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CompletedNCT03596489Updated Jul 5, 2024

Objective Assessment of Sensory Nerve Fiber Sensitivity

An observational study in Nerve Pain, sponsored by Julia Finkel. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-05.

Sponsored by Julia Finkel · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
16
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Nerve Pain

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03

In context

Neuralgia

1,287 studies on the registry are indexed under Neuralgia; 256 are open to participants now.

This study's enrollment of 16 is below the median of 100 across 260 observational studies indexed under Neuralgia.

Browse Neuralgia studies →

Lead sponsor

Julia Finkel is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Healthy Adult Volunteers will be from within the Children's National Medical Center and the surrounding community.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
16 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • Children's National Health System
    Washington, District of Columbia 20010, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 5, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03596489
Lead sponsor
Julia Finkel
Responsible party
Julia Finkel (Principal Investigator, Children's National Research Institute) — Sponsor-investigator
First posted
Jul 24, 2018
Start date
Jun 27, 2018
Primary completion
Jul 1, 2023
Completion
Jul 11, 2023
Last update
Jul 5, 2024

Study contacts

Julia C Finkel, MD
principal investigator · Children's National Health System

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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