Trial Outcomes & Findings for Q-collar and Brain Injury Biomarkers (NCT NCT02271451)
NCT ID: NCT02271451
Last Updated: 2020-09-04
Results Overview
measured white matter changes, mean diffusivity (MD), and radial diffusivity (RD)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
15 participants
Primary outcome timeframe
2 years
Results posted on
2020-09-04
Participant Flow
Participant milestones
| Measure |
Q Collar
subjects wearing the q collar
Q collar: collar worn around neck
|
Control
subjects not wearing the Q collar
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
8
|
|
Overall Study
COMPLETED
|
7
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Q-collar and Brain Injury Biomarkers
Baseline characteristics by cohort
| Measure |
Q Collar
n=7 Participants
subjects wearing the q collar
Q collar: collar worn around neck
|
Control
n=8 Participants
subjects not wearing the Q collar
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Changes seen on DTI imaging
measured white matter changes, mean diffusivity (MD), and radial diffusivity (RD)
Outcome measures
| Measure |
Q Collar
n=7 Participants
subjects wearing the q collar
Q collar: collar worn around neck
|
Control
n=7 Participants
subjects not wearing the Q collar
|
|---|---|---|
|
Longitudinal DTI Changes
Baseline MD
|
0.000809 voxels
Standard Deviation 0.000056
|
0.000760 voxels
Standard Deviation 0.000089
|
|
Longitudinal DTI Changes
Mid-Season MD
|
0.000763 voxels
Standard Deviation 0.000072
|
0.000843 voxels
Standard Deviation 0.000062
|
|
Longitudinal DTI Changes
Baseline RD
|
0.000525 voxels
Standard Deviation 0.000044
|
0.000426 voxels
Standard Deviation 0.000062
|
|
Longitudinal DTI Changes
Mid-Season RD
|
0.000447 voxels
Standard Deviation 0.000062
|
0.000511 voxels
Standard Deviation 0.000037
|
Adverse Events
Q Collar
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place