Ignite Creation Date:
2025-12-25 @ 1:09 AM
Ignite Modification Date:
2026-02-25 @ 4:48 PM
Study NCT ID:
NCT02011893
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2013-12-10
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
SUNBURST (Success Using Neuromodulation With BURST) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'RDiaz@sjm.com', 'phone': '972-309-8601', 'title': 'Roni Diaz, Director Clinical Studies', 'organization': 'St. Jude Medical'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'following enrollment through 6 months of treatment', 'description': 'Subjects at risk (denominators for risk %) are defined as follows: enrollment to device activation (randomization) is 173, device activation (randomization) to 24 weeks is 100. The only events identified as device (stimulation) related are reported per intervention, by therapy (Burst and Tonic Stimulation). The subjects at risk (denominators for risk %) for are defined as follows: subjects active through 12 weeks (100) or subjects active through 24 weeks (97).', 'eventGroups': [{'id': 'EG000', 'title': 'All Subjects', 'description': 'All subjects who were enrolled in the SUNBURST clinical study', 'otherNumAtRisk': 100, 'otherNumAffected': 13, 'seriousNumAtRisk': 173, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Diminished or loss of symptom relief (Burst Stimulation)', 'notes': 'Categorized as Device-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders'}, {'term': 'Diminished or loss of symptom relief (Tonic Stimulation)', 'notes': 'Categorized as Device-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 97, 'numEvents': 8, 'numAffected': 6}], 'organSystem': 'General disorders'}, {'term': 'Persistent pain and/or numbness', 'notes': 'Categorized as neither Device- nor Procedure-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 8, 'numAffected': 8}], 'organSystem': 'General disorders'}], 'seriousEvents': [{'term': 'Persistent pain and/or numbness', 'notes': 'Categorized as Procedure-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Unsuccessful lead placement', 'notes': 'Categorized as Procedure-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Abdominal pain', 'notes': 'Categorized as neither Device- nor Procedure-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Bowel obstruction', 'notes': 'Categorized as neither Device- nor Procedure-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Femur fracture', 'notes': 'Categorized as neither Device- nor Procedure-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Hip pain/hip replacement', 'notes': 'Categorized as neither Device- nor Procedure-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Low Potassium Levels', 'notes': 'Categorized as neither Device- nor Procedure-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Persistent pain and/or numbness', 'notes': 'Categorized as neither Device- nor Procedure-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 173, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Cancerous tumor on vocal chords', 'notes': 'Categorized as neither Device- nor Procedure-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)'}, {'term': 'Infection', 'notes': 'Categorized as neither Device- nor Procedure-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Loss of speech and memory, and headache', 'notes': 'Categorized as neither Device- nor Procedure-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Scheduled right total knee arthroplasty', 'notes': 'Categorized as neither Device- nor Procedure-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures'}, {'term': 'Shortness of breath', 'notes': 'Categorized as neither Device- nor Procedure-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Somnolence', 'notes': 'Categorized as neither Device- nor Procedure-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Temporary paralysis', 'notes': 'Categorized as neither Device- nor Procedure-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Withdrawal symptoms from tapering off oxymorphone', 'notes': 'Categorized as neither Device- nor Procedure-Related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 100, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Burst Stimulation', 'description': 'Burst Stimulation using the Prodigy system\n\nBurst Stimulation: Prodigy Neurostimulation System with associated components'}, {'id': 'OG001', 'title': 'Tonic Stimulation', 'description': 'Tonic Stimulation using the Prodigy system\n\nTonic Stimulation: Prodigy Neurostimulation System with associated components'}], 'classes': [{'categories': [{'measurements': [{'value': '43.5', 'spread': '25.6', 'groupId': 'OG000'}, {'value': '48.7', 'spread': '23.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-distribution', 'nonInferiorityType': 'NON_INFERIORITY_OR_EQUIVALENCE', 'statisticalComment': '95% UCB and p-value for non-inferiority are based on t-distribution with n1 + n2-2 degrees of freedom where n1 and n2 are number of subjects per arm.', 'nonInferiorityComment': 'Non-inferiority margin is 7.5 points, where the Visual Analog Scale (VAS) scores were measured on a scale of 0 to 100. Testing was carried out at a 5% significance level.'