Longitudinal Brain Health in Youth Tackle Football Players
NCT ID: NCT03104244
Last Updated: 2017-06-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
280 participants
OBSERVATIONAL
2016-07-31
2020-08-31
Brief Summary
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During contact practices and games, players wear a football helmet containing an impact sensor. Before and after each season, players complete neurological testing to measure several different aspects of brain function.
Two groups of football players will be in the study:
5th and 6th grade tackle football players from the Brighton Bulldogs Football and Cheer league (about 70 players).
Varsity football players from Brighton High School (about 70 players per year).
The study begins in July 2016 and will continue for 4 years (through the winter of 2020).
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Detailed Description
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Each year pre and post-season, subjects will complete several tests of brain function during a clinic visit. These tests are listed in the "secondary outcomes" section.
Specific Aims:
1. To quantify the cumulative head impact burden during consecutive seasons of youth tackle football and high school football.
2. To detect impairment in neurologic and cognitive function from playing youth tackle football and high school football.
3. To use cumulative head impact burden to predict the development of neurologic and neurocognitive impairment.
4. To compare the effect of head impacts on youth tackle football players verses high school football players.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Youth Football
5th and 6th grade tackle football players will be enrolled in 2016. They will be followed as a cohort, participating in the study each year they play tackle football, through 8th grade. Total enrollment is expected to reach 70 players.
No interventions assigned to this group
High School Football
Varsity football players from Brighton High School are eligible for the study in each year of the study. The varsity team consists of approximately 80 players. Total enrollment in this group is expected to reach 200 subjects; 80 the first year with 40 additional enrolled each subsequent year of the study.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Youth Football:
* 5th and 6th grade tackle football players from the Brighton Bulldogs Football and Cheer league.
* High School Football:
* Varsity Brighton High School football players.
Exclusion Criteria
* Hearing problem preventing completion of the study testing.
* Legal blindness, preventing completion of the study testing.
* Non-English speaking subjects, preventing completion of the study testing.
* Ward of the State.
9 Years
19 Years
MALE
No
Sponsors
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Riddell, LLC
UNKNOWN
ElMindA Ltd
INDUSTRY
Mimic Systems
OTHER
More Foundation
OTHER
Responsible Party
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Sean Rose, M. D.
Director of Clinical Research and Regional Director
Principal Investigators
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Sean Rose, M.D.
Role: PRINCIPAL_INVESTIGATOR
The Sports Neurology Clinic
Locations
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The Sports Neurology Clinic at the CORE Institute
Brighton, Michigan, United States
Countries
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Central Contacts
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Facility Contacts
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Sean Rose, M.D.
Role: primary
Other Identifiers
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MoreFoundation
Identifier Type: -
Identifier Source: org_study_id
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