Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2025-12-30 @ 4:50 PM
Study NCT ID:
NCT03350256
Status:
COMPLETED
Last Update Posted:
2020-03-19
First Post:
2017-11-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
BurstDR™ micrOdosing stimuLation in De-novo Patients
Sponsor:
Organization:
Raw JSON
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will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.\n\nStimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.', 'otherNumAtRisk': 60, 'deathsNumAtRisk': 60, 'otherNumAffected': 3, 'seriousNumAtRisk': 60, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Trial lead migration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Subject fractured <1 vertebrae (compression) and was hospitalized overnight', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization for abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microdosing Group', 'description': 'Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.\n\nStimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '-46.28', 'spread': '23.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 1 week after trial lead implant (trial stimulation)', 'description': 'Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in visual analogue scale score between baseline and spinal cord stimulation (SCS) trial missing data for 3 subjects'}, {'type': 'PRIMARY', 'title': 'Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microdosing Group', 'description': 'Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.\n\nStimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '-41.07', 'spread': '24.74', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 month follow up visit', 'description': 'Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in VAS score between baseline and 1 month follow up missing data for 2 subjects'}, {'type': 'PRIMARY', 'title': 'Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microdosing Group', 'description': 'Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.\n\nStimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.56', 'spread': '29.53', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 month follow up visit', 'description': 'Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in VAS between baseline and 3 month follow up missing data for 2 subject'}, {'type': 'PRIMARY', 'title': 'Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microdosing Group', 'description': 'Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.\n\nStimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.62', 'spread': '29.54', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 month follow up visit', 'description': 'Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in VAS score between baseline and 6 months visit'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life Between Baseline and Trial Stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microdosing Group', 'description': 'Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.\n\nStimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.172', 'spread': '0.1625', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week after trial lead implant 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delivered with different ON/OFF periods to identify the best setting for each patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.148', 'spread': '0.121', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 month follow up visit', 'description': 'Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in EQ-5D score between baseline and 1 month follow up Two subjects had missing data'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life Between Baseline and Follow up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microdosing Group', 'description': 'Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.\n\nStimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.106', 'spread': '0.209', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 month follow up visit', 'description': 'Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in EQ-5D score between baseline and 3 month follow up One subjects had missing data'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life Between Baseline and Follow up 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microdosing Group', 'description': 'Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.\n\nStimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.148', 'spread': '0.136', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 month follow up visit', 'description': 'Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in EQ-5D score between baseline and 6 month follow up'}, {'type': 'SECONDARY', 'title': 'Change in Disability Index Between Baseline and Trial Stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microdosing Group', 'description': 'Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.\n\nStimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '-17.6', 'spread': '18.15', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week after trial lead implant (trial stimulation)', 'description': 'questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in ODI score between baseline and SCS trial 3 subjects had missing data'}, {'type': 'SECONDARY', 'title': 'Change in Disability Index Between Baseline and and Follow up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microdosing Group', 'description': 'Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.\n\nStimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.76', 'spread': '14.5', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 month follow up visit', 'description': 'questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in ODI score between baseline and 1 month follow up 2 subjects had missing data'}, {'type': 'SECONDARY', 'title': 'Change in Disability Index Between Baseline and and Follow up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microdosing Group', 'description': 'Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.\n\nStimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '-17', 'spread': '19.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 month follow up visit', 'description': 'questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in disability score between baseline and 3 month follow up Two subjects had missing data'}, {'type': 'SECONDARY', 'title': 'Change in Disability Index Between Baseline and and Follow up 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microdosing Group', 'description': 'Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.\n\nStimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.5', 'spread': '16.6', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 month follow up visit', 'description': 'questionnaire on disability (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in disability score between baseline and 6 month follow up'}, {'type': 'SECONDARY', 'title': 'Change in Pain Catastrophizing Scale Between Baseline and Trial Stimulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microdosing Group', 'description': 'Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.\n\nStimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '-8.98', 'spread': '12.