Clinical Trial: Longitudinal Brain Health in Youth Tackle Football Players

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Longitudinal Brain Health in Youth Tackle Football Players

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 Summary:

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.

Sponsor: More Foundation

Current Primary Outcome: Impact Monitoring (g force) [ Time Frame: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Neurological history and neurological physical examination [ Time Frame: Occurs pre-season & post season and continues for 4 years ]
  • Cogstate [ Time Frame: Occurs pre-season & post-season and continues for 4 years ]
    Brief computerized neurocognitive test
  • Pen and paper neuropsychological tests [ Time Frame: 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 [ Time Frame: Occurs pre-season & post-season and continues for 4 years ]
    evoked-response electroencephalogram
  • Vestibular/Ocular Motor Screening (VOMS) test [ Time Frame: Occurs pre-season & post-season and continues for 4 years ]
    Assessment of eye movements and associated symptoms of headache, dizziness, nausea, and fogginess
  • MimicBalance! [ Time Frame: 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 [ Time Frame: Occurs pre-season & post-season and continues for 4 years ]
    Self assessment questionnaire
  • SWAN ADHD Questionnaire [ Time Frame: 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.


Original Secondary Outcome: Same as current

Information By: More Foundation

Dates:
Date Received: September 12, 2016
Date Started: July 2016
Date Completion: August 2020
Last Updated: March 31, 2017
Last Verified: March 2017