Back to resultsTraumatic Brain Injury Biological Diagnosis Via High Definition Tractography Asymmetry Screening
Primary Purpose
Traumatic Brain Injury
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MRI of the Brain (No Contrast) Scan
Sponsored by
About this trial
This is an interventional diagnostic trial for Traumatic Brain Injury
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Active Comparator
Arm Label
Traumatic Brain Injury
Normal Controls
Sequence Development Volunteers
Arm Description
Documented history of Traumatic Brain Injury
No prior history of concussion, TBI, blast exposure, stroke, or other major neurological disorder
Outcomes
Primary Outcome Measures
Diagnosis reliability measured by MRI scanning data results
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
Comparison of severity of subjects with TBI using Diffusion Tension Imaging (DTI)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02728960
Brief Title
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
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Study under review. Temporarily suspended
Study Start Date
February 2015 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Traumatic Brain Injury
Arm Type
Experimental
Arm Description
Documented history of Traumatic Brain Injury
Arm Title
Normal Controls
Arm Type
Active Comparator
Arm Description
No prior history of concussion, TBI, blast exposure, stroke, or other major neurological disorder
Arm Title
Sequence Development Volunteers
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
MRI of the Brain (No Contrast) Scan
Intervention Description
DSI data will be acquired on 3T Tim Trio System (Siemens) using a 32-channel coil
Primary Outcome Measure Information:
Title
Diagnosis reliability measured by MRI scanning data results
Time Frame
2 Hours
Title
Amount of white matter damage using HDTAS DSI diffusion evaluation of volume and connectivity across 40 fiber tracts over 150 brain regions.
Description
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
Time Frame
2 Hours
Title
Comparison of severity of subjects with TBI using Diffusion Tension Imaging (DTI)
Time Frame
2 Hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernando Boada, PhD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Traumatic Brain Injury Biological Diagnosis Via High Definition Tractography Asymmetry Screening
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