}], 'paramType': 'MEAN', 'timeFrame': 'Over 7 days after 3 months of treatment of burst or tonic stimulation', 'description': 'Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, from 0 mm to 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects randomized were analyzed for this outcome measure. Statistical measures were used to impute Visual Analog Scale (VAS) scores according the study Statistical Analysis Plan (SAP) if data was not available.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Response as Measured by Overall Daily Visual Analog Scale (VAS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Burst Stimulation', 'description': 'Burst Stimulation using the Prodigy system\n\nBurst Stimulation: Prodigy Neurostimulation System with associated components'}, {'id': 'OG001', 'title': 'Tonic Stimulation', 'description': 'Tonic Stimulation using the Prodigy system\n\nTonic Stimulation: Prodigy Neurostimulation System with associated components'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '51', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.083', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Superiority analysis performed', 'statisticalMethod': 'McNemar', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Over 7 days at baseline and after 3 months of treatment of burst or tonic stimulation', 'description': 'Number of subjects responding to Burst and Tonic Stimulation defined as 30% or greater decrease in overall Visual Analog Scale (VAS) score from baseline. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects randomized were analyzed for this outcome measure. Statistical measures were used to impute Visual Analog Scale (VAS) scores according the study Statistical Analysis Plan (SAP) if data was not available.'}, {'type': 'SECONDARY', 'title': 'Percentage of Paresthesia Coverage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '73', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Burst Stimulation', 'description': 'Burst Stimulation using the Prodigy system\n\nBurst Stimulation: Prodigy Neurostimulation System with associated components'}, {'id': 'OG001', 'title': 'Tonic Stimulation', 'description': 'Tonic Stimulation using the Prodigy system\n\nTonic Stimulation: Prodigy Neurostimulation System with associated components'}], 'classes': [{'categories': [{'measurements': [{'value': '4.5', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '22.7', 'spread': '16.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'During in-office visit after 3 months of treatment while utilizing burst or tonic stimulation', 'description': 'Paresthesia mapping (percentage of paresthesia coverage) analyzed to demonstrate the differences between Burst and Tonic Stimulation. Data is presented as areas of paresthesia reported while utilizing either Burst or Tonic Stimulation as a percentage of the total number of areas possible.', 'unitOfMeasure': 'Percentage of paresthesia areas', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 73 subjects in whom paresthesia coverage data at both the 12 and 24 week visits were available and included in the analysis. The remaining 23 subjects were excluded due to questionnaire completion errors at the time of data collection.'}, {'type': 'SECONDARY', 'title': 'Test for Superiority of Overall Daily Visual Analog Scale (VAS) Score With Burst Stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '100', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Burst Stimulation', 'description': 'Burst Stimulation using the Prodigy system\n\nBurst Stimulation: Prodigy Neurostimulation System with associated components'}, {'id': 'OG001', 'title': 'Tonic Stimulation', 'description': 'Tonic Stimulation using the Prodigy system\n\nTonic Stimulation: Prodigy Neurostimulation System with associated components'}], 'classes': [{'categories': [{'measurements': [{'value': '43.5', 'spread': '25.6', 'groupId': 'OG000'}, {'value': '48.7', 'spread': '23.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Superiority analysis performed', 'statisticalMethod': 't-distribution', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': '95% UCB and p-value for superiority are based on t-distribution with n1 + n2-2 degrees of freedom where n1 and n2 are number of subjects per arm.'}], 'paramType': 'MEAN', 'timeFrame': 'Over 7 days after 3 months of treatment of burst or tonic stimulation', 'description': 'Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation to evaluate for superiority of Burst Stimulation. Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects randomized were analyzed for this outcome measure. Statistical measures were used to impute Visual Analog Scale (VAS) scores according the study Statistical Analysis Plan (SAP) if data was not available.