NCT02728960

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2016

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

May 10, 2019

Status Verified

May 1, 2019

Enrollment Period

3.8 years

First QC Date

March 8, 2016

Last Update Submit

May 8, 2019

Conditions

Traumatic Brain Injury

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (3)

Traumatic Brain Injury

EXPERIMENTAL

Documented history of Traumatic Brain Injury

Procedure: MRI of the Brain (No Contrast) Scan

Normal Controls

ACTIVE COMPARATOR

No prior history of concussion, TBI, blast exposure, stroke, or other major neurological disorder

Procedure: MRI of the Brain (No Contrast) Scan

Sequence Development Volunteers

ACTIVE COMPARATOR
Procedure: MRI of the Brain (No Contrast) Scan

Interventions

MRI of the Brain (No Contrast) ScanPROCEDURE

DSI data will be acquired on 3T Tim Trio System (Siemens) using a 32-channel coil

Normal ControlsSequence Development VolunteersTraumatic Brain Injury

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Inability or unwillingness of subject to provide written informed consent.
  • History of penetrating gunshot wound.
  • 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.
  • Inability or unwillingness of subject to provide written informed consent.
  • History of concussions, stroke, or penetrating gunshot wound.
  • No MRI contraindications such as implanted ferrous metal, pacemakers, body weight above 125 Kg, (might not fit in the scanner), or concerns about claustrophobia.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Fernando Boada, PhD

    New York University Medical School

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2016

First Posted

April 6, 2016

Study Start

February 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

May 10, 2019

Record last verified: 2019-05