Longitudinal Brain Health in Youth Tackle Football Players

NCT03104244 | Unknown DMC

• 1 other identifier: MoreFoundation
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

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).

Conditions

Concussion, Brain; Athletic Injuries

Keywords

concussion; subconcussive impacts; brain function; football

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Neurological history

  Occurs pre-season & post season and continues for 4 years

• Neurological physical examination

  Occurs pre-season & post season and continues for 4 years

• Cogstate

  Occurs pre-season & post-season and continues for 4 years

• Pen and paper neuropsychological tests

  Occurs pre-season & post-season and continues for 4 years

• Brain Network Activation (BNA) EEG test

  Occurs pre-season & post-season and continues for 4 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 9 Years - 19 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Male football players 9-19 years of age at time of enrollment.
• Youth Football:
• th and 6th grade tackle football players from the Brighton Bulldogs Football and Cheer league.
• High School Football:
• Varsity Brighton High School football players.

You may not qualify if:

• 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.

Sponsors & Collaborators

• More Foundation: lead
• Riddell, LLC: collaborator
• ElMindA Ltd: collaborator
• Mimic Systems: collaborator

Study Sites (1)

The Sports Neurology Clinic at the CORE Institute

Brighton, Michigan, 48114, United States

RECRUITING

MeSH Terms

Conditions

Brain Concussion; Athletic Injuries

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Sean Rose, M.D.

  The Sports Neurology Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalie M Pizzimenti, M.S.

CONTACT

248-485-7025; natalie.pizzimenti@thecoreinsitute.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research and Regional Director

Study Record Dates

• First Submitted: September 12, 2016
• First Posted: April 7, 2017
• Study Start: July 1, 2016
• Primary Completion: August 1, 2020
• Study Completion: August 1, 2020
• Last Updated: June 12, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)