Nerve Pain Clinical Trial
Official title:
Developing a Method to Objectively Assess Sensory Nerve Fiber Sensitivity: A Pilot Study
Verified date | January 2023 |
Source | Children's National Research Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Children's National Health System | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Julia Finkel |
United States,
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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