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临床试验/NCT01803048
NCT01803048已完成不适用

A Model for Predicting Cognitive and Emotional Health From Structural and Functional Neurocircuitry Following Traumatic Brain Injury

University of Arizona1 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
190
试验地点
1
主要终点
Diffusion Weighted Imaging Metric: fractional anisotropy (FA)

研究概览

简要总结

Abnormalities in structural and functional connectivity between brain regions have been suggested as putative biomarkers of mild traumatic brain injury (TBI) and significant contributors to neuropsychological functioning and injury outcome. The purpose of this study is to use two advanced magnetic resonance imaging (MRI) techniques called diffusion-weighted imaging (DWI) and resting state functional MRI to compare structural and functional connectivity between individuals with documented mild TBI and healthy controls. To evaluate the significance of structural and functional connectivity for behavior, the brain imaging data will then be related to measures of cognition and emotion. Over a 4-year period, 150 adults with documented mild TBI and 30 healthy controls will participate in the study.

The study will investigate the following questions and hypotheses:

  1. Evaluate the DWI metric fractional anisotropy (FA) as a measure of white matter integrity across multiple stages of recovery following mild TBI relative to healthy controls. It is hypothesized that mild TBI will be associated with greater white matter abnormalities than healthy controls.
  2. It is hypothesized that there will be a relationship between FA, cognition and emotion as a function of the injury.
  3. It is hypothesized that functional connectivity will be related to FA.

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
20 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • English as first language
  • Ability to provide informed consent
  • For TBI group: documented TBI experienced within 12 months prior to testing.

排除标准

  • Metal within the body, claustrophobia or other contraindications for MRI
  • Complicating medical conditions that may influence the outcome of neuropsychological assessment or neuroimaging (e.g., HIV, brain tumor, etc.)
  • Less than 9th grade education
  • History of alcoholism or substance use disorder
  • Excess current alcohol use or illicit substance use
  • for Healthy Controls (HC): life-time history of TBI or Axis I disorder
  • Pregnancy (ruled out by urine β-HCG)
  • Colorblindness
  • for HC: Having participated in a sport with a high risk of concussive/subconcussive blows for a period of at least 1 month including but not limited to: football, rugby, boxing, ice hockey, wrestling, soccer, martial arts

结局指标

主要结局

Diffusion Weighted Imaging Metric: fractional anisotropy (FA)

时间窗: Measured on the day of the MRI scan

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

William D. Killgore

Principal Investigator

University of Arizona

研究点 (1)

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