Tests a nerve-stimulating device for major depression in adults

Trial details

Who runs it

Neurovalens Ltd.

Trial code

NCT06470035

Record updated

9 August 2024

Original description

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 StudyRead full original descriptionShow less

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

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

Inclusion: 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: Use of recreational drugs (e.g nalgesics, depressants, stimulants, and hallucinogens). Subject can enrol after a washout period of 30 days; Previous or current diagnosis of a chronic viral infection, for example hepatitis or HIV (potential damage to vestibular system, known as vestibular neuropathy); 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; Previous use of Modius device or any VeNS device; 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; History of diagnosed cognitive impairment / disorder such as delirium or dementia; History of stroke or head injury requiring intensive care or neurosurgery (potential damage to neurological pathways affected by vestibular stimulation); 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; 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; Risk of persistent self-harm or suicide as confirmed by the Columbia Suicide Severity Rating Scale (CSSRS); Female who is pregnant or breast-feeding; Presence of permanently implanted batterypowered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator, etc.); Diagnosis of active migraines; Participation in other clinical trials sponsored by Neurovalens; Participation in any other depression studies at the time of enrolment and throughout this study duration.

ClinicalTrials.gov NCT06470035