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临床试验/NCT02754206
NCT02754206终止不适用

Association Between Brain Blood Flow Regulation, Cognition, and Balance in Sports-Related Concussion

Southern Methodist University1 个研究点 分布在 1 个国家目标入组 79 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
79
试验地点
1
主要终点
Cerebral blood flow regulation

研究概览

简要总结

The purpose of this study is to understand how biochemical markers in blood, balance disturbances, and cognitive performance are related to brain blood flow changes after a concussion.

详细描述

Comparisons will be made between control data and data following a concussion collected from athletes participating in contact-collision sports. For those suffering a concussion, comparisons will be made between day 3 (acute phase), day 21 (recovery phase), and 3 months post-concussion.

研究设计

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

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Student athletes actively participating in collegiate sports. Subjects should be wiling to provide informed consent for participation in the study.

排除标准

  • Participants who are unable to play as a result of injury. Presence of irregular heart beat.

结局指标

主要结局

Cerebral blood flow regulation

时间窗: Change in Control, 3 days post concussion, 21 days post concussion, and 3 months post concussion

Subject's cerebral blood flow regulation (cm/sec) at rest, during a cognitive test, and during a breathing test will be measured.

次要结局

  • Balance Test(Control, 3 days post concussion, 21 days post concussion, 3 months post concussion)
  • Blood Biomarkers(Control, 3 days post concussion, 21 days post concussion, 3 months post concussion)
  • Cerebral Vasoreactivity(Control, 3 days post concussion, 21 days post concussion, 3 months post concussion)
  • Orthostatic Tolerance Test(Control, 3 days post concussion, 21 days post concussion, 3 months post concussion)
  • Memory Function Test(Control, 3 days post concussion, 21 days post concussion, 3 months post concussion)

研究者

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

Heather McClary

Director of Research Compliance

Southern Methodist University

研究点 (1)

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