Mild Traumatic Brain InjuryNCT03529799
Disparity Driven Vergence in Mild Traumatic Brain Injury (mTBI)
A study testing I-PAS Goggles in people with Mild Traumatic Brain Injury, run by University of Miami at 1 site in United States.
Trial summary
This study aims to determine the validity and safety of disparity driven vergence using a portable goggle system (I-PAS) using a pseudorandom ternary sequence of frequencies for testing. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury
- 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
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Apr 2018to 25 Sep 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 to 65
- Both females and males
Who cannot join
- Central processing disorder
- Impaired vision without corrective lenses (max 20/60 uncorrected)
- Moderate to severe hearing loss (>55 decibels (dB) pure tone audiometry (PTA), <50% word identification)
- Vestibular disorder except for patients recruited for subjects recruited with a history of mild traumatic brain injury to compare to normal participants
- History of ear surgery other than myringotomy with or without tube placement
- Pregnant women
- Prisoners
- Adults unable to consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining Disparity Driven Vergence as a Potential Diagnostic Test for Mild Traumatic Brain Injury (mTBI)
This study aims to determine the validity and safety of disparity driven vergence using a portable goggle system (I-PAS) using a pseudorandom ternary sequence of frequencies for testing.
- Conditions
- Mild Traumatic Brain Injury
- Being tested
- I-PAS Goggles
- Keywords
- mTBI, TBI, brain injury, concussion
- Medical subject headings
- Brain Concussion, Brain Injuries
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 |
|---|---|---|
| Injured Participants | Experimental | Participants with mild traumatic brain injury (mTBI) tested using the I-PAS goggles Receives: Device: I-PAS Goggles |
| Uninjured Participants | Active comparator | Participants with no mild traumatic brain injury (mTBI) tested using 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.
Pseudorandom Ternary Sequence of Frequency
Pseudorandom Ternary Sequence of Frequency (reported in Hertz) will be measured via mergence testing using the IPAS goggles.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2018
- Study start20 Apr 2018
- Primary completion25 Sep 2019
- Study completion25 Sep 2019
Why it stopped: COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild 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
- 40 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
- NCT03529799
- Sponsor's protocol ID
- 20180058
- Status last verified
- Jun 2026
- First submitted
- 24 Apr 2018
- Last updated
- 24 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- 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 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Disparity Driven Vergence as a Potential Diagnostic Test for Mild Traumatic Brain Injury (mTBI)
- ClinicalTrials.gov ID
- NCT03529799
- Acronym / sponsor ID
- 20180058
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- mTBI, TBI, brain injury, concussion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19 pandemic
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Neurolign
- Study start
- 20 Apr 2018 (actual)
- Primary completion
- 25 Sep 2019 (actual)
- Study completion
- 25 Sep 2019 (actual)
- First posted
- 18 May 2018 (actual)
- Results
- Posted 29 Jun 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the validity and safety of disparity driven vergence using a portable goggle system (I-PAS) using a pseudorandom ternary sequence of frequencies for testing.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Injured Participants | Experimental | Device: I-PAS GogglesParticipants with mild traumatic brain injury (mTBI) tested using the I-PAS goggles |
| Uninjured Participants | Active comparator | Device: I-PAS GogglesParticipants with no mild traumatic brain injury (mTBI) tested using the I-PAS goggles |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 to 65
- Both females and males
Key exclusion criteria (8 listed)
- Central processing disorder
- Impaired vision without corrective lenses (max 20/60 uncorrected)
- Moderate to severe hearing loss (>55 decibels (dB) pure tone audiometry (PTA), <50% word identification)
- Vestibular disorder except for patients recruited for subjects recruited with a history of mild traumatic brain injury to compare to normal participants
- History of ear surgery other than myringotomy with or without tube placement
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 | Injured Participants, Uninjured Participants |
Primary outcome
Pseudorandom Ternary Sequence of Frequency
Time frame: 15 minutes
Pseudorandom Ternary Sequence of Frequency (reported in Hertz) will be measured via mergence testing using the IPAS goggles.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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 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 2 inclusion and 8 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: stopped early, as of the sponsor's last update on 24 Jul 2026. 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?
Yes. Results are posted in the registry (first posted 29 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Pseudorandom Ternary Sequence of Frequency (time frame: 15 minutes). 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 24 Jul 2026.