Longitudinal Brain Health in Youth Tackle Football Players

Study Overview
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Brief Summary
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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).

Detailed Description
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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: To quantify the cumulative head impact burden during consecutive seasons of youth tackle football and high school football. To detect impairment in neurologic and cognitive function from playing youth tackle football and high school football. To use cumulative head impact burden to predict the development of neurologic and neurocognitive impairment. To compare the effect of head impacts on youth tackle football players verses high school football players.

Official Title
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Longitudinal Brain Health in Youth Tackle Football Players

Conditions
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Concussion, Brain, Athletic Injuries

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Youth Football<br>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<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact Monitoring (g force) | Each subject in the study group will be fitted with a football helmet containing the InSite impact response system. Subjects will be monitored for impacts during all contact practices and games. | The football season runs from early August through late October or November (3-4 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological history | Determine family and personal neurological history of the subject | Occurs pre-season & post season and continues for 4 years | 
| Neurological physical examination | Physician performed neurological examination | Occurs pre-season & post season and continues for 4 years | 
| Cogstate | Brief computerized neurocognitive test | Occurs pre-season & post-season and continues for 4 years | 
| Pen and paper neuropsychological tests | Pen and paper tasks that assess memory, attention, and processing | Occurs pre-season & post-season and continues for 4 years | 
| Brain Network Activation (BNA) EEG test | evoked-response electroencephalogram | Occurs pre-season & post-season and continues for 4 years | 
| Vestibular/Ocular Motor Screening (VOMS) test | Assessment of eye movements and associated symptoms of headache, dizziness, nausea, and fogginess | Occurs pre-season & post-season and continues for 4 years | 
| MimicBalance! | video capture balance test that incorporates several different postures, including BESS postures | Occurs pre-season & post-season and continues for 4 years | 
| Strength and Difficulties Questionnaire | Self assessment questionnaire | Occurs pre-season & post-season and continues for 4 years | 
| SWAN ADHD Questionnaire | Strengths and weaknesses of ADHD symptoms and normal behavior (SWAN) questionnaire completed by parent or legal guardian. | Occurs pre-season & post season and continues for 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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concussion, subconcussive impacts, brain function, football