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临床试验/NCT01628003
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

Sheba Medical Center2 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2009年8月最近更新:
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适应症

试验速览

阶段
不适用
入组人数
240
试验地点
2
主要终点
Neuropsychological battery
研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

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:

  1. to determine whether such reserves exist.
  2. to study their convergent and discriminant validity.
  3. 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

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

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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