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

Part of paid clinical trials in San Diego, California.

Sponsor
Neurovalens Ltd.
Study ID
NCT06470035
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Active VeNS Device — DEVICE
    Battery powered non-invasive neurostimulation device
  • Sham VeNS Device — DEVICE
    Placebo comparator sham device (no active stimulation)

Study Details

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

Key Dates

Start date
Apr 30, 2025
Status verified
Aug 2024
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
170 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Active VeNS
    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.
  • Sham Comparator: Sham VeNS
    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.

Primary Outcome Measure

Hamilton Depression Rating Scale (HDRS-17) [ Time Frame: Change in score from baseline to 6 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
VA San Diego Healthcare SystemSan DiegoCalifornia92161
Peter Colvonen
[email protected]
442-369-7964
Peter Colvonen (PRINCIPAL_INVESTIGATOR)

Find similar trials in San Diego, CA

By condition
Depression
By specialty
PsychiatryMental healthBehavioral health
By research site
VA San Diego Healthcare System· San Diego, CA

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