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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

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 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

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.

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.

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
945 Previous Clinical Trials
427,206 Total Patients Enrolled
NeurolignIndustry Sponsor
7 Previous Clinical Trials
1,642 Total Patients Enrolled
Michael Hoffer, MDPrincipal InvestigatorUniversity of Miami
3 Previous Clinical Trials
118 Total Patients Enrolled

Media Library

I-PAS Goggles (Diagnostic Device) Clinical Trial Eligibility Overview. Trial Name: NCT03539848 — N/A
Traumatic Brain Injury Research Study Groups: Subjects with mTBI, Subjects with minor injuries
Traumatic Brain Injury Clinical Trial 2023: I-PAS Goggles Highlights & Side Effects. Trial Name: NCT03539848 — N/A
I-PAS Goggles (Diagnostic Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03539848 — N/A
~95 spots leftby Sep 2026