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 week after trial lead implant (trial stimulation)', 'description': 'Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in PCS between baseline and SCS trial One subject had missing data'}, {'type': 'SECONDARY', 'title': 'Change in Pain Catastrophizing Scale Between Baseline and Follow up 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microdosing Group', 'description': 'Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.\n\nStimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.17', 'spread': '12.83', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 1 month follow up visit', 'description': 'Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in PCS score between baseline and 1 month follow up 2 subjects had missing data'}, {'type': 'SECONDARY', 'title': 'Change in Pain Catastrophizing Scale Between Baseline and Follow up 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microdosing Group', 'description': 'Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.\n\nStimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.32', 'spread': '14.38', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 month follow up visit', 'description': 'Questionnaire on pain catastrophizing (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in PCS between baseline and 3 month follow up 2 subjects had missing data'}, {'type': 'SECONDARY', 'title': 'Change in Pain Catastrophizing Scale Between Baseline and Follow up 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microdosing Group', 'description': 'Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.\n\nStimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.42', 'spread': '12.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 6 month follow up visit', 'description': 'Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Change in PCS score between baseline and 6 month follow up\n\n1 subject had missing data'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Stimulation ON/OFF Ratio', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Microdosing Group', 'description': 'Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.\n\nStimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.'}], 'classes': [{'categories': [{'title': 'subjects using 360 seconds OFF intervals', 'measurements': [{'value': '11', 'groupId': 'OG000'}]}, {'title': 'subjects using 240 seconds OFF intervals', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'subjects using 150 seconds OFF intervals', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'subjects using 120 seconds OFF intervals', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'subjects using 90 seconds OFF intervals', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 month follow up visit', 'description': 'Percentage of patients using each ON/OFF ratio', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Microdosing Group', 'description': 'Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.\n\nStimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}]}, {'type': 'Spinal Cord Stimulation Trial', 'achievements': [{'comment': 'Subject that underwent SCS trial', 'groupId': 'FG000', 'numSubjects': '50'}]}, {'type': 'Permanent Implant', 'achievements': [{'comment': 'subjects that underwent permanent SCS implant', 'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': '1 Month Follow up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '30'}]}, {'type': '3 Month Follow up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}]}, {'type': '6 Month Follow up', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}]}], 'dropWithdraws': [{'type': 'Inclusion/exclusion violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Recommended for other therapies', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Non compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Denial by insurance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Trial failure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'Did not proceed to permanent implant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Subject moving out of state', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Microdosing Group', 'description': 'Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.\n\nStimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.: BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '56.8', 'spread': '3.95', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '19', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '49', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'duration of pain', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '9.98', 'spread': '3.31', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'One subject had missing data for duration of pain'}], 'populationDescription': 'Included subjects that started the SCS trial (50). One subjects had missing demographic data'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-19', 'size': 746508, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-02-18T14:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-06', 'studyFirstSubmitDate': '2017-11-10', 'resultsFirstSubmitDate': '2020-02-24', 'studyFirstSubmitQcDate': '2017-11-20', 'lastUpdatePostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-06', 'studyFirstPostDateStruct': {'date': '2017-11-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Stimulation ON/OFF Ratio', 'timeFrame': '6 month follow up visit', 'description': 'Percentage of patients using each ON/OFF ratio'}], 'primaryOutcomes': [{'measure': 'Change in Visual Analog Scale Pain (VAS) Scores Between Baseline and Trial Stimulation', 'timeFrame': 'baseline and 1 week after trial lead implant (trial stimulation)', 'description': 'Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)'}, {'measure': 'Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 1', 'timeFrame': 'Baseline and 1 month follow up visit', 'description': 'Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)'}, {'measure': 'Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 2', 'timeFrame': 'Baseline and 3 month follow up visit', 'description': 'Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)'}, {'measure': 'Change in Visual Analog Scale Pain Scores Between Baseline and Follow up 3', 'timeFrame': 'Baseline and 6 month follow up visit', 'description': 'Pain questionnaire - (Scale is 0-100 mm with 0 meaning no pain and 100 meaning worst pain imaginable)'}], 'secondaryOutcomes': [{'measure': 'Change in Quality of Life Between Baseline and Trial Stimulation', 'timeFrame': 'Baseline and 1 week after trial lead implant (trial stimulation)', 'description': 'Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)'}, {'measure': 'Change in Quality of Life Between Baseline and Follow up 1', 'timeFrame': 'Baseline and 1 month follow up visit', 'description': 'Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)'}, {'measure': 'Change in Quality of Life Between Baseline and Follow up 2', 'timeFrame': 'Baseline and 3 month follow up visit', 'description': 'Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)'}, {'measure': 'Change in Quality of Life Between Baseline and Follow up 3', 'timeFrame': 'Baseline and 6 month follow up visit', 'description': 'Questionnaire on quality of life using european quality of life - 5 dimension questionnaire (EQ-5D) - (Scale is between 0 and 