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Protection Against Potential Brain Injury During Competitive Football

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02696200
Recruitment Status : Completed
First Posted : March 2, 2016
Results First Posted : December 9, 2020
Last Update Posted : December 9, 2020
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Concussion
Intervention Device: Q Collar
Enrollment 62
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Subjects Wearing the Q Collar Subjects Not Wearing the Q Collar
Hide Arm/Group Description

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.

Control group of subjects not wearing the q collar
Period Title: Overall Study
Started 32 30
Completed 32 30
Not Completed 0 0
Arm/Group Title Subjects Wearing the Q Collar Subjects Not Wearing the Q Collar Total
Hide Arm/Group Description

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.

Control group of subjects not wearing the q collar Total of all reporting groups
Overall Number of Baseline Participants 32 30 62
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 30 participants 62 participants
<=18 years
32
 100.0%
30
 100.0%
62
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 32 participants 30 participants 62 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
32
 100.0%
30
 100.0%
62
 100.0%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 32 participants 30 participants 62 participants
32 30 62
1.Primary Outcome
Title Determine Average Number of Hits Between Groups
Hide Description monitor the differences in average number of hits between the group wearing the collar and the group not wearing the collar
Time Frame 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subjects Wearing the Q Collar Subjects Not Wearing the Q Collar
Hide Arm/Group Description:

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.

Control group of subjects not wearing the q collar
Overall Number of Participants Analyzed 32 30
Mean (Standard Deviation)
Unit of Measure: number of hits
Avg # of hits >20g 896.43  (600.03) 795.40  (508.92)
Avg # of hits >50g 144.67  (106.55) 145.85  (109.98)
Avg # of hits >100g 14.38  (11.29) 18.3  (20.85)
Avg # of hits >150g 2.43  (3.11) 1.8  (2.04)
Avg # of hits >200g 0.43  (1.17) 0.30  (0.73)
2.Primary Outcome
Title Number of Participants Undergoing EEG Assessment
Hide Description determine the number of subjects in the collar group and the non collar group that underwent EEG assessment
Time Frame 5 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subjects Wearing the Q Collar Subjects Not Wearing the Q Collar
Hide Arm/Group Description:

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.

Control group of subjects not wearing the q collar
Overall Number of Participants Analyzed 32 30
Measure Type: Count of Participants
Unit of Measure: Participants
32
 100.0%
30
 100.0%
3.Primary Outcome
Title Change in Fractional Anisotropy (FA)
Hide Description Change in fractional anisotropy (FA) from Pre to Post season
Time Frame 6 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Subjects Wearing the Q Collar Subjects Not Wearing the Q Collar
Hide Arm/Group Description:

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.

Control group of subjects not wearing the q collar
Overall Number of Participants Analyzed 32 30
Mean (Standard Deviation)
Unit of Measure: percentage of change
0.03  (1.24) 2.43  (1.01)
Time Frame 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Subjects Wearing the Q Collar Subjects Not Wearing the Q Collar
Hide Arm/Group Description

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.

Control group of subjects not wearing the q collar
All-Cause Mortality
Subjects Wearing the Q Collar Subjects Not Wearing the Q Collar
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/30 (0.00%) 
Hide Serious Adverse Events
Subjects Wearing the Q Collar Subjects Not Wearing the Q Collar
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/30 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Subjects Wearing the Q Collar Subjects Not Wearing the Q Collar
Affected / at Risk (%) Affected / at Risk (%)
Total   0/32 (0.00%)   0/30 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kim Foss
Organization: Cincinnati Childrens Hospital
Phone: 513-636-5971
EMail: kim.foss@cchmc.org
Layout table for additonal information
Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02696200    
Other Study ID Numbers: 2015-2205
First Submitted: May 28, 2015
First Posted: March 2, 2016
Results First Submitted: July 24, 2020
Results First Posted: December 9, 2020
Last Update Posted: December 9, 2020