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 60 TBI patients and 20 controls.
Interventions
HITT device to scan the eyes of participants up to 3 times (\~45 seconds each) at the time of admittance to study. The participant is to place the chin in the chin-rest and fixate on the illuminated light on the device.
Sponsors
Rebiscan, Inc.
Boston Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Age 18-45 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 consent 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 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 present with suspected TBI to the clinic 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 present with suspected TBI to the clinic and had initially been tested for TBI detection 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
Outcome results
None listed