Traumatic Brain Injury (TBI) Feasibility Study to Determine Possible Prognostic Indicators as Provided by the EPIC ClearView™
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Traumatic Brain Injury
- Sponsor
- Epic Research & Diagnostics, Inc.
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Agreement of ClearView Scan versus Active Diagnosis
- Last Updated
- 10 years ago
Overview
Brief Summary
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.
Detailed Description
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 ClearView™ TBI Feasibility (EPIC-011) is to collect data to further develop the ClearView™ Response Scale to measure electrophysiology associated with TBI
Investigators
Eligibility Criteria
Inclusion Criteria
- •Suspected TBI population:
- •Acute head trauma within 24-72 hours of presentation
- •18-65 age inclusive
- •GCS of 3-15 on initial evaluation in ED
- •Control population:
- •18-65 age inclusive
- •GCS score of 15
Exclusion Criteria
- •Current neurological disease
- •Current severe psychological disorder
- •History of substance or alcohol abuse
- •Under drug or alcohol influence, if so, must wait at least 24 hrs. prior to consent
- •Documented current diagnosis/treatment of cancer (including Sickle Cell Disease)
- •Current treatment to the head/brain (radiation, whole brain therapy, gamma knife)
- •Head injury in the last two years
- •Unwilling to sign informed consent
- •Pregnant or potentially pregnant
- •Pacemaker, automatic implanted cardiac defibrillator or other implanted electrical device
Outcomes
Primary Outcomes
Agreement of ClearView Scan versus Active Diagnosis
Time Frame: I day unless TBI population chooses to participate in one week follow up
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
Secondary Outcomes
- Comparison of TBI subjects to Controls(1 day unless TBI population chooses to participate in one week follow up)