EYE-TRAC Advance: Technology Verification (ETA-TV) Cohort 2
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 8
- 主要终点
- Reliability of EYE-SYNC Data
研究概览
简要总结
This is a prospective multi-center cohort feasibility and exploratory study.
详细描述
Investigators propose to prospectively study a cohort of 18-25-year-old athletes to establish the reliability of EYE-SYNC data and the utility of the EYE-SYNC eye-tracking device as a sideline concussion assessment tool. The clinical research study will be conducted to 1) determine if eye-tracking, assessed on the sideline by EYE-SYNC eye-tracking device, is a potential marker of injury that can be used in conjunction with other sideline evaluations to inform decisions regarding removal of athletes from play and 2) to use the EYE-SYNC goggle data as a post- injury recovery monitor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Both CCS and CTR must meet the following 3 criteria:
- •Athletes between the age of 18- 25-years-old.
- •20/30 or better eyesight (corrected vision allowed).
- •English fluency.
- •Control Subject:
- •Control Subject (CTR) - a teammate of the concussed subject who did not experience impact but who was actively participating in the same sport and session along with the injured teammate at the time of injury
- •Concussed Subject:
- •Concussed Subject (CCS) - those who experience impact where concussion is highly suspected as evidenced by impairment in any of the SCAT-3 Domains: Symptoms, Physical Signs, Immediate Memory and Orientation. An Injured Athlete is concussed if he/she is FAIL on the Physical Signs, Score = 0 on the Orientation or Scoring below the cutoff scores on the Symptom Checklist and/or Immediate memory SCAT-3 domains.
- •A) Symptoms: Rating of 2 or higher on any of the following items:
- •Nausea or Vomiting
- •Balance Problems
- •Blurred Vision
- •Feeling Slowed Down
- •Feeling like "in a fog"
- •"Don't feel right"
- •B) Physical Signs:
- •Balance (Leg Stances): Number of Error(s) on any of the following 7 subtests classifies a subject as concussed.
- •I. Double Leg Stance: At least 3 errors II. Single Leg Stance: At least 3 errors with either dominant or non-dominant foot III. Tandem Stance: At least 3 errors or more.
- •Balance (Tandem Gait): FAIL on at least 2 of 4 trials:
- •I. FAIL per trial: more than 14 seconds to complete a trial II. FAIL per trial, if one or more of the following errors are made
- •If step off the line;
- •Separation between heel and toe
- •Touch/grab the examiner or an object
- •D) Orientation: Score = 0 on any of the following 5 items Date: Score = 0 (any date different from current) Month: Score = 0 (any month different from current) Day of the week: Score = 0 (any different from current) Year: Score = 0 (any different from current) Time: Score = 0 AND answer is MORE than + or - 1 hour apart from the correct time.
- •E) Immediate Memory Recall Total Score = less than 13 words recalled.
排除标准
- •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.
- •Cannot have participated previously in any of the ETA-TV study visits (for instance, a subject that has completed any study visit as a control subject cannot participate as a concussed subject at a later time point).
研究组 & 干预措施
Concussed Subject
EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM. Investigators will be collecting medical history and demographics from each subject.
干预措施: EYE-SYNC eye-tracking (Device)
Concussed Subject
EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM. Investigators will be collecting medical history and demographics from each subject.
干预措施: SCAT-3 subtests (Other)
Concussed Subject
EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM. Investigators will be collecting medical history and demographics from each subject.
干预措施: DEM (Other)
Concussed Subject
EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM. Investigators will be collecting medical history and demographics from each subject.
干预措施: Simple Reaction Time subtest of ANAM-SRT (Other)
Concussed Subject
EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM. Investigators will be collecting medical history and demographics from each subject.
干预措施: Level of Alertnesss (Other)
Control Subject
EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM. Investigators will be collecting medical history and demographics from each subject.
干预措施: EYE-SYNC eye-tracking (Device)
Control Subject
EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM. Investigators will be collecting medical history and demographics from each subject.
干预措施: SCAT-3 subtests (Other)
Control Subject
EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM. Investigators will be collecting medical history and demographics from each subject.
干预措施: DEM (Other)
Control Subject
EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM. Investigators will be collecting medical history and demographics from each subject.
干预措施: Simple Reaction Time subtest of ANAM-SRT (Other)
Control Subject
EYE-SYNC eye-tracking device, Level of Alertness, SCAT-3 subtests (Symptom, Immediate memory, Balance and Orientation), Simple Reaction Time subtest of ANAM-SRT and DEM. Investigators will be collecting medical history and demographics from each subject.
干预措施: Level of Alertnesss (Other)
结局指标
主要结局
Reliability of EYE-SYNC Data
时间窗: Immediate post impact, 2 days, 7 days and 14 days post impact.
The integrity will be analyzed based on the score obtained from EYE-SYNC device.
Changes in the Measurement of EYE-SYNC Data Immediately After Concussive Event, 2 Days, 7 Days and 14 Days Post Concussive Event.
时间窗: Immediate post impact, 2 days, 7 days and 14 days post impact.
The EYE-SYNC test will be performed immediately after an impact, 2 days, 7 days and 14 days post impact. The movement of eye will be tracked using EYE-SYNC. The data will be recorded in a surface tablet connected to EYE-SYNC.
Integrity of EYE-SYNC Data
时间窗: Immediate post impact, 2 days, 7 days and 14 days post impact.
The reliability will be analyzed based on the score obtained from EYE-SYNC.
次要结局
- Compare Sport Concussion Assessment Tool (SCAT-3) Test and EYE-SYNC Score(Immediate post impact, 2 days, 7 days and 14 days post impact.)
- Compare ANAM-SRT Test and EYE-SYNC Score(Immediate post impact, 2 days, 7 days and 14 days post impact.)
- Compare DEM Test and EYE-SYNC Score(Immediate post impact, 2 days, 7 days and 14 days post impact.)
研究者
Jamshid Ghajar
Clinical Professor of Neurosurgery
Stanford University