Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-02-22 @ 12:23 PM
Study NCT ID:
NCT02250469
Status:
TERMINATED
Last Update Posted:
2022-11-09
First Post:
2014-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-08', 'studyFirstSubmitDate': '2014-09-09', 'studyFirstSubmitQcDate': '2014-09-24', 'lastUpdatePostDateStruct': {'date': '2022-11-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Specificity of Stimulation Induced Paresthesia', 'timeFrame': '3 Months post implantation', 'description': 'A comparative analysis will be made between groups to determine the percentage of a patients painful and non-painful anatomy that is covered by stimulation induced paresthesia'}, {'measure': 'Stability of Stimulation Induced Paresthesia', 'timeFrame': '3 Months post implantation', 'description': 'A comparative analysis will be made between groups to determine any changes in the intensity of stimulation induced paresthesia in response to changes in body position'}, {'measure': 'Patient Interactions with System', 'timeFrame': '3 Months post implantation', 'description': 'A comparative analysis will be made between groups to determine the number of device interactions patients need to have on average, daily'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': '12-SMI-2014 is a post-market, randomised, pilot study to identify and rate differences in patient experiences with two different types of Spinal Cord Stimulator devices which are routinely used to treat chronic pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject is appropriate for SCS implantation according to standard criteria\n2. Subject is \\>18 to \\<75 years old\n3. Subject is able and willing to comply with the follow-up schedule and protocol\n4. Subject has chronic (\\> 6 months) uni/bi-lateral neuropathic pain in the lower limb(s) (below the knee) with predominant foot pain\n5. Minimum baseline pain rating of 50 mm on the VAS in the primary region of pain\n6. Subject is able to provide written informed consent\n\nExclusion Criteria:\n\n1. Subject has no other exclusion criteria for SCS implantation according to standard criteria\n2. Subject has had corticosteroid therapy at an intended site of stimulation within the past 30 days\n3. Subject has had radiofrequency treatment of an intended target DRG within the past 3 months\n4. Subject has participated in another clinical study within 30 days\n5. Subject has been previously treated with and failed to respond to an implantable neuromodulation therapy'}, 'identificationModule': {'nctId': 'NCT02250469', 'acronym': 'CHARACTER SCS', 'briefTitle': 'A Randomised Pilot Study to Assess Differences in Stimulation Induced Paresthesia Between 2 Spinal Cord Stimulation Systems', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': "A Randomised Pilot Study to Assess differenCes in tHe Subjects' Experience of stimulAtion-Induced paRaesthesiA Between Two Different Spinal Cord sTimulation dEvices: the Axium® DoRsal Root Ganglion Stimulation System Versus the Prime Advanced Dorsal Column Stimulation System", 'orgStudyIdInfo': {'id': '12-SMI-2014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Axium SCS System', 'description': 'Implantation with the Axium Neurostimulator', 'interventionNames': ['Device: Treatment with the Axium SCS system']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Medtronic SCS System', 'description': 'Implantation with the Medtronic Prime Advanced Dorsal Column Stimulation System', 'interventionNames': ['Device: Treatment with the Medtronic SCS System']}], 'interventions': [{'name': 'Treatment with the Axium SCS system', 'type': 'DEVICE', 'armGroupLabels': ['Axium SCS System']}, {'name': 'Treatment with the Medtronic SCS System', 'type': 'DEVICE', 'armGroupLabels': ['Medtronic SCS System']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amsterdam', 'country': 'Netherlands', 'facility': 'Academisch Medisch Centrum', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}], 'overallOfficials': [{'name': 'M W Hollmann, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AIDS Malignancy Consortium'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}