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mTBI Identification and Monitoring Through Retinal Scanning

Rebiscan, Inc. · with Boston Medical Center · NCT06142435

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–45 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
60
US sites recruiting
1
Study start
August 15, 2023
Record last updated
May 20, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Head and Intraocular Trauma Tool

Conditions: Brain Injuries, Traumatic

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Age 18-45 years
  • Presents to the facility within 2 weeks of head trauma
  • Able to provide informed consent
  • If minor, then able to provide parental consent and minor consent
  • Able to participate in the examination, including the ability to follow simple instructions
  • Fluency in English or Spanish

Exclusion Criteria

  • Glasgow Coma Scale score equal to or less than 13 at the time of study enrollment
  • Under the influence of alcohol or drugs
  • Previous eye surgery
  • Visual acuity known to be 20/200 or less in either eye
  • Known strabismus, amblyopia (lazy eye), or double vision
  • Known eye movement disorder, including nystagmus
  • Known optic nerve disease, including papilledema or optic neuropathy
  • Known retinal disease, including macular degeneration or retinal degeneration
  • Known cataract
  • History of neurosurgery
  • History of stroke/brain hemorrhage, brain tumor, or epilepsy
  • Any head trauma requiring medical attention from a physician within the last 6 months
  • Diagnosed dementia or cognitive impairment requiring assistance for daily living
  • Other condition(s) under the care of a neurologist
  • Psychiatric hospitalization in the last 90 days
  • Subject considered unsuitable for participation in this clinical trial by PI, treating clinician, or study research staff
  • Any minor brain injury regardless of loss of consciousness

Recruiting US locations

  • Boston Medical Center Concussion Clinic, Ryan Center for Sports Medicine & Rehabilitation at Boston University

    Boston, MA 02215

    Site contact: Nathan Cardoos, MD · 617-414-6800 · ncardoos@bu.edu

All healthy volunteers studies in Massachusetts →
mTBI Identification and Monitoring Through Retinal Scanning (NCT06142435) | Bored Studies