NCT03596489

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 27, 2018

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 12, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 24, 2018

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
10 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 11, 2023

Completed
Last Updated

July 5, 2024

Status Verified

July 1, 2024

Enrollment Period

5 years

First QC Date

July 12, 2018

Last Update Submit

July 3, 2024

Conditions

Nerve Pain

Outcome Measures

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.

    0,5,10,15,20,25,30,35 minutes

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's National Health System

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Neuralgia

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Julia C Finkel, MD

    Children's National Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 12, 2018

First Posted

July 24, 2018

Study Start

June 27, 2018

Primary Completion

July 1, 2023

Study Completion

July 11, 2023

Last Updated

July 5, 2024

Record last verified: 2024-07

Locations

US(1)