Multimodal Approach to Testing the Acute Effects of Mild Traumatic Brain Injury (mTBI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 3
- 主要终点
- Change in objective measures of brain function (MEG/EEG, blood biomarkers)
研究概览
简要总结
The objective of the study is to determine the relative roles for various testing modalities in the diagnosis and prognosis of mild traumatic brain injury.
详细描述
Subjects will undergo functional brain testing (magnetoencephalography, electroencephalography), anatomical brain imaging (diffusion tensor imaging, susceptibility-weighted imaging), neuropsychological testing (memory, language, processing speed), sleep patterns using actigraphy, and blood testing of candidate biomarkers. Testing will be done at 3 time points post-injury: 1 day, 14 days, and 30 days post-injury. Analysis of these tests collectively will be used to develop diagnostic tools for acute mTBI.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Civilian (non-military) presenting to HMH ED.
排除标准
- •Prior history of diagnosed TBI.
- •Other significant non-head injury/trauma or open wound.
- •Other significant medical co-morbidities, such as heart disease or cancer.
- •Self-reported current use or substances contributing to ED visit (e.g. illicit drugs, medications, alcohol abuse).
- •Currently diagnosed psychological condition (e.g. depression, PTSD).
- •Medications for psychological or neurological disorder.
- •Any implanted metal, such as medical device or braces on teeth.
- •Injury to the back or other injury that will make it difficult for the participant to tolerate tests.
- •Injury to dominant arm that would cause difficulty using computer or responding to stimuli during functional imaging.
结局指标
主要结局
Change in objective measures of brain function (MEG/EEG, blood biomarkers)
时间窗: Day 1, day 14, and day 30 post-injury
For MEG/EEG, resting state analyses of brain function will be conducted to include frequency band analyses localizing, for example, delta slow wave activity, and establishing functional connectivity scores at three time points post injury (day 1, day 14, day 30). For blood biomarkers, serum levels in approximately ten biomarkers will be measured to determine amount in each and if changes occur at three time points post-injury.
次要结局
- Change in anatomical measures of brain function (DTI, SWI)(Day 1, day 14, and day 30 post-injury)
研究者
Michael G Harrington
Research Scientist
Huntington Medical Research Institutes