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

NCT ID: NCT05092295

Last Updated: 2025-04-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2025-12-31

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Head and Intraocular Trauma Tool

Intervention Type: 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.

SCAT-5

Intervention Type: DIAGNOSTIC_TEST

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

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.

Head and Intraocular Trauma Tool

Intervention Type: 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.

SCAT-5

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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.

Intervention Type: DEVICE

SCAT-5

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

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

HITT device; Sport Concussion Assessment Tool - 5th Edition

Eligibility Criteria

Inclusion Criteria

1. Age 13-45 years

2. Presents to the facility within 2 weeks of head trauma

3. Able to provide informed consent

• If minor, then able to provide parental consent and minor assent

4. Able to participate in the examination, including the ability to follow simple instructions

5. Fluency in English or Spanish

Exclusion Criteria

1. Glasgow Coma Scale score of equal to or less than 13 at the time of study enrollment

2. Under the influence of alcohol or drugs

3. Previous eye surgery

4. Visual acuity known to be 20/200 or less in either eye

5. Known strabismus, amblyopia (lazy eye), or double vision

6. Known eye movement disorder, including nystagmus

7. Known optic nerve disease, including papilledema or optic neuropathy

8. Known retinal disease, including macular degeneration or retinal degeneration

9. Known cataract

10. History of neurosurgery

11. History of stroke/brain hemorrhage, brain tumor, or epilepsy

12. Any head trauma requiring medical attention from a physician within the last 6 months

13. Diagnosed dementia or cognitive impairment requiring assistance for daily living

14. Other condition(s) under the care of a neurologist

15. Psychiatric hospitalization in the last 90 days

16. Subject considered unsuitable for participation in this clinical trial by PI, treating clinician, or study research staff

17. Any minor brain injury regardless of loss of consciousness

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Carilion Clinic

OTHER

Sponsor Role: collaborator

Rebiscan, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Damon R Kuehl, MD

Role: PRINCIPAL_INVESTIGATOR

Carilion Roanoke Memorial Hospital

Locations

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States

Countries

United States

Other Identifiers

002_Q201535

Identifier Type: -

Identifier Source: org_study_id