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| Name | Class |
|---|---|
| Neurolign | INDUSTRY |
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The purpose of this research study is to test whether a portable goggle system (I-PAS) is good at diagnosing mild traumatic brain injury (mTBI) in a community setting. The goal is to determine whether the IPAS goggle system can be used reliably in an urgent care or emergency department setting.
The purpose of this research study is to test whether a portable goggle system (I-PAS) is good at diagnosing mild traumatic brain injury (mTBI) in a community setting. The goal is to determine whether the IPAS goggle system can be used reliably in an urgent care or emergency department setting. The study further looks at current metrics and compares their efficacy in both the diagnosis and prognostic value of individuals with mTBI.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with mTBI | Experimental | Individuals who come to the emergency department or urgent/acute care facility with an mTBI will undergo testing with the I-PAS Goggles. |
|
| Subjects with minor injuries | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| I-PAS Goggles | Device | Portable, head-mounted display goggle system with integrated eye capture technology |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with mTBI | How many participants were detected to have mTBI following an injury. | 33 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to recover | Measuring the time (days) it takes for readiness to return to normal activity after a head injury for participants with a detected mTBI | 33 months |
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Participants must meet one of the following inclusion criteria:
Exclusion Criteria:
History of head injury characterized by any of the following:
Head injury history
Presence of severe aphasia
History of diagnosed neuropsychiatric disorders (e.g. hypochondriasis, major depression, schizophrenia)
Documented neurodegenerative disorders
Pregnancy [Female candidates will be asked if they are pregnant]
Prior disorders of hearing and balance including:
History of Cerebrovascular disorders
History of ear operation other than myringotomy and tube placement in the past
Systemic disorders to include chronic renal failure, cirrhosis of the liver, autoimmune disease, heart disease, lung disease, or severe arthritis
Children
Individuals who cannot provide informed consent
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| Name | Affiliation | Role |
|---|---|---|
| Michael Hoffer, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami Miller School of Medicine | Miami | Florida | 33136 | United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 16, 2026 | May 7, 2026 | 12 | ||
| Jun 29, 2026 |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001924 | Brain Concussion |
| D001930 | Brain Injuries |
| D006259 | Craniocerebral Trauma |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| D014947 | Wounds and Injuries |
| D016489 | Head Injuries, Closed |
| D014949 | Wounds, Nonpenetrating |