University of Pittsburgh Brain Health Initiative (BHI)

David Okonkwo, MD, PhD

Status: Enrolling

Conditions: Traumatic Brain Injury

Treatments: Diagnostic Test: Physical Function; Diagnostic Test: PET brain imaging; Diagnostic Test: Vestibular/Ocular-Motor Testing; Diagnostic Test: MRI, High-Resolution; Diagnostic Test: Sleep Evaluation; Diagnostic Test: Cognitive/Neuropsychological Testing; Diagnostic Test: Health & Physical Exam; Diagnostic Test: Blood Testing and Biomarker Analysis; Diagnostic Test: Applanation Tonometry; Drug: [C-11]6-OH-BTA-1; Drug: [F-18]AV-1451

Study type: Observational

Funder types: Other

Identifiers

NCT04708613

Brain Health Initiative

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: Male

Ages: 29 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Former Professional Football Players

Description:

Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.

Treatment:

Drug: [F-18]AV-1451

Drug: [C-11]6-OH-BTA-1

Diagnostic Test: Applanation Tonometry

Diagnostic Test: Blood Testing and Biomarker Analysis

Diagnostic Test: Health & Physical Exam

Diagnostic Test: Cognitive/Neuropsychological Testing

Diagnostic Test: MRI, High-Resolution

Diagnostic Test: Sleep Evaluation

Diagnostic Test: Vestibular/Ocular-Motor Testing

Diagnostic Test: PET brain imaging

Diagnostic Test: Physical Function

Control Groups

Description:

Friends and brothers of the Former Professional Football Player group.

Treatment:

Drug: [F-18]AV-1451

Drug: [C-11]6-OH-BTA-1

Diagnostic Test: Applanation Tonometry

Diagnostic Test: Blood Testing and Biomarker Analysis

Diagnostic Test: Health & Physical Exam

Diagnostic Test: Cognitive/Neuropsychological Testing

Diagnostic Test: MRI, High-Resolution

Diagnostic Test: Sleep Evaluation

Diagnostic Test: Vestibular/Ocular-Motor Testing

Diagnostic Test: PET brain imaging

Diagnostic Test: Physical Function