Traumatic Brain Injury Biological Diagnosis Via High Definition Tractography Asymmetry Screening

NCT ID: NCT02728960

Last Updated: 2019-05-10

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-12-31

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.

Conditions

Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Traumatic Brain Injury

Documented history of Traumatic Brain Injury

Group Type: EXPERIMENTAL

MRI of the Brain (No Contrast) Scan

Intervention Type: PROCEDURE

DSI data will be acquired on 3T Tim Trio System (Siemens) using a 32-channel coil

Normal Controls

No prior history of concussion, TBI, blast exposure, stroke, or other major neurological disorder

Group Type: ACTIVE_COMPARATOR

MRI of the Brain (No Contrast) Scan

Intervention Type: PROCEDURE

DSI data will be acquired on 3T Tim Trio System (Siemens) using a 32-channel coil

Sequence Development Volunteers

Group Type: ACTIVE_COMPARATOR

MRI of the Brain (No Contrast) Scan

Intervention Type: PROCEDURE

DSI data will be acquired on 3T Tim Trio System (Siemens) using a 32-channel coil

Interventions

MRI of the Brain (No Contrast) Scan

DSI data will be acquired on 3T Tim Trio System (Siemens) using a 32-channel coil

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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.

• 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.

• 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

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

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Fernando Boada, PhD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Other Identifiers

12-03539

Identifier Type: -

Identifier Source: org_study_id