I-PAS Goggles for Concussion Diagnosis

Overseen By Erin Williams

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Neuropsychiatric disorders, Neurodegenerative disorders, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if the I-PAS goggles, a diagnostic device, can accurately diagnose mild traumatic brain injuries (mTBI), such as concussions, in settings like emergency rooms or urgent care. Participants include individuals with a recent head impact causing changes in consciousness and symptoms like dizziness, as well as a control group with minor injuries, such as sprained ankles. Ideal participants have recently experienced a mild head injury or minor non-head injury and are seeking care. As an unphased trial, this study provides participants the opportunity to contribute to the advancement of diagnostic tools for brain injuries.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the I-PAS Goggles are safe for diagnosing mTBI?

Research has shown that the I-PAS Goggles are safe for use. The FDA has approved these goggles for diagnosing mild traumatic brain injury (mTBI), confirming their safety for this purpose. The goggles track eye movements to perform tests, which do not involve surgery or cutting and are considered low risk. Previous studies have described the device as having "non-significant risk," indicating it is unlikely to cause harm. Overall, users have reported no major problems with the goggles. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the I-PAS Goggles because they offer a new way to diagnose concussions quickly and accurately. Traditional methods, like cognitive tests and symptom checklists, can be subjective and time-consuming. But these goggles use eye-tracking technology to detect subtle changes in eye movements that are often missed by standard tests. This innovative approach could lead to faster and more reliable concussion diagnoses, helping patients receive appropriate care sooner.

What evidence suggests that the I-PAS Goggles are effective for diagnosing mTBI?

Research has shown that the I-PAS Goggles have received FDA approval for diagnosing mild traumatic brain injury (mTBI). These goggles use advanced technology to track eye movements, which can change after a brain injury. In this trial, participants with mTBI will undergo testing with the I-PAS Goggles to help identify the presence of an mTBI. The goggles have proven effective in diagnosing brain injuries quickly and accurately in emergency situations, making them a valuable tool. ^{3 4 5 6 7}

Who Is on the Research Team?

Michael E Hoffer, MD

Principal Investigator

University of Miami

Are You a Good Fit for This Trial?

This trial is for adults aged 18-50 who've had a head impact and are diagnosed with mild traumatic brain injury (mTBI) or concussion at specific hospitals. It's also for similar adults without head injuries as controls. Excluded are those with severe injuries, past significant head trauma, certain medical conditions, or inability to consent.

Inclusion Criteria

I am 18-50 years old and was diagnosed with a concussion after a head injury.

I am a control participant with minor injuries, not involving the head, and not needing hospital stay.

Exclusion Criteria

I am unable to understand and agree to the study's details on my own.

I have had a head injury from something piercing my skull.

You have had a head injury where you were unconscious for more than 59 minutes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Testing

Participants undergo testing with the I-PAS Goggles to diagnose mTBI or assess minor injuries

1 day

1 visit (in-person)

Follow-up

Participants are monitored for recovery and readiness to return to normal activity after a head injury

33 months

What Are the Treatments Tested in This Trial?

Interventions

• I-PAS Goggles

Trial Overview The study tests the I-PAS Goggle System's ability to diagnose mTBI in community healthcare settings like emergency departments. Researchers want to see if it works reliably outside of traditional hospital environments.

How Is the Trial Designed?

Group I: Subjects with mTBI Experimental Treatment 1 Intervention

Individuals who come to the emergency department or urgent/acute care facility with an mTBI will undergo testing with the I-PAS Goggles.

Group II: Subjects with minor injuries Active Control 1 Intervention

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.

I-PAS Goggles is already approved in United States for the following indications:

Approved in United States as I-PAS for:

• Diagnosis of mild traumatic brain injury (mTBI)

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Neurolign

Industry Sponsor

Trials

8

Recruited

2,000+

Published Research Related to This Trial

Visual symptoms like photophobia and blurred vision are common in concussion patients, highlighting the importance of eye movement control areas in the brain that are vulnerable to injury.

Testing vision and eye movements can be a reliable method for detecting concussions and monitoring recovery, helping guide treatment decisions and rehabilitation strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuro-ophthalmologic disorders following concussion. Debacker, J., Ventura, R., Galetta, SL., et al.[2019]

Concussions can cause subtle changes in brain function, particularly affecting balance, cognition, and vision, which can be detected through specialized visual tests like the King-Devick (K-D) test.

