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The purpose of this research study is to evaluate whether data made by the ClearView System can be used to detect whether someone has a traumatic brain injury and how severe the injury is.
Traumatic brain injury (TBI) is a significant cause of death and disability in the U.S. The severity of a TBI may range from "mild" (i.e. a brief change in mental status or consciousness) to "severe" (i.e. an extended period of unconsciousness or memory loss after the injury). However, most TBI's that occur each year are mild and are commonly called concussions. Unfortunately, TBI terminology does not adequately describe the injury or impairment, its treatment, or the resulting outcomes. Due to the complexity of the human brain, each person's physiology can result in different patterns of impairment and secondary conditions, requiring different treatment or rehabilitation. The intent of EPIC ClearViewâ„¢ TBI Feasibility (EPIC-011) is to collect data to further develop the ClearViewâ„¢ Response Scale to measure electrophysiology associated with TBI
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traumatic Brain Injury | Men and women ages 18-65 with suspected acute head trauma within 24-72hrs. of presentation, scoring a 3-15 on initial evaluation on GCS scale. | ||
| Control | Men and women ages 18-65 with no history of head trauma and a score of 15 on the GCS scale. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ClearView Scanning | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Agreement of ClearView Scan versus Active Diagnosis | The EPIC ClearView software produces a Response Scale report that summaries the electrophysiological measurements associated with organ systems. The autonomic numbers indicate how the person's stress response is affecting different body systems and the physical numbers reflect physiological function. These measurements will then be compared to TBI diagnosis, based on one or two possible scans | I day unless TBI population chooses to participate in one week follow up |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of TBI subjects to Controls | Will measure comparisons of data from one visit | 1 day unless TBI population chooses to participate in one week follow up |
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Inclusion Criteria:
Suspected TBI population:
Control population:
Exclusion Criteria:
Additional exclusion criteria for control population:
Previous head trauma
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Men and women ages 18-65 who present to the ER with suspected head trauma and meet all inclusion and no exclusion criteria will be approached for consent to participate in the study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Iowa | Iowa City | Iowa | 52242 | United States |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |