Detection of Small Fiber Neuropathy Using Skin Properties

Recruiting

• Conditions: Small Fiber Neuropathy

• Registration Number: NCT04759443
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

Small fiber neuropathy affects millions of peoples worldwide. The neuropathy is causing disabling burning pain and dysautonomia such as dizziness with standing, brain fog, fatigue, constipation, too much or too little sweating. The detection of nerve damage is complicated and not widely available; it requires either skin biopsy or specialized equipment and training. This project utilizes the mathematical processing of skin pictures for the purpose to extract the statistical features related to loss of small fibers. This approach can improve the availability of diagnosis of small fiber neuropathy.

Detailed Description

Small fiber neuropathy, including cardiovascular diabetic neuropathy, affects millions of peoples worldwide. The neuropathy is causing disabling burning pain and dysautonomia such as dizziness with standing, brain fog, fatigue, constipation, urinary problems and cold or hot intolerance. Early and accurate diagnosis of neuropathy is essential for correct treatment. Available diagnostic methods are either invasive such as skin biopsy or available only in few specialized centers. This project addresses the limited availability of small fiber neuropathy detection.

The project utilizes utilize specialized image processing of skin pictures for the purpose to extract the statistical features that are related to loss of small fibers. The accuracy of the diagnosis verified using skin biopsies.

This approach can improve the availability of diagnosis of small fiber neuropathy.

Study Timeline

• Study First Submitted: 2021-02-15
• Study First Submitted QC: 2021-02-15
• Study First Posted: 2021-02-18
• Study Start: 2021-07-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-06
• Primary Completion: 2027-02-01
• Study Completion: 2027-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Patients with age 18 year or older
• Patients that sign the informed consent form to participate in this study
• Patients completed the autonomic testing with skin biopsies

Exclusion Criteria

• Patients with significant hairs at the legs that will cover the skin
• Any dermatological disorder that can affect the skin composition
• The use of skin lotion

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of image processing	2 years	The diagnostic accuracy of image processing will be evaluated by using the skin biopsy as a reference.

Trial Locations

Locations (1)

Brigham and Women's Faulkner Hospital; 🇺🇸 Boston, Massachusetts, United States