An Early Prospective Study of the Traq™ Device for Characterization of Binocular Ocular Function in Normal Subjects and Subjects With Recent Traumatic Brain Injury (REB-001)
2026年7月30日 更新者：Rebiscan, Inc.
The early prospective study of Traq™ (an investigational binocular ophthalmic neurodiagnostic device) will measure binocular ocular functions (bilateral foveal fixation, foveal binocularity, and fovea-tracked saccadic latency) in normal subjects and those with history of mild-to moderate traumatic brain injury (mTBI).
研究概览
详细说明
An initial, single-center, prospective, non-masked, non-randomized, parallel-arm clinical study designed to collect Traq™ measurement data from normal subjects (normal arm) and subjects with a history of mild to moderate traumatic brain injury (mTBI) within the last six months (post-TBI arm) to characterize binocular ocular function measurement outcomes across the two study populations.
研究类型
观察性的
注册 (估计的)
10
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Justin Shaka
- 电话号码：857-600-0982
- 邮箱：jgshaka@rebiscan.com
学习地点
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Iowa
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Waukee、Iowa、美国、50263
- 招聘中
- Elite Eye Care/Elite Vision Therapy
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接触：
- Heidi Bell, OD
- 电话号码：515-987-3937
- 邮箱：heidibellod@gmail.com
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
是的
取样方法
非概率样本
研究人群
Eye care clinic patients
描述
Inclusion Criteria:
- Age 12 years or older at the time of enrollment.
- Able to understand and sign an informed consent form (or with parent/guardian for subjects less than 18 years of age).
- Willing and able to complete all required study visits and test assessments.
- Subjects with no history of traumatic brain injury (normal arm).
- Subjects with a history of mild to moderate traumatic brain injury (mTBI) within the last six months, (post-TBI arm).
Exclusion Criteria:
- Concurrent participation in another drug or device clinical investigation.
- Subject with a history of eye disease which could reduce, or limit reflected polarized light from the retina, such as corneal scarring, cataract, glaucoma, degenerative retinal conditions (e.g., age-related macular degeneration, diabetic retinopathy), or other conditions which may decrease device signal reflectance.
- Subjects who are pregnant, planning to become pregnant, or are breastfeeding.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Head trauma group
Subjects with history of head trauma within the prior 6 months
|
Participants will undergo non-invasive binocular ophthalmic neurodiagnostic measurements and ocular assessments.
No treatment or intervention will be administered as part of the study.
|
|
Controls
Subjects with no history of head trauma
|
Participants will undergo non-invasive binocular ophthalmic neurodiagnostic measurements and ocular assessments.
No treatment or intervention will be administered as part of the study.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Device Metrics
大体时间：Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
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A composite Traq score will be calculated on a scale of 0.00-to-2.00 at each visit. The score will be a calculated combination of the following, additional outcome measures:
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Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
|
|
Device Metrics
大体时间：Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
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Bilateral foveal fixation will be measured as a percentage (from 0.00-1.00%) of time in which both eyes fixate together during the scan.
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Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
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|
Foveal fixation
大体时间：Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
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The device will capture each individual eye's ability to fixate as a percentage (from 0.00 to 1.00) of time during the scan.
A result will be provided for each individual eye.
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Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
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Device outputs
大体时间：Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
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Fovea-tracked saccadic latency will be calculated in milliseconds to measure when fixation is attained and lost throughout the scan.
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Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Heidi Bell, OD、Elite Eye Car / Elite Vision Therapy
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月14日
初级完成 (估计的)
2026年10月1日
研究完成 (估计的)
2026年10月1日
研究注册日期
首次提交
2026年7月21日
首先提交符合 QC 标准的
2026年7月30日
首次发布 (实际的)
2026年8月3日
研究记录更新
最后更新发布 (实际的)
2026年8月3日
上次提交的符合 QC 标准的更新
2026年7月30日
最后验证
2026年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.