Completed

NCT Number: NCT04927832

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

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.

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Key information

Conditions

Systemic Autoimmune Pathologies Unexplained Pain Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BENNANI

Marseille, 13003, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

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

Time frame: 53 months

Sponsors and collaborators

Lead sponsor

Hôpital Européen Marseille