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Recruiting NCT04708613

University of Pittsburgh Brain Health Initiative

— Observational Traumatic Brain Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Cognitive/Neuropsychological Testing, Vestibular/Ocular-Motor Testing, Sleep Evaluation, MRI, High-Resolution.
Who it may be relevant to
Registry conditions: Traumatic Brain Injury. Basic parameters: 29 years — 59 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Prevalence of Brain Health Versus Neurodegeneration in Former Professional Football Players

Overview

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.

Interventions

  • Diagnostic test Cognitive/Neuropsychological Testing
    Comprehensive testing of cognitive function and brain health.
  • Diagnostic test Vestibular/Ocular-Motor Testing
    A series of tests and questionnaires that asses vestibular function, balance, ocular-motor coordination, and reflexes.
  • Diagnostic test 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.
  • Diagnostic test MRI, High-Resolution
    A high-resolution MRI to provide qualitative and quantitative assessments of brain structure.
  • Diagnostic test Health & Physical Exam
    Participants will undergo an executive history and physical exam of all body systems.
  • Diagnostic test Physical Function
    These assessments will involve a series of tests and questionnaires that focus on physical function.
  • Diagnostic test 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,
  • Diagnostic test Applanation Tonometry
    Hearth health is evaluated through testing of arterial stiffness and pulse wave reflections using a high fidelity applanation tonometer.
  • Diagnostic test PET 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.

Primary outcome measures

  • Rates of Brain Health versus Cognitive Impairment [Time frame: 1-week]
Secondary outcome measures (1)
  • Clinical Syndromes of Neurodegeneration [Time frame: 1-week]

Eligibility criteria

Inclusion criteria

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 criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • University of Pittsburgh Department of Neurosurgery — Pittsburgh

Publications

  • Lopez OL, Jagust WJ, DeKosky ST, Becker JT, Fitzpatrick A, Dulberg C, Breitner J, Lyketsos C, Jones B, Kawas C, Carlson M, Kuller LH. Prevalence and classification of mild cognitive impairment in the Cardiovascular Health Study Cognition Study: part 1. Arch Neurol. 2003 Oct;60(10):1385-9. doi: 10.1001/archneur.60.10.1385. PMID 14568808
  • Petersen RC. Mild cognitive impairment clinical trials. Nat Rev Drug Discov. 2003 Aug;2(8):646-53. doi: 10.1038/nrd1155. No abstract available. PMID 12904814

Identifiers

NCT: NCT04708613 · Brain Health Initiative

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