Detecting brain injuries through retinal scanning

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Boston Medical Center Concussion Clinic, Ryan Center for Sports Medicine & Rehabilitation at Boston University
  Boston, Massachusetts, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.