Clinical Trial

mTBI Identification and Monitoring Through Retinal Scanning

Recruiting
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Summary
Rebion has developed a device, the Rebion trauma tool (referred to as the head and intraocular trauma tool, or "HITT"), that detects ocular fixation and alignment using a binocular retinal scan. Preliminary data obtained from hospitalized patients with a clinically-confirmed traumatic brain injury (TBI) and uninjured controls indicates that the device can detect changes in ocular fixation, alignment, and saccades that are related to brain injury. This study seeks to evaluate the ability of the Rebion trauma tool to assess perturbations in eye movements resulting from TBI. The study will enroll 60 TBI patients and 20 controls.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-11-16; most recent amendment 2026-05-18.
Trial Details
NCT Number NCT06142435
Lead Sponsor Rebiscan, Inc.
Collaborators: Boston Medical Center
Conditions Brain Injuries, Traumatic
Enrollment 60 participants
Start Date 2023-08-15
Primary Completion 2026-08-31 (estimated)
Study Completion 2026-08-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-20