Traumatic Brain Injury Biological Diagnosis Via High Definition Tractography Asymmetry Screening



Status:Suspended
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - 60
Updated:6/3/2018
Start Date:February 2015
End Date:December 2018

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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.

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.

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
We found this trial at
1
site
550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Fernando Boada, PhD
New York University School of Medicine NYU School of Medicine has a proud history that...
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from
New York, NY
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