Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2025-12-30 @ 2:20 AM
Study NCT ID:
NCT01106404
Status:
COMPLETED
Last Update Posted:
2012-08-30
First Post:
2010-04-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
RestoreSensor 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': 'mark.sun@medtronic.com', 'phone': '763-526-8098', 'title': 'Mark Sun, Senior Clinical Research Manager', 'organization': 'Neuromodulation Emerging Therapy Clinical Research, Medtronic, Inc'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The time frame for safety reporting was from study enrollment to final visit. After implant, subjects were followed for an average duration of 16 weeks during which they experienced both manual and AdaptiveStim programming of the RestoreSensor device.', 'eventGroups': [{'id': 'EG000', 'title': 'Overall Adverse Events', 'description': 'Overall adverse events were reported.', 'otherNumAtRisk': 76, 'otherNumAffected': 53, 'seriousNumAtRisk': 76, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Undesirable change in stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 25, 'numAffected': 21}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Change in sensation of stimulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 17, 'numAffected': 12}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 11, 'numAffected': 10}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 10, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Implant site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}], 'seriousEvents': [{'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Implant site infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Lung adenocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Seroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (8.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Subjects With Improved Pain Relief and/or Convenience During the AdaptiveStim Programming Arm Relative to the Manual Programming Arm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '6-week AdaptiveStim Followed by 6-week Manual Programming', 'description': 'Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.'}, {'id': 'OG001', 'title': '6-week Manual Followed by 6-week AdaptiveStim Programming', 'description': 'Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.'}], 'classes': [{'title': 'Intent-to-treat analysis (n = 34, 40)', 'categories': [{'measurements': [{'value': '91.2', 'groupId': 'OG000'}, {'value': '82.5', 'groupId': 'OG001'}]}]}, {'title': 'Completed case analysis (n = 33, 38)', 'categories': [{'measurements': [{'value': '93.9', 'groupId': 'OG000'}, {'value': '86.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'binomial proportion', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.865', 'ciLowerLimit': '0.765', 'estimateComment': 'In this ITT analysis, the combined percentage of subjects with improved pain relief and/or convenience during the AdaptiveStim programming relative to the manual programming in both groups was reported.', 'groupDescription': 'ITT analysis:\n\nHypothesis: The percentage of subjects who succeed must be greater than 25%. H0: p ≤ 0.25 HA: p \\> 0.25', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'binomial proportion', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '97.5', 'paramValue': '0.901', 'ciLowerLimit': '0.807', 'estimateComment': 'In this completed case analysis, the combined percentage of subjects with improved pain relief and/or convenience during the AdaptiveStim programming relative to the manual programming in both groups was reported.', 'groupDescription': 'Completed case analysis', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '16 weeks post-implant', 'description': 'After subjects experienced both AdaptiveStim and manual programming at 16 weeks post-implant, subjects were asked to compare pain relief and convenience when they had AdaptiveStim ON to AdaptiveStim OFF in two separate domains using two 5-point Likert scales. The outcome measure for the primary objective is the percentage of subjects who report improved pain relief with no loss of convenience or improved convenience with no loss of pain relief during the AdaptiveStim programming arm relative to the manual programming arm. These subjects were considered successful for the primary objective.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT analysis included 74 subjects; 2 randomized subjects, who discontinued early due to infections, were excluded per protocol. The 3 other subjects who discontinued early were included in ITT analysis and imputed as failures for the primary objective.\n\nNo imputation method was used for 71 subjects included in the completed case analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Subjects With Worsened Pain Relief When Using AdaptiveStim Compared to Manual Programming', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '6-week AdaptiveStim Followed by 6-week Manual Programming', 'description': 'Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.'}, {'id': 'OG001', 'title': '6-week Manual Followed by 6-week AdaptiveStime Programming', 'description': 'Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.3%', 'upperLimit': '9.8%'}, {'value': '5.