Traumatic Brain Injury Biological Diagnosis Via High Definition Tractography Asymmetry Screening

Traumatic Brain Injury Clinical Trial

Official title:

TBI Biological Diagnosis Via High Definition Tractography Asymmetry Screening

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02728960
• Other study ID #: 12-03539
• Status: Withdrawn
• Phase: N/A
• Start date: February 2015
• Est. completion date: December 2018

Study information

• Verified date: May 2019
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

Procedure:
• MRI of the Brain (No Contrast) Scan
DSI data will be acquired on 3T Tim Trio System (Siemens) using a 32-channel coil

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis reliability measured by MRI scanning data results		2 Hours
Primary	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
Primary	Comparison of severity of subjects with TBI using Diffusion Tension Imaging (DTI)		2 Hours

External Links

•   NYU School of Medicine - Dept. of Radiology - Research Study Recruitment Link