RecruitingNCT04708613

University of Pittsburgh Brain Health Initiative

Prevalence of Brain Health Versus Neurodegeneration in Former Professional Football Players


Sponsor

David Okonkwo, MD, PhD

Enrollment

300 participants

Start Date

Nov 18, 2019

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 29 YearsMax Age: 59 Years

Inclusion Criteria8

  • Former professional football player/exposed group:
  • Professional football retiree aged 29-59
  • Played a minimum of 3 professional football seasons, with a minimum of 3 games in each season
  • Fluent in English (translations are not available/validated for most neuropsychological tests)
  • Control/unexposed group:
  • Age 29-59 male
  • High school education or beyond
  • Fluent in English (translations are not available/validated for most neuropsychological tests)

Exclusion Criteria7

  • Control/unexposed group:
  • Played organized football beyond high school
  • History of severe TBI
  • Current unstable cardiovascular disorder
  • For both groups:
  • Prior history of psychosis (such as schizophrenia), or other major neurological disorder that would interfere with testing, in the opinion of the primary investigator.
  • Contraindication to MR imaging, such as ferrous metal, pacemakers, or concerns about claustrophobia

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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.


Locations(1)

University of Pittsburgh Department of Neurosurgery

Pittsburgh, Pennsylvania, United States

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NCT04708613


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