosed cognitive impairment / disorder such as delirium or dementia
• Previous or current diagnosis of a chronic viral infection, for example hepatitis or HIV (potential damage to vestibular system, known as vestibular neuropathy).
• History of stroke or head injury requiring intensive care or neurosurgery (potential damage to neurological pathways affected by vestibular stimulation)
• Presence of permanently implanted batterypowered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator, etc.)
• History of epilepsy
• History of severe tinnitus or vertigo
• History of skin breakdown, eczema or other dermatological condition (e.g. psoriasis) affecting the skin behind the ears.
• History or presence of malignancy within the last year (except basal and squamous cell skin cancer and in-situ carcinomas)
• History of vestibular dysfunction or another inner ear disease

Sponsors & Collaborators

• Neurovalens Ltd.: lead

Study Sites (2)

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location

Biomedical Science Research University of Ulster, Coleraine

Belfast, Co.Antrim, BT52 1SA, United Kingdom

Location

MeSH Terms

Conditions

Depressive Disorder, Major; Depression

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Peter Colvonen

  San Diego Healthcare System

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joe Reel

CONTACT

02890991835; trials@neurovalens.com

Rachel Robinson

CONTACT

02890991835; trials@neurovalens.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2024
• First Posted: June 24, 2024
• Study Start: April 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 9, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1); US (1)