NCT07006415尚未招募不适用
Brain-computer Interface Rehabilitation And Virtual Environments in Functional Neurological Disorder (BRAVE-FND)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 24
- 主要终点
- Change in sense of agency over limb movements
研究概览
简要总结
The purpose of this study is to determine whether a course of rehabilitation using a device called a brain-computer interface can change the level of control people feel over bodily movements, in functional neurological disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM5 diagnosis of motor FND (limb weakness, gait disorder, tremor or dystonia) from a neurologist and/or neuropsychiatrist.
- •Moderate or severe symptoms (≥4 on Clinical Global Impression Severity (CGI-S) scale).
- •Able to tolerate VR and BCI use.
- •Age 18 - 60 years.
- •English speaking.
排除标准
- •Current diagnosis of epilepsy, severe depression, bipolar disorder, psychotic disorder, personality disorder, or drug/alcohol dependence/harmful use (defined as meeting DSM-5 criteria) (Mini International Neuropsychiatric Interview [MINI] 7.0). Positive diagnoses on the MINI will be subject to confirmation at clinical interview by a psychiatrist.
- •Current diagnosis of epilepsy, autistic spectrum disorder, dementia, learning disability (defined as meeting DSM-5 criteria) based on clinical interview by a psychiatrist.
- •A pacemaker, implantable cardioverter-defibrillator or any other implanted electronic or metallic device.
- •Current pregnancy.
- •Non-registration with a GP or failure to consent to sharing of the GP summary care record and any psychiatric assessments held.
- •Those enrolled in another clinical or research study.
- •Those unable to give informed consent.
结局指标
主要结局
Change in sense of agency over limb movements
时间窗: Baseline (same day as rehabilitation session 1, immediately before session) and after course of 10 sessions of brain-computer interface rehabilitation (same day as rehabilitation session 10, immediately after session) (intra-subject)
Seven point Likert scale for explicit self-reported sense of agency over limb movements
次要结局
未报告次要终点
研究者
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