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Longitudinal Brain Health in Youth Tackle Football Players

Longitudinal Brain Health in Youth Tackle Football Players

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03104244
Enrollment
280
Registered
2017-04-07
Start date
2016-07-31
Completion date
2020-08-31
Last updated
2017-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Athletic Injuries, Concussion, Brain

Keywords

concussion, subconcussive impacts, brain function, football

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.

Interventions

None listed

Sponsors

Riddell, LLC
CollaboratorUNKNOWN
ElMindA Ltd
CollaboratorINDUSTRY
Mimic Systems
CollaboratorOTHER
More Foundation
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
MALE
Age
9 Years to 19 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Impact Monitoring (g force)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.

Secondary

MeasureTime frameDescription
Neurological physical examinationOccurs pre-season & post season and continues for 4 yearsPhysician performed neurological examination
CogstateOccurs pre-season & post-season and continues for 4 yearsBrief computerized neurocognitive test
Pen and paper neuropsychological testsOccurs pre-season & post-season and continues for 4 yearsPen and paper tasks that assess memory, attention, and processing
Brain Network Activation (BNA) EEG testOccurs pre-season & post-season and continues for 4 yearsevoked-response electroencephalogram
Neurological historyOccurs pre-season & post season and continues for 4 yearsDetermine family and personal neurological history of the subject
MimicBalance!Occurs pre-season & post-season and continues for 4 yearsvideo capture balance test that incorporates several different postures, including BESS postures
Strength and Difficulties QuestionnaireOccurs pre-season & post-season and continues for 4 yearsSelf assessment questionnaire
SWAN ADHD QuestionnaireOccurs pre-season & post season and continues for 4 yearsStrengths and weaknesses of ADHD symptoms and normal behavior (SWAN) questionnaire completed by parent or legal guardian.
Vestibular/Ocular Motor Screening (VOMS) testOccurs pre-season & post-season and continues for 4 yearsAssessment of eye movements and associated symptoms of headache, dizziness, nausea, and fogginess

Countries

United States

Contacts

Primary ContactNatalie M Pizzimenti, M.S.
natalie.pizzimenti@thecoreinsitute.com248-485-7025

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026