Clinical trial NCT03104244: Longitudinal Brain Health in Youth Tackle Football Players
Official title: Longitudinal Brain Health in Youth Tackle Football Players
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Concussion, Brain
Athletic Injuries
Keywords: concussion
subconcussive impacts
brain function
football
Lead sponsor: More Foundation
Sponsor class: OTHER
Collaborators: name: Riddell, LLC
name: ElMindA Ltd
name: Mimic Systems
First posted: 2017-04-07
Enrollment: 280
Sex: MALE
Minimum age (years): 9
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Youth and high school football players from teams included in the study

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Impact Monitoring (g force)
timeFrame: The football season runs from early August through late October or November (3-4 months)
Secondary outcomes:
measure: Neurological history
timeFrame: Occurs pre-season & post season and continues for 4 years
measure: Neurological physical examination
timeFrame: Occurs pre-season & post season and continues for 4 years
measure: Cogstate
timeFrame: Occurs pre-season & post-season and continues for 4 years
measure: Pen and paper neuropsychological tests
timeFrame: Occurs pre-season & post-season and continues for 4 years
measure: Brain Network Activation (BNA) EEG test
timeFrame: Occurs pre-season & post-season and continues for 4 years
measure: Vestibular/Ocular Motor Screening (VOMS) test
timeFrame: Occurs pre-season & post-season and continues for 4 years
measure: MimicBalance!
timeFrame: Occurs pre-season & post-season and continues for 4 years
measure: Strength and Difficulties Questionnaire
timeFrame: Occurs pre-season & post-season and continues for 4 years
measure: SWAN ADHD Questionnaire
timeFrame: Occurs pre-season & post season and continues for 4 years
Other outcomes:
Locations:
city: Brighton
country: United States
facility: The Sports Neurology Clinic at the CORE Institute
state: Michigan
Study officials:
affiliation: The Sports Neurology Clinic
name: Sean Rose, M.D.
role: PRINCIPAL_INVESTIGATOR
References: