Objective Assessment of Sensory Nerve Fiber Sensitivity
Completed
- Conditions
- Nerve Pain
- Registration Number
- NCT03596489
- Lead Sponsor
- Julia Finkel
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Pupillary Reflex Parameters 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Children's National Health System
🇺🇸Washington, District of Columbia, United States