TBI Biological Diagnosis Via High Definition Tractography Asymmetry Screening
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Diagnosis reliability measured by MRI scanning data results
研究概览
简要总结
The primary purpose of this study is to validate the High Definition Fiber Tracking (HDFT/HDFTAS) technology, so that faster, more reliable diagnosis can be implemented in Traumatic Brain Injury (TBI). This study will involve Traumatic Brain Injury Patients and normal controls, in addition to 30 pilot participants who will be undergoing MRI in order to develop a statistically sound range for the metrics derived from HDFT.
详细描述
This descriptive study sponsored by the United States Department of Defense involves the examination of TBI participants and normal control participants through MRI (Without Contrast) scanning. Normal controls are essential to develop a statistically sound range for the metrics derived from High Definition Fiber Tracking (HDFT). TBI subjects will undergo 1 MRI scan and normal controls will be asked to undergo 1 MRI scan. The study will involve blinded evaluations of results to determine the ability of HDFT imaging methods to evaluate TBI.
In addition to the TBI and normal controls evaluated in this research study, investigators will be running 30 pilot participants. These participants will be undergoing MRI in order to streamline our pulse sequence and calibrate the MRIs. This is part of the technical development for the project and will occur before the recruitment of TBI subjects and normal controls for comparison. Data from the pilot subjects will not serve as control data for the TBI subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Traumatic Brain Injury
Documented history of Traumatic Brain Injury
干预措施: MRI of the Brain (No Contrast) Scan (Procedure)
Normal Controls
No prior history of concussion, TBI, blast exposure, stroke, or other major neurological disorder
干预措施: MRI of the Brain (No Contrast) Scan (Procedure)
Sequence Development Volunteers
干预措施: MRI of the Brain (No Contrast) Scan (Procedure)
结局指标
主要结局
Diagnosis reliability measured by MRI scanning data results
时间窗: 2 Hours
Amount of white matter damage using HDTAS DSI diffusion evaluation of volume and connectivity across 40 fiber tracts over 150 brain regions.
时间窗: 2 Hours
Tract anomalies will be coded as significant differences either to normative data of the tract or expected left/right ratio of tract axonal volume. White matter damage will first be quantified through HDFT evaluation of volume and connectivity across 40 fiber tracts over 150 brain regions
Comparison of severity of subjects with TBI using Diffusion Tension Imaging (DTI)
时间窗: 2 Hours
次要结局
未报告次要终点
