Набор скоро начнётся NCT06470035

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

Без фазы С лечением Major Depressive Disorder \(MDD Depressive Disorder, Major

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Active VeNS Device, Sham VeNS Device.
Кому может быть актуально: Состояния в реестре: Major Depressive Disorder \(MDD, Depressive Disorder, Major. Базовые параметры: 18 лет — 80 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Великобритания
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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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 \&lt;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