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Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 (mTBI-phase2)

Primary Purpose

Concussion, Traumatic Brain Injury

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI
Sponsored by
GE Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Concussion focused on measuring TBI, MR, mTBI, NFL, MRI

Eligibility Criteria

15 Years - 50 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Subjects included as mTBI patients (Segment 1) will:

  1. Be aged ≥15 and ≤50 years old at the time of enrollment;
  2. Be diagnosed with mTBI according to the standard diagnostic procedures at the investigational site in a timeframe that meets enrollment criteria for enrollment within 72 hours (Visit 1) or 7±2 days (Visit 3) from injury.
  3. Be capable of sufficiently clear communication and language fluency to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors, and to complete study assessments (as per Section 6.3 - Protection of Vulnerable Subjects) for participation in all parts of the study.

Subjects included as non-mTBI controls (Segment 2) will:

  1. Be aged ≥15 and ≤50 years old at the time of enrollment;
  2. Are of similar characteristics as the mTBI population in terms of gender, age, handedness, educational level, and scanner criteria (as per Section 6.1.1 Enrollment of non-mTBI controls)
  3. Be capable of sufficiently clear communication and language fluency to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors, and to complete study assessments (as per Section 6.3 - Protection of Vulnerable Subjects), for participation in all parts of the study.

Exclusion Criteria:

Subjects will be excluded that have: mTBI

  1. Loss of consciousness (LOC) ≥5 minutes;
  2. Posttraumatic amnesia lasting ≥24 hr following mTBI;
  3. Current or prior (within past 10 years) moderate to severe TBI
  4. Diagnosis of mTBI within the past 6 months;
  5. Epilepsy with recurring seizures in past 10 years;
  6. Drug abuse (except marijuana) in past 10 years based on DAST-10 screening;
  7. Alcohol abuse based on AUDIT-C screening;
  8. Current primary Axis I or II psychiatric disorders, except for disorders classified as minor and not expected to impact study conduct or integrity (as detailed in Appendix C - Screening Axis I/II Disorders):
  9. History of brain mass, neurosurgery, stroke, white matter disease, and/or dementia;
  10. Known cognitive dysfunction or structural brain disease/malformation;
  11. Structural brain injury on prior neuroimaging findings;
  12. Been prescribed antipsychotic/antiepileptic medications;
  13. Unable (such as due to urgent medical care needs) or unwilling to complete study procedures accurately or have any conflict of interest that could affect study results, in the opinion of the investigator;
  14. Contraindications to MRI scanning, including:

    • Current or suspected pregnancy, per site practice;
    • Other conditions that may constitute a hazard to the subject during study participation, per investigator;
    • Inability to comply with any part of the site's MR safety policy.

Subjects will be excluded that have:- non-TBI (controls)

  1. Diagnosis of mTBI within the past 6 months;
  2. Prior (within past 10 years) moderate to severe TBI (GCS <13);
  3. Epilepsy with recurring seizures in past 10 years;
  4. Drug abuse (except marijuana) in past 10 years based on DAST-10 screening;
  5. Alcohol abuse based on AUDIT-C screening;
  6. Current primary Axis I or II psychiatric disorders, except for disorders classified as minor and not expected to impact study conduct or integrity (as detailed in Appendix C - Screening Axis I/II Disorders):
  7. History of brain mass, neurosurgery, stroke, white matter disease, and/or dementia;
  8. Known cognitive dysfunction or structural brain disease/malformation;
  9. Structural brain injury on prior neuroimaging findings;
  10. Been prescribed antipsychotic/antiepileptic medications;
  11. Unable (such as due to urgent medical care needs) or unwilling to complete study procedures accurately or have any conflict of interest that could affect study results, in the opinion of the investigator;

Sites / Locations

  • University of California-San Diego
  • University of California San Francisco
  • Universtiy of Miami Health System
  • Hospital for Special Surgery
  • University of Pittsburgh Medical College
  • Houston Methodist Neurological Institute
  • Medical College of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

mTBI patient group (Segment 1)

non-TBI patients (Segment 2)

Arm Description

1.5T or 3.0T MRI brain scanning with research sequences at 3 to 4 intervals in the acute period, with psychological cognitive evaluations at each MR visit Patients in the acute period following recent diagnosis of mild traumatic brain injury (mTBI)

Control subjects with no recent mild traumatic brain injury. 1.5T or 3.0T MRI brain scanning with research sequences at 3 to 4 intervals in the acute period, with psychological cognitive evaluations at each MR visit

Outcomes

Primary Outcome Measures

MRI Image Data Sets
MRI image data sets collected from subjects who completed the study.
Neuropsychological Assessments
Neuropsychological assessments collected from subjects who completed the study.

