Clinical trial NCT02471625: Traumatic Brain Injury Feasibility Study (EPIC-011)
Official title: Traumatic Brain Injury (TBI) Feasibility Study to Determine Possible Prognostic Indicators as Provided by the EPIC ClearView™
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Traumatic Brain Injury
Controls
Keywords: Controls
Lead sponsor: Epic Research & Diagnostics, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-15
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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

Eligibility criteria: 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

Primary outcomes:
measure: Agreement of ClearView Scan versus Active Diagnosis
timeFrame: I day unless TBI population chooses to participate in one week follow up
Secondary outcomes:
measure: Comparison of TBI subjects to Controls
timeFrame: 1 day unless TBI population chooses to participate in one week follow up
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
References: