NCT07742878 · Rebiscan, Inc.
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)
What this study is about
The early forward-looking study of Traq™ (an experimental 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).
View original scientific description
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).
Interventions
DEVICE
Binocular ophthalmic neurodiagnostic device
Participants will undergo non-invasive binocular ophthalmic neurodiagnostic measurements and ocular assessments. No treatment or intervention will be administered as part of the study.
Primary outcome measures
Device Metrics
Time frame: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
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: * Bilateral foveal fixation * Foveal binocularity * Fovea-tracked saccadic latency
Device Metrics
Time frame: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
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.
Foveal fixation
Time frame: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
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.
Device outputs
Time frame: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
Fovea-tracked saccadic latency will be calculated in milliseconds to measure when fixation is attained and lost throughout the scan.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Waukee, Iowa
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 3, 2026 · Source of record for eligibility and locations