Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2

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.

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;