Ignite Creation Date:
2025-12-24 @ 5:45 PM
Ignite Modification Date:
2026-01-01 @ 7:19 AM
Study NCT ID:
NCT01261468
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2010-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-14', 'studyFirstSubmitDate': '2010-12-15', 'studyFirstSubmitQcDate': '2010-12-15', 'lastUpdatePostDateStruct': {'date': '2012-03-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in sensory parameters', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Chronic pain', 'Electric Stimulation Therapy', 'Neurologic Examination'], 'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '11465587', 'type': 'BACKGROUND', 'citation': 'Kemler MA, Reulen JP, Barendse GA, van Kleef M, de Vet HC, van den Wildenberg FA. Impact of spinal cord stimulation on sensory characteristics in complex regional pain syndrome type I: a randomized trial. Anesthesiology. 2001 Jul;95(1):72-80. doi: 10.1097/00000542-200107000-00016.'}]}, 'descriptionModule': {'briefSummary': 'The primary purpose is to study the effect of spinal cord stimulation (SCS) on sensory parameters, using quantitative sensory testing (QST).\n\nPatients with established SCS treatment will be examined with QST. Subjects will be randomized to have their SCS device turned off or kept active (1:1) for a 12-hour period, then be reexamined using the same QST protocol.\n\nAfter the 2nd examination all patients cross over (ie. inactive devices are activated, active devices are deactivated) and are reexamined after a new 12-hour period.\n\nThe investigators expect to demonstrate that SCS treatment has a significant effect on sensory parameters associated with pain hypersensitivity but no significant effect on sensory parameters associated with detection of non-painful stimuli.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* minimum age 18\n* able to understand participant information and cooperate at the neurological examination\n* uncomplicated treatment with spinal cord stimulation for at least 3 months\n* pain in only one extremity\n* treatment effect in only one extremity\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01261468', 'briefTitle': 'Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters', 'organization': {'class': 'OTHER', 'fullName': 'Danish Pain Research Center'}, 'officialTitle': 'Treatment With Spinal Cord Stimulation: Effect on Sensory Parameters', 'orgStudyIdInfo': {'id': 'SCS-24h'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active SCS', 'interventionNames': ['Device: Active SCS']}, {'type': 'SHAM_COMPARATOR', 'label': 'Inactive SCS', 'interventionNames': ['Device: Deactivated']}], 'interventions': [{'name': 'Active SCS', 'type': 'DEVICE', 'description': 'SCS IPG activated', 'armGroupLabels': ['Active SCS']}, {'name': 'Deactivated', 'type': 'DEVICE', 'description': 'SCS IPG deactivated', 'armGroupLabels': ['Inactive SCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus C', 'country': 'Denmark', 'facility': 'Danish Pain Research Center', 'geoPoint': {'lat': 56.16558, 'lon': 10.21231}}], 'overallOfficials': [{'name': 'Troels S Jensen, prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Danish Pain Research Center'}, {'name': 'Kaare Meier, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Danish Pain Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Pain Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}