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

This study is currently recruiting participants.
Verified May 2017 by GE Healthcare
Sponsor:
ClinicalTrials.gov Identifier:
NCT02556177
First Posted: September 22, 2015
Last Update Posted: May 4, 2017
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
ICON plc
Information provided by (Responsible Party):
GE Healthcare
  Purpose
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 Intervention
Concussion Traumatic Brain Injury Procedure: MRI

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • 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

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

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


Secondary Outcome Measures:
  • 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.

  • 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


Estimated Enrollment: 525
Study Start Date: November 2015
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

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;
  Contacts and Locations
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


Contacts
Contact: John Strohmeyer (609) 865-7423 john.strohmeyer@ge.com
Contact: Kevin Siewert (262) 409-5722 Kevin.R.Siewert@ge.com

Locations
United States, California
University of California-San Diego Recruiting
San Diego, California, United States, 92161
Contact: Roland Lee, MD    858-552-8585    rrlee@ucsd.edu   
Contact: Donna Brusch    858-822-2649    dbrusch@ucsd.edu   
University of California San Francisco Recruiting
San Francisco, California, United States, 94121
Contact: Patrick Mukherjee, MD    415-750-2146    pratik.mukherjee@ucsf.edu   
Principal Investigator: Patrick Mukherjee, MD         
United States, Florida
Universtiy of Miami Health System Recruiting
Miami, Florida, United States, 33136
Contact: Gillian Holtz, MD    305-243-4004    ghotz@med.miami.edu   
Principal Investigator: Gillian Holtz, MD         
United States, New York
Hospital for Special Surgery Recruiting
New York, New York, United States, 10021
Contact: Teena Shetty, MD    212-774-2158    ShettyT@HSS.edu   
Principal Investigator: Teena Shetty, MD         
United States, Pennsylvania
University of Pittsburgh Medical College Recruiting
Pittsburgh, Pennsylvania, United States, 15203
Contact: Michael Collins, MD    412-432-3668    collinsmw@upmc.edu   
United States, Texas
Houston Methodist Neurological Institute Recruiting
Houston, Texas, United States, 77030
Contact: Joseph C Masdeu, MD    713-441-1150    jcmasdeu@houstonmethodist.org   
Principal Investigator: Joseph C Masdeu, MD         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Michael McCrea, MD    414-955-7300    mmccrea@mcw.edu   
Principal Investigator: Michael McCrea, MD         
Sponsors and Collaborators
GE Healthcare
ICON plc
Investigators
Study Director: Victor Miranda, MD GE Healthcare
  More Information

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT02556177     History of Changes
Other Study ID Numbers: 114-2015-GES-0017
First Submitted: August 7, 2015
First Posted: September 22, 2015
Last Update Posted: May 4, 2017
Last Verified: May 2017

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