Clinical trial NCT02728960: Traumatic Brain Injury Biological Diagnosis Via High Definition Tractography Asymmetry Screening
Official title: TBI Biological Diagnosis Via High Definition Tractography Asymmetry Screening
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Traumatic Brain Injury
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-06
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Diagnosis reliability measured by MRI scanning data results
timeFrame: 2 Hours
measure: Amount of white matter damage using HDTAS DSI diffusion evaluation of volume and connectivity across 40 fiber tracts over 150 brain regions.
timeFrame: 2 Hours
measure: Comparison of severity of subjects with TBI using Diffusion Tension Imaging (DTI)
timeFrame: 2 Hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: New York University Medical School
name: Fernando Boada, PhD
role: PRINCIPAL_INVESTIGATOR
References: