Traumatic Brain Injury Feasibility Study (EPIC-011)
Status unconfirmed
Conditions studied: Traumatic Brain Injury, Controls
In brief
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.
Key facts
- Study ID
- NCT02471625
- Run by
- Epic Research & Diagnostics, Inc.
- People needed
- 200
- Starts
- 2015-04-01
- Last updated by the study team
- 2015-11-20
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Suspected TBI population:
- Acute head trauma within 24-72 hours of presentation
- 18-65 age inclusive
- GCS of 3-15 on initial evaluation in ED
- Control population:
- 18-65 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
- Additional exclusion criteria for control population:
- Previous head trauma
Where it is running
- University of Iowa — Iowa City, Iowa, United States
Full record on ClinicalTrials.gov
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