NCT05242367已完成不适用
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 Post- Traumatic Stress Disorder (PTSD)
Neurovalens Ltd.2 个研究点 分布在 1 个国家目标入组 383 人开始时间: 2023年2月13日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 383
- 试验地点
- 2
- 主要终点
- Posttraumatic Stress Disorder Checklist PCL-5 score
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 PTSD
The aim of this study: To better evaluate the efficacy of non-invasive electrical vestibular nerve stimulation (VeNS) as a method of treating PTSD, 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
Sample size: The aim is to recruit a total of up to 400 participants. The study will last 12 weeks in total for each subject.
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
- 22 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
- •Diagnosed PTSD by a medical practitioner
- •Post-Traumatic Checklist (PCL-5) score or 31 or above
- •Eligibility confirmed via the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
- •Male or female, age ≥ 22 years and ≤ 80 years at the time of signing informed consent
- •Ability and willingness to complete all study visits and procedures, including completion of mental health questionnaires
- •Ability and willingness to adhere to 30 minutes usage of the device daily for the duration of the trial
- •Agreement not to start any new PTSD, mental health, or insomnia medications for the duration of the trial and/or to inform the study team if intending on starting any new PTSD, mental health, or insomnia medications
- •Agreement not to change any PTSD specific treatments for the duration of the trial e.g cognitive processing therapy
- •Agreement not to undergo any significant lifestyle changes that may affect sleep (e.g. excessive exercise, sleep interventions etc.) for the duration of the trial
- •Agreement not to use sleep trackers (e.g. Fitbit) for the duration of the trial
- •Agreement not to travel across different time zones for the duration of the trial
- •Access to Wi-Fi (for app to be able to upload usage data)
- •Access to computer, laptop, iPad or tablet (to conduct remote study visits and complete study questionnaires remotely)
- •Screening review by PTSD physician (study PI)
- •Willingness to download and use a video platform (e.g Zoom) to conduct remote study visits
- •Willingness to engage weekly with your Clinical Trial Mentor (CTM)
排除标准
- •History of skin breakdown, eczema, or other dermatological condition (e.g., psoriasis) affecting the skin behind the ears
- •History of severe tinnitus or vertigo
- •History or presence of malignancy within the last year
- •Use of beta-blockers within 1 month of starting the study
- •History of chronic viral infection that causes vestibular neuropathy (e.g., hepatitis or HIV)
- •Use of antihistamines
- •A history of stroke or severe head injury as defined by a head injury that required a craniotomy or endotracheal intubation (in case this damaged the neurological pathways involved in vestibular stimulation)
- •Taking H2-receptor antagonist medication
- •Presence of permanently implanted battery powered medical device or stimulator (e.g., pacemaker, implanted defibrillator, deep brain stimulator, vagal nerve stimulator etc.)
- •Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method
- •Diagnosis of epilepsy
- •Diagnosis of active migraines
- •Previous use of Modius device
- •Participation in other research studies sponsored by Neurovalens
- •Participation in any other PTSD studies
- •Not fluent in English language
- •Have a member of the same household who is currently participating in this study
- •Failure to agree to use of device daily during study participation
- •Any other medical condition, or medication use, that in the opinion of the PI is likely to make the subject refractory to VeNS.
结局指标
主要结局
Posttraumatic Stress Disorder Checklist PCL-5 score
时间窗: 12 weeks
To evaluate the effect of the Modius Sleep device, relative to control group, on the symptoms of PTSD, quantified by change in the PCL-5 Score.
次要结局
- Insomnia Severity Index (ISI) score(12 weeks)
- 36-Item Short Form Survey (SF-36) score(12 weeks)
- Generalised Anxiety Disorder (GAD-7) score(12 weeks)
研究者
研究点 (2)
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