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'binomial proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.028', 'ciLowerLimit': '0.003', 'ciUpperLimit': '0.098', 'estimateComment': 'The combined percentage of subjects with worsened pain relief was reported.', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '16 weeks post-implant', 'description': 'The pain relief question was a 5-point Likert scale question comparing pain relief when using AdaptiveStim programming relative to manual programming after subjects finished both programming periods. The choices were much worse pain relief with AdaptiveStim, somewhat worse pain relief with AdaptiveStim, no difference in pain relief, somewhat better pain relief with AdaptiveStim, and much better pain relief with AdaptiveStim. Subjects who had worsening pain relief were defined as subjects who responded "much worse pain relief with AdaptiveStim" or "somewhat worse pain relief with AdaptiveStim".', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A total of 71 subjects with completed data were included in this analysis.'}, {'type': 'SECONDARY', 'title': 'Manual Adjustments Presented as Button Presses', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AdaptiveStim Treatment Arm', 'description': 'Subjects in AdaptiveStim treatment arm received programming provided by the RestoreSensor neurostimulator with AdaptiveStim ON.'}, {'id': 'OG001', 'title': 'Manual Treatment Arm', 'description': 'Subjects in manual treatment arm received programming provided by the RestoreSensor neurostimulator with AdaptiveStim OFF.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.9', 'spread': '41.4', 'groupId': 'OG000'}, {'value': '35.7', 'spread': '71.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '14.8', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '51.9', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 10 weeks and 16 weeks post-implant', 'description': 'The number of individual adjustments, ie, button presses, were recorded automatically in the patient programmer, which was specifically designed for this study. The number of button presses per day for manual patient programmer adjustments during the manual programming arm and the AdaptiveStim programming arm of the study were compared.', 'unitOfMeasure': 'Button presses per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with manual adjustments data from patient programmer were included in the analysis.'}, {'type': 'SECONDARY', 'title': 'NPRS Scores From Baseline to Follow-up Visits at 10 Weeks and 16 Weeks Post-implant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '69', 'groupId': 'OG000'}, {'value': '69', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '69', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'NPRS at Baseline (Subject With Score at 10 Weeks Post-implant)', 'description': 'Included subjects with NPRS scores from both baseline and 10 weeks post-implant'}, {'id': 'OG001', 'title': 'NPRS at 10 Weeks Post-implant', 'description': 'Included subjects with NPRS scores from both baseline and 10 weeks post-implant'}, {'id': 'OG002', 'title': 'NPRS at Baseline (Subject With Score at 16 Weeks Post-implant)', 'description': 'Included subjects with NPRS scores from both baseline and 16 weeks post-implant'}, {'id': 'OG003', 'title': 'NPRS at 16 Weeks Post-implant', 'description': 'Included subjects with NPRS scores from both baseline and 16 weeks post-implant'}], 'classes': [{'categories': [{'measurements': [{'value': '5.99', 'spread': '1.82', 'groupId': 'OG000'}, {'value': '4.22', 'spread': '2.05', 'groupId': 'OG001'}, {'value': '5.90', 'spread': '1.81', 'groupId': 'OG002'}, {'value': '4.41', 'spread': '2.18', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '< 0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciPctValue': '95', 'paramValue': '1.77', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '1.93', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '< 0.001', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.50', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.04', 'statisticalMethod': 'Wilcoxon signed rank test', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 10 weeks and 16 weeks post-implant', 'description': 'The 11-point (ie, 0-10) numeric rating scale of pain intensity (NPRS) was used to assess the overall pain at baseline and follow-up visits. In the pain diary, subjects were presented a numeric scale with numbers from 0 to 10, with 0 meaning "No pain" and 10 meaning "Pain as bad as you can imagine," accompanied by the instructions "Please rate your pain by indicating the number that best describes your pain on average in the last 24 hours." The subjects were asked to complete a diary for 7 consecutive days before implant, 10 weeks, and 16 weeks post-implant visits.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '69 of the 76 subjects completed pain diary for both baseline and 10 weeks. 69 of the 76 subjects completed pain diary for both baseline and 16 weeks. Since 2 datasets had 2 different pairs of data due to different subjects who completed the pain diary, baseline NPRS in two analyses varied slightly.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '6-week AdaptiveStim Followed by 6-week Manual Programming', 'description': 'Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.'