Objective Assessment of Sensory Nerve Fiber Sensitivity

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03596489

Enrollment

Registered

2018-07-24

Start date

2018-06-27

Completion date

2023-07-11

Last updated

2024-07-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nerve Pain

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pupillary Reflex Parameters	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.

Countries

United States

Outcome results