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临床试验/NCT03011983
NCT03011983已完成不适用

Neural Injury in Adolescents With Concussion

Children's Hospital of Philadelphia1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2017年4月11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
4
试验地点
1
主要终点
Difference in MEG Whole-Brain Slow-Wave Sensitivity between Controls and Concussion Patients

研究概览

简要总结

This study utilizes multimodal brain imaging to obtain quantitative biomarkers of brain injury and to improve understanding of the biological basis of brain pathology in adolescents with concussion. Adolescents with a concussion will undergo neuroimaging and neuropsychology assessments acutely and four months after injury.

详细描述

Concussion is a highly prevalent condition in adolescence, but it remains a clinical diagnosis that largely relies on subjective patient report with no reliable objective biomarkers for diagnosis. Traditional clinical brain imaging has not been found useful for concussion as the pathology is generally not visible on conventional acute MRI or CT. The proposed study addresses this gap in concussion diagnosis and management by examining the sensitivity of magnetoencephalography (MEG) for identifying areas of brain injury through detection of abnormal neural activity (slowing) in adolescents with concussion compared to healthy controls. Adolescents with a concussion will complete neuroimaging (MEG and MRI) and neuropsychology assessments at two time points within ten days and then again 4 months post-injury. Healthy controls will complete neuroimaging and neuropsychology assessments at a single time point.

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
12 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of concussion and within 2 weeks of injury (case subjects)
  • No history of diagnosed concussion (control subjects)

排除标准

  • Head injury within 1 year of recent concussion (case subjects)
  • History of neurologic, psychiatric, developmental or learning disorders (all subjects)

结局指标

主要结局

Difference in MEG Whole-Brain Slow-Wave Sensitivity between Controls and Concussion Patients

时间窗: Up to 2 months

Whole-brain, resting-state slow-wave maps of whole brain activity will be obtained from the MEG imaging in both adolescents with a concussion and healthy controls. Control images will be analyzed to determine a whole brain z-score value that includes typically developing controls below the 95th percentile, the z-score threshold for this group). Z-score images for the adolescents with concussion will be obtained and the number of adolescents with concussion above this z-score threshold will be determined, and compared to the healthy controls. The sensitivity and specificity of this method determined.

次要结局

  • Difference in MRI White-Matter Diffusion Measures between Controls and Concussion Patients(Up to 2 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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Neural Injury in Adolescents With Concussion | 临床试验