Overview

This trial is active, not recruiting.

Conditions traumatic brain injury, controls
Treatment clearview scanning
Sponsor Epic Research & Diagnostics, Inc.
Start date April 2015
End date May 2016
Trial size 200 participants
Trial identifier NCT02471625, EPIC-011

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective cross-sectional
Arm
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.
Men and women ages 18-65 with no history of head trauma and a score of 15 on the GCS scale.
clearview scanning

Primary Outcomes

Measure
Agreement of ClearView Scan versus Active Diagnosis
time frame: I day unless TBI population chooses to participate in one week follow up

Secondary Outcomes

Measure
Comparison of TBI subjects to Controls
time frame: 1 day unless TBI population chooses to participate in one week follow up

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Traumatic Brain Injury (TBI) Feasibility Study to Determine Possible Prognostic Indicators as Provided by the EPIC ClearView™
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
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Epic Research & Diagnostics, Inc..