Objective Assessment of Sensory Nerve Fiber Sensitivity

Julia Finkel16 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Nerve Pain

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. The subject is 18 to 65 years of age 2. The subject is willing to have a tourniquet applied as part of the study 3. The subject is willing and able to provide written informed consent to the study participation 4. The subject is willing and able to comply with all study procedures Exclusion Criteria: 1. Eye pathology precluding pupillometry 2. Subjects who have ongoing pain requiring medical attention 3. Subjects who are not normotensive 4. Subjects with peripheral vascular disease 5. Subjects who are morbidly obese (BMI \>40) 6. Subjects with diabetes or diabetic retinopathy 7. Subjects who are or may be pregnant 8. Subjects with cardiac disease 9. Subjects with neuropathic disease states

Locations (1)

Children's National Health System

Washington D.C., District of Columbia, United States

Outcomes

Primary Outcomes

Pupillary Reflex Parameters

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.

Time frame: 0,5,10,15,20,25,30,35 minutes

Data from ClinicalTrials.gov

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