Traumatic Brain Injury
Conditions
Keywords
Brain Health, Football, Contact Sport, Concussion
Brief summary
This project will define the prevalence of brain health (i.e., normal cognitive, neuromotor, behavioral function) in living professional football retirees and group-matched controls through a comprehensive assessment of clinical, neuroimaging, and biomarker measures.
Interventions
DIAGNOSTIC_TESTCognitive/Neuropsychological Testing
Comprehensive testing of cognitive function and brain health.
DIAGNOSTIC_TESTVestibular/Ocular-Motor Testing
A series of tests and questionnaires that asses vestibular function, balance, ocular-motor coordination, and reflexes.
DIAGNOSTIC_TESTSleep Evaluation
A full assessment of sleep health, including insomnia (duration, frequency, daytime consequences) and other sleep disorders such as obstructive sleep apnea. Overnight sleep study is included.
DIAGNOSTIC_TESTMRI, High-Resolution
A high-resolution MRI to provide qualitative and quantitative assessments of brain structure.
DIAGNOSTIC_TESTHealth & Physical Exam
Participants will undergo an executive history and physical exam of all body systems.
DIAGNOSTIC_TESTPhysical Function
These assessments will involve a series of tests and questionnaires that focus on physical function.
DIAGNOSTIC_TESTBlood Testing and Biomarker Analysis
A blood draw will be performed to measure standard clinical labs as part of a full history and physical, as well as additional analysis of biomarkers indicative of brain health. An optional lumbar puncture will be performed and CSF samples (20-30 mL) stored in the NCTC Biorepository until shipment to the CLIA-certified laboratory. Both CSF and blood samples will be analyzed for t-tau, p-tau, and Aβ42 and stored for future testing,
DIAGNOSTIC_TESTApplanation Tonometry
Hearth health is evaluated through testing of arterial stiffness and pulse wave reflections using a high fidelity applanation tonometer.
DIAGNOSTIC_TESTPET brain imaging
PET imaging of the brain using tau and amyloid ligands.
DRUG[C-11]6-OH-BTA-1
PET imaging of the brain using an amyloid ligand.
DRUG[F-18]AV-1451
PET imaging of the brain using a tau ligand.
Sponsors
National Football League Scientific Advisory Board
Avid Radiopharmaceuticals, Inc.
Harvard University
David Okonkwo, MD, PhD
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
29 Years to 59 Years
Healthy volunteers
Yes
Inclusion criteria
Former professional football player/exposed group: 1. Professional football retiree aged 29-59 2. Played a minimum of 3 professional football seasons, with a minimum of 3 games in each season 3. Fluent in English (translations are not available/validated for most neuropsychological tests) Control/unexposed group: 1. Age 29-59 male 2. High school education or beyond 3. Fluent in English (translations are not available/validated for most neuropsychological tests)
Exclusion criteria
Control/unexposed group: 1. Played organized football beyond high school 2. History of severe TBI 3. Current unstable cardiovascular disorder For both groups: 1. Prior history of psychosis (such as schizophrenia), or other major neurological disorder that would interfere with testing, in the opinion of the primary investigator. 2. Contraindication to MR imaging, such as ferrous metal, pacemakers, or concerns about claustrophobia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rates of Brain Health versus Cognitive Impairment | 1-week | The diagnosis of cognitive impairment is based on the ADRC National Alzheimer's Coordinating Center (NACC) criteria for mild cognitive impairment. This criteria is adjudicated following a comprehensive neuropsychological exam, and includes: (1) Self- or informant-reported cognitive complaint, (2) Objective cognitive impairment, (3) Preserved independence in functional abilities, and (4) No dementia. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Syndromes of Neurodegeneration | 1-week | The determination of trauma-related neurodegeneration will be based on: 1) presence of cognitive deficits, and/or neuromotor manifestations, and/or behavioral/mood-related symptoms; 2) PET scans demonstrating abnormal amyloid and/or tau deposition; 3) quantitative MR evidence of cortical volume loss and/or white matter injury; and 4) elevated CSF tau/Aβ42 ratio. These multiple measures will be combined to arrive at a single overall outcome measure. This will be adjudicated at a blinded Diagnostic Consensus Conference comprised of experts from each field. |
Countries
United States
Contacts
Primary ContactKathryn L Edelman, MS
Outcome results
None listed