NCT02772302已完成不适用
Feasibility Study of the mindBEAGLE Device in Patients With Disorders of Consciousness or Locked-In Syndrome
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Behavioral Diagnosis of Level of Consciousness (LoC)
研究概览
简要总结
The primary aims of this study are:
- To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based system, in the Intensive Care Unit in patients with disorders of consciousness (DOC) or locked-in syndrome (LIS);
- To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness;
- To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with functional MRI (fMRI) and electroencephalography (EEG) biomarkers of consciousness;
- To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.
详细描述
- To determine the feasibility of deploying mindBEAGLE, a portable, bedside EEG-based system, in the Neurosciences Intensive Care Unit in patients with DOC or LIS;
- To determine if mindBEAGLE neurophysiologic markers of cognitive function correlate with bedside behavioral assessments of consciousness;
- To determine if mindBEAGLE can serve as an assistive communication device for people with LIS.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosis of coma
- •Vegetative state
- •Minimally conscious state
- •Confusional state
- •Locked-in state
排除标准
- •History of developmental, neurologic, or major psychiatric disorder resulting in functional disability
研究组 & 干预措施
Patients
Experimental
Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface
干预措施: mindBEAGLE EEG-based brain-computer interface (Device)
Healthy Controls
Experimental
Application of bedside, EEG-based mindBEAGLE Brain-Computer Interface
干预措施: mindBEAGLE EEG-based brain-computer interface (Device)
结局指标
主要结局
Behavioral Diagnosis of Level of Consciousness (LoC)
时间窗: on the day of intervention
LoC will be defined using the Coma Recovery Scale-Revised behavioral evaluation (score range 0-23). Higher scores are generally associated with a higher level of consciousness.
次要结局
未报告次要终点
研究者
Brian L. Edlow, M.D.
Instructor of Neurology
Massachusetts General Hospital
研究点 (1)
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