Clinical trial NCT02556177: Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2
Official title: Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Concussion
Traumatic Brain Injury
Keywords: TBI
MR
mTBI
NFL
MRI
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: ICON plc
First posted: 2015-09-22
Enrollment: 477
Sex: ALL
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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;

Primary outcomes:
measure: MRI Image Data Sets
timeFrame: Per patient scanning over 3 months
measure: Neuropsychological Assessments
timeFrame: Per patient scanning over 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California-San Diego
state: California
city: San Francisco
country: United States
facility: University of California San Francisco
state: California
city: Miami
country: United States
facility: Universtiy of Miami Health System
state: Florida
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical College
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist Neurological Institute
state: Texas
city: Milwaukee
country: United States
facility: Medical College of Wisconsin
state: Wisconsin
Study officials:
affiliation: GE Healthcare
name: Victor Miranda, MD
role: STUDY_DIRECTOR
References: