Trial Outcomes & Findings for Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2 (NCT NCT02556177)
NCT ID: NCT02556177
Last Updated: 2019-09-10
Results Overview
MRI image data sets collected from subjects who completed the study.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
477 participants
Primary outcome timeframe
Per patient scanning over 3 months
Results posted on
2019-09-10
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
325
|
152
|
|
Overall Study
COMPLETED
|
42
|
91
|
|
Overall Study
NOT COMPLETED
|
283
|
61
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
Overall Study
Subjects did not complete all 4 visits
|
283
|
61
|
Baseline Characteristics
8 subjects in Segment 1 did not collect age, as a result the overall subjects to be counted for age is 317. 13 subjects in Segment 2 did not collect age, as a result the overall subjects to be counted for age is 139.
Baseline characteristics by cohort
| Measure |
mTBI Patient Group (Segment 1)
n=325 Participants
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
|
Non-TBI Patients (Segment 2)
n=152 Participants
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
|
Total
n=477 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
168 Participants
n=317 Participants • 8 subjects in Segment 1 did not collect age, as a result the overall subjects to be counted for age is 317. 13 subjects in Segment 2 did not collect age, as a result the overall subjects to be counted for age is 139.
|
76 Participants
n=139 Participants • 8 subjects in Segment 1 did not collect age, as a result the overall subjects to be counted for age is 317. 13 subjects in Segment 2 did not collect age, as a result the overall subjects to be counted for age is 139.
|
244 Participants
n=456 Participants • 8 subjects in Segment 1 did not collect age, as a result the overall subjects to be counted for age is 317. 13 subjects in Segment 2 did not collect age, as a result the overall subjects to be counted for age is 139.
|
|
Age, Categorical
Between 18 and 65 years
|
149 Participants
n=317 Participants • 8 subjects in Segment 1 did not collect age, as a result the overall subjects to be counted for age is 317. 13 subjects in Segment 2 did not collect age, as a result the overall subjects to be counted for age is 139.
|
63 Participants
n=139 Participants • 8 subjects in Segment 1 did not collect age, as a result the overall subjects to be counted for age is 317. 13 subjects in Segment 2 did not collect age, as a result the overall subjects to be counted for age is 139.
|
212 Participants
n=456 Participants • 8 subjects in Segment 1 did not collect age, as a result the overall subjects to be counted for age is 317. 13 subjects in Segment 2 did not collect age, as a result the overall subjects to be counted for age is 139.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=317 Participants • 8 subjects in Segment 1 did not collect age, as a result the overall subjects to be counted for age is 317. 13 subjects in Segment 2 did not collect age, as a result the overall subjects to be counted for age is 139.
|
0 Participants
n=139 Participants • 8 subjects in Segment 1 did not collect age, as a result the overall subjects to be counted for age is 317. 13 subjects in Segment 2 did not collect age, as a result the overall subjects to be counted for age is 139.
|
0 Participants
n=456 Participants • 8 subjects in Segment 1 did not collect age, as a result the overall subjects to be counted for age is 317. 13 subjects in Segment 2 did not collect age, as a result the overall subjects to be counted for age is 139.
|
|
Sex: Female, Male
Female
|
141 Participants
n=317 Participants • 8 subjects in Segment 1 did not collect gender, as a result the overall subjects to be counted for gender is 317. 13 subjects in Segment 2 did not collect gender, as a result the overall subjects to be counted for gender is 139.
|
76 Participants
n=139 Participants • 8 subjects in Segment 1 did not collect gender, as a result the overall subjects to be counted for gender is 317. 13 subjects in Segment 2 did not collect gender, as a result the overall subjects to be counted for gender is 139.
|
217 Participants
n=456 Participants • 8 subjects in Segment 1 did not collect gender, as a result the overall subjects to be counted for gender is 317. 13 subjects in Segment 2 did not collect gender, as a result the overall subjects to be counted for gender is 139.
|
|
Sex: Female, Male
Male
|
176 Participants
n=317 Participants • 8 subjects in Segment 1 did not collect gender, as a result the overall subjects to be counted for gender is 317. 13 subjects in Segment 2 did not collect gender, as a result the overall subjects to be counted for gender is 139.
|
63 Participants
n=139 Participants • 8 subjects in Segment 1 did not collect gender, as a result the overall subjects to be counted for gender is 317. 13 subjects in Segment 2 did not collect gender, as a result the overall subjects to be counted for gender is 139.
|
239 Participants
n=456 Participants • 8 subjects in Segment 1 did not collect gender, as a result the overall subjects to be counted for gender is 317. 13 subjects in Segment 2 did not collect gender, as a result the overall subjects to be counted for gender is 139.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
325 participants
n=325 Participants
|
152 participants
n=152 Participants
|
477 participants
n=477 Participants
|
PRIMARY outcome
Timeframe: Per patient scanning over 3 monthsMRI image data sets collected from subjects who completed the study.
Outcome measures
| Measure |
mTBI Patient Group (Segment 1)
n=325 Participants
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
|
Non-TBI Patients (Segment 2)
n=152 Participants
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
|
|---|---|---|
|
MRI Image Data Sets
Study Visit 1 images collected
|
79 Images collected
|
150 Images collected
|
|
MRI Image Data Sets
Study Visit 2 images collected
|
290 Images collected
|
111 Images collected
|
|
MRI Image Data Sets
Study Visit 3 images collected
|
240 Images collected
|
105 Images collected
|
|
MRI Image Data Sets
Study Visit 4 images collected
|
218 Images collected
|
118 Images collected
|
|
MRI Image Data Sets
Total number of images collected
|
827 Images collected
|
484 Images collected
|
PRIMARY outcome
Timeframe: Per patient scanning over 3 monthsNeuropsychological assessments collected from subjects who completed the study.
