Objective Assessment of Sensory Nerve Fiber Sensitivity

Nerve Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03596489
• Other study ID #: 10134
• Status: Active, not recruiting
• Start date: June 27, 2018
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2023
• Source: Children's National Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 1, 2023
• Est. primary completion date: July 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Nerve Pain
• Neuralgia

Locations

Country	Name	City	State
United States	Children's National Health System	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Julia Finkel

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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