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Goggle gadget aims to spot concussions in minutes

NCT ID NCT04372797

Diagnosis Sponsor: Carey Balaban Source: ClinicalTrials.gov ↗

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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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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
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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This status has not been confirmed recently, so it may be out of date.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 tested whether a special goggle system (Neurolign Dx_100 I-PAS) and standard tests can reliably detect mild traumatic brain injury (concussion) in people who recently had a head injury. Researchers compared 161 people with concussions to those with minor injuries. The goal was to find a fast, objective way to diagnose concussions in busy emergency rooms.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

161 people

The number who actually took part.

Started

Sep 2020

Finished

Mar 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: For the mTBI group, participants must present to a recruitment site within 10 days of injury with a diagnosed concussion that meets all of the following criteria: 1. clear mechanism of injury (i.e., direct or indirect impact to head), 2. Glasgow Coma Scale= 13-15, 3) observed or reported signs (e.g., loss of consciousness, amnesia, or confusion) or symptoms (e.g., headache, dizziness, nausea), and 3. neurosensory symptoms. For Control group, participants will have minor, non-surgical injuries (e.g., sprains, strains) not requiring hospital admission and no history of mTBI will be recruited from the same study sites. Exclusion Criteria: 1. History of moderate to severe TBI characterized by any of the following: 1. Penetrating head trauma 2. GCS\< 13 at the time of injury 3. Associated with LOC \> 30 minutes or amnesia \>24 hours 4. Associated with subdural or epidural hemorrhage 2. mTBI history 1. mTBI Group - history of mTBI within the last 6 months or experiencing head injury symptoms immediately prior to the current head injury or history of 3 or more mTBIs 2. Controls - No history of mTBI within the last 12 months and no presence of any mTBI-related symptoms at time of enrollment 3. Presence of severe aphasia 4. History of diagnosed psychiatric disorder (e.g., schizophrenia) 5. Documented neurological disorders (e.g., Epilepsy, stroke, dementia) 6. Pregnancy (females will be asked if they are pregnant) 7. Prior disorders of hearing and balance including: 1. Meniere's disease 2. Multiple sclerosis 3. Vestibular neuritis 4. Vestibular schwannoma 5. Sudden sensorineural hearing loss 8. History of tumor of the brain or central nervous system

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Conditions

The condition(s) this trial relates to.

Brain Concussion traumatic brain injury

As listed by the trial registrant

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

Mild traumatic brain injury

Contacts and locations

Locations

  • Naval Medical Center San Diego

    San Diego, California, 92134, United States

  • University of Miami

    Miami, Florida, 33136, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15203, United States

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