Recruiting

Observational Study

Sponsor:

David Okonkwo, MD, PhD

Code:

NCT04708613

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: Male

Age: 29 - 59

Healthy Volunteers: Accepted

Interventions

Cognitive/Neuropsychological Testing

Vestibular/Ocular-Motor Testing

Sleep Evaluation

MRI, High-Resolution

Health & Physical Exam

Study Details

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.

Conditions

Traumatic Brain Injury

Study ID

NCT04708613

Start date

Nov 18, 2019

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 29 - 59

Healthy Volunteers: Accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Former Professional Football Players

Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.

Control Groups

Friends and brothers of the Former Professional Football Player group.

Interventions

Cognitive/Neuropsychological Testing

Comprehensive testing of cognitive function and brain health.

Vestibular/Ocular-Motor Testing

A series of tests and questionnaires that asses vestibular function, balance, ocular-motor coordination, and reflexes.

Sleep 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.

MRI, High-Resolution

A high-resolution MRI to provide qualitative and quantitative assessments of brain structure.

Health & Physical Exam

Participants will undergo an executive history and physical exam of all body systems.

Physical Function

These assessments will involve a series of tests and questionnaires that focus on physical function.

Blood 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,

Applanation Tonometry

Hearth health is evaluated through testing of arterial stiffness and pulse wave reflections using a high fidelity applanation tonometer.

PET brain imaging

PET imaging of the brain using tau and amyloid ligands.

[C-11]6-OH-BTA-1

PET imaging of the brain using an amyloid ligand.

[F-18]AV-1451

PET imaging of the brain using a tau ligand.

Primary outcome measure

  • Rates of Brain Health versus Cognitive Impairment [ Time Frame: 1-week ]

Central Contacts and Locations

Central contacts

Kathryn L Edelman, MS

412-624-1077dunfeekl@upmc.edu

Locations

University of Pittsburgh Department of Neurosurgery

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Kathryn Edelman, MS

412-624-1077dunfeekl@upmc.edu

Jane Sharpless, MS

412-648-2176sharplessjm@upmc.edu

Principal Investigator:

David O Okonkwo, MD, PhD

More Information

Sponsor

David Okonkwo, MD, PhD

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Keywords

  • Brain Health
  • Football
  • Contact Sport
  • Concussion

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by David Okonkwo, MD, PhD on 2026-06-22.