Outcome measures
| Measure |
mTBI Patient Group (Segment 1)
n=325 Participants
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
|
Non-TBI Patients (Segment 2)
n=152 Participants
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
|
|---|---|---|
|
Neuropsychological Assessments
Visit 1 Neuropsychological assessments
|
84 Neuropsychological assessments
|
152 Neuropsychological assessments
|
|
Neuropsychological Assessments
Visit 2 Neuropsychological assessments
|
303 Neuropsychological assessments
|
114 Neuropsychological assessments
|
|
Neuropsychological Assessments
Visit 3 Neuropsychological assessments
|
244 Neuropsychological assessments
|
107 Neuropsychological assessments
|
|
Neuropsychological Assessments
Visit 4Neuropsychological assessments
|
222 Neuropsychological assessments
|
119 Neuropsychological assessments
|
|
Neuropsychological Assessments
Total number of Neuropsychological assessments
|
853 Neuropsychological assessments
|
492 Neuropsychological assessments
|
Adverse Events
mTBI Patient Group (Segment 1)
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Non-TBI Patients (Segment 2)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
mTBI Patient Group (Segment 1)
n=325 participants at risk
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
|
Non-TBI Patients (Segment 2)
n=152 participants at risk
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
|
|---|---|---|
|
Nervous system disorders
Peripheral Nerve Stimulation
|
1.5%
5/325 • Number of events 5 • Each visit lasted approximately 90 minutes.
Subjects were followed for adverse events and device effects from the time they arrived for each study visit (immediately after providing informed consent for the first visit, and upon arriving to the study area for each subsequent visit,) until the subject left the study area after each visit.
|
0.00%
0/152 • Each visit lasted approximately 90 minutes.
Subjects were followed for adverse events and device effects from the time they arrived for each study visit (immediately after providing informed consent for the first visit, and upon arriving to the study area for each subsequent visit,) until the subject left the study area after each visit.
|
|
Nervous system disorders
Claustrophobia
|
2.2%
7/325 • Number of events 7 • Each visit lasted approximately 90 minutes.
Subjects were followed for adverse events and device effects from the time they arrived for each study visit (immediately after providing informed consent for the first visit, and upon arriving to the study area for each subsequent visit,) until the subject left the study area after each visit.
|
0.66%
1/152 • Number of events 1 • Each visit lasted approximately 90 minutes.
Subjects were followed for adverse events and device effects from the time they arrived for each study visit (immediately after providing informed consent for the first visit, and upon arriving to the study area for each subsequent visit,) until the subject left the study area after each visit.
|
|
General disorders
Headache
|
0.62%
2/325 • Number of events 2 • Each visit lasted approximately 90 minutes.
Subjects were followed for adverse events and device effects from the time they arrived for each study visit (immediately after providing informed consent for the first visit, and upon arriving to the study area for each subsequent visit,) until the subject left the study area after each visit.
|
0.00%
0/152 • Each visit lasted approximately 90 minutes.
Subjects were followed for adverse events and device effects from the time they arrived for each study visit (immediately after providing informed consent for the first visit, and upon arriving to the study area for each subsequent visit,) until the subject left the study area after each visit.
|
|
Psychiatric disorders
Anxiety
|
0.31%
1/325 • Number of events 1 • Each visit lasted approximately 90 minutes.
Subjects were followed for adverse events and device effects from the time they arrived for each study visit (immediately after providing informed consent for the first visit, and upon arriving to the study area for each subsequent visit,) until the subject left the study area after each visit.
|
0.00%
0/152 • Each visit lasted approximately 90 minutes.
Subjects were followed for adverse events and device effects from the time they arrived for each study visit (immediately after providing informed consent for the first visit, and upon arriving to the study area for each subsequent visit,) until the subject left the study area after each visit.
|
|
General disorders
Pain
|
0.92%
3/325 • Number of events 3 • Each visit lasted approximately 90 minutes.
Subjects were followed for adverse events and device effects from the time they arrived for each study visit (immediately after providing informed consent for the first visit, and upon arriving to the study area for each subsequent visit,) until the subject left the study area after each visit.
|
0.00%
0/152 • Each visit lasted approximately 90 minutes.
Subjects were followed for adverse events and device effects from the time they arrived for each study visit (immediately after providing informed consent for the first visit, and upon arriving to the study area for each subsequent visit,) until the subject left the study area after each visit.
|
|
Nervous system disorders
Concussion
|
0.92%
3/325 • Number of events 3 • Each visit lasted approximately 90 minutes.
Subjects were followed for adverse events and device effects from the time they arrived for each study visit (immediately after providing informed consent for the first visit, and upon arriving to the study area for each subsequent visit,) until the subject left the study area after each visit.
|
0.00%
0/152 • Each visit lasted approximately 90 minutes.
Subjects were followed for adverse events and device effects from the time they arrived for each study visit (immediately after providing informed consent for the first visit, and upon arriving to the study area for each subsequent visit,) until the subject left the study area after each visit.
|
|
Musculoskeletal and connective tissue disorders
ACL tear
|
0.31%
1/325 • Number of events 1 • Each visit lasted approximately 90 minutes.
Subjects were followed for adverse events and device effects from the time they arrived for each study visit (immediately after providing informed consent for the first visit, and upon arriving to the study area for each subsequent visit,) until the subject left the study area after each visit.
|
0.00%
0/152 • Each visit lasted approximately 90 minutes.
Subjects were followed for adverse events and device effects from the time they arrived for each study visit (immediately after providing informed consent for the first visit, and upon arriving to the study area for each subsequent visit,) until the subject left the study area after each visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place