NCT04708613 University of Pittsburgh Brain Health Initiative
| NCT ID | NCT04708613 |
| Status | Recruiting |
| Phase | — |
| Sponsor | David Okonkwo, MD, PhD |
| Condition | Traumatic Brain Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2019-11-18 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2019-11-18 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
David O Okonkwo, MD, PhD
PRINCIPAL INVESTIGATOR
University of Pittsburgh Department of Neurological Surgery
Frequently Asked Questions
Who can join the NCT04708613 clinical trial?
This trial is open to male participants only, aged 29 Years or older, up to 59 Years, studying Traumatic Brain Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04708613 currently recruiting?
Yes, NCT04708613 is actively recruiting participants. Contact the research team at dunfeekl@upmc.edu for enrollment information.
Where is the NCT04708613 trial being conducted?
This trial is being conducted at Pittsburgh, United States.
Who is sponsoring the NCT04708613 clinical trial?
NCT04708613 is sponsored by David Okonkwo, MD, PhD. The principal investigator is David O Okonkwo, MD, PhD at University of Pittsburgh Department of Neurological Surgery. The trial plans to enroll 300 participants.