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COVID-19 pandemic
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| Name | Class |
|---|---|
| Neurolign | INDUSTRY |
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This study aims to determine the validity and safety of disparity driven vergence using a portable goggle system (I-PAS) using a pseudorandom ternary sequence of frequencies for testing.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Injured Participants | Experimental | Participants with mild traumatic brain injury (mTBI) tested using the I-PAS goggles |
|
| Uninjured Participants | Active Comparator | Participants with no mild traumatic brain injury (mTBI) tested using the I-PAS goggles |
|
| 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 |
|---|---|---|
| Pseudorandom Ternary Sequence of Frequency | Pseudorandom Ternary Sequence of Frequency (reported in Hertz) will be measured via mergence testing using the IPAS goggles. | 15 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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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 | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Injured Participants | Participants with mild traumatic brain injury (mTBI) tested using the I-PAS goggles I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology |
| FG001 | Uninjured Participants | Participants with no mild traumatic brain injury (mTBI) tested using the I-PAS goggles I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Injured Participants | Participants with mild traumatic brain injury (mTBI) tested using the I-PAS goggles I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology |
| BG001 | Uninjured Participants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pseudorandom Ternary Sequence of Frequency | Pseudorandom Ternary Sequence of Frequency (reported in Hertz) will be measured via mergence testing using the IPAS goggles. | All participants | Posted | Median | Standard Deviation | Hertz | 15 minutes |
|
24 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Injured Participants | Participants with mild traumatic brain injury (mTBI) tested using the I-PAS goggles I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Hoffer | University of Miami | 305 243-1484 | michael.hoffer@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 23, 2020 | May 13, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Participants with no mild traumatic brain injury (mTBI) tested using the I-PAS goggles I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 0 |
| 14 |
| EG001 | Uninjured Participants | Participants with no mild traumatic brain injury (mTBI) tested using the I-PAS goggles I-PAS Goggles: Portable, head-mounted display goggle system with integrated eye capture technology | 0 | 26 | 0 | 26 | 0 | 26 |
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| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |