University of Pittsburgh Brain Health Initiative

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
David Okonkwo, MD, PhD
Study ID
NCT04708613
Status
Recruiting
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Conditions

  • Traumatic Brain Injury

Eligibility Criteria

Sex
MALE
Age
29 Years - 59 Years
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Nov 18, 2019
Status verified
Jun 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: Former Professional Football Players
    Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
  • Arm: Control Groups
    Friends and brothers of the Former Professional Football Player group.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Pittsburgh Department of NeurosurgeryPittsburghPennsylvania15213
Kathryn Edelman, MS
[email protected]
412-624-1077
Jane Sharpless, MS
[email protected]
412-648-2176
David O Okonkwo, MD, PhD (PRINCIPAL_INVESTIGATOR)
James Mountz, MD, PhD (PRINCIPAL_INVESTIGATOR)
Michael Collins, PhD (PRINCIPAL_INVESTIGATOR)
Oscar Lopez, MD (PRINCIPAL_INVESTIGATOR)
Anthony Kontos, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Pittsburgh, PA

By research site
University of Pittsburgh Department of Neurosurgery· Pittsburgh, PA

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