Diagnosis of mTBI in a Community Setting

Study Overview
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Brief Summary
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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.

Official Title
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The Use of a Portable 3D Head Mounted Display (HMD) With Integrated Eye Capture Technology (IPAS Goggles) for the Diagnosis of Mild Traumatic Brain Injury (mTBI) in a Community Setting

Conditions
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Traumatic Brain Injury, Mild Traumatic Brain Injury, Brain Injuries, Brain Injuries, Traumatic, Head Injury

Intervention / Treatment
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* Device: I-PAS Goggles


Participation Criteria
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Eligibility Criteria
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Participants must meet one of the following inclusion criteria: 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 all of the following: 1) Blow or impact to head, 2) Period of loss or alteration of consciousness, 3) Neurosensory symptoms, and 4) Diagnosis by Emergency Room Staff or Medical Staff of having suffered an mTBI/Concussion. An age- and sex- matched control group also recruited from emergency department or urgent/acute care facility at the University of Miami Hospital, Jackson Memorial Hospital, or by direct referral to the clinic. These will include individuals with minor injuries (e.g ankle sprains, minor knee injuries, etc.) not involving the head and not requiring admission to the hospital. Exclusion Criteria: History of head injury characterized by any of the following: Resulting from penetrating trauma Resulting from an automobile accident with significant associated injuries Associated with a Glasgow Comma Scale Score of less than 13 at the time of injury Associated with a loss of consciousness period greater than 59 minutes Judged to be more than mild by Medical Staff Requiring admission to the hospital for any reason Associated with subdural or epidural hemorrhage Head injury history For control group - history of head injury within the last six months or currently experience any head injury symptoms at time of enrollment For head injured group - history of head injury within the last three months or experiencing head injury symptoms immediately prior to the current head injury 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: Meniere's disease Multiple sclerosis Vestibular neuritis Vestibular schwannoma Sudden sensorineural hearing loss 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Subjects with mTBI<br>Individuals who come to the emergency department or urgent/acute care facility with an mTBI will undergo testing with the I-PAS Goggles. | Device: I-PAS Goggles<br>* Portable, head-mounted display goggle system with integrated eye capture technology<br>|
| Active Comparator: Subjects with minor injuries<br>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. | Device: I-PAS Goggles<br>* Portable, head-mounted display goggle system with integrated eye capture technology<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with mTBI | How many participants were detected to have mTBI following an injury. | 33 months | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TBI, Community Setting, Mild TBI