EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 155
- 试验地点
- 1
- 主要终点
- Changes in the Eye-tracking Score Before and After Practice or Game: Tangential and Radial Error
研究概览
简要总结
This study will assess the effects of exercise and non-concussive bodily contact on eye-tracking scores collected by the EYE-SYNC eye-tracking device.
详细描述
The investigators propose to prospectively study a cohort of 18-25-year-old athletes. Athletes will be tested with the EYE-SYNC eye-tracking device prior to the start of an athletic practice or competition (pre-test) and then after the conclusion of the practice/competition (post-test). The investigators hope to understand if eye-tracking scores are effected by exercise and non-concussive bodily contact commonly incurred during athletic play.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Athletes between the age of 18- 25-years-old.
- •20/30 or better eyesight (corrected vision allowed).
- •English fluency.
排除标准
- •Note: Under Cohort 1, Athletes that have conditions listed below will not be excluded from the study. They will be enrolled and their subject data will be analyzed separately from subjects who do not endorse any significant medical hx under neurological, eye-sight, or psychiatric categories.
- •Clinical diagnosis of a neurological condition including the following: Stroke, Multiple Sclerosis, Epilepsy, Brain Tumor/Cancer, Nystagmus and/or other major neurological condition.
- •Clinical diagnosis of any of the following eye-sight abnormalities: Uncorrected Amblyopia, Uncorrected Myopia, Uncorrected Presbyopia, Uncorrected Farsightedness, or Uncorrected Astigmatism.
- •Psychiatric history with any of the following:
- •Clinical diagnosis of a psychotic disorder, bipolar disorder - lifetime
- •Clinical diagnosis of ADHD or ADD - Lifetime
- •Clinical diagnosis of major depressive disorder - within last year
- •Clinical diagnosis of substance abuse disorder - within last year
- •Clinical diagnosis of major anxiety disorder - within last year
- •Requires use of a psychotropic medication.
研究组 & 干预措施
Athletes
Participants will be evaluated using the EYE-SYNC eye-tracking device, Desktop Eye-Tracker, and Sport Concussion Assessment Tool (SCAT-3) tool.
干预措施: EYE-SYNC eye-tracking device (Device)
Athletes
Participants will be evaluated using the EYE-SYNC eye-tracking device, Desktop Eye-Tracker, and Sport Concussion Assessment Tool (SCAT-3) tool.
干预措施: SCAT-3 (Other)
Athletes
Participants will be evaluated using the EYE-SYNC eye-tracking device, Desktop Eye-Tracker, and Sport Concussion Assessment Tool (SCAT-3) tool.
干预措施: Desktop Eye-Tracker (Device)
结局指标
主要结局
Changes in the Eye-tracking Score Before and After Practice or Game: Tangential and Radial Error
时间窗: Up to 6 hours
The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC. Tangential and radial error are defined as degrees of variation in eye tracking along a circular path (tangential) and at 90 degrees to the tangential path (radial). Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target.
Changes in the Eye-tracking Score Before and After Practice or Game: Vertical and Horizontal Gain
时间窗: Up to 6 hours
The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC. Vertical and horizontal gain are defined as the ratio of velocity (velocity of the eye:velocity of the target). Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target.
Changes in the Eye-tracking Score Before and After Practice or Game: Phase Error
时间窗: Up to 6 hours
The EYE-SYNC test was performed before and after practice to analyze the effect of exercise and sub-concussive impact. The movement of eye was tracked using EYE-SYNC. The data were recorded in a surface tablet connected to EYE-SYNC. Phase error is defined as the difference in degrees between movement of the target and the movement of the eye. Positive values indicate the eye is ahead of the target; negative values indicate the eye is behind the target.
次要结局
- Changes in Sport Concussion Assessment Tool (SCAT-3) Standardized Assessment of Concussion (SAC) Score(Day of study/event (up to 6 hours))
研究者
Jamshid Ghajar
Clinical Professor of Neurosurgery
Stanford University