Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-10 @ 6:04 AM
Study NCT ID:
NCT01496950
Status:
COMPLETED
Last Update Posted:
2018-04-05
First Post:
2011-05-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Double-blind Randomized Clinical Trial of Transcranial Magnetic Stimulation in Chronic Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-04', 'studyFirstSubmitDate': '2011-05-25', 'studyFirstSubmitQcDate': '2011-12-19', 'lastUpdatePostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of days with pain per month', 'timeFrame': 'After all treatment sessions (total, 23 sessions within 60 days)'}], 'secondaryOutcomes': [{'measure': 'adverse effects', 'timeFrame': 'After all treatment sessions (total, 23 sessions within 60 days)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['migraine'], 'conditions': ['Chronic Migraine']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether active repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex is safe and effective for preventive treatment of chronic migraine, compared to placebo repetitive transcranial magnetic stimulation.', 'detailedDescription': 'Patients with chronic migraine according to the criteria of the International Headache Society will be randomized to either active repetitive transcranial magnetic stimulation of the left dorsolateral prefrontal cortex or placebo repetitive transcranial magnetic stimulation, in a total of 23 sessions of treatment (15 sessions in the first month and 8 sessions in the second month of treatment). Outcomes will be evaluated at baseline, after one, two months after treatment, and one month after end of treatment'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* chronic migraine according to the criteria of the International Headache Society\n* no change in prophylactic medication in the past 3 months\n\nExclusion Criteria:\n\n* other neurological disorders\n* bipolar disorder\n* alcohol or drug dependence in the past 2 months\n* suicidal ideation, psychotic symptoms\n* contraindications to transcranial magnetic stimulation (cardiac pacemaker, implanted electronic devices, metal in the skull, skull fractures, history of seizures)\n* use of antidepressants in the past 4 weeks\n* pregnancy or lack of birth-control method in women of childbearing age'}, 'identificationModule': {'nctId': 'NCT01496950', 'acronym': 'TMS-CHROMIG', 'briefTitle': 'Double-blind Randomized Clinical Trial of Transcranial Magnetic Stimulation in Chronic Migraine', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Israelita Albert Einstein'}, 'officialTitle': 'Double-blind Randomized Clinical Trial to Evaluate Safety and Efficacy of Repetitive Transcranial Magnetic Stimulation in the Preventive Treatment of Chronic Migraine', 'orgStudyIdInfo': {'id': 'IIEP394-07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Active Comparator: Active rTMS', 'description': '10Hz active rTMS delivered to the left dorsolateral prefrontal cortex', 'interventionNames': ['Device: 10Hz active rTMS']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '10Hz placebo rTMS delivered to the vertex', 'interventionNames': ['Device: Placebo']}], 'interventions': [{'name': '10Hz active rTMS', 'type': 'DEVICE', 'otherNames': ['Repetitive transcranial magnetic stimulation'], 'description': '10Hz active rTMS delivered to the left dorsolateral prefrontal cortex', 'armGroupLabels': ['Active Comparator: Active rTMS']}, {'name': 'Placebo', 'type': 'DEVICE', 'otherNames': ['Repetitive transcranial magnetic stimulation'], 'description': '10Hz placebo rTMS delivered to the vertex', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05652901', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto Israelita de Ensino e Pesquisa Albert Einstein', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Adriana Conforto, MD,PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto Israelita de Ensino e Pesquisa Albert Einstein'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Israelita Albert Einstein', 'class': 'OTHER'}, 'collaborators': [{'name': 'Conselho Nacional de Desenvolvimento Científico e Tecnológico', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Neurology, MD PhD', 'investigatorFullName': 'Adriana Conforto', 'investigatorAffiliation': 'Hospital Israelita Albert Einstein'}}}}