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临床试验/NCT01496586
NCT01496586已完成不适用

Fatigue and Amotivation Following Mild Traumatic Brain Injury and Their Influence on Service Member Community Reintegration

National Institute of Neurological Disorders and Stroke (NINDS)1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2011年12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
45
试验地点
1
主要终点
Correlations between fractional anisotropy, effective connectivity measured by size of cortical and subcortical structures on DTI, and VBM that correlate with measures of fatigue, apathy, effort expenditure.

研究概览

简要总结

Background:

  • Many service members have reported feeling tired, a loss of motivation, mood changes, and problems working with others after they have a concussion during deployment. These problems may lead to problems with their job and relationships. This study hopes to figure out what parts of the brain may be affected in people with these problems after a concussion.

Objectives:

  • To learn more about the problems that may occur after service members have a concussion during deployment and return home.

Eligibility:

  • Service members or veterans between 18 and 40 years of age who have had a mild traumatic brain injury (concussion) in the past 6 months.
  • Companions (at least 18 years of age) of the service members will also be included in this study. Companions will have interacted with the service member at least 1 hour a week since deployment.

Design:

  • Service members will have 1 week of tests at the National Institutes of Health Clinical Center. Companions will have 2 days of tests at the Center.
  • Each day, service members will have 4 or 8 hours of tests. Tests will include a medical history and physical exam, neuropsychological tests and imaging studies. The tests will ask about fatigue, stress, mood, pain, daily activities, and family support. The imaging studies will measure brain function at rest and during activity.
  • Companions will have a medical history and physical exam. They will also complete several questionnaires about themselves as well as the service member/veteran. The tests will ask about fatigue, stress, mood, pain, daily activities, and family support....

详细描述

Objective

The primary objective of this study is to determine the behavioral-anatomical relationships that underlie fatigue and amotivation following mild traumatic brain injury in deployed military service members. The specific aims are to 1) determine the neural correlates of fatigue, and 2) assess how fatigue and social cognition relate to social outcomes including employment, community integration and participation in social activities. The theory we will test is that fatigue in this population is the result of subtle changes in frontal cortical and subcortical structures.

Study Design: Observational, natural history study.

Populations: 1) Individuals who have sustained a mild traumatic brain injury as a service member deployed in support of Operation Enduring Freedom/Operation Iraqi Freedom/Operation New Dawn, and who continue to experience symptoms more than 6 months after injury, and 2) Companions of individuals from the first group.

Outcome Measures: We will seek statistical associations between fatigue measures and brain morphometric and white matter diffusion measurements obtained by MRI as well as task and resting state fMRI.

研究设计

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

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Correlations between fractional anisotropy, effective connectivity measured by size of cortical and subcortical structures on DTI, and VBM that correlate with measures of fatigue, apathy, effort expenditure.

时间窗: One year

次要结局

  • Correlations between fractional anisotropy, effective connectivity measured by size of cortical and subcortical structures on DTI, and VBM that correlate with measures of alexithymia and perceived stress(One year)

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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