Combining visual assessments with cognitive and balance tests, as well as advanced techniques like neuroimaging, enhances our ability to identify concussions and make informed return-to-play decisions, potentially reducing the risk of long-term effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Concussion Toolbox: The Role of Vision in the Assessment of Concussion. Ventura, RE., Balcer, LJ., Galetta, SL.[2022]

In a study of 30 children aged 5-15 with neuro-ophthalmic disease, Goldmann perimetry was completed successfully by 90% of participants, compared to 72.4% for Octopus perimetry, indicating Goldmann may be more feasible for this population.

While both perimetry methods showed broad agreement in visual field outputs, Octopus perimetry tended to underestimate severe visual field defects, which could affect the consistency of assessments over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Study of Optimal Perimetric Testing in Children (OPTIC): evaluation of kinetic approaches in childhood neuro-ophthalmic disease. Patel, DE., Cumberland, PM., Walters, BC., et al.[2020]

The eye tracking algorithm demonstrated a sensitivity of 80.4% and specificity of 66.1% for diagnosing concussion, indicating it can effectively identify concussed individuals in emergency settings.

With an area under the curve (AUC) of 0.718, the eye tracking method shows promise as an objective tool for detecting neurophysiological disruptions caused by brain injuries, potentially serving as a 'gold-standard' diagnostic aid.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eye tracking for classification of concussion in adults and pediatrics. Samadani, U., Spinner, RJ., Dynkowski, G., et al.[2022]

In a study of 295 non-concussed children aged 6-18 presenting to a pediatric emergency department, 24% failed at least one vestibular and oculomotor examination element, indicating that some neurologically normal children may show abnormalities in these tests.

The failure rates varied by age, with 32% of children aged 9-14 failing the tests, suggesting that age may influence the results of vestibular and oculomotor assessments, which are most useful when there is a history of concussion symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vestibular and oculomotor findings in neurologically-normal, non-concussed children. Corwin, DJ., Zonfrillo, MR., Wiebe, DJ., et al.[2019]

Vision-based assessments are becoming important tools for detecting concussions, as the visual pathways are often affected after a head injury, leading to symptoms like ocular motor dysfunction.

Rapid automatized naming (RAN) tasks, such as the King-Devick test, have shown effectiveness in identifying concussed athletes, while video-oculography (VOG) provides objective data on eye movement abnormalities associated with concussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of vision in concussion. Akhand, O., Balcer, LJ., Galetta, SL.[2019]

In a study of 400 pediatric patients aged 6 to 18, 64% received a vestibular and oculomotor (VOM) examination after implementing training and support tools, indicating that such exams are feasible in an emergency setting.

Factors like provider type, concussion history, and symptom burden significantly influenced whether the VOM exam was performed, with patients less likely to receive the exam if they had a non-concussion diagnosis and fewer symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of the vestibular and oculomotor examination for concussion in a pediatric emergency department. Corwin, DJ., Propert, KJ., Zorc, JJ., et al.[2020]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04372797

Study Details | NCT04372797 | Standardized Instruments ... The I-PAS Goggles are FDA approved for the diagnosis of mTBI. Individuals will undergo a subset of tests from the tests listed below. Tests: Explanation/eye ...

2. withpower.com withpower.com/trial/phase-brain-injuries-7-2018-46a79

I-PAS Goggles for Concussion Diagnosis This trial tests if the I-PAS goggle system can reliably diagnose mild brain injuries in urgent care or emergency settings.

3. indycar.com indycar.com/News/2018/05/05-17-INDYCAR-IPAS-concussion-protocol

I-PAS 'goggles test' provides major advancement in ... The I-Portal Portable Assessment System, commonly referred to as the “goggles test,” runs high-quality diagnostic tests to evaluate patients with symptoms of ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8513422/

Normative data for ages 18‐45 for ocular motor and vestibular ... This normative database can serve as a tool to aid in diagnosis, treatment, and/or rehabilitation protocols for vestibular and neurological conditions, ...

5. dallasspine.com dallasspine.com/diagnostic-testing-for-mild-traumatic-brain-injury/

Concussion Testing (I-PAS) Dallas, TX I-PAS testing is a diagnostic exam that uses virtual reality goggles to track eye movements. When the brain is injured, these movements often change in ways ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02486003

Study Details | NCT02486003 | Testing mTBI in Athletes The IPAS goggles are programmed with a series of tests that track eye motions in response to a target. This device has been determined to be a Non-Significant ...

7. eurekalert.org eurekalert.org/news-releases/907624

I-PAS™ chosen by Department of Defense to baseline ... I-PAS was cleared by the U.S. Food and Drug Administration (FDA) in November 2017, predicated on NKI's cleared I-Portal Neurotologic Testing ...