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)

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).

Study Overview

• Status: Recruiting
• Conditions: Neuro-Ophthalmology; Mild Traumatic Brain Injury, Concussion; Saccadic Eye Movements; Binocular Visual Function
• Intervention / Treatment: Device: Binocular ophthalmic neurodiagnostic device

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.

• Study Type: Observational
• Enrollment (Estimated): 10

Contacts and Locations

• Study Contact: Name: Justin Shaka; Phone Number: 857-600-0982; Email: jgshaka@rebiscan.com

Study Locations

• United States
  • Iowa
    • Waukee, Iowa, United States, 50263
      • Recruiting
      • Elite Eye Care/Elite Vision Therapy
      • Contact: Heidi Bell, OD; Phone Number: 515-987-3937; Email: heidibellod@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Eye care clinic patients

Description

Inclusion Criteria:

1. Age 12 years or older at the time of enrollment.
2. Able to understand and sign an informed consent 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:

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Head trauma group; Subjects with history of head trauma within the prior 6 months	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.
Controls; Subjects with no history of head trauma	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
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.	Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
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.	Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.
Device outputs	Fovea-tracked saccadic latency will be calculated in milliseconds to measure when fixation is attained and lost throughout the scan.	Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90.

Collaborators and Investigators

• Sponsor: Rebiscan, Inc.
• Investigators: Principal Investigator: Heidi Bell, OD, Elite Eye Car / Elite Vision Therapy

Study record dates

Study Major Dates

• Study Start (Actual): July 14, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: July 21, 2026
• First Submitted That Met QC Criteria: July 30, 2026
• First Posted (Actual): August 3, 2026

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 30, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Injuries, Traumatic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Concussion
• Other Study ID Numbers: REB-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Data will be shared should legal or regulatory needs require such sharing.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No