Longitudinal Brain Health in Youth Tackle Football Players

Concussion, Brain Clinical Trial

Official title:

Longitudinal Brain Health in Youth Tackle Football Players

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03104244
• Other study ID #: MoreFoundation
• Status: Recruiting
• Phase: N/A
• First received: September 12, 2016
• Last updated: June 9, 2017
• Start date: July 2016
• Est. completion date: August 2020

Study information

• Verified date: June 2017
• Source: More Foundation
• Contact: Natalie M Pizzimenti, M.S.
• Phone: 248-485-7025
• Email: natalie.pizzimenti[@]thecoreinsitute.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 9 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Athletic Injuries
• Brain Concussion
• Concussion, Brain

Locations

Country	Name	City	State
United States	The Sports Neurology Clinic at the CORE Institute	Brighton	Michigan

Sponsors (4)

Lead Sponsor	Collaborator
More Foundation	ElMindA Ltd, Riddell, LLC, S Dallas Rowe & Associates LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Neurological history	Determine family and personal neurological history of the subject	Occurs pre-season & post season and continues for 4 years
Secondary	Neurological physical examination	Physician performed neurological examination	Occurs pre-season & post season and continues for 4 years
Secondary	Cogstate	Brief computerized neurocognitive test	Occurs pre-season & post-season and continues for 4 years
Secondary	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
Secondary	Brain Network Activation (BNA) EEG test	evoked-response electroencephalogram	Occurs pre-season & post-season and continues for 4 years
Secondary	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
Secondary	MimicBalance!	video capture balance test that incorporates several different postures, including BESS postures	Occurs pre-season & post-season and continues for 4 years
Secondary	Strength and Difficulties Questionnaire	Self assessment questionnaire	Occurs pre-season & post-season and continues for 4 years
Secondary	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