University of Pittsburgh Brain Health Initiative

RecruitingOBSERVATIONAL
Enrollment

300

Participants

Timeline

Start Date

November 18, 2019

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2026

Conditions
Traumatic Brain Injury
Interventions
DIAGNOSTIC_TEST

Cognitive/Neuropsychological Testing

Comprehensive testing of cognitive function and brain health.

DIAGNOSTIC_TEST

Vestibular/Ocular-Motor Testing

A series of tests and questionnaires that asses vestibular function, balance, ocular-motor coordination, and reflexes.

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

MRI, High-Resolution

A high-resolution MRI to provide qualitative and quantitative assessments of brain structure.

DIAGNOSTIC_TEST

Health & Physical Exam

Participants will undergo an executive history and physical exam of all body systems.

DIAGNOSTIC_TEST

Physical Function

These assessments will involve a series of tests and questionnaires that focus on physical function.

DIAGNOSTIC_TEST

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 Aβ42 and stored for future testing,"

DIAGNOSTIC_TEST

Applanation Tonometry

Hearth health is evaluated through testing of arterial stiffness and pulse wave reflections using a high fidelity applanation tonometer.

DIAGNOSTIC_TEST

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.

DRUG

[F-18]AV-1451

PET imaging of the brain using a tau ligand.

Trial Locations (1)

15213

RECRUITING

University of Pittsburgh Department of Neurosurgery, Pittsburgh

Sponsors
All Listed Sponsors
collaborator

National Football League Scientific Advisory Board

UNKNOWN

collaborator

Avid Radiopharmaceuticals, Inc.

UNKNOWN

collaborator

Harvard University

OTHER

lead

David Okonkwo, MD, PhD

OTHER