Developing a Method to Objectively Assess Sensory Nerve Fiber Sensitivity: A Pilot Study

Julia Finkel1 site in 1 country16 target enrollmentJune 27, 2018

ConditionsNerve Pain

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nerve Pain
Sponsor: Julia Finkel
Enrollment: 16
Locations: 1
Primary Endpoint: Pupillary Reflex Parameters
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 27, 2018

End Date

July 11, 2023

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Julia Finkel

Responsible Party

Sponsor Investigator

Principal Investigator

Julia Finkel

Principal Investigator

Children's National Research Institute

Eligibility Criteria

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

Outcomes

Primary Outcomes

Pupillary Reflex Parameters

Time Frame: 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.