NCT Number: NCT04708613
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.
Interested in participating?
Request Info29 year–59 year
Male
Observational
Pittsburgh, Pennsylvania, 15213, United States
Location status: Recruiting
Anthony Kontos, PhD
PRINCIPAL_INVESTIGATOR
David O Okonkwo, MD, PhD
PRINCIPAL_INVESTIGATOR
James Mountz, MD, PhD
PRINCIPAL_INVESTIGATOR
Jane Sharpless, MS
CONTACT
Kathryn Edelman, MS
CONTACT
Michael Collins, PhD
PRINCIPAL_INVESTIGATOR
Oscar Lopez, MD
PRINCIPAL_INVESTIGATOR
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Former professional football player/exposed group:
Control/unexposed group:
Exclusion criteria
Control/unexposed group:
For both groups:
Comprehensive testing of cognitive function and brain health.
A series of tests and questionnaires that asses vestibular function, balance, ocular-motor coordination, and reflexes.
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.
A high-resolution MRI to provide qualitative and quantitative assessments of brain structure.
Participants will undergo an executive history and physical exam of all body systems.
These assessments will involve a series of tests and questionnaires that focus on physical function.
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,
Hearth health is evaluated through testing of arterial stiffness and pulse wave reflections using a high fidelity applanation tonometer.
Other names: Continuous arterial pressure
PET imaging of the brain using tau and amyloid ligands.
PET imaging of the brain using an amyloid ligand.
Other names: Pittsburgh Compound B
PET imaging of the brain using a tau ligand.
Other names: [F-18]T807, LY3191748
Time frame: 1-week
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
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.
Contact information is provided by the study sponsor or research team.
David Okonkwo, MD, PhD
Other
Prevalence of Brain Health Versus Neurodegeneration in Former Professional Football Players
Acronym: BHI
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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