| Registry | NCT03104244 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 280 (Estimated) |
| Sponsor | More Foundation (Other); collaborators: Riddell, LLC, ElMindA Ltd, Mimic Systems |
| Conditions | Concussion, Brain, Athletic Injuries |
| Dates | start 2016-07-01, primary completion 2020-08-01 (estimated), completion 2020-08-01 (estimated), first posted 2017-04-07, last updated 2017-06-12 |
| Locations | 1 site in United States |
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The purpose of this study is to determine the neurologic and cognitive effects of playing tackle football in grade school and high school.
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).
Football players wear a football helmet containing the InSite Impact Response System that measures when, how hard, and where the helmet is hit. Coaches (or athletic trainer) are notified of threshold impacts via a sideline handheld device.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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. | ||
| 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. |
Sex: Male, ages: 9 Years to 19 Years
Inclusion Criteria: * Male football players 9-19 years of age at time of enrollment. * 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: * History of moderate or severe traumatic brain injury. This is defined as loss of consciousness >30 minutes or amnesia >24 hours. * 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.
| Facility | City | Country | Status |
|---|---|---|---|
| The Sports Neurology Clinic at the CORE Institute | Brighton, Michigan | United States | Recruiting |