Recruiting

Observational Study

Sponsor:

Brigham and Women's Hospital

Code:

NCT04759443

Conditions

Small Fiber Neuropathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Image processing of skin

Study Details

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

Study ID

NCT04759443

Start date

Jul 1, 2021

Status verified date

Feb, 2025

Completion date

Feb 1, 2027

Anticipated

Primary completion date

Feb 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Interventions and Outcome Measures

Interventions

Image processing of skin

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

Primary outcome measure

  • Diagnostic accuracy of image processing [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Locations

Brigham and Women's Faulkner Hospital

Recruiting

Boston, Massachusetts, United States, 02130

Contacts

More Information

Sponsor

Brigham and Women's Hospital

Last update posted

Feb 6, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Brigham and Women's Hospital on 2025-02-06.