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enrolled', 'description': 'All subjects enrolled through device activation/randomization'}, {'id': 'FG001', 'title': 'Arm 1', 'description': 'Tonic stimulation first, then Burst'}, {'id': 'FG002', 'title': 'Arm 2', 'description': 'Burst stimulation first, then Tonic'}], 'periods': [{'title': 'Enrollment to Randomization', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '173'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Baseline', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Trial Stimulation Implant', 'achievements': [{'groupId': 'FG000', 'numSubjects': '121'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Permanent Stimulation Implant', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Randomization', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '73'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Screening Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Temporary Trial Stimulation Failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Insurance/Financial Reasons', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Period 1 (Randomization to 12 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '55'}]}, {'type': '6 Week Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': '12 Week Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}, {'title': 'Period 2 (12 Weeks to 24 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '52'}]}, {'type': '18 Week Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '44'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': '24 Week Follow-up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '51'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Subjects', 'description': 'All subjects who were enrolled in the SUNBURST clinical study'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.1', 'spread': '13.5', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '85', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 173}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-28', 'studyFirstSubmitDate': '2013-12-10', 'resultsFirstSubmitDate': '2017-02-01', 'studyFirstSubmitQcDate': '2013-12-10', 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-11', 'studyFirstPostDateStruct': {'date': '2013-12-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS) Pain Diary Scores for Average Overall Pain', 'timeFrame': 'Over 7 days after 3 months of treatment of burst or tonic stimulation', 'description': 'Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, from 0 mm to 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Response as Measured by Overall Daily Visual Analog Scale (VAS)', 'timeFrame': 'Over 7 days at baseline and after 3 months of treatment of burst or tonic stimulation', 'description': 'Number of subjects responding to Burst and Tonic Stimulation defined as 30% or greater decrease in overall Visual Analog Scale (VAS) score from baseline. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.'}, {'measure': 'Percentage of Paresthesia Coverage', 'timeFrame': 'During in-office visit after 3 months of treatment while utilizing burst or tonic stimulation', 'description': 'Paresthesia mapping (percentage of paresthesia coverage) analyzed to demonstrate the differences between Burst and Tonic Stimulation. Data is presented as areas of paresthesia reported while utilizing either Burst or Tonic Stimulation as a percentage of the total number of areas possible.'}, {'measure': 'Test for Superiority of Overall Daily Visual Analog Scale (VAS) Score With Burst Stimulation', 'timeFrame': 'Over 7 days after 3 months of treatment of burst or tonic stimulation', 'description': 'Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation to evaluate for superiority of Burst Stimulation. Differences for average daily overall pain using the Visual Analog Scale (VAS) pain diary between Burst and Tonic Stimulation. Visual Analog Scale (VAS) scores were averaged using a 7 day diary where the subject rates his/her pain on a horizontal line, 100mm in length, anchored by word descriptors on each end (no pain to worst imaginable pain). A higher score indicates a higher level of pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '27906080', 'type': 'DERIVED', 'citation': 'Slavin KV, North RB, Deer TR, Staats P, Davis K, Diaz R. Tonic and burst spinal cord stimulation waveforms for the treatment of chronic, intractable pain: study protocol for a randomized controlled trial. Trials. 2016 Dec 1;17(1):569. doi: 10.1186/s13063-016-1706-5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to demonstrate the safety and efficacy of the Prodigy system for the treatment of chronic intractable pain of the trunk and/or limbs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject is 22 years of age or older\n* Subject has chronic intractable pain of the trunk and/or limbs\n* Subject has a average score of 60 or higher for average daily overall pain on the Visual Analog Scale (VAS) 7 day pain diary\n* Subject has attempted "best" medical therapy and has tried and failed at least three documented medically supervised treatments (including, but not limited to physical therapy, acupuncture, etc.) and has failed medication treatment from at least two different classes\n* Subject\'s pain-related medication regimen is stable 4 weeks prior to the baseline evaluation\n* Subject agrees not to add or increase pain-related medication from activation through the 24 week follow-up visit\n\nExclusion Criteria:\n\n* Subject is currently participating in a clinical investigation that includes an active treatment arm\n* Subject has been implanted with a previous neurostimulation system or participated in a trial period for a neurostimulation system\n* Subject\'s overall Beck Depression