}, {'id': 'FG001', 'title': '6-week Manual Followed by 6-week AdaptiveStim Programming', 'description': 'Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.'}], 'periods': [{'title': 'Period I (First 6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': 'Period II (Second 6 Weeks)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '38'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The sponsor activated 10 study centers after the study protocol was approved by FDA in March 2010. The overall recruitment for study subjects lasted less than 5 months, with the first enrollment on April 20, 2010, and last enrollment on September 3, 2010.', 'preAssignmentDetails': 'Among the 79 subjects enrolled into the study, there were 3 subjects discontinued prior to implantation. The reasons for discontinuations were withdrawal of consent (n = 2) and eligibility criteria not met (n = 1). A total of 76 subjects were implanted and randomized at 4 weeks post implant.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '6-week AdaptiveStim Followed by 6-week Manual Programming', 'description': 'Subjects received AdaptiveStim programming for 6 weeks, followed by manual programming for 6 weeks.'}, {'id': 'BG001', 'title': '6-week Manual Followed by 6-week AdaptiveStim Programming', 'description': 'Subjects received manual programming for 6 weeks, followed by AdaptiveStim programming for 6 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '31', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.5', 'spread': '13.0', 'groupId': 'BG000'}, {'value': '53.1', 'spread': '14.1', 'groupId': 'BG001'}, {'value': '52.8', 'spread': '13.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'average Numeric Pain Rating Scale (NPRS)', 'classes': [{'categories': [{'measurements': [{'value': '6.26', 'spread': '1.48', 'groupId': 'BG000'}, {'value': '5.88', 'spread': '2.15', 'groupId': 'BG001'}, {'value': '6.06', 'spread': '1.86', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'NPRS is a 11-point scale with numbers from 0 to 10, with 0 meaning "No pain" and 10 meaning "Pain as bad as you can imagine." For average NPRS, study subjects were instructed to "Please rate your pain by indicating the number that best describes your pain on average in the last 24 hours."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'worst Numeric Pain Rating Scale (NPRS)', 'classes': [{'categories': [{'measurements': [{'value': '7.60', 'spread': '1.15', 'groupId': 'BG000'}, {'value': '7.60', 'spread': '1.63', 'groupId': 'BG001'}, {'value': '7.60', 'spread': '1.41', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'NPRS is a 11-point scale with numbers from 0 to 10, with 0 meaning "No pain" and 10 meaning "Pain as bad as you can imagine." For worst NRPS, study subjects were instructed to "Please rate your pain by indicating the number that best describes your worst pain in the last 24 hours."', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-17', 'studyFirstSubmitDate': '2010-04-02', 'resultsFirstSubmitDate': '2012-01-12', 'studyFirstSubmitQcDate': '2010-04-16', 'lastUpdatePostDateStruct': {'date': '2012-08-30', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2012-06-25', 'studyFirstPostDateStruct': {'date': '2010-04-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2012-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Subjects With Improved Pain Relief and/or Convenience During the AdaptiveStim Programming Arm Relative to the Manual Programming Arm', 'timeFrame': '16 weeks post-implant', 'description': 'After subjects experienced both AdaptiveStim and manual programming at 16 weeks post-implant, subjects were asked to compare pain relief and convenience when they had AdaptiveStim ON to AdaptiveStim OFF in two separate domains using two 5-point Likert scales. The outcome measure for the primary objective is the percentage of subjects who report improved pain relief with no loss of convenience or improved convenience with no loss of pain relief during the AdaptiveStim programming arm relative to the manual programming arm. These subjects were considered successful for the primary objective.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Subjects With Worsened Pain Relief When Using AdaptiveStim Compared to Manual Programming', 'timeFrame': '16 weeks post-implant', 'description': 'The pain relief question was a 5-point Likert scale question comparing pain relief when using AdaptiveStim programming relative to manual programming after subjects finished both programming periods. The choices were much worse pain relief with AdaptiveStim, somewhat worse pain relief with AdaptiveStim, no difference in pain relief, somewhat better pain relief with AdaptiveStim, and much better pain relief with AdaptiveStim. Subjects who had worsening pain relief were defined as subjects who responded "much worse pain relief with AdaptiveStim" or "somewhat worse pain relief with AdaptiveStim".'}, {'measure': 'Manual Adjustments Presented as Button Presses', 'timeFrame': 'Baseline, 10 weeks and 16 weeks post-implant', 'description': 'The number of individual adjustments, ie, button presses, were recorded automatically in the patient programmer, which was specifically designed for this study. The number of button presses per day for manual patient programmer adjustments during the manual programming arm and the AdaptiveStim programming arm of the study were compared.'