Detection of Hemodynamic Changes in TBI Population With Functional Near Infrared Spectroscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Measure of hemodynamic response function
研究概览
简要总结
The goal of this project is to develop a test to assess frontal lobe function using a rapid, inexpensive, objective, and standardized method, without the need for expertise in cognitive test administration. Such methods would be particularly helpful in traumatic brain injury (TBI), where objective measures are needed, and would greatly expand the capacity to make such assessments in clinical practice and research.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to read, write, speak and understand English
- •history of having sustained a TBI prior to enrollment. Evidence will be any one of the following 3 criteria:
- •Post-traumatic amnesia > 24 hours
- •TBI-related abnormality on neuroimaging (either CT or MRI). (Some missing information about the initial injury (i.e. documentation of initial GCS) is not necessarily exclusionary if the bulk of the available history is indicative that the patient suffered a TBI and meets the inclusion criteria)
排除标准
- •Multiple sclerosis, pre- or co-existing
- •Stroke (other than stroke at the time of TBI)
- •Pre-existing developmental disorder
- •Pre-existing epilepsy
- •Pre-existing major depressive disorder
- •Pre-existing schizophrenia
结局指标
主要结局
Measure of hemodynamic response function
时间窗: Two years
In two population groups: TBI and non TBI, we will determine normative data for the cognitive parametric experiment by measuring the local hemodynamic response function with functional near infrared spectroscopy
次要结局
- Measure of the degree of impairment(Two years)
研究者
Ramon Diaz-Arrastia
Director of Clinical Research
Uniformed Services University of the Health Sciences