An observational study in Traumatic Brain Injury, sponsored by David Okonkwo, MD, PhD. Recruiting at 1 site in United States. Open to male participants aged 29 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-22.
Sponsored by David Okonkwo, MD, PhD · Observational
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.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's planned enrollment of 300 is above the median of 117 across 557 observational studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →This is the only study on the registry with David Okonkwo, MD, PhD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Professional Football Players:
There will be 2 cohorts of former professional football players in this group: (a) random sample, and (b) non-random sample.
Random-Sample participants
Recruitment of random-sample former professional football players will be conducted via collaboration with the Football Players Health Study (FPHS) at Harvard University. Subjects for the Brain Health Initiative (BHI) will include a random sample of enrollees in the FPHS who meet basic eligibility for BHI.
We will also enroll a non-random cohort of former professional football players that will be comprised of volunteers.
There will be 3 cohorts of unexposed controls in this group: (a) friends of former players, (b) brothers or former players, and (c) general population. Football players will be invited to refer friend(s) and/or brother(s), but it is not required for participation.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Former professional football player/exposed group:
Control/unexposed group:
Exclusion criteria:
Control/unexposed group:
For both groups:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
Diagnostic Test: Cognitive/Neuropsychological Testing · Diagnostic Test: Vestibular/Ocular-Motor Testing · Diagnostic Test: Sleep Evaluation · Diagnostic Test: MRI, High-Resolution · Diagnostic Test: Health & Physical Exam · Diagnostic Test: Physical Function · Diagnostic Test: Blood Testing and Biomarker Analysis · Diagnostic Test: Applanation Tonometry · Diagnostic Test: PET brain imaging · Drug: [C-11]6-OH-BTA-1 · Drug: [F-18]AV-1451
Friends and brothers of the Former Professional Football Player group.
Diagnostic Test: Cognitive/Neuropsychological Testing · Diagnostic Test: Vestibular/Ocular-Motor Testing · Diagnostic Test: Sleep Evaluation · Diagnostic Test: MRI, High-Resolution · Diagnostic Test: Health & Physical Exam · Diagnostic Test: Physical Function · Diagnostic Test: Blood Testing and Biomarker Analysis · Diagnostic Test: Applanation Tonometry · Diagnostic Test: PET brain imaging · Drug: [C-11]6-OH-BTA-1 · Drug: [F-18]AV-1451
Comprehensive testing of cognitive function and brain health.
A series of tests and questionnaires that asses vestibular function, balance, ocular-motor coordination, and reflexes.
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.
A high-resolution MRI to provide qualitative and quantitative assessments of brain structure.
Participants will undergo an executive history and physical exam of all body systems.
These assessments will involve a series of tests and questionnaires that focus on physical function.
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,
Hearth health is evaluated through testing of arterial stiffness and pulse wave reflections using a high fidelity applanation tonometer.
Also known as: Continuous arterial pressure
PET imaging of the brain using tau and amyloid ligands.
PET imaging of the brain using an amyloid ligand.
Also known as: Pittsburgh Compound B
PET imaging of the brain using a tau ligand.
Also known as: [F-18]T807, LY3191748
Rates of Brain Health versus Cognitive Impairment
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.
Time frame: 1-week
Clinical Syndromes of Neurodegeneration
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.
Time frame: 1-week
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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