Detection of Small Fiber Neuropathy Using Skin Properties
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Image processing of skin.
- Who it may be relevant to
- Registry conditions: Small Fiber Neuropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Image processing of skin
Image processing will be used to extract skin features that correlate with loss of small skin fibers.
Primary outcome measures
- Diagnostic accuracy of image processing [Time frame: 2 years]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Brigham and Women's Faulkner Hospital — Boston
Identifiers
NCT: NCT04759443 · 2021P000410