Recruiting

Observational Study

Sponsor:

More Foundation

Code:

NCT03104244

Conditions

Concussion, Brain

Athletic Injuries

Eligibility Criteria

Sex: Male

Age: 9 - 19

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT03104244

Start date

Jul, 2016

Status verified date

Jun, 2017

Completion date

Aug, 2020

Anticipated

Primary completion date

Aug, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 9 - 19

Healthy Volunteers: Not accepted

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 Design

Enrollment

280 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Impact Monitoring (g force) [ Time Frame: The football season runs from early August through late October or November (3-4 months) ]

Central Contacts and Locations

Central contacts

Natalie M Pizzimenti, M.S.

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

Locations

The Sports Neurology Clinic at the CORE Institute

Recruiting

Brighton, Michigan, United States, 48114

Contacts

Sean Rose, M.D.

866-974-2673

More Information

Sponsor

More Foundation

Last update posted

Jun 12, 2017

Last verified

Jun, 2017

Keywords

  • concussion
  • subconcussive impacts
  • brain function
  • football

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by More Foundation on 2017-06-12.