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RECRUITING
NCT06142435

mTBI Identification and Monitoring Through Retinal Scanning

Sponsor: Rebiscan, Inc.

View on ClinicalTrials.gov

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.

Official title: Mild Traumatic Brain Injury Identification and Monitoring Through Retional Scanning

Key Details

Gender

All

Age Range

18 Years - 45 Years

Study Type

OBSERVATIONAL

Enrollment

60

Start Date

2023-08-15

Completion Date

2025-08-31

Last Updated

2025-04-06

Healthy Volunteers

Yes

Interventions

DEVICE

Head and Intraocular Trauma Tool

HITT device to scan the eyes of participants up to 3 times (\~45 seconds each) at the time of admittance to study. The participant is to place the chin in the chin-rest and fixate on the illuminated light on the device.

Locations (1)

Boston Medical Center Concussion Clinic, Ryan Center for Sports Medicine & Rehabilitation at Boston University

Boston, Massachusetts, United States