Detection of Small Fiber Neuropathies by the Non-invasive SUDOSCAN Method During Chronic Autoimmune Pathologies and / or Unexplained Pain Syndromes (SUDOCU)

September 24, 2025 updated by: Hôpital Européen Marseille

Very few studies have evaluated the prevalence of small fiber neuropathy (SFN) during pathologies that may be responsible for small fibers damage.

SUDOSCAN is a new rapid (2 minutes), automated, reproducible and non-invasive technology to assess small fiber neuropathy by sweat function.

With quantitative and reproducible results, SUDOSCAN allows physicians to early detect and follow-up peripheral neuropathy to monitor disease progression and assess treatment efficacy for a better patient management.

SUDOSCAN® could allow the identification of SFN in painful patients apart from another pathology already diagnosed responsible for SFN.

The purpose of the study SUDOCU is to assess the prevalence of small fiber neuropathies (SFN) in patients with systemic autoimmune pathologies or unexplained pain syndrome.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

139

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13003
        • BENNANI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patient corresponding to one of the two following groups:

    1. Systemic autoimmune pathology known to be complicated by small fiber neuropathies.

      The following autoimmune pathologies will be included: Lupus, Sjogren, Scleroderma, Myositis, rheumatoid arthritis, Sarcoidosis, Vasculitis of small or medium vessels

    2. No conditions known to be responsible at SFN, unexplained pain symptoms
  • Aged ≥ 18 years
  • Having given free and informed written consent

Exclusion Criteria:

  • Chronic alcoholism
  • Unbalanced diabetes
  • Chemotherapies
  • HIV
  • Vitamins B12, B1, B6 deficiencies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient with chronic autoimmune pathology
Other: SUDOSCAN and EMG (electromyogram)
The participants are evaluated clinically by a neurologist with evaluation by DN4 questionnaire, treatments and comorbidities (alcohol consumption, diabetes, etc.). They undergo from exploration by SUDOSCAN according to the already established methodology and an EMG
Experimental: Patients with unexplained pain syndrome
Other: SUDOSCAN and EMG (electromyogram)
The participants are evaluated clinically by a neurologist with evaluation by DN4 questionnaire, treatments and comorbidities (alcohol consumption, diabetes, etc.). They undergo from exploration by SUDOSCAN according to the already established methodology and an EMG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients presenting diagnosis of small fiber neuropathy in chronic pathologies and / or unexplained pain syndrome
Time Frame: 53 months
53 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hôpital Européen Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 6, 2017

Primary Completion (Actual)

February 23, 2023

Study Completion (Actual)

February 23, 2023

Study Registration Dates

First Submitted

June 9, 2021

First Submitted That Met QC Criteria

June 9, 2021

First Posted (Actual)

June 16, 2021

Study Record Updates

Last Update Posted (Estimated)

September 25, 2025

Last Update Submitted That Met QC Criteria

September 24, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-A01515-46

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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