}, {'measure': 'NPRS Scores From Baseline to Follow-up Visits at 10 Weeks and 16 Weeks Post-implant', 'timeFrame': 'Baseline, 10 weeks and 16 weeks post-implant', 'description': 'The 11-point (ie, 0-10) numeric rating scale of pain intensity (NPRS) was used to assess the overall pain at baseline and follow-up visits. In the pain diary, subjects were presented a numeric scale with numbers from 0 to 10, with 0 meaning "No pain" and 10 meaning "Pain as bad as you can imagine," accompanied by the instructions "Please rate your pain by indicating the number that best describes your pain on average in the last 24 hours." The subjects were asked to complete a diary for 7 consecutive days before implant, 10 weeks, and 16 weeks post-implant visits.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Pain']}, 'referencesModule': {'references': [{'pmid': '22270733', 'type': 'DERIVED', 'citation': 'Schultz DM, Webster L, Kosek P, Dar U, Tan Y, Sun M. Sensor-driven position-adaptive spinal cord stimulation for chronic pain. Pain Physician. 2012 Jan-Feb;15(1):1-12.'}]}, 'descriptionModule': {'briefSummary': "The purpose of the study is to gather clinical information on subjects' experiences with and without the use of the new feature of the RestoreSensor implantable neurostimulator (INS).", 'detailedDescription': "This study is a multi-center, prospective, open-label, randomized, crossover study that is designed to gather clinical information on subjects' experiences with the use of the new feature of the RestoreSensor implantable neurostimulator. Current spinal cord stimulators for chronic intractable pain stimulate targeted nerves along the spine using electrical impulses. The stimulation interferes with the transmission of pain signals to the brain replacing painful sensations with a tingling sensation called paresthesia. Variation in the intensity of neurostimulation with body position is a challenge for some patients implanted with conventional spinal cord stimulation systems because positional changes may result in overstimulation or understimulation. Patients need to manually adjust their stimulation using the patient programmer to maintain their comfort level during position changes. The AdaptiveStim feature of the RestoreSensor neurostimulator was developed to address this challenge by improving pain relief and/or convenience relative to manual programming adjustments."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meets the indications as an appropriate surgical candidate (after successful SCS screening trial) for implant of a neurostimulation system for spinal cord stimulation (SCS) treatment of trunk and/or limb pain, per labeled indications\n* 18 years of age or older\n* Willing and able to attend visits and comply with the study protocol\n* Capable of using the patient programmer and recharging the neurostimulator (INS), able to read and answer questionnaires in English, without assistance of a caregiver\n* Males and non-pregnant females\n\nExclusion Criteria:\n\n* Has had a prior implantable SCS neurostimulation system\n* Currently enrolled, or plans to enroll in another investigational device or drug trial during the study\n* Has unresolved legal issues related to their pain condition for which they would be receiving neurostimulation\n* Requires cervical placement of leads.'}, 'identificationModule': {'nctId': 'NCT01106404', 'briefTitle': 'RestoreSensor Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'MedtronicNeuro'}, 'officialTitle': 'RestoreSensor Study', 'orgStudyIdInfo': {'id': '1651'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': '6-week AdaptiveStim followed by 6-week manual programming', 'interventionNames': ['Device: RestoreSensor Neurostimulation System']}, {'type': 'OTHER', 'label': '6-week manual followed by 6-week AdaptiveStim programming', 'interventionNames': ['Device: RestoreSensor Neurostimulation System']}], 'interventions': [{'name': 'RestoreSensor Neurostimulation System', 'type': 'DEVICE', 'description': 'Adjustments to stimulation settings are automatic when the AdaptiveStim feature of the device is turned "ON" and manual when the AdaptiveStim feature of the device is turned "OFF".', 'armGroupLabels': ['6-week AdaptiveStim followed by 6-week manual programming', '6-week manual followed by 6-week AdaptiveStim programming']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35801', 'city': 'Huntsville', 'state': 'Alabama', 'country': 'United States', 'geoPoint': {'lat': 34.7304, 'lon': -86.58594}}, {'zip': '92056', 'city': 'Oceanside', 'state': 'California', 'country': 'United States', 'geoPoint': {'lat': 33.19587, 'lon': -117.37948}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '89149', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08043', 'city': 'Voorhees Township', 'state': 'New Jersey', 'country': 'United States', 'geoPoint': {'lat': 40.4795, 'lon': -74.49062}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '75237', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78258', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84106', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MedtronicNeuro', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}