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Clinical Trials in the USA / NCT05092295
Active, not recruiting Observational

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

NCT05092295 · tracked via the Priya Life Science USA tracker
Sponsor
Rebiscan, Inc.
Phase
Observational
Started
2021-12-01
Last updated
2026-08-12

Condition(s) studied

Brain Injuries, Traumatic

Investigational drug(s) / intervention(s)

Head and Intraocular Trauma ToolSCAT-5

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.

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

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.

Eligibility

Sex
ALL
Min age
13 Years
Max age
45 Years
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Carilion Roanoke Memorial Hospital Roanoke Virginia

More Rebiscan, Inc. trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05092295 on ClinicalTrials.gov ↗ ← All trials in the USA