Ignite Creation Date:
2025-12-24 @ 8:03 PM
Ignite Modification Date:
2026-01-27 @ 8:04 AM
Study NCT ID:
NCT04121104
Status:
COMPLETED
Last Update Posted:
2020-03-03
First Post:
2019-05-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Electrodermal Activity and Respiration in Patients Treated With Spinal Cord Stimulation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055111', 'term': 'Failed Back Surgery Syndrome'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-02', 'studyFirstSubmitDate': '2019-05-04', 'studyFirstSubmitQcDate': '2019-10-08', 'lastUpdatePostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skin conductance changes', 'timeFrame': 'Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.]', 'description': 'The investigators will examine the difference in skin conductance between both measurements (SCS on versus SCS off)'}, {'measure': 'Respiration rate', 'timeFrame': 'Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.]', 'description': 'The investigators will examine the difference in respiration rate between both measurements (SCS on versus SCS off)'}], 'secondaryOutcomes': [{'measure': 'Pain intensity scores using the Visual Analogue Scale', 'timeFrame': 'Two times on the same day; once while SCS is switched off and once while SCS is switched on. Total study duration lasts one day.]', 'description': 'Pain intensity score on that time on a Visual Analogue Scale (VAS) ranging from zero (no pain) towards 10 (worst possible pain) for the pain intensity.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Spinal cord stimulation', 'Electrodermal activity'], 'conditions': ['Failed Back Surgery Syndrome']}, 'descriptionModule': {'briefSummary': 'This study is investigating skin conductance and respiration during on and off states of the spinal cord stimulator, in patients with failed back surgery syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is at least 18 years old.\n* Diagnosis of FBSS (Failed conservative treatments for pain including but not limited to pharmacological therapy and physical therapy) and currently being treated with spinal cord stimulation.\n* Cognitive and language functioning enabling coherent communication between the examiner and the participant.\n\nExclusion Criteria:\n\n* Patients with impaired skin integrity at the fingers.\n* Patients with major psychiatric problems.'}, 'identificationModule': {'nctId': 'NCT04121104', 'briefTitle': 'Electrodermal Activity and Respiration in Patients Treated With Spinal Cord Stimulation', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Electrodermal Activity and Respiration in Patients Treated With Spinal Cord Stimulation', 'orgStudyIdInfo': {'id': 'SWEAT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SCS off', 'interventionNames': ['Other: SCS is switched off']}, {'type': 'EXPERIMENTAL', 'label': 'SCS on', 'interventionNames': ['Other: SCS is switched on']}], 'interventions': [{'name': 'SCS is switched off', 'type': 'OTHER', 'description': 'Spinal cord stimulator is switched off for 12 hours', 'armGroupLabels': ['SCS off']}, {'name': 'SCS is switched on', 'type': 'OTHER', 'description': 'Spinal cord stimulator is on', 'armGroupLabels': ['SCS on']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Jette', 'state': 'Brussels Capital', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.87309, 'lon': 4.33419}}, {'city': 'Verviers', 'country': 'Belgium', 'facility': 'Clinique Ste Elisabeth', 'geoPoint': {'lat': 50.58907, 'lon': 5.86241}}], 'overallOfficials': [{'name': 'Maarten Moens, Prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitair Ziekenhuis Brussel'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Moens Maarten', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Moens Maarten', 'investigatorAffiliation': 'Universitair Ziekenhuis Brussel'}}}}