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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04927832

Acronym

SUDOCU

Enrollment

139

Registered

2021-06-16

Start date

2017-07-06

Completion date

2023-02-23

Last updated

2025-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Autoimmune Pathologies, Unexplained Pain Syndrome

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.

Interventions

OTHERSUDOSCAN 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

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026