Inventory II Score is \\>24 or has a score of 3 on question 9 relating to suicidal thoughts or wishes at the screening visit\n* Subject has an infusion pump or any implantable neurostimulator device\n* Subjects with concurrent clinically significant or disabling chronic pain problem that requires additional treatment\n* Subject has an existing medical condition that is likely to require repetitive Magnetic Resonance Imaging (MRI) evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor)\n* Subject has an existing medical condition that is likely to require the use of diathermy in the future\n* Subject\'s pain originates from peripheral vascular disease\n* Subject is immunocompromised\n* Subject has documented history of allergic response to titanium or silicone\n* Subject has a documented history of substance abuse (narcotics, alcohol, etc.) or substance dependency in the 6 months prior to baseline data collection\n* Female candidates of child bearing potential that are pregnant (confirmed by positive urine/blood pregnancy test)'}, 'identificationModule': {'nctId': 'NCT02011893', 'acronym': 'SUNBURST', 'briefTitle': 'SUNBURST (Success Using Neuromodulation With BURST) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Success Using Neuromodulation With BURST (SUNBURST™) Study', 'orgStudyIdInfo': {'id': 'C-12-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Burst Stimulation', 'description': 'Burst Stimulation using the Prodigy system', 'interventionNames': ['Device: Burst Stimulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Tonic Stimulation', 'description': 'Tonic Stimulation using the Prodigy system', 'interventionNames': ['Device: Tonic Stimulation']}], 'interventions': [{'name': 'Tonic Stimulation', 'type': 'DEVICE', 'description': 'Prodigy Neurostimulation System with associated components', 'armGroupLabels': ['Tonic Stimulation']}, {'name': 'Burst Stimulation', 'type': 'DEVICE', 'description': 'Prodigy Neurostimulation System with associated components', 'armGroupLabels': ['Burst Stimulation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Newport Beach Headache and Pain', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'zip': '94558', 'city': 'Napa', 'state': 'California', 'country': 'United States', 'facility': 'Napa Biomedical Services', 'geoPoint': {'lat': 38.29714, 'lon': -122.28553}}, {'zip': '92270', 'city': 'Rancho Mirage', 'state': 'California', 'country': 'United States', 'facility': 'Eisenhower Desert Orthopedic Center', 'geoPoint': {'lat': 33.73974, 'lon': -116.41279}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'IPM Medical Group', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '46202', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Goodman Campbell Brain and Spine', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'country': 'United States', 'facility': 'Bronson Neuroscience Center', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}, {'zip': '39531', 'city': 'Biloxi', 'state': 'Mississippi', 'country': 'United States', 'facility': 'The Neuroscience Center', 'geoPoint': {'lat': 30.39603, 'lon': -88.88531}}, {'zip': '39202', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Jackson Pain Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '39581', 'city': 'Pascagoula', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Comprehensive Pain & Rehabilitation', 'geoPoint': {'lat': 30.36576, 'lon': -88.55613}}, {'zip': '64132', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Midwest Neurosurgery Associates', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '25301', 'city': 'Kalispell', 'state': 'Montana', 'country': 'United States', 'facility': 'The Montana Center for Wellness & Pain Management', 'geoPoint': {'lat': 48.19579, 'lon': -114.31291}}, {'zip': '12208', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical Center', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '13212', 'city': 'North Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'New York Spine & Wellness Center', 'geoPoint': {'lat': 43.13479, 'lon': -76.12992}}, {'zip': '73120', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Oklahoma Pain Physicians', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'NeuroSpine Institute', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '18015', 'city': 'Bethlehem', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "St. Luke's Hospital", 'geoPoint': {'lat': 40.62593, 'lon': -75.37046}}, {'zip': '29406', 'city': 'North Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Clinical Trials of South Carolina', 'geoPoint': {'lat': 32.85462, 'lon': -79.97481}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Pain Centers', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84403', 'city': 'Ogden', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah Spine Care', 'geoPoint': {'lat': 41.223, 'lon': -111.97383}}, {'zip': '25301', 'city': 'Charleston', 'state': 'West Virginia', 'country': 'United States', 'facility': 'The Center for Pain Relief', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}], 'overallOfficials': [{'name': 'Timothy Deer, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'The Center for Pain Relief'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}