ClinicalTrials.gg
RecruitingNCT07742878REB-001Updated Aug 3, 2026

An Early Prospective Study of the Traq™ Device for Characterization of Binocular Ocular Function in Normal Subjects and Subjects With Recent Traumatic Brain Injury

An observational study in Mild Traumatic Brain Injury, Concussion, Binocular Visual Function and Neuro-Ophthalmology, sponsored by Rebiscan, Inc.. Recruiting at 1 site in United States. Open to participants aged 12 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-03.

Sponsored by Rebiscan, Inc. · Observational

From the registry’s dates

  • Started Jul 2026; still recruiting 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10
Ages
12 Years and older
Sex
All
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Study summary

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).

Read the detailed description

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.

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Conditions studied

  • Mild Traumatic Brain Injury, Concussion
  • Binocular Visual Function
  • Neuro-Ophthalmology
  • Saccadic Eye Movements

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03

In context

Brain Concussion

637 studies on the registry are indexed under Brain Concussion; 163 are open to participants now.

This study's planned enrollment of 10 is below the median of 149 across 166 observational studies indexed under Brain Concussion.

Browse Brain Concussion studies →

Lead sponsor

Rebiscan, Inc. is the lead sponsor of 11 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Eye care clinic patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Age 12 years or older at the time of enrollment.
  2. Able to understand and sign an form (or with parent/guardian for subjects less than 18 years of age).
  3. Willing and able to complete all required study visits and test assessments.
  4. Subjects with no history of traumatic brain injury (normal arm).
  5. Subjects with a history of mild to moderate traumatic brain injury (mTBI) within the last six months, (post-TBI arm).

Exclusion criteria

Exclusion Criteria:

  1. Concurrent participation in another drug or device clinical investigation.
  2. 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.
  3. Subjects who are pregnant, planning to become pregnant, or are breastfeeding.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10 participants (estimated)
Patient registry
No

Groups and cohorts

  • Head trauma group

    Subjects with history of head trauma within the prior 6 months

    Device: Binocular ophthalmic neurodiagnostic device

  • Controls

    Subjects with no history of head trauma

    Device: Binocular ophthalmic neurodiagnostic device

Interventions

  • DeviceBinocular 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.

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What researchers measure

Primary outcomes

  1. Device Metrics

    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

    Time frame: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.

  2. Device Metrics

    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.

    Time frame: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.

  3. Foveal fixation

    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.

    Time frame: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.

  4. Device outputs

    Fovea-tracked saccadic latency will be calculated in milliseconds to measure when fixation is attained and lost throughout the scan.

    Time frame: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.

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Study locations

1 of 1 sites recruiting
  • Elite Eye Care/Elite Vision Therapy
    Waukee, Iowa 50263, United States
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided — Data will be shared should legal or regulatory needs require such sharing.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07742878
Lead sponsor
Rebiscan, Inc.
Responsible party
Sponsor
First posted
Aug 3, 2026
Start date
Jul 14, 2026
Primary completion
Oct 2026 (estimated)
Completion
Oct 2026 (estimated)
Last update
Aug 3, 2026

Study contacts

Justin Shaka
Contact
jgshaka@rebiscan.com
857-600-0982
Heidi Bell, OD
principal investigator · Elite Eye Car / Elite Vision Therapy

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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