Traumatic Brain Injury (TBI) Feasibility Study to Determine Possible Prognostic Indicators as Provided by the EPIC ClearView™
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Agreement of ClearView Scan versus Active Diagnosis
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Agreement of ClearView Scan versus Active Diagnosis
时间窗: I day unless TBI population chooses to participate in one week follow up
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
次要结局
- Comparison of TBI subjects to Controls(1 day unless TBI population chooses to participate in one week follow up)