Traumatic Brain Injury Biological Diagnosis Via High Definition Tractography Asymmetry Screening

Not Applicable

Withdrawn

• Conditions: Traumatic Brain Injury
• Interventions: Procedure: MRI of the Brain (No Contrast) Scan

• Registration Number: NCT02728960
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2016-03-08
• Study First Submitted QC: 2016-03-30
• Study First Posted: 2016-04-06
• Primary Completion: 2018-12
• Study Completion: 2018-12
• Status Verified: 2019-05
• Last Update Submitted: 2019-05-08
• Last Update Posted: 2019-05-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sequence Development Volunteers	MRI of the Brain (No Contrast) Scan	-
Normal Controls	MRI of the Brain (No Contrast) Scan	No prior history of concussion, TBI, blast exposure, stroke, or other major neurological disorder
Traumatic Brain Injury	MRI of the Brain (No Contrast) Scan	Documented history of Traumatic Brain Injury

Primary Outcome Measures

Name	Time	Method
Diagnosis reliability measured by MRI scanning data results	2 Hours
Amount of white matter damage using HDTAS DSI diffusion evaluation of volume and connectivity across 40 fiber tracts over 150 brain regions.	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)	2 Hours