Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2026-03-03 @ 6:45 PM
Study NCT ID:
NCT04909593
Status:
COMPLETED
Last Update Posted:
2024-12-06
First Post:
2021-05-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-10-23', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D010148', 'term': 'Pain, Intractable'}, {'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D009437', 'term': 'Neuralgia'}, {'id': 'D001416', 'term': 'Back 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'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D062187', 'term': 'Spinal Cord Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D012046', 'term': 'Rehabilitation'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'BSNClinicalTrials@bsci.com', 'phone': '855-213-9890', 'title': 'Sr. Director, Clinical Operations', 'organization': 'Boston Scientific Corporation'}, 'certainAgreement': {'otherDetails': 'A contractual agreement is in place between the PI and the Sponsor that restricts the rights to discuss or publish trial results without prior review by the sponsor.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Informed consent through End of Study Visit (approximately 15 days).', 'description': 'Other (Not including Serious) Adverse Events reported include device hardware and/or procedure related adverse events which were monitored/assessed.\n\nAll Serious Adverse Events and All-Cause Mortality were monitored/assessed.', 'eventGroups': [{'id': 'EG000', 'title': 'Spinal Cord Stimulation', 'description': 'SCS trial systems including external trial stimulators, lead(s)/extensions(s), and operating room (OR) cable(s)/extender(s) and optional sensor.\n\nSpinal Cord Stimulation: Spinal cord stimulation at varied electrode, pulse width, frequency and amplitude parameters', 'otherNumAtRisk': 21, 'deathsNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Perception Threshold', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Spinal Cord Stimulation', 'description': 'SCS trial systems including external trial stimulators, lead(s)/extensions(s), and operating room (OR) cable(s)/extender(s) and optional sensor.\n\nSpinal Cord Stimulation: Spinal cord stimulation at varied electrode, pulse width, frequency and amplitude parameters'}], 'classes': [{'categories': [{'measurements': [{'value': '157', 'spread': '52', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Programming Visit (up to 15 days post-screening)', 'description': "Percent change in patient's perceiving spinal cord stimulation (i.e. Perception Threshold) when going from a reclining to sitting position in a reclining chair", 'unitOfMeasure': 'percent change in perception threshold', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received programming with SCS trial neurostimulator system.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Spinal Cord Stimulation', 'description': 'SCS trial systems including external trial stimulators, lead(s)/extensions(s), and operating room (OR) cable(s)/extender(s) and optional sensor.\n\nSpinal Cord Stimulation: Spinal cord stimulation at varied electrode, pulse width, frequency and amplitude parameters'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Spinal Cord Stimulation', 'description': 'SCS trial systems including external trial stimulators, lead(s)/extensions(s), and operating room (OR) cable(s)/extender(s) and optional sensor.\n\nSpinal Cord Stimulation: Spinal cord stimulation at varied electrode, pulse width, frequency and amplitude parameters'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}, {'title': 'Native American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Black, of African Heritage', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All consented subjects'}}, 'documentSection': {'largeDocumentModule': {'noSap': True, 'largeDocs': [{'date': '2021-07-02', 'size': 8981387, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-12-02T14:31', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2021-05-21', 'resultsFirstSubmitDate': '2024-10-01', 'studyFirstSubmitQcDate': '2021-05-26', 'lastUpdatePostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-02', 'studyFirstPostDateStruct': {'date': '2021-06-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perception Threshold', 'timeFrame': 'Programming Visit (up to 15 days post-screening)', 'description': "Percent change in patient's perceiving spinal cord stimulation (i.e. Perception Threshold) when going from a reclining to sitting position in a reclining chair"}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Chronic Pain', 'Intractable Pain', 'Low Back Pain', 'Pain, Neuropathic', 'Pain, Back']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to assess the feasibility of using information extracted from physiologic signals to automatically adjust stimulation in patients undergoing Spinal Cord Stimulation (SCS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Study candidate is undergoing a temporary SCS trial of commercially approved BSC neurostimulator system, per local directions for use (DFU).\n* Subject signed a valid, EC/IRB-approved informed consent form.\n* Age 18 or above, or above legal age and willing and capable of giving informed consent specific to national law when written informed consent is obtained.\n* In the clinician best judgment, subject is able to distinguishably describe quality and location of sensation and pain.\n\nKey Exclusion Criteria:\n\n* Subject meets any contraindication in BSC neurostimulation system local DFU.\n* Investigator-suspected gross lead migration during the SCS trial period which may preclude the study candidate from receiving adequate SCS therapy.\n* Subject is currently diagnosed with cognitive impairment, or exhibits any characteristic, that in the clinician's best judgement would limit study candidate's ability to assess and report sensation information.\n* Subject is currently diagnosed with a physical impairment, or exhibits a condition that would limit study candidate's ability to complete study assessments."}, 'identificationModule': {'nctId': 'NCT04909593', 'acronym': 'AIM', 'briefTitle': 'Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Study to Evaluate Automated Intensity Management in Patients Undergoing a BSC SCS Temporary Trial: The AIM Study', 'orgStudyIdInfo': {'id': 'A4091'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spinal Cord Stimulation', 'description': 'SCS trial systems including external trial stimulators, lead(s)/extensions(s), and operating room (OR) cable(s)/extender(s) and optional sensor.', 'interventionNames': ['Device: Spinal Cord Stimulation']}], 'interventions': [{'name': 'Spinal Cord Stimulation', 'type': 'DEVICE', 'otherNames': ['neurostimulation'], 'description': 'Spinal cord stimulation at varied electrode, pulse width, frequency and amplitude parameters', 'armGroupLabels': ['Spinal Cord Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29601', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'PCPMG Clinical Research Unit, LLC', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}], 'overallOfficials': [{'name': 'Natalie Bloom Lyons', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Boston Scientific Neuromodulation Corporation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}