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临床试验/NCT03218332
NCT03218332招募中不适用

Post-Concussion Syndrome in Professional Athletes: A Multidisciplinary Study

University Health Network, Toronto1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2011年7月4日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
150
试验地点
1
主要终点
Biomarkers for possible CTE

研究概览

简要总结

to examine the relationship between repeated concussions and late decline of brain function. In addition, all participants agreeing to participate in the study will be asked to will their brains to The Krembil Neuroscience Centre Concussion Project at the Toronto Western Hospital with the consent and full knowledge of their families and doctors. However, it is possible to participate in the research without agreeing to a brain donation.

The Project Team is specifically attempting a clinical-MRI-brain tissue research analysis to determine the exact mechanism of the damage to brain tissue following repeated concussions. This condition is known as chronic traumatic encephalopathy (CTE), and shows an abnormal protein in the brain called tau-protein.

详细描述

We hypothesize that repeated concussions in retired professional athletes will be associated with abnormalities in neurological, neuropsychological, biofluids and neuroimaging assessments. The primary objectives of the study are:

  1. To determine the effects of repeated concussions on neurological, neuropsychological and psychosocial functioning.
  2. To determine the relationship between repeated concussions and neuroanatomical abnormalities in brain gray and white matter subserving cognitive and motor functions using structural MRI assessment.
  3. To determine the relationship between repeated concussions and changes in the cerebrospinal fluid composition.
  4. To (i) establish the infrastructure to conduct ongoing pathological examination of donated brains.
  5. In order to investigate whether the effects of repeated concussions on brain function and brain structure are progressive and related to the condition known as Chronic Traumatic Encephalopathy, prospective, longitudinal, follow-up data will be collected

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
25 Years 至 85 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • fluent in English, and a history of multiple concussions , low exposures , or no concussions (Control group ). Determination of concussion exposure will be determined as follows: Previous concussion will be based on the player's recall of injury and defined as "an injury resulting from a blow to the head that caused an alteration in mental status and one or more of the following symptoms: headache, nausea, vomiting, dizziness/balance problems, fatigue, trouble sleeping, drowsiness, sensitivity to light or noise, blurred vision, difficulty remembering, and difficulty concentrating.

排除标准

  • Neurological disorders prior to concussions (e.g.: seizure disorder); systemic illnesses known to affect the brain (e.g., diabetes and lupus); a history of psychotic disorder; known developmental disorders (e.g., attention deficit disorder, dyslexia); history of migraines; and, active engagement in litigation.

结局指标

主要结局

Biomarkers for possible CTE

时间窗: several visits every two years up to 10 years

Neuropsychological/MRI/genetics/CSF/PET-tau/oculomotor

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

Carmela Tartaglia

Marion and Gerald Soloway Professorship in Brain Injury and Concussion Research,Assistant Professor

University Health Network, Toronto

研究点 (1)

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