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Not yet recruiting NCT06470035

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

No phase Interventional Major Depressive Disorder \(MDD Depressive Disorder, Major

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Active VeNS Device, Sham VeNS Device.
Who it may be relevant to
Registry conditions: Major Depressive Disorder \(MDD, Depressive Disorder, Major. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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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

Overview

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

Interventions

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

Primary outcome measures

  • Hamilton Depression Rating Scale (HDRS-17) [Time frame: Change in score from baseline to 6 weeks]
  • Hamilton Depression Rating Scale (HDRS-17) [Time frame: 6 weeks]
Secondary outcome measures (5)
  • WHO Disability Assessment Schedule 2.0 (WHODAS2) [Time frame: Change in score from baseline to 6 weeks]
  • Insomnia Severity Index (ISI) [Time frame: Change in score from baseline to 6 weeks]
  • Quality of Life (EQ-5D-5L) [Time frame: Change in score from baseline to 6 weeks]
  • Hamilton Depression Rating Scale (HDRS-17) [Time frame: Change in score at 4 week post-intervention timepoint]
  • WHO Disability Assessment Schedule 2.0 (WHODAS2) [Time frame: Change in score at 4 week post-intervention timepoint]

Eligibility criteria

Inclusion criteria

  • 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
  • Agree not to undergo any extreme lifestyle changes during the duration of the study that could impact mood e.g. dietary , exercise changes
  • 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

Exclusion criteria

  • 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
  • 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
  • Diagnosis of active migraines
  • Previous use of Modius device or any VeNS device
  • Participation in other clinical trials sponsored by Neurovalens
  • Participation in any other depression studies at the time of enrolment and throughout this study duration
  • Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.
  • Failure to use device daily during trial participation (no more than 14 consecutive days usage drop without reasonable explanation)
  • Persistent failure to comply with study protocol and procedures

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • VA San Diego Healthcare System — San Diego
United Kingdom · 1 center
  • Biomedical Science Research University of Ulster, Coleraine — Belfast

Identifiers

NCT: NCT06470035 · MMS002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