Traumatic Brain Injury Feasibility Study (EPIC-011)

Epic Research & Diagnostics, Inc.200 enrolled

Overview

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 ClearView™ TBI Feasibility (EPIC-011) is to collect data to further develop the ClearView™ Response Scale to measure electrophysiology associated with TBI

Study Type

OBSERVATIONAL

Enrollment

200

Conditions

Traumatic Brain Injury Controls

Interventions

ClearView ScanningDEVICE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Suspected TBI population: 1. Acute head trauma within 24-72 hours of presentation 2. 18-65 age inclusive 3. GCS of 3-15 on initial evaluation in ED Control population: 1. 18-65 age inclusive 2. GCS score of 15 Exclusion Criteria: 1. Current neurological disease 2. Current severe psychological disorder 3. History of substance or alcohol abuse 4. Under drug or alcohol influence, if so, must wait at least 24 hrs. prior to consent 5. Documented current diagnosis/treatment of cancer (including Sickle Cell Disease) 6. Current treatment to the head/brain (radiation, whole brain therapy, gamma knife) 7. Head injury in the last two years 8. Unwilling to sign informed consent 9. Pregnant or potentially pregnant 10. Pacemaker, automatic implanted cardiac defibrillator or other implanted electrical device 11. Connected to an electronic device that cannot be removed 12. Missing all or part of fingers or cuts/burns on pads of fingers 13. Long fingernails and unwilling to cut them and keep them cut for the duration of the study 14. Hand tremors or involuntary oscillations ("shaking") of the hands that prevents clear imaging Additional exclusion criteria for control population: Previous head trauma

Locations (1)

University of Iowa

Iowa City, Iowa, United States

Outcomes

Primary Outcomes

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

Time frame: I day unless TBI population chooses to participate in one week follow up

Secondary Outcomes

Comparison of TBI subjects to Controls

Will measure comparisons of data from one visit

Time frame: 1 day unless TBI population chooses to participate in one week follow up

Data from ClinicalTrials.gov

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