NCT01628003Unknown不适用
Study of Reserves After Traumatic Brain Injury:Influence of Brain, Cognitive, and Emotional Reserves on Long-Term Consequences of Traumatic Brain Injury
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Neuropsychological battery
研究概览
简要总结
It is hypothesized that the long-term results of rehabilitation and subsequent aging after Brain Trauma depend on brain's premorbid anatomical (structural) and functional (cognitive, emotional) reserves.
The purpose of this study are:
- to determine whether such reserves exist.
- to study their convergent and discriminant validity.
- to study their characteristics.
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
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Moderate-Severe Traumatic Brain Injury according to at least 1 the following:
- •Duration of loss of consciousness (LOC) - more then 1/2 hour
- •Glasgow Coma Scale (GCS) - less then 13
- •Post Traumatic Amnesia (PTA) - more then 24 hours.
- •At least 1 year after the injury.
排除标准
- •Mild Traumatic Brain Injury
- •the present state of Post Traumatic Amnesia
- •the age less than 18 years on the moment of injury
- •less than 1 year since the injury
- •incapacity of the patient to cooperate in the study (incapacity of any source including physical, mental, and language problems)
- •premorbid diagnosis of Mental Retardation
研究组 & 干预措施
healthy persons
Active Comparator
干预措施: Brain MRI (Device)
healthy persons
Active Comparator
干预措施: MRI (Device)
patients after moderate-severe TBI
Experimental
干预措施: Brain MRI (Device)
patients after moderate-severe TBI
Experimental
干预措施: MRI (Device)
结局指标
主要结局
Neuropsychological battery
时间窗: neuropsychological baterry for every participant will be performed during 3-4 meetings. An expected average for complete neuropsychological assessment is about 8 weeks
次要结局
未报告次要终点
研究者
研究点 (1)
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