Recruiting

Traq™

Sponsor:

Rebiscan, Inc.

Code:

NCT07742878

Conditions

Mild Traumatic Brain Injury, Concussion

Binocular Visual Function

Neuro-Ophthalmology

Saccadic Eye Movements

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

Interventions

Binocular ophthalmic neurodiagnostic device

Study Details

Brief 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).

Conditions

Mild Traumatic Brain Injury, Concussion

Binocular Visual Function

Neuro-Ophthalmology

Saccadic Eye Movements

Study ID

NCT07742878

Start date

Jul 14, 2026

Status verified date

Jul, 2026

Completion date

Oct, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Accepted

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 Design

Enrollment

10 participants

Anticipated

Interventions and Outcome Measures

Arms

Head trauma group

Subjects with history of head trauma within the prior 6 months

Controls

Subjects with no history of head trauma

Interventions

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 measure

  • Device Metrics [ Time Frame: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90. ]
  • Device Metrics [ Time Frame: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90. ]
  • Foveal fixation [ Time Frame: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90. ]
  • Device outputs [ Time Frame: Four individual scans through study completion: Day 0, Day 30, Day 60, Day 90. ]

Central Contacts and Locations

Central contacts

Locations

Elite Eye Care/Elite Vision Therapy

Recruiting

Waukee, Iowa, United States, 50263

Contacts

More Information

Sponsor

Rebiscan, Inc.

Last update posted

Aug 3, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-19. This information was provided to ClinicalTrials.gov by Rebiscan, Inc. on 2026-08-03.