Concussion, BrainNCT03104244
Longitudinal Brain Health in Youth Tackle Football Players
An observational study of Concussion, Brain and Athletic Injuries, run by More Foundation at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 9 to 19 years, men only
- Conditions the study is for
- Concussion, Brain, Athletic Injuries
- How many people
- 280 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Aug 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 19 years
- Men only
- No healthy volunteers
- Child, Adult
Study population: Youth and high school football players from teams included in the study
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Sports Neurology Clinic at the CORE Institute
Brighton, Michigan, 48114
Sean Rose, M.D., 866-974-2673
About this study
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).
Read the 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:
- To quantify the cumulative head impact burden during consecutive seasons of youth tackle football and high school football.
- To detect impairment in neurologic and cognitive function from playing youth tackle football and high school football.
- To use cumulative head impact burden to predict the development of neurologic and neurocognitive impairment.
- To compare the effect of head impacts on youth tackle football players verses high school football players.
- Conditions
- Concussion, Brain, Athletic Injuries
- Keywords
- concussion, subconcussive impacts, brain function, football
- Medical subject headings
- Brain Concussion, Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The football season runs from early August through late October or November (3-4 months)
Secondary outcomes (9)
Neurological history
Determine family and personal neurological history of the subject
Measured: Occurs pre-season & post season and continues for 4 years
Neurological physical examination
Physician performed neurological examination
Measured: Occurs pre-season & post season and continues for 4 years
Cogstate
Brief computerized neurocognitive test
Measured: Occurs pre-season & post-season and continues for 4 years
Pen and paper neuropsychological tests
Pen and paper tasks that assess memory, attention, and processing
Measured: Occurs pre-season & post-season and continues for 4 years
Brain Network Activation (BNA) EEG test
evoked-response electroencephalogram
Measured: Occurs pre-season & post-season and continues for 4 years
Vestibular/Ocular Motor Screening (VOMS) test
Assessment of eye movements and associated symptoms of headache, dizziness, nausea, and fogginess
Measured: Occurs pre-season & post-season and continues for 4 years
MimicBalance!
video capture balance test that incorporates several different postures, including BESS postures
Measured: Occurs pre-season & post-season and continues for 4 years
Strength and Difficulties Questionnaire
Self assessment questionnaire
Measured: Occurs pre-season & post-season and continues for 4 years
SWAN ADHD Questionnaire
Strengths and weaknesses of ADHD symptoms and normal behavior (SWAN) questionnaire completed by parent or legal guardian.
Measured: Occurs pre-season & post season and continues for 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study startJul 2016
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Concussion, BrainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- More Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Riddell, LLC, ElMindA Ltd, Mimic Systems
- Responsible party
- Principal investigator, Sean Rose, M. D., The CORE Institute
- Investigators
- Sean Rose, M.D., Principal investigator, The Sports Neurology Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104244
- Sponsor's protocol ID
- MoreFoundation
- Status last verified
- Jun 2017
- First submitted
- 12 Sep 2016
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Brain Health in Youth Tackle Football Players
- ClinicalTrials.gov ID
- NCT03104244
- Acronym / sponsor ID
- MoreFoundation
- Conditions
- Concussion, Brain, Athletic Injuries
- Keywords
- concussion, subconcussive impacts, brain function, football
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- More FoundationUniversity, hospital or other
- Collaborators
- Riddell, LLC, ElMindA Ltd, Mimic Systems
- Study start
- Jul 2016
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 7 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To quantify the cumulative head impact burden during consecutive seasons of youth tackle football and high school football.
- To detect impairment in neurologic and cognitive function from playing youth tackle football and high school football.
- To use cumulative head impact burden to predict the development of neurologic and neurocognitive impairment.
- To compare the effect of head impacts on youth tackle football players verses high school football players.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 9 to 19 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Youth and high school football players from teams included in the study
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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.
9 secondary outcomes
Neurological history
Time frame: Occurs pre-season & post season and continues for 4 years
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
Pen and paper neuropsychological tests
Time frame: Occurs pre-season & post-season and continues for 4 years
Brain Network Activation (BNA) EEG test
Time frame: Occurs pre-season & post-season and continues for 4 years
Vestibular/Ocular Motor Screening (VOMS) test
Time frame: Occurs pre-season & post-season and continues for 4 years
MimicBalance!
Time frame: Occurs pre-season & post-season and continues for 4 years
Strength and Difficulties Questionnaire
Time frame: Occurs pre-season & post-season and continues for 4 years
SWAN ADHD Questionnaire
Time frame: Occurs pre-season & post season and continues for 4 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean Rose, M.D. principal investigator
The Sports Neurology Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Concussion, Brain and Athletic Injuries, run by More Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Natalie M Pizzimenti, M.S. (248-485-7025, natalie.pizzimenti@thecoreinsitute.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact Monitoring (g force) (time frame: The football season runs from early August through late October or November (3-4 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.