Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-25 @ 5:14 PM
Study NCT ID:
NCT03414203
Status:
COMPLETED
Last Update Posted:
2019-08-28
First Post:
2018-01-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Comparison Between Transcranial Stimulation Protocols With Continuous Current in the Chronic Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D065908', 'term': 'Transcranial Direct Current Stimulation'}], 'ancestors': [{'id': 'D004599', 'term': 'Electric Stimulation Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D003295', 'term': 'Convulsive Therapy'}, {'id': 'D013000', 'term': 'Psychiatric Somatic Therapies'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D004597', 'term': 'Electroshock'}, {'id': 'D011580', 'term': 'Psychological Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The patients will be randomized into 1 of 3 groups:\n\ngroup A: active tDCS for 15 minutes, group B: active tDCS for 15 minutes, with an interval of 20 minutes and group C: more 15 minutes os stimulation, sham tDCS for 15 minutes.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-24', 'studyFirstSubmitDate': '2018-01-10', 'studyFirstSubmitQcDate': '2018-01-22', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Migraine Disability Assessment - MIDAS', 'timeFrame': '"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"', 'description': 'Change in perform activities of daily living associate to migraine assessed on the Migraine Disability Assessment - MIDAS.'}], 'secondaryOutcomes': [{'measure': 'Headache Impact Test - HIT-6', 'timeFrame': '"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"', 'description': 'Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6)'}, {'measure': 'Wechsler Intelligence Scale Letters', 'timeFrame': '"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"', 'description': 'Change in cognitive ability assessed on the Wechsler Adult Intelligence Scale Letters'}, {'measure': 'Wechsler Intelligence Scale Numbers Test', 'timeFrame': '"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"', 'description': 'Change in cognitive ability assessed on the Wechsler Adult Intelligence Scale Numbers Test'}, {'measure': "Hayling's Test Hayling's Test", 'timeFrame': '"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"', 'description': "Change in operational memory assessed on the Hayling's Test Evaluate operational memory"}, {'measure': 'Trail Making Test part B', 'timeFrame': '"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"', 'description': 'Change in executive functions assessed on the Trail Making Test part B'}, {'measure': 'Salthouse Visual Patterns and Lyrics', 'timeFrame': '"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"', 'description': 'Change in visual processing speed assessed on the Salthouse Visual Patterns and Lyrics'}, {'measure': 'Nine Hole Peg Test', 'timeFrame': '"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"', 'description': 'Change in the motor processing speed assessed on the Nine Hole Peg Test'}, {'measure': 'Paced Auditory Serial Addition Task', 'timeFrame': '"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"', 'description': 'Change in selective attention assessed on the Paced Auditory Serial Addition Task'}, {'measure': 'Concentrated Attention Test', 'timeFrame': '"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"', 'description': 'Change in selective attention assessed on the Concentrated Attention Test'}, {'measure': 'Visual Attention Test (Attention Matrices)', 'timeFrame': '"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"', 'description': 'Change in selective attention assessed on the Visual Attention Test (Attention Matrices)'}, {'measure': 'Montreal Cognitive Assessment', 'timeFrame': '"before treatment", "after treatment - up to 2 weeks " and "up to 1 month after the last day of treatment"', 'description': 'Change in cognition assessed on the Montreal Cognitive Assessment'}, {'measure': 'Side Effects Questionnaire', 'timeFrame': '"every day for up to 2 weeks"', 'description': 'adverse effects assessment'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transcranial Direct Current Stimulation', 'Migraine Disorders', 'Cognitive Symptoms'], 'conditions': ['Chronic Migraine']}, 'descriptionModule': {'briefSummary': 'This study aims to compare the effects of transcranial direct current stimulation on the clinical and cognitive function in patients with chronic migraine.', 'detailedDescription': 'The patients will be randomized into 1 of 3 groups: active tDCS for 15 minutes, active tDCS for 15 minutes, with an interval of 20 minutes and more 15 minutes os stimulation, sham tDCS for 15 minutes. The tDCS will be applied for 10 days over 2 weeks.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* females\n* clinical diagnosis of chronic migraine according to the International Classification of Headaches Disorders (ICHD-3 beta).\n\nExclusion Criteria:\n\n* headache attributable to some pathological condition, associated neurologic or neuropsychiatric disease\n* use of central nervous system modulating drugs\n* pregnancy\n* metallic head implants\n* use of a cardiac pacemaker'}, 'identificationModule': {'nctId': 'NCT03414203', 'acronym': 'NEUROMIG', 'briefTitle': 'Comparison Between Transcranial Stimulation Protocols With Continuous Current in the Chronic Migraine', 'organization': {'class': 'OTHER', 'fullName': 'Federal University of Paraíba'}, 'officialTitle': 'Comparison Between Stimulation Transcranial Protocols With Continuous Current in the Chronic Migraine: Clinical Trial, Triple-blind, Placebo-controlled', 'orgStudyIdInfo': {'id': 'NEUROMIG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'active tDCS', 'description': 'Active tDCS for 15 minutes for 10 days over 2 weeks. Intensity: 2 milliampere. Placement: anode - left DLPFC; cathode - right supraorbital region', 'interventionNames': ['Other: tDCS']}, {'type': 'EXPERIMENTAL', 'label': 'active tDCS with interval', 'description': 'Active tDCS for 15 minutes, interval of 20 minutes and more 15 minutes for 10 days over 2 weeks. Intensity: 2 milliampere. Placement: anode - left DLPFC; cathode - right supraorbital region', 'interventionNames': ['Other: tDCS']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham tDCS', 'description': 'Sham tDCS for 15 minutes for 10 days over 2 weeks. The stimulation is non-active. Placement: anode - left DLPFC; cathode - right supraorbital region', 'interventionNames': ['Other: tDCS']}], 'interventions': [{'name': 'tDCS', 'type': 'OTHER', 'description': 'Transcranial Current Stimulation equipment consists of an ammeter (measured with current intensity), a potentiometer (voltage controller between the electrodes), a generator (two 9-volt batteries) and two electrodes (anode and cathode). The direct low-amplitude currents released by the electrodes reach the cortex and modify the neuronal potentials.', 'armGroupLabels': ['active tDCS', 'active tDCS with interval', 'sham tDCS']}]}, 'contactsLocationsModule': {'locations': [{'city': 'João Pessoa', 'state': 'Paraíba', 'country': 'Brazil', 'facility': 'Federal University of Paraiba', 'geoPoint': {'lat': -7.115, 'lon': -34.86306}}], 'overallOfficials': [{'name': 'Renata Aranha', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Federal University of Paraiba'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal University of Paraíba', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'researcher', 'investigatorFullName': 'Renata Emanuela Lyra de Brito Aranha', 'investigatorAffiliation': 'Federal University of Paraíba'}}}}