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NCT07742878

Overview

NCT ID: NCT07742878
Lead Sponsor: Rebiscan, Inc.INDUSTRY
Official Title: An Early Prospective Study of the Traq™ Device for Characterization of Binocular Ocular Function in Normal Subjects and Subjects With Recent Traumatic Brain Injury
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

Ages Eligible for Study: Child (0-17)Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 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.