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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03596489
Other study ID # 10134
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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