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

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.

Study Overview

• Status: Completed
• Conditions: Traumatic Brain Injury; Concussion
• Intervention / Treatment: Procedure: MRI

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
• Enrollment (Actual): 477
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161
      • University of California-San Diego
    • San Francisco, California, United States, 94121
      • University of California San Francisco
  • Florida
    • Miami, Florida, United States, 33136
      • Universtiy of Miami Health System
  • New York
    • New York, New York, United States, 10021
      • Hospital For Special Surgery
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15203
      • University of Pittsburgh Medical College
  • Texas
    • Houston, Texas, United States, 77030
      • Houston Methodist Neurological Institute
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MRI Image Data Sets	MRI image data sets collected from subjects who completed the study.	Per patient scanning over 3 months
Neuropsychological Assessments	Neuropsychological assessments collected from subjects who completed the study.	Per patient scanning over 3 months

Collaborators and Investigators

• Sponsor: GE Healthcare
• Collaborators: ICON plc
• Investigators: Study Director: Victor Miranda, MD, GE Healthcare

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): January 31, 2018
• Study Completion (Actual): January 31, 2018

Study Registration Dates

• First Submitted: August 7, 2015
• First Submitted That Met QC Criteria: September 18, 2015
• First Posted (Estimate): September 22, 2015

Study Record Updates

• Last Update Posted (Actual): September 10, 2019
• Last Update Submitted That Met QC Criteria: September 9, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: MRI; mTBI; TBI; MR; NFL
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Wounds and Injuries; Brain Injuries, Traumatic; Brain Concussion
• Other Study ID Numbers: 114-2015-GES-0017