Eye scan could spot brain injuries in minutes

NCT ID NCT06142435

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a new device that scans the eyes to find signs of mild traumatic brain injury (TBI). The device looks at how the eyes move and focus, which can be affected by a brain injury. Researchers will scan 60 people with a recent head injury and 20 healthy volunteers to see if the device can accurately tell who has a TBI. The goal is to create a quick, non-invasive tool to help diagnose and monitor brain injuries.

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 60 people

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

Started

Aug 2023

Expected to finish

Aug 2026

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

The population includes target participants that enroll within two weeks of blunt head trauma, with a Glasgow Coma Scale score equal to or greater than thirteen, A minimum of sixty Target Condition subjects will be enrolled. All studies will be complete within thirty days of enrollment.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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 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

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    RECRUITING

    Boston, Massachusetts, 02215, United States

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