NCT06470035尚未招募不适用
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
Neurovalens Ltd.4 个研究点 分布在 2 个国家目标入组 170 人开始时间: 2025年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 170
- 试验地点
- 4
- 主要终点
- Hamilton Depression Rating Scale (HDRS-17)
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Hamilton Depression Rating Scale (HDRS-17)
时间窗: 6 weeks
The HDRS (also known as the HAM-D) is the most widely used clinician-administered depression assessment scale. The original version contains 17 items (HDRS-17) pertaining to symptoms of depression experienced over the past week. Scoring is based on the 17-item scale and scores of 0-7 are considered as being normal, 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale. The HDRS-17 scoring shall be the Primary Outcome of the study and will be completed at baseline and each study visit. The proportion (%) of participants achieving the HDRS-17 minimal clinically important difference (≥3 point reduction) by the 6-week time point between the active and sham groups.
次要结局
- Hamilton Depression Rating Scale (HDRS-17)(Change in score at 4 week post-intervention timepoint)
- Quality of Life (EQ-5D-5L)(Change in score from baseline to 6 weeks)
- WHO Disability Assessment Schedule 2.0 (WHODAS2)(Change in score at 4 week post-intervention timepoint)
- Insomnia Severity Index (ISI)(Change in score from baseline to 6 weeks)
研究者
研究点 (4)
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