Systemic Autoimmune PathologiesSUDOCUNCT04927832
Detection of Small Fiber Neuropathies by the Non-invasive SUDOSCAN Method During Chronic Autoimmune Pathologies and / or Unexplained Pain Syndromes
A study testing SUDOSCAN and EMG (electromyogram) in people with Systemic Autoimmune Pathologies and Unexplained Pain Syndrome, run by Hôpital Européen Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Autoimmune Pathologies, Unexplained Pain Syndrome
- What is being tested?
- SUDOSCAN and EMG (electromyogram)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 1 siteFrance
- Study dates
- 6 Jul 2017to 23 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Chronic alcoholism
- Unbalanced diabetes
- Chemotherapies
- HIV
- Vitamins B12, B1, B6 deficiencies
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Being tested
- SUDOSCAN and EMG (electromyogram)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Patient with chronic autoimmune pathology | Experimental | Not described Receives: Other: SUDOSCAN and EMG (electromyogram) |
| Patients with unexplained pain syndrome | Experimental | Not described Receives: Other: SUDOSCAN and EMG (electromyogram) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients presenting diagnosis of small fiber neuropathy in chronic pathologies and / or unexplained pain syndrome
Measured: 53 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start6 Jul 2017
- Primary completion23 Feb 2023
- Study completion23 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Autoimmune PathologiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Européen Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927832
- Sponsor's protocol ID
- 2016-A01515-46
- Acronym
- SUDOCU
- Status last verified
- Sep 2025
- First submitted
- 9 Jun 2021
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Small Fiber Neuropathies by the Non-invasive SUDOSCAN Method During Chronic Autoimmune Pathologies and / or Unexplained Pain Syndromes
- ClinicalTrials.gov ID
- NCT04927832
- Acronym / sponsor ID
- SUDOCU / 2016-A01515-46
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Hôpital Européen MarseilleUniversity, hospital or other
- Study start
- 6 Jul 2017 (actual)
- Primary completion
- 23 Feb 2023 (actual)
- Study completion
- 23 Feb 2023 (actual)
- First posted
- 16 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with chronic autoimmune pathology | Experimental | Other: SUDOSCAN and EMG (electromyogram) |
| Patients with unexplained pain syndrome | Experimental | Other: SUDOSCAN and EMG (electromyogram) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient corresponding to one of the two following groups:
- The following autoimmune pathologies will be included: Lupus, Sjogren, Scleroderma, Myositis, rheumatoid arthritis, Sarcoidosis, Vasculitis of small or medium vessels
- Aged ≥ 18 years
- Having given free and informed written consent
Key exclusion criteria (5 listed)
- Chronic alcoholism
- Unbalanced diabetes
- Chemotherapies
- HIV
- Vitamins B12, B1, B6 deficiencies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | Patient with chronic autoimmune pathology, Patients with unexplained pain syndrome |
Primary outcome
Percentage of patients presenting diagnosis of small fiber neuropathy in chronic pathologies and / or unexplained pain syndrome
Time frame: 53 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SUDOSCAN and EMG (electromyogram) in people with Systemic Autoimmune Pathologies and Unexplained Pain Syndrome, run by Hôpital Européen Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients presenting diagnosis of small fiber neuropathy in chronic pathologies and / or unexplained pain syndrome (time frame: 53 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.