University of Pittsburgh Brain Health Initiative

Recruiting

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

• Registration Number: NCT04708613
• Lead Sponsor: David Okonkwo, MD, PhD

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-18
• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-13
• Study First Posted: 2021-01-14
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 300

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Former Professional Football Players	Cognitive/Neuropsychological Testing	Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
Former Professional Football Players	Vestibular/Ocular-Motor Testing	Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
Former Professional Football Players	Sleep Evaluation	Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
Former Professional Football Players	MRI, High-Resolution	Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
Former Professional Football Players	Health & Physical Exam	Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
Former Professional Football Players	Physical Function	Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
Control Groups	Cognitive/Neuropsychological Testing	Friends and brothers of the Former Professional Football Player group.
Former Professional Football Players	Blood Testing and Biomarker Analysis	Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
Former Professional Football Players	Applanation Tonometry	Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
Former Professional Football Players	PET brain imaging	Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
Former Professional Football Players	[C-11]6-OH-BTA-1	Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
Former Professional Football Players	[F-18]AV-1451	Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
Control Groups	Blood Testing and Biomarker Analysis	Friends and brothers of the Former Professional Football Player group.
Control Groups	Vestibular/Ocular-Motor Testing	Friends and brothers of the Former Professional Football Player group.
Control Groups	Sleep Evaluation	Friends and brothers of the Former Professional Football Player group.
Control Groups	MRI, High-Resolution	Friends and brothers of the Former Professional Football Player group.
Control Groups	Health & Physical Exam	Friends and brothers of the Former Professional Football Player group.
Control Groups	Physical Function	Friends and brothers of the Former Professional Football Player group.
Control Groups	Applanation Tonometry	Friends and brothers of the Former Professional Football Player group.
Control Groups	PET brain imaging	Friends and brothers of the Former Professional Football Player group.
Control Groups	[C-11]6-OH-BTA-1	Friends and brothers of the Former Professional Football Player group.
Control Groups	[F-18]AV-1451	Friends and brothers of the Former Professional Football Player group.

Primary Outcome Measures

Name	Time	Method
Rates of Brain Health versus Cognitive Impairment	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.

Secondary Outcome Measures

Name	Time	Method
Clinical Syndromes of Neurodegeneration	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.

Trial Locations

Locations (1)

University of Pittsburgh Department of Neurosurgery; 🇺🇸 Pittsburgh, Pennsylvania, United States