What side effects are associated with this type of intervention?

The most common treatments for mild Traumatic Brain Injury (mTBI) primarily involve rest, symptom management, and gradual return to normal activities. Advanced diagnostic tools like the I-PAS Goggle System aim to improve diagnosis accuracy but do not have direct side effects. However, treatments for mTBI can include medications for pain relief, which may cause side effects such as dizziness, nausea, and gastrointestinal issues. Cognitive and physical rest are recommended, and improper management can lead to prolonged symptoms or complications. Advanced imaging techniques, while useful for diagnosis, may expose patients to radiation or contrast agents, which can have their own risks.

What prior FDA approvals exist?

As of now, there are no specific FDA-approved pharmacological treatments for Traumatic Brain Injury (TBI). Management of TBI typically involves supportive care, rehabilitation, and symptomatic treatments. Diagnostic tools like the I-PAS Goggle System are being studied to improve the diagnosis of mild traumatic brain injury (mTBI) in community settings, but they are not treatments. Current research continues to explore potential therapeutic options, but no drugs have been specifically approved for TBI treatment by the FDA.

What other types of research exist?

Promising alternatives to the I-PAS Goggle System for diagnosing mTBI include: 1) Portable brain-computer interface systems that use wearable, wireless, dry electroencephalogram (EEG) and electrooculogram (EOG) technologies to assess brain activity. 2) Near-infrared spectroscopy (NIRS) devices, which can monitor regional tissue oxygenation and may be adapted for brain injury assessment. These technologies offer non-invasive, real-time monitoring capabilities that could be beneficial in urgent care or emergency settings.

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Diagnostic Device

I-PAS Goggles for Concussion Diagnosis

N/A

Recruiting

Led By Michael Hoffer, MD

Research Sponsored by University of Miami

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 blow or impact to head, period of loss or alteration of consciousness, neurosensory symptoms, and diagnosis of mTBI/Concussion by Emergency Room Staff or Medical Staff

Be between 18 and 65 years old

Must not have

History of head injury resulting from penetrating trauma

Presence of severe aphasia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 33 months

Awards & highlights

No Placebo-Only Group

Summary

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

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves diagnostic equipment rather than medication, typical drug side effects aren't expected. However, discomfort or disorientation during use of the goggles could occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have severe difficulty speaking or understanding speech.

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I have a chronic condition like kidney failure, liver cirrhosis, autoimmune disease, heart or lung disease, or severe arthritis.

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I have had a head injury that caused bleeding around my brain.

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I have had issues with my hearing or balance, including past surgeries on my ears.

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

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I have a diagnosed neurodegenerative condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 33 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~33 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 33 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of participants with mTBI

Secondary study objectives

Time to recover

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Subjects with mTBIExperimental Treatment1 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 injuriesActive Control1 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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Traumatic Brain Injury (TBI) include medical management to reduce intracranial pressure, surgical interventions to remove hematomas or repair skull fractures, and rehabilitation therapies to restore function. Medical management often involves the use of diuretics, hyperosmolar therapy, and barbiturates to decrease brain swelling and prevent further injury. Surgical interventions may be necessary to alleviate pressure on the brain and prevent secondary damage. Rehabilitation therapies, including physical, occupational, and speech therapy, aim to improve cognitive and motor functions. These treatments are crucial for TBI patients as they help mitigate the immediate and long-term effects of brain injury, promoting recovery and improving quality of life. The I-PAS Goggle System, while primarily a diagnostic tool for mild TBI, underscores the importance of early and accurate diagnosis in guiding appropriate treatment strategies and improving patient outcomes.

Montreal Brain Injury Vision Screening Test for General Practitioners.Efficacy of the All-in-One Therapeutic Strategy for Severe Traumatic Brain Injury: Preliminary Outcome and Limitation.