Multi-modality Magnetic Resonance Imaging Biomarkers of Mild Traumatic Brain Injury: a Longitudinal Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Correlation between brain diffusion tensor imaging measures and Posttraumatic Stress Disorder symptom
研究概览
简要总结
This longitudinal cohort study aims to detect the topographical nature of the white matter microstructure and resting state functional connectivity patterns across the whole brain in the evolution of pathology as a function of time following mild TBI. All consecutively patients with the non-contrast head CT because of acute head trauma from the local emergency department (ED) formed the initial population of this study. Age, sex, education-level matched healthy controls will also be enrolled. The initial scan will performed within 7 days post-injury. Clinical assessment was performed within 24 hours of MR imaging and included a broad neuropsychological and symptom assessments. Follow-up examination will conduct at 1 month, 3 month, 6-12 months.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Glasgow Coma Score of 13-15;
- •one or more of the following: loss of consciousness (if present) < 30 min, post-traumatic amnesia (if present) < 24 h, and/or other transient neurological abnormalities such as focal signs, seizure, and intracranial lesion not requiring surgery.
- •no contraindications to MRI;
- •injury within 7 days;
- •agreement to communicate by telephone or e-mail for 1, 3 to 6-12 months after enrollment and come back to the hospital for follow-up
排除标准
- •history of neurological disease
- •head injury, or history of substance or alcohol abuse, intubation and/or presence of a skull fracture
- •administration of sedatives on arrival in the emergency department
- •spinal cord injury, manifestation of mild TBI due to other injuries (e.g., systemic injuries, facial injuries, or intubation) or other problems (e.g., psychological trauma, language barrier, or coexisting medical conditions), or caused by penetrating craniocerebral injury.
结局指标
主要结局
Correlation between brain diffusion tensor imaging measures and Posttraumatic Stress Disorder symptom
时间窗: 1 month
次要结局
- Changes in post-concussive symptoms(baseline, 1 month)
- changes in affective complaints(baseline and follow-up)
- Changes in somatic complaints(baseline and follow-up)