Investigation of the Behavioral Signs of Consciousness Recovery in Patients With Disorders of Consciousness (DOCSIGNS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Change from baseline score in the Coma Recovery Scale-Revised until study completion
研究概览
简要总结
Precise description of behavioral signs denoting transition from unresponsive wakefulness syndrome/vegetative state (UWS/VS) to minimally conscious state (MCS) or emergence from MCS after severe brain injury is crucial for prognostic purposes. A few studies have attempted this goal but involved either non-standardized instruments, limited temporal accuracy or samples, or focused on (sub)acute patients. The objective of this study is to describe the behavioral signs that led to a change of diagnosis, as well as the factors influencing this transition, in a large sample of patients with chronic disorders of consciousness after severe brain injury.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •documented medical diagnosis of CRS-R-based diagnosis of UWS or MCS at admission to the neurorehabilitation program
排除标准
- 未提供
结局指标
主要结局
Change from baseline score in the Coma Recovery Scale-Revised until study completion
时间窗: From inclusion in the study until discharge or death, assessed up to 24 months
The Coma Recovery Scale-Revised consists of 29 hierarchically organised items divided into 6 subscales addressing auditory, visual, motor, oromotor, communication, and arousal processes.
次要结局
- Change from baseline score in the Disability Rating Scale until study completion(rom inclusion in the study until discharge or death, assessed up to 24 months)
- Change from baseline score in the Functional Independence Measure until study completion(From inclusion in the study until discharge or death, assessed up to 24 months)
研究者
Enrique Noe
Research director
Hospitales Nisa