Clinical trial NCT04708613: University of Pittsburgh Brain Health Initiative
Official title: Prevalence of Brain Health Versus Neurodegeneration in Former Professional Football Players
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Traumatic Brain Injury
Keywords: Brain Health
Football
Contact Sport
Concussion
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: National Football League Scientific Advisory Board
name: Avid Radiopharmaceuticals, Inc.
name: Harvard University
First posted: 2021-01-14
Enrollment: 300
Sex: MALE
Minimum age (years): 29
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 1. Professional Football Players:

   There will be 2 cohorts of former professional football players in this group: (a) random sample, and (b) non-random sample.
   1. Random-Sample participants

      Recruitment of random-sample former professional football players will be conducted via collaboration with the Football Players Health Study (FPHS) at Harvard University. Subjects for the Brain Health Initiative (BHI) will include a random sample of enrollees in the FPHS who meet basic eligibility for BHI.
   2. Non-Random participants:

   We will also enroll a non-random cohort of former professional football players that will be comprised of volunteers.
2. Controls:

There will be 3 cohorts of unexposed controls in this group: (a) friends of former players, (b) brothers or former players, and (c) general population. Football players will be invited to refer friend(s) and/or brother(s), but it is not required for participation.

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

Primary outcomes:
measure: Rates of Brain Health versus Cognitive Impairment
timeFrame: 1-week
Secondary outcomes:
measure: Clinical Syndromes of Neurodegeneration
timeFrame: 1-week
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Department of Neurosurgery
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Department of Neurological Surgery
name: David O Okonkwo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lopez OL, Jagust WJ, DeKosky ST, Becker JT, Fitzpatrick A, Dulberg C, Breitner J, Lyketsos C, Jones B, Kawas C, Carlson M, Kuller LH. Prevalence and classification of mild cognitive impairment in the Cardiovascular Health Study Cognition Study: part 1. Arch Neurol. 2003 Oct;60(10):1385-9. doi: 10.1001/archneur.60.10.1385.
citation: Petersen RC. Mild cognitive impairment clinical trials. Nat Rev Drug Discov. 2003 Aug;2(8):646-53. doi: 10.1038/nrd1155. No abstract available.