Skip to main content
OpenTrials
Completed

NCT Number: NCT03596489

Objective Assessment of Sensory Nerve Fiber Sensitivity

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Nerve Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's National Health System

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Julia Finkel

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Jul 24, 2018
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.