Traumatic Brain Injury Feasibility Study (EPIC-011)

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.

Full Title of Study: “Traumatic Brain Injury (TBI) Feasibility Study to Determine Possible Prognostic Indicators as Provided by the EPIC ClearView™”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Cross-Sectional
  • Study Primary Completion Date: May 2016

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

Interventions

  • Device: ClearView Scanning

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • Comparison of TBI subjects to Controls
    • Time Frame: 1 day unless TBI population chooses to participate in one week follow up
    • Will measure comparisons of data from one visit

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Epic Research & Diagnostics, Inc.
  • Provider of Information About this Clinical Study
    • Sponsor

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.