Detection of Small Fiber Neuropathy Using Skin Properties

Small Fiber Neuropathy Clinical Trial

Official title:

Detection of Small Fiber Neuropathy Using Skin Properties

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04759443
• Other study ID #: 2021P000410
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: February 1, 2025

Study information

• Verified date: February 2024
• Source: Brigham and Women's Hospital
• Contact: Peter Novak, MD
• Phone: 617-732-7432
• Email: pnovak2[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: February 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Small Fiber Neuropathy

Intervention

Other:
• Image processing of skin
Image processing will be used to extract skin features that correlate with loss of small skin fibers.

Locations

Country	Name	City	State
United States	Brigham and Women's Faulkner Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy of image processing	The diagnostic accuracy of image processing will be evaluated by using the skin biopsy as a reference.	2 years