Can High-Tech goggles spot concussions in the ER?
NCT ID NCT03539848
First seen Jun 26, 2026 · Last updated Jun 26, 2026
Summary
This study tested whether a portable goggle system with eye-tracking technology can accurately diagnose mild traumatic brain injury (mTBI) in community settings like emergency rooms. Researchers enrolled 120 adults aged 18-50 who had a head injury with symptoms. The goal was to see if the goggles could reliably detect mTBI and measure recovery time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- I-PAS goggles (portable head-mounted display with eye-tracking)
- What this could lead to
- If successful, this could provide a quick, portable tool for diagnosing mild traumatic brain injury in urgent care or emergency rooms.
- What could go wrong
- This is a small, completed study with 120 participants, so results may not apply to all settings or injury types. The device may not be accurate enough for widespread use.
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
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120 people
The number who actually took part.
- Started
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Aug 2018
- Finished
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Apr 2025
- Lead sponsor
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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
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18 to 50 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
Participants must meet one of the following inclusion criteria: 1. Males and females from 18-50 years of age who present to the emergency department or urgent/acute care facility at the University of Miami Hospital, Jackson Memorial Hospital, or by direct referral to the clinic with a history of all of the following: 1) Blow or impact to head, 2) Period of loss or alteration of consciousness, 3) Neurosensory symptoms, and 4) Diagnosis by Emergency Room Staff or Medical Staff of having suffered an mTBI/Concussion. 2. An age- and sex- matched control group also recruited from emergency department or urgent/acute care facility at the University of Miami Hospital, Jackson Memorial Hospital, or by direct referral to the clinic. These will include individuals with minor injuries (e.g ankle sprains, minor knee injuries, etc.) not involving the head and not requiring admission to the hospital. Exclusion Criteria: 1. History of head injury characterized by any of the following: 1. Resulting from penetrating trauma 2. Resulting from an automobile accident with significant associated injuries 3. Associated with a Glasgow Comma Scale Score of less than 13 at the time of injury 4. Associated with a loss of consciousness period greater than 59 minutes 5. Judged to be more than mild by Medical Staff 6. Requiring admission to the hospital for any reason 7. Associated with subdural or epidural hemorrhage 2. Head injury history 1. For control group - history of head injury within the last six months or currently experience any head injury symptoms at time of enrollment 2. For head injured group - history of head injury within the last three months or experiencing head injury symptoms immediately prior to the current head injury 3. Presence of severe aphasia 4. History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia) 5. Documented neurodegenerative disorders 6. Pregnancy \[Female candidates will be asked if they are pregnant\] 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 Cerebrovascular disorders 9. History of ear operation other than myringotomy and tube placement in the past 10. Systemic disorders to include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, or severe arthritis 11. Children 12. Individuals who cannot provide informed consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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University of Miami Miller School of Medicine
Miami, Florida, 33136, United States
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