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ACTIVE NOT RECRUITING
NCT05092295

Head and Intraocular Trauma Tool for the Identification of Mild Traumatic Brain Injury

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 100 TBI patients and 100 controls.

Key Details

Gender

All

Age Range

13 Years - 45 Years

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2021-12-01

Completion Date

2025-12-31

Last Updated

2025-04-04

Healthy Volunteers

No

Interventions

DEVICE

Head and Intraocular Trauma Tool

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

DIAGNOSTIC_TEST

SCAT-5

Participant is to complete Step 2 (Symptom Evaluation) and Step 3 (Cognitive Screening) of SCAT-5 test.

Locations (1)

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States