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

Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

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

Вторичные конечные точки (5)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• VA San Diego Healthcare System — San Diego

Великобритания · 1 центр

• Biomedical Science Research University of Ulster, Coleraine — Belfast

Идентификаторы

NCT: NCT06470035 · MMS002

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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