Traumatic Brain Injury Feasibility Study (EPIC-011)
This trial is active, not recruiting.
|Conditions||traumatic brain injury, controls|
|Sponsor||Epic Research & Diagnostics, Inc.|
|Start date||April 2015|
|End date||May 2016|
|Trial size||200 participants|
|Trial identifier||NCT02471625, EPIC-011|
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.
|Observational model||case control|
Agreement of ClearView Scan versus Active Diagnosis
time frame: I day unless TBI population chooses to participate in one week follow up
Comparison of TBI subjects to Controls
time frame: 1 day unless TBI population chooses to participate in one week follow up
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
|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|
Call for more information