Trial Outcomes & Findings for TBI MR Study 3 Houston Methodist (NCT NCT02218216)
NCT ID: NCT02218216
Last Updated: 2017-07-24
Results Overview
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
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
16 participants
Primary outcome timeframe
Baseline to 3 months
Results posted on
2017-07-24
Participant Flow
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.
Participant milestones
| Measure |
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
|
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
|
Volunteers
MRI Diagnostic of Volunteer Controls for Device Calibration
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
|
|---|---|---|---|
|
Overall Study
STARTED
|
14
|
2
|
3
|
|
Overall Study
COMPLETED
|
8
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
6
|
0
|
0
|
Reasons for withdrawal
| Measure |
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
|
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
|
Volunteers
MRI Diagnostic of Volunteer Controls for Device Calibration
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
|
|---|---|---|---|
|
Overall Study
Study terminated before completed
|
6
|
0
|
0
|
Baseline Characteristics
TBI MR Study 3 Houston Methodist
Baseline characteristics by cohort
| Measure |
Experimental: Diagnostic mTBI
n=14 Participants
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
|
Experimental: Diagnostic Non mTBI
n=2 Participants
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
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 3 monthsPopulation: Study was terminated and no subject outcome data were collected
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
Outcome measures
| Measure |
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
|
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
|
Volunteers
MRI Diagnostic of Volunteer Controls for Device Calibration
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
|
|---|---|---|---|
|
mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software
|
0
|
0
|
0
|
Adverse Events
Experimental: Diagnostic mTBI
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Experimental: Diagnostic Non mTBI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Volunteer Controls
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Experimental: Diagnostic mTBI
n=14 participants at risk
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
|
Experimental: Diagnostic Non mTBI
n=2 participants at risk
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
|
Volunteer Controls
n=3 participants at risk
Non injured volunteers for device calibration
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
|
|---|---|---|---|
|
Infections and infestations
Influenza
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected during the period of participant enrollment.
|
0.00%
0/2 • Adverse event data was collected during the period of participant enrollment.
|
0.00%
0/3 • Adverse event data was collected during the period of participant enrollment.
|
|
General disorders
Headache/Dizziness
|
7.1%
1/14 • Number of events 1 • Adverse event data was collected during the period of participant enrollment.
|
0.00%
0/2 • Adverse event data was collected during the period of participant enrollment.
|
0.00%
0/3 • Adverse event data was collected during the period of participant enrollment.
|
Additional Information
Chief Medical Officer - Head Health Initiative
GE Healthcare
Phone: 262-544-3633
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place