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Traumatic Brain Injury Biological Diagnosis Via High Definition Tractography Asymmetry Screening

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02728960
Recruitment Status : Withdrawn (Study under review. Temporarily suspended)
First Posted : April 6, 2016
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Procedure: MRI of the Brain (No Contrast) Scan Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: TBI Biological Diagnosis Via High Definition Tractography Asymmetry Screening
Actual Study Start Date : February 2015
Actual Primary Completion Date : December 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Traumatic Brain Injury
Documented history of Traumatic Brain Injury
Procedure: MRI of the Brain (No Contrast) Scan
DSI data will be acquired on 3T Tim Trio System (Siemens) using a 32-channel coil

Active Comparator: Normal Controls
No prior history of concussion, TBI, blast exposure, stroke, or other major neurological disorder
Procedure: MRI of the Brain (No Contrast) Scan
DSI data will be acquired on 3T Tim Trio System (Siemens) using a 32-channel coil

Active Comparator: Sequence Development Volunteers Procedure: MRI of the Brain (No Contrast) Scan
DSI data will be acquired on 3T Tim Trio System (Siemens) using a 32-channel coil




Primary Outcome Measures :
  1. Diagnosis reliability measured by MRI scanning data results [ Time Frame: 2 Hours ]
  2. Amount of white matter damage using HDTAS DSI diffusion evaluation of volume and connectivity across 40 fiber tracts over 150 brain regions. [ Time Frame: 2 Hours ]
    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

  3. Comparison of severity of subjects with TBI using Diffusion Tension Imaging (DTI) [ Time Frame: 2 Hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02728960


Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Fernando Boada, PhD New York University Medical School
Additional Information:
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02728960    
Other Study ID Numbers: 12-03539
First Posted: April 6, 2016    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System