Back to resultsDetection of Small Fiber Neuropathies by the Non-invasive SUDOSCAN Method During Chronic Autoimmune Pathologies and / or Unexplained Pain Syndromes (SUDOCU)
Primary Purpose
Systemic Autoimmune Pathologies, Unexplained Pain Syndrome
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
SUDOSCAN and EMG (electromyogram)
Sponsored by
About this trial
This is an interventional other trial for Systemic Autoimmune Pathologies
Eligibility Criteria
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
Sites / Locations
- BENNANIRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patient with chronic autoimmune pathology
Patients with unexplained pain syndrome
Arm Description
Outcomes
Primary Outcome Measures
Percentage of patients presenting diagnosis of small fiber neuropathy in chronic pathologies and / or unexplained pain syndrome
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04927832
Brief Title
Detection of Small Fiber Neuropathies by the Non-invasive SUDOSCAN Method During Chronic Autoimmune Pathologies and / or Unexplained Pain Syndromes
Acronym
SUDOCU
Official Title
Detection of Small Fiber Neuropathies by the Non-invasive SUDOSCAN Method During Chronic Autoimmune Pathologies and / or Unexplained Pain Syndromes
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 6, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hôpital Européen Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Autoimmune Pathologies, Unexplained Pain Syndrome
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient with chronic autoimmune pathology
Arm Type
Experimental
Arm Title
Patients with unexplained pain syndrome
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
SUDOSCAN and EMG (electromyogram)
Intervention Description
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 Outcome Measure Information:
Title
Percentage of patients presenting diagnosis of small fiber neuropathy in chronic pathologies and / or unexplained pain syndrome
Time Frame
53 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
BENNANI
City
Marseille
ZIP/Postal Code
13003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myriam BENNANI
Phone
0413428351
Email
m.bennani@hopital-europeen.fr
First Name & Middle Initial & Last Name & Degree
Laurent CHICHE, Dr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Detection of Small Fiber Neuropathies by the Non-invasive SUDOSCAN Method During Chronic Autoimmune Pathologies and / or Unexplained Pain Syndromes
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