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Study under review. Temporarily suspended
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traumatic Brain Injury | Experimental | Documented history of Traumatic Brain Injury |
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| Normal Controls | Active Comparator | No prior history of concussion, TBI, blast exposure, stroke, or other major neurological disorder |
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| Sequence Development Volunteers | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI of the Brain (No Contrast) Scan | Procedure | DSI data will be acquired on 3T Tim Trio System (Siemens) using a 32-channel coil |
|
| 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 |
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Inclusion Criteria TBI subjects:
Exclusion Criteria TBI subjects:
Inclusion Criteria Control subjects:
Exclusion Criteria TBI subjects:
Inclusion Criteria Sequence Development Subjects:
Exclusion Criteria Sequence Development Subjects:
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| Name | Affiliation | Role |
|---|---|---|
| Fernando Boada, PhD | New York University Medical School | Principal Investigator |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |