Ignite Creation Date:
2025-12-24 @ 10:12 PM
Ignite Modification Date:
2026-02-18 @ 11:32 PM
Study NCT ID:
NCT01775735
Status:
TERMINATED
Last Update Posted:
2020-11-13
First Post:
2013-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D006261', 'term': 'Headache'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D000092122', 'term': 'Bronchiolitis Obliterans Syndrome'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000092124', 'term': 'Organizing Pneumonia'}, {'id': 'D001989', 'term': 'Bronchiolitis Obliterans'}, {'id': 'D001988', 'term': 'Bronchiolitis'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D006086', 'term': 'Graft vs Host Disease'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Roshini.Jain@bsci.com', 'title': 'Director, Clinical Sciences and Scientific Communication', 'organization': 'Boston Scientific'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Early termination leading to small numbers of subjects analyzed. Statistical analysis was not performed as the sample size was too small to draw any statistically relevant conclusions.'}}, 'adverseEventsModule': {'timeFrame': 'Non-serious adverse events were collected from consent through the 6-month post-randomization visit. Serious adverse events were collected from consent through the 24-month post-randomization visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment', 'description': 'The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization\n\nOccipital nerve stimulator: Electrical stimulation of the greater occipital nerve', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 3, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Control', 'description': 'The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization\n\nOccipital nerve stimulator: Electrical stimulation of the greater occipital nerve', 'otherNumAtRisk': 7, 'deathsNumAtRisk': 7, 'otherNumAffected': 3, 'seriousNumAtRisk': 7, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Implant site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Carpal tunnel syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Impaired healing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Surgical skin tear', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Suture related complication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Myofascial pain syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Rotator cuff syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders'}, {'term': 'Renal failure acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders'}, {'term': 'Body temperature increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations'}], 'seriousEvents': [{'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 12, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Status migrainosus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Hemiplegic migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Migraine without aura', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Wound dehiscence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Device related infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 7, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Number of Moderate-to-severe Headache Days Per Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment', 'description': 'The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization\n\nOccipital nerve stimulator: Electrical stimulation of the greater occipital nerve'}, {'id': 'OG001', 'title': 'Control', 'description': 'The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization\n\nOccipital nerve stimulator: Electrical stimulation of the greater occipital nerve'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.2', 'spread': '7.3', 'groupId': 'OG000'}, {'value': '0', 'spread': '10.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'from Baseline to 6 months post-randomization', 'description': "A moderate-to-severe headache day will be defined as any calendar day with:\n\n1. headache pain that lasts ≥4 hours AND peak severity of moderate or severe intensity\n\n OR\n2. a subject taking a triptan or ergot, regardless of headache pain duration or severity\n\nThe Baseline number was calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the first 30 calendar days of eDiary entries if the eDiary contained ≥70% of data. The 6 months post-randomization number was calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the 30 calendar days of eDiary entries immediately preceding the subject's 6-Month Visit if the eDiary contained ≥70% of data.", 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who completed Baseline and 6 months post-randomization and had ≥70% of eDiary data. Data for 5 subjects was not calculated due to missing eDiary data. Statistical analysis was not performed as the sample size is too small to draw any statistically relevant conclusions.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment', 'description': 'The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization\n\nOccipital nerve stimulator: Electrical stimulation of the greater occipital nerve'}, {'id': 'FG001', 'title': 'Control', 'description': 'The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization\n\nOccipital nerve stimulator: Electrical stimulation of the greater occipital nerve'}], 'periods': [{'title': 'Intervention (6 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Open Label (24 Months)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}]}], 'preAssignmentDetails': '28 subjects were consented in the study. 13 failed screening and 15 were randomized. Statistically relevant conclusions cannot be made from this small sample size.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment', 'description': 'The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System\n\nOccipital nerve stimulator: Electrical stimulation of the greater occipital nerve'}, {'id': 'BG001', 'title': 'Control', 'description': 'The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System\n\nOccipital nerve stimulator: Electrical stimulation of the greater occipital nerve'}, {'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': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race/Ethnicity', 'categories': [{'title': 'American Indian or Alaska native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Randomized subjects'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-04-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2017-01-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-10', 'studyFirstSubmitDate': '2013-01-23', 'resultsFirstSubmitDate': '2018-05-29', 'studyFirstSubmitQcDate': '2013-01-23', 'lastUpdatePostDateStruct': {'date': '2020-11-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-10-29', 'studyFirstPostDateStruct': {'date': '2013-01-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-11-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Number of Moderate-to-severe Headache Days Per Month', 'timeFrame': 'from Baseline to 6 months post-randomization', 'description': "A moderate-to-severe headache day will be defined as any calendar day with:\n\n1. headache pain that lasts ≥4 hours AND peak severity of moderate or severe intensity\n\n OR\n2. a subject taking a triptan or ergot, regardless of headache pain duration or severity\n\nThe Baseline number was calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the first 30 calendar days of eDiary entries if the eDiary contained ≥70% of data. The 6 months post-randomization number was calculated as the total count of eDiary calendar days which meet the definition of a moderate-to-severe headache day during the 30 calendar days of eDiary entries immediately preceding the subject's 6-Month Visit if the eDiary contained ≥70% of data."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['headache', 'pain', 'chronic'], 'conditions': ['Migraine Disorders']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to evaluate the safety and efficacy of occipital nerve stimulation (ONS) using the Boston Scientific Corporation (BSC) Precision™ System in the management of intractable chronic migraine, when used in conjunction with anti-migraine medications.', 'detailedDescription': 'Initial reports of managing migraine headache with ONS described a technique in which electrical leads were implanted in the subcutaneous space transverse to the occipital nerve, in the back of the head, under x-ray guidance. The leads were tunneled under the skin to an implantable pulse generator (IPG) implanted in the chest wall or abdomen. The OPTIMISE Trial is designed to be a pivotal study of the Boston Scientific PRECISION neurostimulation system, when the system is used for ONS. The PRECISION System has been previously been approved for Spinal Cord Stimulation (SCS).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Onset of chronic migraine at least 6 months prior to start of Screening determined by a well-documented history\n* Evidence of intractability\n* Posterior-dominant head pain\n* Stable pattern of headache symptoms for at least 6 months prior to the beginning of Screening\n* Onset of migraine before the age of 50\n* If female of childbearing potential: not pregnant, as evidenced by a negative pregnancy test\n\nKey Exclusion Criteria:\n\n* Diagnosed with any major psychiatric disorder not specifically listed in Key Exclusion Criteria 2-4 (e.g. multiple personality disorder, schizophrenia)\n* Untreated panic disorder\n* Untreated major depression evidenced by a PHQ-9 score \\>20\n* Untreated generalized anxiety disorder evidenced by a GAD-7 score ≥15\n* Currently diagnosed with severe personality disorder\n* A female of childbearing potential planning to get pregnant during the course of the study or not using adequate contraception\n* Participating in another drug, device, or biologics trial within 3 months prior to Screening\n* A terminal illness associated with survival \\<24 months'}, 'identificationModule': {'nctId': 'NCT01775735', 'acronym': 'OPTIMISE', 'briefTitle': 'Occipital Nerve Stimulation (ONS) for Migraine: OPTIMISE', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boston Scientific Corporation'}, 'officialTitle': 'Occipital Nerve Stimulation (ONS) for Migraine OPTIMISE', 'orgStudyIdInfo': {'id': 'G120051'}, 'secondaryIdInfos': [{'id': 'CDM00046436', 'type': 'OTHER', 'domain': 'BSC protocol number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment', 'description': 'The treatment is continuous stimulation with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization', 'interventionNames': ['Device: Occipital nerve stimulator']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'The control is intermittent stimulation for 20 seconds every 90 minutes with an occipital nerve stimulator, specifically the BSC Precision™ ONS System for 6 months post-randomization', 'interventionNames': ['Device: Occipital nerve stimulator']}], 'interventions': [{'name': 'Occipital nerve stimulator', 'type': 'DEVICE', 'otherNames': ['Boston Scientific Precision System'], 'description': 'Electrical stimulation of the greater occipital nerve', 'armGroupLabels': ['Control', 'Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91355', 'city': 'Valencia', 'state': 'California', 'country': 'United States', 'facility': 'Boston Scientific Clinical Research Information Toll Free Number', 'geoPoint': {'lat': 34.44361, 'lon': -118.60953}}, {'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago (Implanting Physician)', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60642', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Diamond Headache Clinic (Headache Physician)', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '71105', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Willis-Knighton River Cities Interventional Pain Specialist (Headache & Implanting Physician)', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital (Headache Physician)', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48322', 'city': 'West Bloomfield', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Medical Group (Implanting Physician)', 'geoPoint': {'lat': 42.56891, 'lon': -83.38356}}, {'zip': '65804', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Pain Management -Surgery Center (Implanting Physician)', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '65807', 'city': 'Springfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Clinvest Research, LLC (Headache Physician)', 'geoPoint': {'lat': 37.21533, 'lon': -93.29824}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Medical Center (Implanting Physician)', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10461', 'city': 'The Bronx', 'state': 'New York', 'country': 'United States', 'facility': 'Montefiore Headache Center (Headache Physician)', 'geoPoint': {'lat': 40.84985, 'lon': -73.86641}}], 'overallOfficials': [{'name': 'Richard Lipton, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Albert Einstein College of Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boston Scientific Corporation', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}