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

NCT ID: NCT04927832

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 139 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-07-06
• Study Completion Date: 2023-02-23

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patient with chronic autoimmune pathology

Group Type: EXPERIMENTAL

SUDOSCAN and EMG (electromyogram)

Intervention Type: 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

Patients with unexplained pain syndrome

Group Type: EXPERIMENTAL

SUDOSCAN and EMG (electromyogram)

Intervention Type: 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

Interventions

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital Européen Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

BENNANI

Marseille, , France

Countries

France

Other Identifiers

2016-A01515-46

Identifier Type: -

Identifier Source: org_study_id