1 with 0 being worse quality of life and 1 best quality of life)'}, {'measure': 'Change in Disability Index Between Baseline and Trial Stimulation', 'timeFrame': 'Baseline and 1 week after trial lead implant (trial stimulation)', 'description': 'questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)'}, {'measure': 'Change in Disability Index Between Baseline and and Follow up 1', 'timeFrame': 'Baseline and 1 month follow up visit', 'description': 'questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)'}, {'measure': 'Change in Disability Index Between Baseline and and Follow up 2', 'timeFrame': 'Baseline and 3 month follow up visit', 'description': 'questionnaire on disability, Oswestry Disability Index (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)'}, {'measure': 'Change in Disability Index Between Baseline and and Follow up 3', 'timeFrame': 'Baseline and 6 month follow up visit', 'description': 'questionnaire on disability (ODI) - (Scale is between 0 and 100 with 0 being no disability and 100 worst disability)'}, {'measure': 'Change in Pain Catastrophizing Scale Between Baseline and Trial Stimulation', 'timeFrame': 'Baseline and 1 week after trial lead implant (trial stimulation)', 'description': 'Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)'}, {'measure': 'Change in Pain Catastrophizing Scale Between Baseline and Follow up 1', 'timeFrame': 'Baseline and 1 month follow up visit', 'description': 'Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)'}, {'measure': 'Change in Pain Catastrophizing Scale Between Baseline and Follow up 2', 'timeFrame': 'Baseline and 3 month follow up visit', 'description': 'Questionnaire on pain catastrophizing (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)'}, {'measure': 'Change in Pain Catastrophizing Scale Between Baseline and Follow up 3', 'timeFrame': 'Baseline and 6 month follow up visit', 'description': 'Questionnaire on pain catastrophizing, Pain Catastrophising Scale (PCS) - (Scale is between 0 and 52 with 0 being no catastrophising and 52 worst catastrophising)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Pain, Intractable', 'Pain, Back']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the therapeutic efficacy of microdosing BurstDR stimulation in spinal cord stimulation (SCS) patients with chronic intractable back and/or leg pain.', 'detailedDescription': 'Microdosing BurstDR consists of periods during which stimulation is delivered with standard BurstDR stimulation parameters alternated with periods during which no stimulation is being delivered.\n\nIn this study the investigators propose to evaluate therapeutic efficacy of BurstDR microdosing, and determine optimal microdosing programming parameters in chronic pain patients, who are eligible for SCS therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subject is able to provide informed consent to participate in the study;\n* Subject diagnosed with chronic intractable pain associated with back and/or limbs;\n* Subject is 18 years of age or older;\n* Subject has failed to respond to at least 6 months of conventional treatment which may include pharmacological treatment, physical therapy, epidural injections;\n* Subject has a back and/or leg pain intensity of at least 6.0 cm out of 10.0 cm on the average back and/or leg pain visual analogue scale at baseline;\n* Subject's medical record has been evaluated by the Investigator to ensure that the subject is a good candidate for a neurostimulation system;\n* Subject is on stable pain medications with a total opioid for at least 28 days prior to enrolling in this study, and is willing to stay on those medications with no dose increase until the 3 month visit;\n* Subject is willing to cooperate with the study requirements including compliance with the regimen and completion of all office visits;\n* Female candidates of child-bearing potential agree to commit to the use of an effective method of contraception (including but not limited to sterilization, barrier devices, oral contraceptives, intrauterine devices (IUDs), condoms, rhythm method, or abstinence) for the duration of the study\n\nExclusion Criteria:\n\nSubject has a current diagnosis of a coagulation disorder, bleeding diathesis, progressive peripheral vascular disease, post-herpetic neuralgia or uncontrolled diabetes mellitus;\n\n* Subject is currently participating in a clinical investigation that includes an active treatment arm;\n* Subject has been implanted with or participated in a trial period for a neurostimulation system;\n* Subject has an infusion pump;\n* Subject has evidence of an active disruptive psychological or psychiatric disorder as determined as per standard of care;\n* Subject has a current diagnosis of a progressive neurological disease as determined by the Investigator;\n* Subject is immunocompromised;\n* Subject has an existing medical condition that is likely to require repetitive MRI evaluation in the future (i.e. epilepsy, stroke, multiple sclerosis, acoustic neuroma, tumor);\n* Subject has history of cancer requiring active treatment in the last 12 months;\n* Subject has an existing medical condition that is likely to require the use of diathermy in the future;\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* Subject is a female candidates of child bearing potential that are pregnant (confirmed by positive urine/blood pregnancy test);\n* Subject has life expectancy of less than 6 months;\n* Subject is involved in an injury claim under current litigation"}, 'identificationModule': {'nctId': 'NCT03350256', 'acronym': 'BOLD', 'briefTitle': 'BurstDR™ micrOdosing stimuLation in De-novo Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'BurstDR™ micrOdosing stimuLation in De-novo Patients', 'orgStudyIdInfo': {'id': 'SJM-CIP-10215'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microdosing group', 'description': 'Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.', 'interventionNames': ['Device: Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.']}], 'interventions': [{'name': 'Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.', 'type': 'DEVICE', 'description': 'BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.', 'armGroupLabels': ['Microdosing group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95403', 'city': 'Santa Rosa', 'state': 'California', 'country': 'United States', 'facility': 'Thrive Clinic', 'geoPoint': {'lat': 38.44047, 'lon': -122.71443}}, {'zip': '89511', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Nevada advanced pain specialists', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '28803', 'city': 'Asheville', 'state': 'North Carolina', 'country': 'United States', 'facility': 'OnSite Clinical Solutions', 'geoPoint': {'lat': 35.60095, 'lon': -82.55402}}, {'zip': '76542', 'city': 'Killeen', 'state': 'Texas', 'country': 'United States', 'facility': 'Ambulatory Surgery Center of Killeen', 'geoPoint': {'lat': 31.11712, 'lon': -97.7278}}, {'zip': '25301', 'city': 'Charleston', 'state': 'West Virginia', 'country': 'United States', 'facility': 'Premier Pain Solutions', 'geoPoint': {'lat': 38.34982, 'lon': -81.63262}}], 'overallOfficials': [{'name': 'Timothy R Deer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Center for Pain Relief'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}