NCT05562544已完成不适用
Development of an EEG Diagnostic for Repetitive Sub-concussive Head Impacts: A Feasibility Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in EEG Signals
研究概览
简要总结
The purpose of this study is to develop a diagnostic algorithm to help with the detection, diagnosis, and monitoring of sub-concussive head impacts.
详细描述
This prospective study will investigate the potential effects of soccer ball heading on EEG and oculomotor measurements.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 - 38 years of age.
- •Have at least 1 year of experience playing soccer.
- •Played soccer within the prior year.
- •Head soccer ball during practice and/or games.
排除标准
- •Subjects with a history of TBI during the prior 12 months.
- •History of moderate or severe Traumatic Brain Injury (TBI).
- •History of seizures.
- •Medical or psychiatric history the precludes participation.
- •Currently receiving treatment in another research study.
- •History of a condition with vestibular, ocular, or vision dysfunction.
结局指标
主要结局
Change in EEG Signals
时间窗: Baseline, 45 minutes post-heading, 24 hours post-heading
Sensitivity of a machine-learning based algorithm containing changes in EEG signals and functional connectivity for distinguishing research participants who headed a soccer ball from research participants who kicked the ball. A leave-one-out cross validation approach will be used.
次要结局
- Change in Eye Tracking Parameters(Baseline, 45 minutes post-heading, 24 hours post-heading)
- Change in King-Devick Testing Scores(Baseline, 45 minutes post-heading, 24 hours post-heading)
研究者
Todd J. Schwedt
Principal Investigator
Mayo Clinic
研究点 (1)
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