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临床试验/NCT00478400
NCT00478400已完成不适用

Awareness of Deficit After Combat-related Brain Injury

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2007年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Longitudinal change in white matter

研究概览

简要总结

This study will use MRI imaging, cognitive testing and outcome questionnaires to determine how the brain recovers and reorganizes after an injury.

详细描述

The extent of recovery from brain injury is often difficult to predict because of our limited understanding of how the brain changes as it heals. New brain imaging methods may help in this regard. One imaging technique called functional magnetic resonance imaging (fMRI) has made it possible to study the brain "at work"; that is, we can see regions of the brain that are active during particular tasks such as focusing attention, making decisions, or remembering words and pictures. Another MRI method called diffusion tensor imaging provides information on the pathways between brain regions that may be altered with brain injury.

The goals of this research are to 1) determine the brain regions involved in making accurate judgments about one's abilities and disabilities after a brain injury and whether damage to these brain areas affects outcome; and 2) examine how recovery of cognitive and physical abilities relates to changes in brain function over time. In order to accomplish the first goal we will recruit Veterans who have sustained a head injury and matched control subjects. For the second goal, we are asking patients and controls who have previously participated in brain injury research with our lab to come back for another visit at three years post-injury.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • History of traumatic brain injury at least 12 months prior to enrollment
  • Control Group: No history of traumatic brain injury

排除标准

  • Claustrophobia
  • Metallic or electronic implants or devices that are not MRI-safe
  • Foreign metal, such as shrapnel, in the body

结局指标

主要结局

Longitudinal change in white matter

时间窗: 2 months, 1 year, and greater than 3 years post-injury

Participants will include post-TBI in survivors the investigators have studied previously

Cognition change at study endpoint between TBI and controls

时间窗: Greater than 3 years post-injury

Longitudinal change in whole brain morphology

时间窗: 2 months, 1 year, and greater than 3 years post-injury

Participants will include post-TBI in survivors the investigators have studied previously

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

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