I-PAS Goggles for Concussion Diagnosis

Overseen by Michael E Hoffer, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Miami

Disqualifiers: Neuropsychiatric disorders, Neurodegenerative disorders, Pregnancy, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the I-PAS Goggles treatment for concussion diagnosis?

Research suggests that vision-based assessments, like those used in the I-PAS Goggles, can help detect subtle changes in brain function after a concussion. Tests involving eye movements and visual performance, such as eye tracking, have shown promise in improving the accuracy of concussion diagnosis. ^{1 2 3 4 5}

How is the I-PAS Goggles treatment unique for diagnosing concussions?

The I-PAS Goggles treatment is unique because it uses vision and eye movement tests to detect concussions, focusing on how the brain controls eye movements, which is often affected by head injuries. This approach is different from other methods that may not emphasize the visual system as much, making it a novel tool for identifying and monitoring concussion symptoms. ^{1 3 4 6 7}

Research Team

Michael E Hoffer, MD

Principal Investigator

University of Miami

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• I-PAS Goggles (Diagnostic Device)

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.

Participant Groups

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.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Sylvia Daunert

University of Miami

Chief Executive Officer since 2011

PhD in Biochemistry and Molecular Biology, University of Kentucky

Bahar Motlagh

University of Miami

Chief Medical Officer since 2021

PhD in Biomedical Engineering, Ecole Polytechnique Montreal

Neurolign

Industry Sponsor

Trials

8

Recruited

2,000+

Findings from Research

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Assessment of vision in concussion. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Use of the vestibular and oculomotor examination for concussion in a pediatric emergency department. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Vestibular and oculomotor findings in neurologically-normal, non-concussed children. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

The Concussion Toolbox: The Role of Vision in the Assessment of Concussion. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Eye tracking for classification of concussion in adults and pediatrics. [2022]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Neuro-ophthalmologic disorders following concussion. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Study of Optimal Perimetric Testing in Children (OPTIC): evaluation of kinetic approaches in childhood neuro-ophthalmic disease. [2020]