NCT03596489已完成不适用
Developing a Method to Objectively Assess Sensory Nerve Fiber Sensitivity: A Pilot Study
Julia Finkel1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2018年6月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Pupillary Reflex Parameters
研究概览
简要总结
This pilot study utilizes a unique technology to determine nerve fiber sensitivity. This will allow us to determine whether this method and device can discern changes in pain intensity and type, which is predicated on differing nerve fiber sensitivities.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The subject is 18 to 65 years of age
- •The subject is willing to have a tourniquet applied as part of the study
- •The subject is willing and able to provide written informed consent to the study participation
- •The subject is willing and able to comply with all study procedures
排除标准
- •Eye pathology precluding pupillometry
- •Subjects who have ongoing pain requiring medical attention
- •Subjects who are not normotensive
- •Subjects with peripheral vascular disease
- •Subjects who are morbidly obese (BMI >40)
- •Subjects with diabetes or diabetic retinopathy
- •Subjects who are or may be pregnant
- •Subjects with cardiac disease
- •Subjects with neuropathic disease states
结局指标
主要结局
Pupillary Reflex Parameters
时间窗: 0,5,10,15,20,25,30,35 minutes
The primary measurable endpoint is the change in the Area Under the Curve (AUC) of the three sensory nerve fiber types that occurs as a response to tourniquet ischemia and reperfusion. The change is calculated by the difference between measurements at various time points: baseline, tourniquet application, and tourniquet release.
次要结局
未报告次要终点
研究者
Julia Finkel
Principal Investigator
Children's National Research Institute
研究点 (1)
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