NCT03529799终止不适用
Examining Disparity Driven Vergence as a Potential Diagnostic Test for Mild Traumatic Brain Injury (mTBI)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Pseudorandom Ternary Sequence of Frequency
研究概览
简要总结
This study aims to determine the validity and safety of disparity driven vergence using a portable goggle system (I-PAS) using a pseudorandom ternary sequence of frequencies for testing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 65
- •Both females and males
排除标准
- •Central processing disorder
- •Impaired vision without corrective lenses (max 20/60 uncorrected)
- •Moderate to severe hearing loss (>55 decibels (dB) pure tone audiometry (PTA), <50% word identification)
- •Vestibular disorder except for patients recruited for subjects recruited with a history of mild traumatic brain injury to compare to normal participants
- •History of ear surgery other than myringotomy with or without tube placement
- •Pregnant women
- •Prisoners
- •Adults unable to consent
研究组 & 干预措施
Injured Participants
Experimental
Participants with mild traumatic brain injury (mTBI) tested using the I-PAS goggles
干预措施: I-PAS Goggles (Device)
Uninjured Participants
Active Comparator
Participants with no mild traumatic brain injury (mTBI) tested using the I-PAS goggles
干预措施: I-PAS Goggles (Device)
结局指标
主要结局
Pseudorandom Ternary Sequence of Frequency
时间窗: 15 minutes
Pseudorandom Ternary Sequence of Frequency (reported in Hertz) will be measured via mergence testing using the IPAS goggles.
次要结局
未报告次要终点
研究者
Michael E. Hoffer
Professor
University of Miami
研究点 (2)
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