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

NCT05092295 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2025-04-04

No results posted yet for this study

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.

Conditions

  • Brain Injuries, Traumatic

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.

Sponsors & Collaborators

  • Carilion Clinic

    collaborator OTHER

  • Rebiscan, Inc.

    lead INDUSTRY

Principal Investigators

  • Damon R Kuehl, MD · Carilion Roanoke Memorial Hospital

Eligibility

Min Age
13 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2025-12-31
Completion
2025-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05092295 on ClinicalTrials.gov