University of Pittsburgh Brain Health Initiative

Traumatic Brain Injury Clinical Trial

— BHI  

Official title:

Prevalence of Brain Health Versus Neurodegeneration in Former Professional Football Players

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04708613
• Other study ID #: Brain Health Initiative
• Status: Recruiting
• Start date: November 18, 2019
• Est. completion date: December 2024

Study information

• Verified date: August 2023
• Source: University of Pittsburgh
• Contact: Kathryn L Edelman, MS
• Phone: 412-624-1077
• Email: dunfeekl[@]upmc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 29 Years to 59 Years

Eligibility

Inclusion criteria:

Former professional football player/exposed group:

1. Professional football retiree aged 29-59

2. Played a minimum of 3 professional football seasons, with a minimum of 3 games in each season

3. Fluent in English (translations are not available/validated for most neuropsychological tests)

Control/unexposed group:

1. Age 29-59 male

2. High school education or beyond

3. Fluent in English (translations are not available/validated for most neuropsychological tests)

Exclusion criteria:

Control/unexposed group:

1. Played organized football beyond high school

2. History of severe TBI

3. Current unstable cardiovascular disorder

For both groups:

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

2. Contraindication to MR imaging, such as ferrous metal, pacemakers, or concerns about claustrophobia

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Traumatic Brain Injury

Intervention

Diagnostic Test:
• Cognitive/Neuropsychological Testing
Comprehensive testing of cognitive function and brain health.
• Vestibular/Ocular-Motor Testing
A series of tests and questionnaires that asses vestibular function, balance, ocular-motor coordination, and reflexes.
• 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.
• MRI, High-Resolution
A high-resolution MRI to provide qualitative and quantitative assessments of brain structure.
• Health & Physical Exam
Participants will undergo an executive history and physical exam of all body systems.
• Physical Function
These assessments will involve a series of tests and questionnaires that focus on physical function.
• 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 Aß42 and stored for future testing,
• Applanation Tonometry
Hearth health is evaluated through testing of arterial stiffness and pulse wave reflections using a high fidelity applanation tonometer.
• 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.
• [F-18]AV-1451
PET imaging of the brain using a tau ligand.

Locations

Country	Name	City	State
United States	University of Pittsburgh Department of Neurosurgery	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
David Okonkwo, MD, PhD	Avid Radiopharmaceuticals, Inc., Harvard University, National Football League Scientific Advisory Board

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

Petersen RC. Mild cognitive impairment clinical trials. Nat Rev Drug Discov. 2003 Aug;2(8):646-53. doi: 10.1038/nrd1155. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1-week
Secondary	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/Aß42 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.	1-week