Health TrialsbyHealthPanel

University of Pittsburgh Brain Health Initiative

ConditionTraumatic Brain Injury
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age29-59
SponsorDavid Okonkwo, MD, PhD

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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)

Age 29-59 male

Disqualifiers

Played organized football beyond high school

History of severe TBI

Current unstable cardiovascular disorder

Prior history of psychosis (such as schizophrenia), or other major neurological disorder that would interfere with testing, in the opinion of the primary investigator.

Trial population

1. Professional Football Players: There will be 2 cohorts of former professional football players in this group: (a) random sample, and (b) non-random sample. 1. 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. 2. Non-Random participants: We will also enroll a non-random cohort of former professional football players that will be comprised of volunteers. 2. Controls: 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.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Cognitive/Neuropsychological Testing

    Diagnostic test

    Comprehensive testing of cognitive function and brain health.

  • Vestibular/Ocular-Motor Testing

    Diagnostic test

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

  • Sleep Evaluation

    Diagnostic test

    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

    Diagnostic test

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

  • Health & Physical Exam

    Diagnostic test

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

  • Physical Function

    Diagnostic test

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

  • Blood Testing and Biomarker Analysis

    Diagnostic test

    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

    Diagnostic test

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

  • PET brain imaging

    Diagnostic test

    PET imaging of the brain using tau and amyloid ligands.

  • [C-11]6-OH-BTA-1

    Drug

    PET imaging of the brain using an amyloid ligand.

  • [F-18]AV-1451

    Drug

    PET imaging of the brain using a tau ligand.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Former Professional Football Players11 interventions
Group B: Control Groups11 interventions

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

David Okonkwo, MD, PhD

Lead sponsor

University of Pittsburgh

Sponsor institution

National Football League

Collaborator

Avid Radiopharmaceuticals, Inc.

Collaborator

Harvard University

Collaborator

Source ClinicalTrials.gov
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