Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-01 @ 7:30 PM
Study NCT ID:
NCT04927832
Status:
COMPLETED
Last Update Posted:
2025-09-25
First Post:
2021-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Small Fiber Neuropathies by the Non-invasive SUDOSCAN Method During Chronic Autoimmune Pathologies and / or Unexplained Pain Syndromes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 139}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-24', 'studyFirstSubmitDate': '2021-06-09', 'studyFirstSubmitQcDate': '2021-06-09', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2021-06-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients presenting diagnosis of small fiber neuropathy in chronic pathologies and / or unexplained pain syndrome', 'timeFrame': '53 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Systemic Autoimmune Pathologies', 'Unexplained Pain Syndrome']}, 'descriptionModule': {'briefSummary': 'Very few studies have evaluated the prevalence of small fiber neuropathy (SFN) during pathologies that may be responsible for small fibers damage.\n\nSUDOSCAN is a new rapid (2 minutes), automated, reproducible and non-invasive technology to assess small fiber neuropathy by sweat function.\n\nWith 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.\n\nSUDOSCAN® could allow the identification of SFN in painful patients apart from another pathology already diagnosed responsible for SFN.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient corresponding to one of the two following groups:\n\n 1. Systemic autoimmune pathology known to be complicated by small fiber neuropathies.\n\n The following autoimmune pathologies will be included: Lupus, Sjogren, Scleroderma, Myositis, rheumatoid arthritis, Sarcoidosis, Vasculitis of small or medium vessels\n 2. No conditions known to be responsible at SFN, unexplained pain symptoms\n* Aged ≥ 18 years\n* Having given free and informed written consent\n\nExclusion Criteria:\n\n* Chronic alcoholism\n* Unbalanced diabetes\n* Chemotherapies\n* HIV\n* Vitamins B12, B1, B6 deficiencies'}, 'identificationModule': {'nctId': 'NCT04927832', 'acronym': 'SUDOCU', 'briefTitle': 'Detection of Small Fiber Neuropathies by the Non-invasive SUDOSCAN Method During Chronic Autoimmune Pathologies and / or Unexplained Pain Syndromes', 'organization': {'class': 'OTHER', 'fullName': 'Hôpital Européen Marseille'}, 'officialTitle': 'Detection of Small Fiber Neuropathies by the Non-invasive SUDOSCAN Method During Chronic Autoimmune Pathologies and / or Unexplained Pain Syndromes', 'orgStudyIdInfo': {'id': '2016-A01515-46'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patient with chronic autoimmune pathology', 'interventionNames': ['Other: SUDOSCAN and EMG (electromyogram)']}, {'type': 'EXPERIMENTAL', 'label': 'Patients with unexplained pain syndrome', 'interventionNames': ['Other: SUDOSCAN and EMG (electromyogram)']}], 'interventions': [{'name': 'SUDOSCAN and EMG (electromyogram)', 'type': 'OTHER', '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', 'armGroupLabels': ['Patient with chronic autoimmune pathology', 'Patients with unexplained pain syndrome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13003', 'city': 'Marseille', 'country': 'France', 'facility': 'BENNANI', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hôpital Européen Marseille', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}