Trial Outcomes & Findings for Protection Against Potential Brain Injury During Competitive Football (NCT NCT02696200)
NCT ID: NCT02696200
Last Updated: 2020-12-09
Results Overview
monitor the differences in average number of hits between the group wearing the collar and the group not wearing the collar
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
5 months
Results posted on
2020-12-09
Participant Flow
Participant milestones
| Measure |
Subjects Wearing the Q Collar
Subjects wearing the Q collar throughout the football season
Q Collar: The device is fitted to the neck to provide a comfortable and precise jugular compression that potentially mitigates cerebral slosh. The device will be worn inside the collar of an athletic compression shirt.
|
Subjects Not Wearing the Q Collar
Control group of subjects not wearing the q collar
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
30
|
|
Overall Study
COMPLETED
|
32
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Subjects Wearing the Q Collar
n=32 Participants
Subjects wearing the Q collar throughout the football season
Q Collar: The device is fitted to the neck to provide a comfortable and precise jugular compression that potentially mitigates cerebral slosh. The device will be worn inside the collar of an athletic compression shirt.
|
Subjects Not Wearing the Q Collar
n=30 Participants
Control group of subjects not wearing the q collar
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
32 Participants
n=32 Participants
|
30 Participants
n=30 Participants
|
62 Participants
n=62 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=32 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=62 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=32 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=62 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=32 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=62 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=32 Participants
|
30 Participants
n=30 Participants
|
62 Participants
n=62 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
32 participants
n=32 Participants
|
30 participants
n=30 Participants
|
62 participants
n=62 Participants
|
PRIMARY outcome
Timeframe: 5 monthsmonitor the differences in average number of hits between the group wearing the collar and the group not wearing the collar
Outcome measures
| Measure |
Subjects Wearing the Q Collar
n=32 Participants
Subjects wearing the Q collar throughout the football season
Q Collar: The device is fitted to the neck to provide a comfortable and precise jugular compression that potentially mitigates cerebral slosh. The device will be worn inside the collar of an athletic compression shirt.
|
Subjects Not Wearing the Q Collar
n=30 Participants
Control group of subjects not wearing the q collar
|
|---|---|---|
|
Determine Average Number of Hits Between Groups
Avg # of hits >20g
|
896.43 number of hits
Standard Deviation 600.03
|
795.40 number of hits
Standard Deviation 508.92
|
|
Determine Average Number of Hits Between Groups
Avg # of hits >50g
|
144.67 number of hits
Standard Deviation 106.55
|
145.85 number of hits
Standard Deviation 109.98
|
|
Determine Average Number of Hits Between Groups
Avg # of hits >100g
|
14.38 number of hits
Standard Deviation 11.29
|
18.3 number of hits
Standard Deviation 20.85
|
|
Determine Average Number of Hits Between Groups
Avg # of hits >150g
|
2.43 number of hits
Standard Deviation 3.11
|
1.8 number of hits
Standard Deviation 2.04
|
|
Determine Average Number of Hits Between Groups
Avg # of hits >200g
|
0.43 number of hits
Standard Deviation 1.17
|
0.30 number of hits
Standard Deviation 0.73
|
PRIMARY outcome
Timeframe: 5 monthsdetermine the number of subjects in the collar group and the non collar group that underwent EEG assessment
Outcome measures
| Measure |
Subjects Wearing the Q Collar
n=32 Participants
Subjects wearing the Q collar throughout the football season
Q Collar: The device is fitted to the neck to provide a comfortable and precise jugular compression that potentially mitigates cerebral slosh. The device will be worn inside the collar of an athletic compression shirt.
|
Subjects Not Wearing the Q Collar
n=30 Participants
Control group of subjects not wearing the q collar
|
|---|---|---|
|
Number of Participants Undergoing EEG Assessment
|
32 Participants
|
30 Participants
|
PRIMARY outcome
Timeframe: 6 monthsChange in fractional anisotropy (FA) from Pre to Post season
Outcome measures
| Measure |
Subjects Wearing the Q Collar
n=32 Participants
Subjects wearing the Q collar throughout the football season
Q Collar: The device is fitted to the neck to provide a comfortable and precise jugular compression that potentially mitigates cerebral slosh. The device will be worn inside the collar of an athletic compression shirt.
|
Subjects Not Wearing the Q Collar
n=30 Participants
Control group of subjects not wearing the q collar
|
|---|---|---|
|
Change in Fractional Anisotropy (FA)
|
0.03 percentage of change
Standard Deviation 1.24
|
2.43 percentage of change
Standard Deviation 1.01
|
Adverse Events
Subjects Wearing the Q Collar
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Subjects Not Wearing the Q Collar
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