mTBI Identification and Monitoring Through Retinal Scanning
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Head and Intraocular Trauma Tool.
- Who it may be relevant to
- Registry conditions: Brain Injuries, Traumatic. Basic parameters: 18 years — 45 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Mild Traumatic Brain Injury Identification and Monitoring Through Retional Scanning
Overview
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
- Device Head and Intraocular Trauma Tool
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.
Primary outcome measures
- TBI Detection [Time frame: 1 day]
Secondary outcome measures (2)
- TBI Monitor [Time frame: 14 days]
- TBI Monitor [Time frame: 30 days]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Boston Medical Center Concussion Clinic, Ryan Center for Sports Medicine & Rehabilitation — Boston
Identifiers
NCT: NCT06142435 · BU-001