NCT03966404已完成不适用
EyeBOX Concussion Study and Registry
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- diagnostic accuracy of clinical diagnosis of post-concussion symptoms
研究概览
简要总结
The objective of this study is to further evaluate eye movements as an aid in the diagnosis of concussion / mTBI and the utility of eye movement assessment in the monitoring of symptoms over time after an initial diagnosis of concussion.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provide written informed consent or assent along with guardian consent.
- •Have sustained a suspected direct or indirect force to the head with or without documented loss of consciousness, memory loss, alteration in consciousness or neurologic deficits. Only individuals presenting for initial evaluation of concussion may be enrolled, however longitudinal assessments may be conducted on enrolled subjects.
- •Have the ability to provide a complete ophthalmologic, medical and neurologic history as well as report medications/drugs/alcohol consumed within the 24 hours prior to tracking.
排除标准
- •Have penetrating trauma.
- •Have had a conventional head CT or MRI demonstrating evidence of structural brain injury (subdural, epidural or intraparenchymal hemorrhage, edema/mass effect per attending radiologist read).
- •Either of the following conditions, immediately related to the incident head trauma: loss of consciousness exceeding 30 minutes or best available GCS score less than 13 within 24 hours.
- •Be blind (no light perception), have missing or non-functional eyes.
- •Be unable to open their eyes.
- •Have a history of unresolved strabismus, diplopia, amblyopia.
- •Have a history of unresolved cranial nerve III, IV, or VI palsy.
- •Have a history of unresolved macular edema, retinal degeneration, extensive cataract, or ocular globe disruption.
- •Have a history of extensive prior eye surgery (examples include strabismus surgery, scleral buckle repair of retinal detachment, repair of blow out fractures of the orbit and any procedures that would interfere with extraocular muscle movements; prior cataract surgery or Lasik are not exclusions) or scarring.
- •Have a prior history of unresolved ocular-motor dysfunctions.
- •Be intoxicated.
结局指标
主要结局
diagnostic accuracy of clinical diagnosis of post-concussion symptoms
时间窗: up to one year after initial presentation
sensitivity and specificity compared to clinical diagnosis of post-concussion symptoms
diagnostic accuracy of initial clinical diagnosis of concussion
时间窗: day 0 (when patient first presents for evaluation)
sensitivity and specificity compared to initial clinical diagnosis of concussion
adverse events
时间窗: through study participation, up to one year
adverse events occurring during use of the diagnostic device
次要结局
- correlation with increases or decreases in post-concussion symptom severity(up to one year after initial presentation)
- diagnostic accuracy of initial clinical diagnosis of concussion(day 0 (when patient first presents for evaluation))
研究者
研究点 (1)
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