Development of a Portable VR-based Chromatic Pupilloperimeter for Diagnosis and Monitoring of Traumatic Brain Injury
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pupil Light Reflex measured by the VR device
研究概览
简要总结
Accurate and non-invasive methods for objectively identifying and monitoring head injuries (such as a concussion) are still an unmet need. It is known that pupil constriction in response to light stimuli can reflect changes in neural activity in the brain and is associated with sleep disturbances.
The investigators aim to examine the feasibility of using virtual reality goggles for monitoring traumatic brain injury by analyzing the pupillary response to multifocal chromatic stimuli. The VR device was programmed to present brief, low-intensity light stimuli (without glare), while the headset's camera records the pupil's reaction.
详细描述
Healthy adults, patients with combat-related mild to moderate TBI and age- and gender-similar soldiers without TBI (defined as war-related injury who screen negative for TBI based on symptoms, blood, and/or head CT) will be recruited as non-TBI trauma (NTT) controls.
All subjects will undergo: A complete ophthalmologic examination to exclude ocular pathologies, including intraocular pressure (Goldmann applanation tonometry), and slit lamp biomicroscopy of the anterior and posterior segments; Assessment of best corrected visual acuity (BCVA); Color vision test, and VR Chromatic Pupilloperimetry (VRCP) testing.
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
- 18 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects
- •Clear ocular media a
- •Combat-related mild to moderate TBI
- •Have either elevated TBI-associated blood biomarkers (Abbott Allinity I, GFAP/ UCHL1) and/or initial trauma head CT positive for acute intracranial trauma
- •Non-TBI Trauma group:
- •1. Age- and gender-similar soldiers without TBI (defined as war-related injury who screen negative for TBI based on symptoms, blood, and/or head CT)
排除标准
- •Neuropsychiatric diseases
- •Any other neurodegenerative diseases
- •History of stroke, epilepsy, head trauma, or head tumors
- •Ocular disease or ocular surgery within the last six months
研究组 & 干预措施
TBI
干预措施: Virtual Reality pupillometry test (Diagnostic Test)
Healthy age- and gender-similar control
干预措施: Virtual Reality pupillometry test (Diagnostic Test)
Non-TBI trauma control
干预措施: Virtual Reality pupillometry test (Diagnostic Test)
结局指标
主要结局
Pupil Light Reflex measured by the VR device
时间窗: Baseline
% pupil contraction
次要结局
未报告次要终点
研究者
Dr. Ygal Rotenstreich
Head, Electrophysiology Clinic , Goldschleger Eye Institute, Sheba Medical Center
Sheba Medical Center