Longitudinal Brain Health in Youth Tackle Football Players
- Conditions
- Athletic InjuriesConcussion, Brain
- Registration Number
- NCT03104244
- Lead Sponsor
- More Foundation
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Male
- Target Recruitment
- 280
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Impact Monitoring (g force) The football season runs from early August through late October or November (3-4 months) 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.
- Secondary Outcome Measures
Name Time Method Neurological history Occurs pre-season & post season and continues for 4 years Determine family and personal neurological history of the subject
Neurological physical examination Occurs pre-season & post season and continues for 4 years Physician performed neurological examination
Vestibular/Ocular Motor Screening (VOMS) test Occurs pre-season & post-season and continues for 4 years Assessment of eye movements and associated symptoms of headache, dizziness, nausea, and fogginess
MimicBalance! Occurs pre-season & post-season and continues for 4 years video capture balance test that incorporates several different postures, including BESS postures
Strength and Difficulties Questionnaire Occurs pre-season & post-season and continues for 4 years Self assessment questionnaire
SWAN ADHD Questionnaire Occurs pre-season & post season and continues for 4 years Strengths and weaknesses of ADHD symptoms and normal behavior (SWAN) questionnaire completed by parent or legal guardian.
Cogstate Occurs pre-season & post-season and continues for 4 years Brief computerized neurocognitive test
Pen and paper neuropsychological tests Occurs pre-season & post-season and continues for 4 years Pen and paper tasks that assess memory, attention, and processing
Brain Network Activation (BNA) EEG test Occurs pre-season & post-season and continues for 4 years evoked-response electroencephalogram
Trial Locations
- Locations (1)
The Sports Neurology Clinic at the CORE Institute
🇺🇸Brighton, Michigan, United States