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

NCT05092295 | Active Not Recruiting FDA Device

• 1 other identifier: 002_Q201535
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• TBI Detection

  Patients who have diagnosed TBI and are admitted to the hospital for treatment will have their eyes scanned to identify whether the HITT device can accurately identify patients with TBI.

  1 day

Secondary Outcomes (1)

• TBI Monitor

  14 days

Study Arms (2)

TBI Patients

TBI participants 13 to 45 years of age, recruited from patients at a clinical research facility who present with head trauma. Clinical evaluation for the patient can be positive (target condition present) or negative (target condition absent) for mTBI. Enrollment is to occur within 2 weeks of the incident injury.

Device: Head and Intraocular Trauma Tool; Diagnostic Test: SCAT-5

Controls

Participants should not be part of the Intended Use Population. Subjects that present to the hospital, clinic or emergency department, either as a patient or non-patient, with no history of head trauma.

Device: Head and Intraocular Trauma Tool; Diagnostic Test: SCAT-5

Interventions

Head and Intraocular Trauma Tool DEVICE

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.

Also known as: HITT device

Controls; TBI Patients

SCAT-5 DIAGNOSTIC_TEST

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

Also known as: Sport Concussion Assessment Tool - 5th Edition

Controls; TBI Patients

Eligibility Criteria

• Age: 13 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Target participants for the study population include those within 2 weeks of blunt head trauma, with a Glasgow Coma Scale score of greater than or equal to thirteen. A minimum of one hundred Target Condition subjects will be enrolled. All studies will be completed on the day of enrollment.

You may qualify if:

• Age 13-45 years
• Presents to the facility within 2 weeks of head trauma
• Able to provide informed consent
• If minor, then able to provide parental consent and minor assent
• Able to participate in the examination, including the ability to follow simple instructions
• Fluency in English or Spanish

You may not qualify if:

• Glasgow Coma Scale score of equal to or less than 13 at the time of study enrollment
• Under the influence of alcohol or drugs
• Previous eye surgery
• Visual acuity known to be 20/200 or less in either eye
• Known strabismus, amblyopia (lazy eye), or double vision
• Known eye movement disorder, including nystagmus
• Known optic nerve disease, including papilledema or optic neuropathy
• Known retinal disease, including macular degeneration or retinal degeneration
• Known cataract
• History of neurosurgery
• History of stroke/brain hemorrhage, brain tumor, or epilepsy
• Any head trauma requiring medical attention from a physician within the last 6 months
• Diagnosed dementia or cognitive impairment requiring assistance for daily living
• Other condition(s) under the care of a neurologist
• Psychiatric hospitalization in the last 90 days

Sponsors & Collaborators

• Rebiscan, Inc.: lead
• Carilion Clinic: collaborator

Study Sites (1)

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Damon R Kuehl, MD

  Carilion Roanoke Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2021
• First Posted: October 25, 2021
• Study Start: December 1, 2021
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: April 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Data will be shared on an ongoing basis, and cumulatively at the end of the study. Study length is expected to be 2 months from the first enrolled participant.
• Access Criteria: Data will only be shared with researchers involved in the study at the Carilion Roanoke Memorial Hospital, and only trained staff members at the device manufacturer.

Locations

US (1)