NCT05092295

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Rebiscan, Inc. · Industry
• Sex: All
• Age: 13 Years – 45 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2021-12-01
• Primary completion: 2025-12-31
• Completion: 2025-12-31
• First posted: 2021-10-25
• Last updated: 2025-04-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study