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
Last Update Posted : July 15, 2020
|Condition or disease||Intervention/treatment||Phase|
|Concussion||Device: Q Collar||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||62 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Novel Protection Against Potential Brain Injury During Competitive Football Head Impacts|
|Study Start Date :||May 2015|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||June 2017|
Experimental: Subjects Wearing the Q Collar
Subjects wearing the Q collar throughout the football season
Device: 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.
No Intervention: Subjects Not Wearing the Q Collar
Control group of subjects not wearing the q collar
- Determine longitudinal changes in brain structure using MRI [ Time Frame: 5 months ]monitor longitudinal changes in brain structure between the preseason and postseason, in a population of football playing athletes wearing the Device and compared to a similar population not wearing the device.
- Determine longitudinal changes in brain function using EEG [ Time Frame: 5 months ]monitor longitudinal changes in brain function between the preseason and postseason, in a population of football playing athletes wearing the Device and compared to a similar population not wearing the device.
- determine Concussion Incidence [ Time Frame: 5 months ]Secondly, the purpose is to determine the protection of the device relative to amount and magnitude of sustained head impacts.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02696200
|United States, Ohio|
|Cincinanti Childrens Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Gregory D Myer, PhD||Children's Hospital Medical Center, Cincinnati|