Traumatic Brain Injury Feasibility Study (EPIC-011)

Traumatic Brain Injury Clinical Trial

— TBI  

Official title:

Traumatic Brain Injury (TBI) Feasibility Study to Determine Possible Prognostic Indicators as Provided by the EPIC ClearView™

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02471625
• Other study ID #: EPIC-011
• Status: Active, not recruiting
• Phase: N/A
• First received: June 4, 2015
• Last updated: November 18, 2015
• Start date: April 2015

Study information

• Verified date: November 2015
• Source: Epic Research & Diagnostics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. primary completion date: May 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Brain Injuries
• Controls
• Traumatic Brain Injury

Intervention

Device:
• ClearView Scanning

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
Epic Research & Diagnostics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No