Traumatic Brain Injury Biological Diagnosis Via High Definition Tractography Asymmetry Screening

NYU Langone Health

Status: Withdrawn

Conditions: Traumatic Brain Injury

Treatments: Procedure: MRI of the Brain (No Contrast) Scan

Study type: Interventional

Funder types: Other

Identifiers

NCT02728960

12-03539

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 3 patient groups

Traumatic Brain Injury

Experimental group

Description:

Documented history of Traumatic Brain Injury

Treatment:

Procedure: MRI of the Brain (No Contrast) Scan

Normal Controls

Active Comparator group

Description:

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

Treatment:

Procedure: MRI of the Brain (No Contrast) Scan

Sequence Development Volunteers

Active Comparator group

Treatment:

Procedure: MRI of the Brain (No Contrast) Scan