Concussion, Traumatic Brain Injury
Conditions
Keywords
TBI, MR, mTBI, NFL, MRI
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.
Interventions
PROCEDUREMRI
MRI scanning
Sponsors
ICON plc
GE Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 50 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MRI Image Data Sets | Per patient scanning over 3 months | MRI image data sets collected from subjects who completed the study. |
| Neuropsychological Assessments | Per patient scanning over 3 months | Neuropsychological assessments collected from subjects who completed the study. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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)
MRI: MRI scanning | 325 |
| 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
MRI: MRI scanning | 152 |
| Total | 477 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Subjects did not complete all 4 visits | 283 | 61 |
Baseline characteristics
| Characteristic | Non-TBI Patients (Segment 2) | Total | mTBI Patient Group (Segment 1) |
|---|---|---|---|
| Age, Categorical <=18 years | 76 Participants | 244 Participants | 168 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants | 212 Participants | 149 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 152 participants | 477 participants | 325 participants |
| Sex: Female, Male Female | 76 Participants | 217 Participants | 141 Participants |
| Sex: Female, Male Male | 63 Participants | 239 Participants | 176 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 325 | 0 / 152 |
| other Total, other adverse events | 22 / 325 | 1 / 152 |
| serious Total, serious adverse events | 0 / 325 | 0 / 152 |
Outcome results
Primary
MRI Image Data Sets
MRI image data sets collected from subjects who completed the study.
Time frame: Per patient scanning over 3 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| mTBI Patient Group (Segment 1) | MRI Image Data Sets | Study Visit 2 images collected | 290 Images collected |
| mTBI Patient Group (Segment 1) | MRI Image Data Sets | Study Visit 4 images collected | 218 Images collected |
| mTBI Patient Group (Segment 1) | MRI Image Data Sets | Study Visit 3 images collected | 240 Images collected |
| mTBI Patient Group (Segment 1) | MRI Image Data Sets | Total number of images collected | 827 Images collected |
| mTBI Patient Group (Segment 1) | MRI Image Data Sets | Study Visit 1 images collected | 79 Images collected |
| Non-TBI Patients (Segment 2) | MRI Image Data Sets | Total number of images collected | 484 Images collected |
| Non-TBI Patients (Segment 2) | MRI Image Data Sets | Study Visit 1 images collected | 150 Images collected |
| Non-TBI Patients (Segment 2) | MRI Image Data Sets | Study Visit 2 images collected | 111 Images collected |
| Non-TBI Patients (Segment 2) | MRI Image Data Sets | Study Visit 3 images collected | 105 Images collected |
| Non-TBI Patients (Segment 2) | MRI Image Data Sets | Study Visit 4 images collected | 118 Images collected |
Primary
Neuropsychological Assessments
Neuropsychological assessments collected from subjects who completed the study.
Time frame: Per patient scanning over 3 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| mTBI Patient Group (Segment 1) | Neuropsychological Assessments | Visit 2 Neuropsychological assessments | 303 Neuropsychological assessments |
| mTBI Patient Group (Segment 1) | Neuropsychological Assessments | Visit 4Neuropsychological assessments | 222 Neuropsychological assessments |
| mTBI Patient Group (Segment 1) | Neuropsychological Assessments | Visit 3 Neuropsychological assessments | 244 Neuropsychological assessments |
| mTBI Patient Group (Segment 1) | Neuropsychological Assessments | Total number of Neuropsychological assessments | 853 Neuropsychological assessments |
| mTBI Patient Group (Segment 1) | Neuropsychological Assessments | Visit 1 Neuropsychological assessments | 84 Neuropsychological assessments |
| Non-TBI Patients (Segment 2) | Neuropsychological Assessments | Total number of Neuropsychological assessments | 492 Neuropsychological assessments |
| Non-TBI Patients (Segment 2) | Neuropsychological Assessments | Visit 1 Neuropsychological assessments | 152 Neuropsychological assessments |
| Non-TBI Patients (Segment 2) | Neuropsychological Assessments | Visit 2 Neuropsychological assessments | 114 Neuropsychological assessments |
| Non-TBI Patients (Segment 2) | Neuropsychological Assessments | Visit 3 Neuropsychological assessments | 107 Neuropsychological assessments |
| Non-TBI Patients (Segment 2) | Neuropsychological Assessments | Visit 4Neuropsychological assessments | 119 Neuropsychological assessments |