Traumatic Brain InjuryNCT03539848
Diagnosis of mTBI in a Community Setting
A study testing I-PAS Goggles in people with Traumatic Brain Injury and Mild Traumatic Brain Injury, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research study is to test whether a portable goggle system (I-PAS) is good at diagnosing mild traumatic brain injury (mTBI) in a community setting. The goal is to determine whether the IPAS goggle system can be used reliably in an urgent care or emergency department setting. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Traumatic Brain Injury, Mild Traumatic Brain Injury, Brain Injuries
- What is being tested?
- I-PAS Goggles
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2018to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- History of head injury characterized by any of the following:
- Resulting from penetrating trauma
- Resulting from an automobile accident with significant associated injuries
- Associated with a Glasgow Comma Scale Score of less than 13 at the time of injury
- Associated with a loss of consciousness period greater than 59 minutes
- Judged to be more than mild by Medical Staff
Show all 26Show fewer
- Requiring admission to the hospital for any reason
- Associated with subdural or epidural hemorrhage
- Head injury history
- For control group - history of head injury within the last six months or currently experience any head injury symptoms at time of enrollment
- 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
- Presence of severe aphasia
- History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia)
- Documented neurodegenerative disorders
- Pregnancy [Female candidates will be asked if they are pregnant]
- Prior disorders of hearing and balance including:
- Meniere's disease
- Multiple sclerosis
- Vestibular neuritis
- Vestibular schwannoma
- Sudden sensorineural hearing loss
- History of Cerebrovascular disorders
- History of ear operation other than myringotomy and tube placement in the past
- Systemic disorders to include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, or severe arthritis
- Children
- Individuals who cannot provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
Official title: The Use of a Portable 3D Head Mounted Display (HMD) With Integrated Eye Capture Technology (IPAS Goggles) for the Diagnosis of Mild Traumatic Brain Injury (mTBI) in a Community Setting
The purpose of this research study is to test whether a portable goggle system (I-PAS) is good at diagnosing mild traumatic brain injury (mTBI) in a community setting. The goal is to determine whether the IPAS goggle system can be used reliably in an urgent care or emergency department setting.
Read the detailed description
The purpose of this research study is to test whether a portable goggle system (I-PAS) is good at diagnosing mild traumatic brain injury (mTBI) in a community setting. The goal is to determine whether the IPAS goggle system can be used reliably in an urgent care or emergency department setting. The study further looks at current metrics and compares their efficacy in both the diagnosis and prognostic value of individuals with mTBI.
- Conditions
- Traumatic Brain Injury, Mild Traumatic Brain Injury, Brain Injuries, Brain Injuries, Traumatic, Head Injury
- Being tested
- I-PAS Goggles
- Keywords
- TBI, Community Setting, Mild TBI
- Medical subject headings
- Brain Injuries, Traumatic, Brain Concussion, Brain Injuries, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
I-PAS GogglesDevice
Portable, head-mounted display goggle system with integrated eye capture technology
| Study group | Role | What they receive |
|---|---|---|
| Subjects with mTBI | Experimental | Individuals who come to the emergency department or urgent/acute care facility with an mTBI will undergo testing with the I-PAS Goggles. Receives: Device: I-PAS Goggles |
| Subjects with minor injuries | Active comparator | Individuals who come to the emergency department or urgent/acute care facility with minor injuries (such as ankle sprains or knee sprains) will undergo testing with the I-PAS Goggles. Receives: Device: I-PAS Goggles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with mTBI
How many participants were detected to have mTBI following an injury.
Measured: 33 months
Secondary outcomes (1)
Time to recover
Measuring the time (days) it takes for readiness to return to normal activity after a head injury for participants with a detected mTBI
Measured: 33 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 Aug 2018
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Neurolign
- Responsible party
- Principal investigator, Michael E. Hoffer, University of Miami
- Investigators
- Michael Hoffer, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539848
- Sponsor's protocol ID
- 20180012
- Status last verified
- Aug 2024
- First submitted
- 15 May 2018
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of a Portable 3D Head Mounted Display (HMD) With Integrated Eye Capture Technology (IPAS Goggles) for the Diagnosis of Mild Traumatic Brain Injury (mTBI) in a Community Setting
- ClinicalTrials.gov ID
- NCT03539848
- Acronym / sponsor ID
- 20180012
- Conditions
- Traumatic Brain Injury, Mild Traumatic Brain Injury, Brain Injuries, Brain Injuries, Traumatic, Head Injury
- Keywords
- TBI, Community Setting, Mild TBI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Neurolign
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to test whether a portable goggle system (I-PAS) is good at diagnosing mild traumatic brain injury (mTBI) in a community setting. The goal is to determine whether the IPAS goggle system can be used reliably in an urgent care or emergency department setting.
Detailed description
The purpose of this research study is to test whether a portable goggle system (I-PAS) is good at diagnosing mild traumatic brain injury (mTBI) in a community setting. The goal is to determine whether the IPAS goggle system can be used reliably in an urgent care or emergency department setting. The study further looks at current metrics and compares their efficacy in both the diagnosis and prognostic value of individuals with mTBI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects with mTBI | Experimental | Device: I-PAS GogglesIndividuals who come to the emergency department or urgent/acute care facility with an mTBI will undergo testing with the I-PAS Goggles. |
| Subjects with minor injuries | Active comparator | Device: I-PAS GogglesIndividuals who come to the emergency department or urgent/acute care facility with minor injuries (such as ankle sprains or knee sprains) will undergo testing with the I-PAS Goggles. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (26 listed)
- History of head injury characterized by any of the following:
- Head injury history
- Presence of severe aphasia
- History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia)
- Documented neurodegenerative disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| I-PAS GogglesPortable, head-mounted display goggle system with integrated eye capture technology | Device | Subjects with mTBI, Subjects with minor injuries |
Primary outcome
Number of participants with mTBI
Time frame: 33 months
How many participants were detected to have mTBI following an injury.
1 secondary outcome
Time to recover
Time frame: 33 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Hoffer, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing I-PAS Goggles in people with Traumatic Brain Injury and Mild Traumatic Brain Injury, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with mTBI (time frame: 33 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.