University of Pittsburgh Brain Health Initiative

ConditionTraumatic Brain Injury

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexMale

Age29-59

SponsorDavid Okonkwo, MD, PhD

About this trial

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.

Eligibility criteria

Qualifiers

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)

Age 29-59 male

Disqualifiers

Played organized football beyond high school

History of severe TBI

Current unstable cardiovascular disorder

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

Trial design

Treatments tested in this trial

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

Treatment groups

300 Participants

are divided into 2 treatment groups

Sponsors and collaborators

David Okonkwo, MD, PhD

Lead sponsor

University of Pittsburgh

Sponsor institution

National Football League

Collaborator

Avid Radiopharmaceuticals, Inc.

Collaborator

Harvard University

Collaborator

Source ClinicalTrials.gov