The Relationship Between Neurostimulation Intensity and Pupillary Dilation Reflex (PRD) in Healthy Volunteers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Pupillary Dilation Amplitude in Response to Increasing Neurostimulation Intensity Measured by AlgometRx Infrared Pupillometer
研究概览
简要总结
This a single site, observational study that will examine how the pupil responds to neurostimulation under different conditions in healthy adults. The objective is to measure pupillary dilation reflex (PRD) in response to increasing neurostimulation intensities using the AlgometRx device.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-60 years.
- •In good general health (self-reported).
- •Able and willing to provide written informed consent.
排除标准
- •Eye pathology that prevents accurate pupillometry.
- •Pregnancy (Self-Report)
- •Diagnosis of autoimmune disorders.
- •Diagnosis of any neuropathic disorder
- •Inability to complete questionnaires.
结局指标
主要结局
Pupillary Dilation Amplitude in Response to Increasing Neurostimulation Intensity Measured by AlgometRx Infrared Pupillometer
时间窗: Day 1
Pupillary dilation amplitude is defined as the maximum increase in pupil diameter from the pre-stimulus baseline, measured in millimeters (mm) using the AlgometRx infrared pupillometer. Pupil diameter is recorded before, during, and for 10 seconds following each 1-second stimulus. Amplitude is assessed at each stimulation intensity, beginning at 1.0 mA and increasing in 1 mA steps until participant perception, followed by measurements at 2 mA and 4 mA above the perception threshold, at each of three frequencies (5 Hz, 250 Hz, and 2000 Hz). Reported as the mean pupillary dilation amplitude in millimeters at each intensity and frequency combination.
次要结局
- Baseline Pupil Diameter Variability During the Pre-Stimulation Period Measured by AlgometRx Infrared Pupillometer(Day 1)
- Area Under the Pupillary Dilation Curve (AUC) Measured by AlgometRx Infrared Pupillometer(Day 1)
- Difference in Pupillary Dilation Amplitude Between Ambient Lighting Conditions Measured by AlgometRx Infrared Pupillometer(Day 1)
- Inter-Ocular Agreement in Pupillary Dilation Amplitude Measured by AlgometRx Binocular Handheld Attachment(Day 1)
- Percentage of Participants With Successful Simultaneous Binocular Pupillary Recording Using the AlgometRx Binocular Handheld Attachment(Day 1)
研究者
Julia Finkel
Professor of Anesthesiology and Pediatrics
Children's National Research Institute