Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-01 @ 7:59 AM
Study NCT ID:
NCT00407992
Status:
COMPLETED
Last Update Posted:
2019-09-23
First Post:
2006-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Italian Randomized Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D006261', 'term': 'Headache'}], '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': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-19', 'studyFirstSubmitDate': '2006-12-04', 'studyFirstSubmitQcDate': '2006-12-04', 'lastUpdatePostDateStruct': {'date': '2019-09-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2006-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and the type of adverse events', 'timeFrame': 'Study period'}, {'measure': 'Reduction of headache frequency and intensity', 'timeFrame': 'Study period'}], 'secondaryOutcomes': [{'measure': 'Reduction in drug intake', 'timeFrame': 'Study period'}, {'measure': 'Changes in QoL and interference in everyday activities', 'timeFrame': 'Study period'}]}, 'conditionsModule': {'keywords': ['Headache', 'Migraine'], 'conditions': ['Headache, Migraine']}, 'referencesModule': {'references': [{'pmid': '22622909', 'type': 'RESULT', 'citation': 'Serra G, Marchioretto F. Occipital nerve stimulation for chronic migraine: a randomized trial. Pain Physician. 2012 May-Jun;15(3):245-53.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and the efficacy of occipital nerve stimulation treating Chronic Migraine Headache'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with migraine\n* patients 18 years aged or above\n\nExclusion Criteria:\n\n* patients which participated within the last 30 days or plan to participate during this study in another device or drug trial\n* patients pregnant or planning on becoming pregnant during the study period'}, 'identificationModule': {'nctId': 'NCT00407992', 'acronym': 'Migraine', 'briefTitle': 'An Italian Randomized Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache', 'organization': {'class': 'OTHER', 'fullName': 'IRCCS Sacro Cuore Don Calabria di Negrar'}, 'officialTitle': 'An Italian, Randomized, Single-centre, Open-label Study of Occipital Nerve Stimulation in the Treatment of Chronic Migraine Headache', 'orgStudyIdInfo': {'id': 'MFGGL113006'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Occipital nerve stimulation ON', 'interventionNames': ['Device: Occipital nerve stimulation ON']}, {'type': 'OTHER', 'label': 'Occipital nerve stimulation OFF', 'interventionNames': ['Device: Occipital nerve stimulation off']}], 'interventions': [{'name': 'Occipital nerve stimulation ON', 'type': 'DEVICE', 'description': 'Implant of an occipital nerve stimulator switched ON', 'armGroupLabels': ['Occipital nerve stimulation ON']}, {'name': 'Occipital nerve stimulation off', 'type': 'DEVICE', 'description': 'Implant of an occipital nerve stimulator switched OFF', 'armGroupLabels': ['Occipital nerve stimulation OFF']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37024', 'city': 'Negrar', 'state': 'Verona', 'country': 'Italy', 'facility': 'Ospedale Sacro Cuore - Don Calabria', 'geoPoint': {'lat': 45.52918, 'lon': 10.93899}}], 'overallOfficials': [{'name': 'Gerardo Serra', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IRCCS Sacro Cuore Don Calabria di Negrar'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IRCCS Sacro Cuore Don Calabria di Negrar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}