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临床试验/NCT02728960
NCT02728960撤回不适用

TBI Biological Diagnosis Via High Definition Tractography Asymmetry Screening

NYU Langone Health0 个研究点开始时间: 2015年2月最近更新:
适应症
干预措施

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Traumatic Brain Injury

Experimental

Documented history of Traumatic Brain Injury

干预措施: MRI of the Brain (No Contrast) Scan (Procedure)

Normal Controls

Active Comparator

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

Active Comparator

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

研究者

申办方类型
Other
责任方
Sponsor

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