Prevalence of Brain Health Versus Neurodegeneration in Former Professional Football Players
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Rates of Brain Health versus Cognitive Impairment
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 29 Years 至 59 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Former professional football player/exposed group:
- •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)
- •Control/unexposed group:
- •Age 29-59 male
- •High school education or beyond
- •Fluent in English (translations are not available/validated for most neuropsychological tests)
排除标准
- •Control/unexposed group:
- •Played organized football beyond high school
- •History of severe TBI
- •Current unstable cardiovascular disorder
- •For both groups:
- •Prior history of psychosis (such as schizophrenia), or other major neurological disorder that would interfere with testing, in the opinion of the primary investigator.
- •Contraindication to MR imaging, such as ferrous metal, pacemakers, or concerns about claustrophobia
研究组 & 干预措施
Former Professional Football Players
Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
干预措施: Health & Physical Exam (Diagnostic Test)
Control Groups
Friends and brothers of the Former Professional Football Player group.
干预措施: Cognitive/Neuropsychological Testing (Diagnostic Test)
Former Professional Football Players
Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
干预措施: Applanation Tonometry (Diagnostic Test)
Former Professional Football Players
Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
干预措施: [C-11]6-OH-BTA-1 (Drug)
Former Professional Football Players
Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
干预措施: [F-18]AV-1451 (Drug)
Former Professional Football Players
Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
干预措施: Cognitive/Neuropsychological Testing (Diagnostic Test)
Former Professional Football Players
Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
干预措施: Vestibular/Ocular-Motor Testing (Diagnostic Test)
Former Professional Football Players
Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
干预措施: Sleep Evaluation (Diagnostic Test)
Former Professional Football Players
Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
干预措施: MRI, High-Resolution (Diagnostic Test)
Former Professional Football Players
Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
干预措施: Physical Function (Diagnostic Test)
Former Professional Football Players
Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
干预措施: Blood Testing and Biomarker Analysis (Diagnostic Test)
Former Professional Football Players
Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
干预措施: PET brain imaging (Diagnostic Test)
Control Groups
Friends and brothers of the Former Professional Football Player group.
干预措施: Vestibular/Ocular-Motor Testing (Diagnostic Test)
Control Groups
Friends and brothers of the Former Professional Football Player group.
干预措施: Sleep Evaluation (Diagnostic Test)
Control Groups
Friends and brothers of the Former Professional Football Player group.
干预措施: MRI, High-Resolution (Diagnostic Test)
Control Groups
Friends and brothers of the Former Professional Football Player group.
干预措施: Health & Physical Exam (Diagnostic Test)
Control Groups
Friends and brothers of the Former Professional Football Player group.
干预措施: Physical Function (Diagnostic Test)
Control Groups
Friends and brothers of the Former Professional Football Player group.
干预措施: Blood Testing and Biomarker Analysis (Diagnostic Test)
Control Groups
Friends and brothers of the Former Professional Football Player group.
干预措施: Applanation Tonometry (Diagnostic Test)
Control Groups
Friends and brothers of the Former Professional Football Player group.
干预措施: PET brain imaging (Diagnostic Test)
Control Groups
Friends and brothers of the Former Professional Football Player group.
干预措施: [C-11]6-OH-BTA-1 (Drug)
Control Groups
Friends and brothers of the Former Professional Football Player group.
干预措施: [F-18]AV-1451 (Drug)
结局指标
主要结局
Rates of Brain Health versus Cognitive Impairment
时间窗: 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.
次要结局
- Clinical Syndromes of Neurodegeneration(1-week)
研究者
David Okonkwo, MD, PhD
Professor
University of Pittsburgh