Head and Intraocular Trauma Tool for the Identification of Mild Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- TBI Detection
研究概览
简要总结
Rebion has developed a device, the Rebion trauma tool (referred to as the head and intraocular trauma tool, or "HITT"), that detects ocular fixation and alignment using a binocular retinal scan. Preliminary data obtained from hospitalized patients with a clinically-confirmed traumatic brain injury (TBI) and uninjured controls indicates that the device can detect changes in ocular fixation, alignment, and saccades that are related to brain injury. This study seeks to evaluate the ability of the Rebion trauma tool to assess perturbations in eye movements resulting from TBI. The study will enroll 100 TBI patients and 100 controls.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 13 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 13-45 years
- •Presents to the facility within 2 weeks of head trauma
- •Able to provide informed consent
- •If minor, then able to provide parental consent and minor assent
- •Able to participate in the examination, including the ability to follow simple instructions
- •Fluency in English or Spanish
排除标准
- •Glasgow Coma Scale score of equal to or less than 13 at the time of study enrollment
- •Under the influence of alcohol or drugs
- •Previous eye surgery
- •Visual acuity known to be 20/200 or less in either eye
- •Known strabismus, amblyopia (lazy eye), or double vision
- •Known eye movement disorder, including nystagmus
- •Known optic nerve disease, including papilledema or optic neuropathy
- •Known retinal disease, including macular degeneration or retinal degeneration
- •Known cataract
- •History of neurosurgery
- •History of stroke/brain hemorrhage, brain tumor, or epilepsy
- •Any head trauma requiring medical attention from a physician within the last 6 months
- •Diagnosed dementia or cognitive impairment requiring assistance for daily living
- •Other condition(s) under the care of a neurologist
- •Psychiatric hospitalization in the last 90 days
- •Subject considered unsuitable for participation in this clinical trial by PI, treating clinician, or study research staff
- •Any minor brain injury regardless of loss of consciousness
研究组 & 干预措施
TBI Patients
TBI participants 13 to 45 years of age, recruited from patients at a clinical research facility who present with head trauma. Clinical evaluation for the patient can be positive (target condition present) or negative (target condition absent) for mTBI. Enrollment is to occur within 2 weeks of the incident injury.
干预措施: Head and Intraocular Trauma Tool (Device)
TBI Patients
TBI participants 13 to 45 years of age, recruited from patients at a clinical research facility who present with head trauma. Clinical evaluation for the patient can be positive (target condition present) or negative (target condition absent) for mTBI. Enrollment is to occur within 2 weeks of the incident injury.
干预措施: SCAT-5 (Diagnostic Test)
Controls
Participants should not be part of the Intended Use Population. Subjects that present to the hospital, clinic or emergency department, either as a patient or non-patient, with no history of head trauma.
干预措施: Head and Intraocular Trauma Tool (Device)
Controls
Participants should not be part of the Intended Use Population. Subjects that present to the hospital, clinic or emergency department, either as a patient or non-patient, with no history of head trauma.
干预措施: SCAT-5 (Diagnostic Test)
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)