ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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: NCT02556177
Recruitment Status : Completed
First Posted : September 22, 2015
Last Update Posted : May 21, 2018
Sponsor:
Collaborator:
ICON plc
Information provided by (Responsible Party):
GE Healthcare

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.

Condition or disease Intervention/treatment Phase
Concussion Traumatic Brain Injury Procedure: MRI Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 478 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2
Study Start Date : November 2015
Actual Primary Completion Date : January 31, 2018
Actual Study Completion Date : January 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: mTBI patient group (Segment 1)

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)

Procedure: MRI
MRI scanning

Active Comparator: non-TBI patients (Segment 2)
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
Procedure: MRI
MRI scanning




Primary Outcome Measures :
  1. mTBI progression indicated by clinical neurological characteristics, [ Time Frame: Per-patient scanning over 3 months ]
    To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing

  2. MRI Images [ Time Frame: Per patient scanning over 3 months ]
    MRI images

  3. quantitative MRI data from novel software [ Time Frame: Per patient scanning over 3 months ]
    quantitative data from novel software post-processing


Secondary Outcome Measures :
  1. Subject demographics [ Time Frame: Per patient scanning over 3 months ]
    To comprehensively collect subject information (i.e. baseline health data, demographics, socioeconomics, injury presentation, post-injury status, and injury type, place, and cause) for mTBI subjects in context of MRI data.

  2. Operator set MRI parameters [ Time Frame: Per patient scanning over 3 months ]
    To record operator-adjusted parameters of the novel software on the MRI system



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   15 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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;

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): NCT02556177


Locations
United States, California
University of California-San Diego
San Diego, California, United States, 92161
University of California San Francisco
San Francisco, California, United States, 94121
United States, Florida
Universtiy of Miami Health System
Miami, Florida, United States, 33136
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
United States, Pennsylvania
University of Pittsburgh Medical College
Pittsburgh, Pennsylvania, United States, 15203
United States, Texas
Houston Methodist Neurological Institute
Houston, Texas, United States, 77030
United States, Wisconsin
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
GE Healthcare
ICON plc
Investigators
Study Director: Victor Miranda, MD GE Healthcare

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT02556177     History of Changes
Other Study ID Numbers: 114-2015-GES-0017
First Posted: September 22, 2015    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: May 2018

Keywords provided by GE Healthcare:
TBI
MR
mTBI
NFL
MRI

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Injuries, Traumatic
Brain Concussion
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds, Nonpenetrating