Traumatic Brain Injury Biological Diagnosis Via High Definition Tractography Asymmetry Screening

TBI Biological Diagnosis Via High Definition Tractography Asymmetry Screening

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.

Study Overview

• Status: Withdrawn
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Procedure: MRI of the Brain (No Contrast) Scan

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria TBI subjects:

• Documented history of TBI (for Chronic).
• No MRI contraindications such as implanted ferrous metal, pacemakers, body weight above 125 Kg, (might not fit in the scanner), or concerns about claustrophobia.

Exclusion Criteria TBI subjects:

• Inability or unwillingness of subject to provide written informed consent.
• History of penetrating gunshot wound.

Inclusion Criteria Control subjects:

• No prior history of concussion, TBI, blast exposure, stroke, or other major neurological disorder.
• No MRI contraindications such as implanted ferrous metal, pacemakers, body weight above 125 Kg, (might not fit in the scanner), or concerns about claustrophobia.

Exclusion Criteria TBI subjects:

• Inability or unwillingness of subject to provide written informed consent.
• History of concussions, stroke, or penetrating gunshot wound.

Inclusion Criteria Sequence Development Subjects:

• No MRI contraindications such as implanted ferrous metal, pacemakers, body weight above 125 Kg, (might not fit in the scanner), or concerns about claustrophobia.

Exclusion Criteria Sequence Development Subjects:

• Inability or unwillingness of subject to provide written informed consent
• Contra-indication to MR imaging, such as ferrous metal, pacemakers, body weight above 125 Kg or concerns

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traumatic Brain Injury; Documented history of Traumatic Brain Injury	Procedure: MRI of the Brain (No Contrast) Scan; DSI data will be acquired on 3T Tim Trio System (Siemens) using a 32-channel coil
Active Comparator: Normal Controls; No prior history of concussion, TBI, blast exposure, stroke, or other major neurological disorder	Procedure: MRI of the Brain (No Contrast) Scan; DSI data will be acquired on 3T Tim Trio System (Siemens) using a 32-channel coil
Active Comparator: Sequence Development Volunteers	Procedure: MRI of the Brain (No Contrast) Scan; DSI data will be acquired on 3T Tim Trio System (Siemens) using a 32-channel coil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	2 Hours
Comparison of severity of subjects with TBI using Diffusion Tension Imaging (DTI)		2 Hours

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Fernando Boada, PhD, New York University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): December 1, 2018

Study Registration Dates

• First Submitted: March 8, 2016
• First Submitted That Met QC Criteria: March 30, 2016
• First Posted (Estimate): April 6, 2016

Study Record Updates

• Last Update Posted (Actual): May 10, 2019
• Last Update Submitted That Met QC Criteria: May 8, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: 12-03539