Brain Injuries, Traumatic
Conditions
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.
Interventions
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_TESTSCAT-5
Participant is to complete Step 2 (Symptom Evaluation) and Step 3 (Cognitive Screening) of SCAT-5 test.
Sponsors
Rebiscan, Inc.
University of Pennsylvania
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
13 Years to 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TBI Detection | 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| TBI Monitor | 14 days | Patients who have remained in the hospital for TBI and received initial HITT device scan will receive a second set of scans at 2 weeks to identify whether the HITT device can accurately identify patients with TBI. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRamon Diaz-Arrastia, MD, PhD
University of Pennsylvania
Outcome results
None listed