Secondary Outcome Measures

Full Information

First Posted
August 7, 2015
Last Updated
September 9, 2019
Sponsor
GE Healthcare
Collaborators
ICON plc
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1. Study Identification

Unique Protocol Identification Number
NCT02556177
Brief Title
Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2
Acronym
mTBI-phase2
Official Title
Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
January 31, 2018 (Actual)
Study Completion Date
January 31, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare
Collaborators
ICON plc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is an open-label, non-randomized, prospective, multi-site, parallel group (segment), hypothesis-generating study designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical neuropsychological assessments and GE Research Pack II advanced MR imaging in mTBI patients. The results are primarily intended for scientific inquiry and engineering development purposes, and may be used in future regulatory submissions.
Detailed Description
This data-driven study is being conducted for hypothesis generation in population of mild traumatic brain injury (mTBI) patients using advanced applications for magnetic resonance imaging (MRI) developed by the Sponsor, GE Healthcare (GEHC), and corresponding clinical neuropsychological assessments. This data is intended for future use in development of specialized MR acquisition, reconstruction, and processing software intended to identify mTBI biomarkers.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Concussion, Traumatic Brain Injury
Keywords
TBI, MR, mTBI, NFL, MRI

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
477 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mTBI patient group (Segment 1)
Arm Type
Active Comparator
Arm Description
1.5T or 3.0T MRI brain scanning with research sequences at 3 to 4 intervals in the acute period, with psychological cognitive evaluations at each MR visit Patients in the acute period following recent diagnosis of mild traumatic brain injury (mTBI)
Arm Title
non-TBI patients (Segment 2)
Arm Type
Active Comparator
Arm Description
Control subjects with no recent mild traumatic brain injury. 1.5T or 3.0T MRI brain scanning with research sequences at 3 to 4 intervals in the acute period, with psychological cognitive evaluations at each MR visit
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Description
MRI scanning
Primary Outcome Measure Information:
Title
MRI Image Data Sets
Description
MRI image data sets collected from subjects who completed the study.
Time Frame
Per patient scanning over 3 months
Title
Neuropsychological Assessments
Description
Neuropsychological assessments collected from subjects who completed the study.
Time Frame
Per patient scanning over 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subjects included as mTBI patients (Segment 1) will: Be aged ≥15 and ≤50 years old at the time of enrollment; Be diagnosed with mTBI according to the standard diagnostic procedures at the investigational site in a timeframe that meets enrollment criteria for enrollment within 72 hours (Visit 1) or 7±2 days (Visit 3) from injury. Be capable of sufficiently clear communication and language fluency to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors, and to complete study assessments (as per Section 6.3 - Protection of Vulnerable Subjects) for participation in all parts of the study. Subjects included as non-mTBI controls (Segment 2) will: Be aged ≥15 and ≤50 years old at the time of enrollment; Are of similar characteristics as the mTBI population in terms of gender, age, handedness, educational level, and scanner criteria (as per Section 6.1.1 Enrollment of non-mTBI controls) Be capable of sufficiently clear communication and language fluency to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors, and to complete study assessments (as per Section 6.3 - Protection of Vulnerable Subjects), for participation in all parts of the study. Exclusion Criteria: Subjects will be excluded that have: mTBI Loss of consciousness (LOC) ≥5 minutes; Posttraumatic amnesia lasting ≥24 hr following mTBI; Current or prior (within past 10 years) moderate to severe TBI Diagnosis of mTBI within the past 6 months; Epilepsy with recurring seizures in past 10 years; Drug abuse (except marijuana) in past 10 years based on DAST-10 screening; Alcohol abuse based on AUDIT-C screening; Current primary Axis I or II psychiatric disorders, except for disorders classified as minor and not expected to impact study conduct or integrity (as detailed in Appendix C - Screening Axis I/II Disorders): History of brain mass, neurosurgery, stroke, white matter disease, and/or dementia; Known cognitive dysfunction or structural brain disease/malformation; Structural brain injury on prior neuroimaging findings; Been prescribed antipsychotic/antiepileptic medications; Unable (such as due to urgent medical care needs) or unwilling to complete study procedures accurately or have any conflict of interest that could affect study results, in the opinion of the investigator; Contraindications to MRI scanning, including: Current or suspected pregnancy, per site practice; Other conditions that may constitute a hazard to the subject during study participation, per investigator; Inability to comply with any part of the site's MR safety policy. Subjects will be excluded that have:- non-TBI (controls) Diagnosis of mTBI within the past 6 months; Prior (within past 10 years) moderate to severe TBI (GCS <13); Epilepsy with recurring seizures in past 10 years; Drug abuse (except marijuana) in past 10 years based on DAST-10 screening; Alcohol abuse based on AUDIT-C screening; Current primary Axis I or II psychiatric disorders, except for disorders classified as minor and not expected to impact study conduct or integrity (as detailed in Appendix C - Screening Axis I/II Disorders): History of brain mass, neurosurgery, stroke, white matter disease, and/or dementia; Known cognitive dysfunction or structural brain disease/malformation; Structural brain injury on prior neuroimaging findings; Been prescribed antipsychotic/antiepileptic medications; Unable (such as due to urgent medical care needs) or unwilling to complete study procedures accurately or have any conflict of interest that could affect study results, in the opinion of the investigator;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Victor Miranda, MD
Organizational Affiliation
GE Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
University of California-San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92161
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94121
Country
United States
Facility Name
Universtiy of Miami Health System
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
University of Pittsburgh Medical College
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15203
Country
United States
Facility Name
Houston Methodist Neurological Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

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Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2

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