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A 45-Second eye scan could reveal hidden brain injury

NCT ID NCT05092295

Diagnosis Sponsor: Rebiscan, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This study tests a device called HITT that scans the eyes to detect subtle changes in eye movement and alignment that may occur after a mild traumatic brain injury (TBI). About 200 people aged 13 to 45 who recently experienced head trauma will have their eyes scanned, along with a group of healthy controls. The goal is to see if the device can accurately identify those with TBI, potentially offering a quick and objective screening tool.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Head and Intraocular Trauma Tool (HITT) device - a binocular retinal scan that checks eye fixation and alignment
What this could lead to
If it works, this eye-scan device could offer a fast, objective way to help diagnose mild traumatic brain injury in emergency settings.
What could go wrong
This is an early study with a modest number of participants, and the device may not prove accurate enough for real-world use. Eye scans are indirect measures of brain injury, so results may vary.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2021

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Target participants for the study population include those within 2 weeks of blunt head trauma, with a Glasgow Coma Scale score of greater than or equal to thirteen. A minimum of one hundred Target Condition subjects will be enrolled. All studies will be completed on the day of enrollment.

Ages

13 to 45 years

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age 13-45 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 assent 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 of 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

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Conditions

The condition(s) this trial relates to.

Brain Injuries, Traumatic traumatic brain injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Brain injuries, traumatic

Contacts and locations

Locations

  • Carilion Roanoke Memorial Hospital

    Roanoke, Virginia, 24014, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.