Traumatic Brain Injury Feasibility Study (EPIC-011)

• Conditions: Controls; Traumatic Brain Injury
• Interventions: Device: ClearView Scanning

• Registration Number: NCT02471625
• Lead Sponsor: Epic Research & Diagnostics, Inc.

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

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-06-04
• Study First Submitted QC: 2015-06-12
• Study First Posted: 2015-06-15
• Status Verified: 2015-11
• Last Update Submitted: 2015-11-18
• Last Update Posted: 2015-11-20
• Primary Completion: 2016-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	ClearView Scanning	Men and women ages 18-65 with no history of head trauma and a score of 15 on the GCS scale.

Primary Outcome Measures

Name	Time	Method
Agreement of ClearView Scan versus Active Diagnosis	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 Outcome Measures

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

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States