Traumatic Brain Injury
Conditions
Keywords
Mild Traumatic Brain Injury
Brief summary
This hypothesis-generating feasibility study compares mTBI Patients and Controls using advanced MRI Applications.
Detailed description
This hypothesis-generating feasibility study is being conducted to determine potential associations between a broad range of clinical neurological symptoms and MR images, data, and clinical findings involved in mild traumatic brain injury (mTBI). These associations will be examined over the acute and sub-acute period (approximately 3 months) following injury to provide information useful for optimization of MR pulse sequences for mTBI applications. The intent of this study is to broadly generate a range of potential mTBI biomarkers detectable using investigational MR pulse sequence technologies. Feasibility data attained in this study may be used for engineering program decision-making and in support of future scientific assessment, engineering development, published research databases or registries mTBI data and images, and other purposes determined by the Sponsor. The results of this study are not intended for use in regulatory submissions. Subjects will be examined on commercially available MR scanners using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MR pulse sequences optimized by GEHC.
Interventions
DEVICEMRI Diagnostic
Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences
Sponsors
GE Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Segment 1:
Exclusion criteria
for mTBI subjects Subjects will be excluded that have: 1. Loss of consciousness (LOC) ≥15 minutes; 2. Posttraumatic amnesia lasting ≥24 hr following a recent TBI event; 3. Diagnosis of moderate to severe TBI or GCS \<13; 4. Structural brain injury indicated by previous neuroimaging findings; 5. Previous history of moderate to severe TBI; 6. Any previous history of mild TBI within the past 12 months; 7. Previously diagnosed brain white matter disease; 8. History of seizures within the past 10 years; 9. History of self-reported illicit drug abuse (except marijuana) in past 10 years; 10. History of alcohol abuse or dependence (per DSM-IV-TR Diagnostic Criteria); 11. 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 F - Screening for Exclusion based on Axis I or II Disorders): 12. History of brain mass; 13. History of neurosurgery; 14. History of stroke; 15. History of dementia; 16. Known cognitive dysfunction; 17. Known structural brain disease or malformation; 18. Current anti-psychotic or antiepileptic medication usage; 19. That are unable or unwilling to complete study procedures accurately or have any conflict of interest that could affect study results, in the opinion of the investigator; 20. Contraindications to MRI scanning, including: 1. Current or suspected pregnancy per site clinical practice; 2. Other conditions that may constitute a hazard to the subject during study participation, determined by the investigator; 3. Inability to comply with any part of the site's MR safety policy. 6.6. Segment 2 (non-TBI subject) Inclusion and
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software | Baseline to 3 months | To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including Volumetry, Kurtosis, Resting State \[RS\], functional magnetic resonance imaging \[fMRI\], and additional post-processing modules may be provided |
Countries
United States
Participant flow
Pre-assignment details
Volunteer Control participants were scanned only for the purpose of operator training and calibrating the MRI device. No data was collected from these participants for the the purpose of analysis.
Participants by arm
| Arm | Count |
|---|---|
| Experimental: Diagnostic mTBI MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI)
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences | 11 |
| Experimental: Diagnostic Non mTBI MRI Diagnostic of Non injured subjects that are closely matched to mTBI
MRI Diagnostic: Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences | 6 |
| Total | 17 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Study Terminated before Visit | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 6 | 0 | 0 |
Baseline characteristics
| Characteristic | Experimental: Diagnostic mTBI | Experimental: Diagnostic Non mTBI | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 2 Participants | 0 Participants | 2 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 6 Participants | 15 Participants |
| Region of Enrollment United States | 11 Participants | 6 Participants | 17 Participants |
| Sex: Female, Male Female | 3 Participants | 3 Participants | 6 Participants |
| Sex: Female, Male Male | 8 Participants | 3 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 0 / 11 | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 11 | 0 / 6 | 0 / 6 |
Outcome results
Primary
mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software
To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including Volumetry, Kurtosis, Resting State \[RS\], functional magnetic resonance imaging \[fMRI\], and additional post-processing modules may be provided
Time frame: Baseline to 3 months
Population: Study was terminated and no subject outcome data were collected
| Arm | Measure | Value |
|---|---|---|
| Experimental: Diagnostic mTBI | mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software | 0 |
| Experimental: Diagnostic Non mTBI | mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software | 0 |
| Volunteer Controls | mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software | 0 |