Feasibility Study of Head and Intraocular Trauma Test (HITT) Device for Potential Detection of Brain Dysfunction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- TBI detection
研究概览
简要总结
The purpose of this research study is to collect data from the eyes of traumatic brain injury (TBI) patients. Patients will look at a green target that will measure the fixation of the eye for 30 seconds. In that 30 seconds, the location of the green target will change and the participant is to track, with their eyes, the light as best they can. The device will measure how well fixation was maintained and the speed of the saccadic movements of the eye. Data will then be used to determine whether there is correlation between these measures and known TBI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documented/ verified mild TBI
- •Mild traumatic brain injury will be defined as Glasgow Coma Scale (GCS) of ≥13 at time of study enrollment
- •Injury occurred < 24 hours ago
- •Positive acute brain CT for clinical care
- •Visual acuity/ hearing adequate for testing
- •Fluency in English or Spanish
- •Ability to provide informed consent
- •Enrolled in TRACK-TBI (IRB #: 825503)
排除标准
- •Catastrophic polytrauma that would interfere with follow-up and outcome assessment
- •Prisoners or patients in custody
- •Pregnancy in female subjects
- •Patients on psychiatric hold (e.g. 5150, 5250)
- •Major debilitating baseline mental health disorders (e.g. schizophrenia or bipolar disorder) that would interfere with follow-up and the validity of outcome assessment
- •Major debilitating neurological disease (e.g. stroke, dementia, tumor) impairing baseline awareness, cognition, or validity of follow-up and outcome assessment
- •Significant history of pre-existing conditions that would interfere with follow-up and outcome assessment (e.g. substance abuse, alcoholism, HIV/AIDS, major transmittable diseases that may interfere with consent, end-stage cancers, learning disabilities, developmental disorders)
- •Low likelihood of follow-up (e.g. participant or family indicating low interest, homelessness or lack of reliable contacts)
- •Penetrating TBI
- •Spinal cord injury with ASIA (American Spinal Injury Assoc.) score of C or worse
- •Any injury to eye including, puncture, scratch, occlusion, fracture to orbital socket (or any fracture to face that would negatively impact eye movement/vision) that would interfere with ability to complete study-device assessment.
- •History of poor vision prior to injury (Visual acuity worse than 20/40 in either eye)
- •Intoxication or chemical impairment at time of examination (upon initial presentation)
- •Evidence on hand-light examination of obvious ocular anomaly or misalignment
研究组 & 干预措施
HITT Device
HITT device to scan eyes of participants 3 times (30 seconds each) at time of admittance to hospital for diagnosed traumatic brain injury. If patient is still in hospital 2 weeks post-enrollment, a second set of 3 tests will be performed
干预措施: HITT device (Device)
结局指标
主要结局
TBI detection
时间窗: 1 day
Patients who have diagnosed TBI and are admitted to the hospital for treatment will have their eyes scanned to identify whether the HITT device can accurately identify patients with TBI
次要结局
- TBI monitor(14 days)