Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2

Not Applicable

Completed

• Conditions: Concussion; Traumatic Brain Injury
• Interventions: Procedure: MRI

• Registration Number: NCT02556177
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-08-07
• Study First Submitted QC: 2015-09-18
• Study First Posted: 2015-09-22
• Study Start: 2015-11
• Primary Completion: 2018-01-31
• Study Completion: 2018-01-31
• Results First Submitted: 2018-09-04
• Status Verified: 2019-09
• Results First Submitted QC: 2019-09-09
• Last Update Submitted: 2019-09-09
• Results First Posted: 2019-09-10
• Last Update Posted: 2019-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 477

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
non-TBI patients (Segment 2)	MRI	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
mTBI patient group (Segment 1)	MRI	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)

Primary Outcome Measures

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

Trial Locations

Locations (7)

University of California-San Diego; 🇺🇸 San Diego, California, United States

University of Pittsburgh Medical College; 🇺🇸 Pittsburgh, Pennsylvania, United States

Hospital for Special Surgery; 🇺🇸 New York, New York, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Universtiy of Miami Health System; 🇺🇸 Miami, Florida, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

Houston Methodist Neurological Institute; 🇺🇸 Houston, Texas, United States