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

Not Applicable

• Conditions: Systemic Autoimmune Pathologies; Unexplained Pain Syndrome
• Interventions: Other: SUDOSCAN and EMG (electromyogram)

• Registration Number: NCT04927832
• Lead Sponsor: Hôpital Européen Marseille

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-06
• Study First Submitted: 2021-06-09
• Study First Submitted QC: 2021-06-09
• Study First Posted: 2021-06-16
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-26
• Last Update Posted: 2022-07-27
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient with chronic autoimmune pathology	SUDOSCAN and EMG (electromyogram)	-
Patients with unexplained pain syndrome	SUDOSCAN and EMG (electromyogram)	-

Primary Outcome Measures

Name	Time	Method
Percentage of patients presenting diagnosis of small fiber neuropathy in chronic pathologies and / or unexplained pain syndrome	53 months

Trial Locations

Locations (1)

BENNANI; 🇫🇷 Marseille, France