Detection of Small Fiber Neuropathy Using Skin Properties

NCT04759443 | Recruiting

• 1 other identifier: 2021P000410
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Small Fiber Neuropathy

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of image processing

  The diagnostic accuracy of image processing will be evaluated by using the skin biopsy as a reference.

  2 years

Interventions

Image processing of skin OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with small fiber neuropathy

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Faulkner Hospital

Boston, Massachusetts, 02130, United States

RECRUITING

MeSH Terms

Conditions

Small Fiber Neuropathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Central Study Contacts

Peter Novak, MD

CONTACT

617-732-7432; pnovak2@bwh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Autonomic Laboratory

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: July 1, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 6, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)