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Detection of Small Fiber Neuropathy Using Skin Properties

Detection of Small Fiber Neuropathy Using Skin Properties

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04759443
Enrollment
400
Registered
2021-02-18
Start date
2021-07-01
Completion date
2027-02-01
Last updated
2025-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Fiber Neuropathy

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.

Interventions

OTHERImage processing of skin

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

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Diagnostic accuracy of image processing2 yearsThe diagnostic accuracy of image processing will be evaluated by using the skin biopsy as a reference.

Countries

United States

Contacts

Primary ContactPeter Novak, MD
pnovak2@bwh.harvard.edu617-732-7432

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026