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

Sponsor

Hôpital Européen Marseille (Other)

Overall Status

Recruiting

CT.gov ID

NCT04927832

Collaborator

(none)

150

Enrollment

Location

Arms

65.8

Anticipated Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Systemic Autoimmune Pathologies Unexplained Pain Syndrome	Other: SUDOSCAN and EMG (electromyogram)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

150 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jul 6, 2017

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient with chronic autoimmune pathology	Other: 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
Experimental: Patients with unexplained pain syndrome	Other: 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

Arm

Intervention/Treatment

Experimental: Patient with chronic autoimmune pathology

Other: 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

Experimental: Patients with unexplained pain syndrome

Other: SUDOSCAN and EMG (electromyogram)

Outcome Measures

Primary Outcome Measures

Percentage of patients presenting diagnosis of small fiber neuropathy in chronic pathologies and / or unexplained pain syndrome [53 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	BENNANI	Marseille		France	13003

Sponsors and Collaborators

Hôpital Européen Marseille

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hôpital Européen Marseille

ClinicalTrials.gov Identifier:

NCT04927832

Other Study ID Numbers:

2016-A01515-46

First Posted:

Jun 16, 2021

Last Update Posted:

Jul 27, 2022

Last Verified:

Jul 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Small Fiber Neuropathy

Syndrome

Somatoform Disorders

Study Results

No Results Posted as of Jul 27, 2022