Objective Assessment of Sensory Nerve Fiber Sensitivity

NCT ID: NCT03596489

Last Updated: 2024-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

16 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-27

Study Completion Date

2023-07-11

Brief Summary

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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.

Detailed Description

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Conditions

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Nerve Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Julia Finkel

OTHER

Sponsor Role lead

Responsible Party

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Julia Finkel

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Julia C Finkel, MD

Role: PRINCIPAL_INVESTIGATOR

Children's National Research Institute

Locations

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Children's National Health System

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

Site Status

Countries

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United States

Other Identifiers

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10134

Identifier Type: -

Identifier Source: org_study_id

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