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

NCT04927832 | Completed DMC

• 1 other identifier: 2016-A01515-46
• Study Type: interventional
• Target: 139
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Systemic Autoimmune Pathologies; Unexplained Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Percentage of patients presenting diagnosis of small fiber neuropathy in chronic pathologies and / or unexplained pain syndrome

  53 months

Study Arms (2)

Patient with chronic autoimmune pathology

EXPERIMENTAL

Other: SUDOSCAN and EMG (electromyogram)

Patients with unexplained pain syndrome

EXPERIMENTAL

Other: SUDOSCAN and EMG (electromyogram)

Interventions

SUDOSCAN and EMG (electromyogram) OTHER

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

Patient with chronic autoimmune pathology; Patients with unexplained pain syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient corresponding to one of the two following groups:
• 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
• No conditions known to be responsible at SFN, unexplained pain symptoms
• Aged ≥ 18 years
• Having given free and informed written consent

You may not qualify if:

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

Sponsors & Collaborators

• Hôpital Européen Marseille: lead

Study Sites (1)

BENNANI

Marseille, 13003, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 16, 2021
• Study Start: July 6, 2017
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)