Traumatic Brain Injury
Conditions
Keywords
Mild Traumatic Brain Injury
Brief summary
This hypothesis-generating feasibility study to determine potential associations between a broad range of clinical neurological symptoms and Magnetic Resonance Image (MRI), data, and clinical findings involved in mild traumatic brain injury (mTBI). These associations will be examined over the acute and sub-acute period (baseline to 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 scanner 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 Sponsor
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 (mTBI patient) Inclusion and
Exclusion criteria
Inclusion Criteria for mTBI subjects Subjects included in the main part of this study (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 in one of the first two intervals of the study, as follows: 1. Meets criteria for enrollment in Encounter 1 (within 72 hours), or 2. Meets criteria for enrollment in Encounter 2 (within 8±2 days) 3. Be capable of sufficiently clear communication to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors as described in Section 6.3 - Protection of Vulnerable Subjects, for participation in all parts of the study. Segment 1:
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 | 14 |
| 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 | 2 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Study terminated before completed | 6 | 0 | 0 |
Baseline characteristics
| Characteristic | Experimental: Diagnostic mTBI | Experimental: Diagnostic Non mTBI | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 10 Participants | 1 Participants | 11 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 1 Participants | 5 Participants |
| Region of Enrollment United States | 14 Participants | 2 Participants | 16 Participants |
| Sex: Female, Male Female | 6 Participants | 0 Participants | 6 Participants |
| Sex: Female, Male Male | 8 Participants | 2 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 2 | 0 / 3 |
| other Total, other adverse events | 2 / 14 | 0 / 2 | 0 / 3 |
| serious Total, serious adverse events | 0 / 14 | 0 / 2 | 0 / 3 |
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 |
| Volunteers | mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software | 0 |