Traumatic Brain Injury Feasibility Study (EPIC-011)

NCT02471625 | Unknown

• 1 other identifier: EPIC-011
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Controls

Keywords

Controls

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Comparison of TBI subjects to Controls

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

Study Arms (2)

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.

Device: ClearView Scanning

Interventions

ClearView Scanning DEVICE

Control

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women ages 18-65 who present to the ER with suspected head trauma and meet all inclusion and no exclusion criteria will be approached for consent to participate in the study.

You may qualify if:

• Suspected TBI population:
• Acute head trauma within 24-72 hours of presentation
• age inclusive
• GCS of 3-15 on initial evaluation in ED
• Control population:
• age inclusive
• GCS score of 15

You may not qualify if:

• 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
• Connected to an electronic device that cannot be removed
• Missing all or part of fingers or cuts/burns on pads of fingers
• Long fingernails and unwilling to cut them and keep them cut for the duration of the study
• Hand tremors or involuntary oscillations ("shaking") of the hands that prevents clear imaging
• Previous head trauma

Sponsors & Collaborators

• Epic Research & Diagnostics, Inc.: lead

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2015
• First Posted: June 15, 2015
• Study Start: April 1, 2015
• Primary Completion: May 1, 2016
• Last Updated: November 20, 2015

Record last verified: 2015-11

Locations

US (1)