mTBI Identification and Monitoring Through Retinal Scanning (NCT06142435) | Clinical Trial Compass
RecruitingNot Applicable
mTBI Identification and Monitoring Through Retinal Scanning
United States60 participantsStarted 2023-08-15
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18-45 years
. Presents to the facility within 2 weeks of head trauma
. Able to provide informed 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study is focused on identifying and monitoring traumatic brain injury through retinal scanning rather than treating it, what would actually happen with the results — would they change my current care plan in any way?
2How does retinal scanning work as a way to detect a brain injury, and is there any risk or discomfort involved in undergoing this type of scan?
3This trial is listed as 'Phase NA,' which often means it's a diagnostic or observational study rather than a treatment trial — does that mean I wouldn't be receiving any experimental therapy, and is that the right fit for what I need right now?
4Are there standard clinical tools already being used to assess my brain injury, and how would participating in this retinal scanning study compare or add to those existing approaches?
5What kind of time commitment or follow-up visits would this study require, and given where I am in my recovery, is this something my care team thinks is worth pursuing at this stage?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.