Protection Against Potential Brain Injury During Competitive Football
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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
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Condition or disease | Intervention/treatment | Phase |
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Concussion | Device: Q Collar | Not Applicable |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 62 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: Subjects Wearing the Q Collar
Subjects wearing the Q collar throughout the football season
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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
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- Determine Average Number of Hits Between Groups [ Time Frame: 5 months ]monitor the differences in average number of hits between the group wearing the collar and the group not wearing the collar
- Number of Participants Undergoing EEG Assessment [ Time Frame: 5 months ]determine the number of subjects in the collar group and the non collar group that underwent EEG assessment
- Change in Fractional Anisotropy (FA) [ Time Frame: 6 months ]Change in fractional anisotropy (FA) from Pre to Post season

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Ages Eligible for Study: | 14 Years to 19 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Normal healthy volunteer
- Able to provide written consent
- Must be 14 years or older and a participant on varsity level high school football team
Exclusion Criteria:
- Unable to provide written consent
- History of neurological deficits, previous cerebral infarction, or severe head trauma as indicated through pre-season screening:
- Medical contraindications to restriction of venous outflow via the internal jugular veins (known increased intracerebral pressure, metabolic acidosis or alkalosis)
- Glaucoma (Narrow Angle or Normal Tension)
- Hydrocephalus
- Recent penetrating brain trauma (within 6 months)
- Known carotid hypersensitivity
- Known increased intracranial pressure
- Central vein thrombosis
- Any known airway obstruction
- Any known seizure disorder

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 |
Documents provided by Children's Hospital Medical Center, Cincinnati:
Responsible Party: | Children's Hospital Medical Center, Cincinnati |
ClinicalTrials.gov Identifier: | NCT02696200 |
Other Study ID Numbers: |
2015-2205 |
First Posted: | March 2, 2016 Key Record Dates |
Results First Posted: | December 9, 2020 |
Last Update Posted: | December 9, 2020 |
Last Verified: | November 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | Results will be published however individual participant data will remain secure. |
Concussion |
Brain Injuries Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |