Detecting brain injuries through retinal scanning
Mild Traumatic Brain Injury Identification and Monitoring Through Retional Scanning
Rebiscan, Inc. · NCT06142435
This study is testing a new eye scanning tool to see if it can help detect brain injuries in people who have recently had head trauma.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Rebiscan, Inc. (industry) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT06142435 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the Rebion trauma tool, which uses binocular retinal scanning to assess eye movement changes associated with traumatic brain injuries (TBI). It aims to enroll 60 patients with confirmed TBIs and 20 uninjured controls to determine the device's effectiveness in detecting ocular fixation and alignment perturbations. Participants must present within two weeks of head trauma and be able to provide informed consent. The study will help establish a non-invasive method for monitoring brain injuries through eye movement analysis.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-45 who have experienced head trauma within the last two weeks.
Not a fit: Patients with severe brain injuries (GCS score ≤ 13), significant eye disorders, or a history of neurosurgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new, non-invasive method for diagnosing and monitoring traumatic brain injuries.
How similar studies have performed: While the approach is innovative, similar studies using eye movement analysis for TBI detection have shown promise but are still emerging.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Boston, Massachusetts
- Boston Medical Center Concussion Clinic, Ryan Center for Sports Medicine & Rehabilitation at Boston University — Boston, Massachusetts, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Brain Injuries, Traumatic