Detection of Small Fiber Neuropathy Using Skin Properties

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04759443
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Anticipated Duration (Months): 19.1
• Patients Per Site Per Month: 21

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Small Fiber Neuropathy	Other: Image processing of skin

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 Design

• Study Type: Observational
• Anticipated Enrollment: 400 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Detection of Small Fiber Neuropathy Using Skin Properties
• Actual Study Start Date: Jul 1, 2021
• Anticipated Primary Completion Date: Feb 1, 2023
• Anticipated Study Completion Date: Feb 1, 2023

Outcome Measures

Primary Outcome Measures

1. Diagnostic accuracy of image processing [2 years]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Faulkner Hospital	Boston	Massachusetts	United States	02130

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter Novak, Director, Autonomic Laboratory, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT04759443
• Other Study ID Numbers: 2021P000410
• First Posted: Feb 18, 2021
• Last Update Posted: Aug 1, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Small Fiber Neuropathy

Study Results

No Results Posted as of Aug 1, 2022