Longitudinal Brain Health in Youth Tackle Football Players

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).

Study Overview

• Status: Unknown
• Conditions: Athletic Injuries; Concussion, Brain

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.

• Study Type: Observational
• Enrollment (Anticipated): 280

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Brighton, Michigan, United States, 48114
      • Recruiting
      • The Sports Neurology Clinic at the CORE Institute
      • Contact: Sean Rose, M.D.; Phone Number: 866-974-2673

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 19 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Youth and high school football players from teams included in the study

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: More Foundation
• Collaborators: ElMindA Ltd; Riddell, LLC; Mimic Systems
• Investigators: Principal Investigator: Sean Rose, M.D., The Sports Neurology Clinic

Study record dates

Study Major Dates

• Study Start: July 1, 2016
• Primary Completion (ANTICIPATED): August 1, 2020
• Study Completion (ANTICIPATED): August 1, 2020

Study Registration Dates

• First Submitted: September 12, 2016
• First Submitted That Met QC Criteria: March 31, 2017
• First Posted (ACTUAL): April 7, 2017

Study Record Updates

• Last Update Posted (ACTUAL): June 12, 2017
• Last Update Submitted That Met QC Criteria: June 9, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: concussion; football; brain function; subconcussive impacts
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Athletic Injuries; Brain Concussion
• Other Study ID Numbers: MoreFoundation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO