Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-03-27 @ 12:01 PM
Study NCT ID:
NCT02122757
Status:
WITHDRAWN
Last Update Posted:
2020-08-18
First Post:
2013-11-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anodal Transcranial Direct Current Stimulation of the Visual Cortex Versus Sham Stimulation in the Episodic Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-15', 'studyFirstSubmitDate': '2013-11-04', 'studyFirstSubmitQcDate': '2014-04-22', 'lastUpdatePostDateStruct': {'date': '2020-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-04-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Migraine frequency', 'timeFrame': '6 months', 'description': 'The investigators evaluate the migraine frequency at baseline (2 months), during the treatment and 2 months after its end.'}], 'secondaryOutcomes': [{'measure': 'Migraine intensity', 'timeFrame': '6 months', 'description': 'The investigators evaluate migraine intensity at baseline, during the treatment and 2 months after its end.'}, {'measure': 'Acute medication intake', 'timeFrame': '6 months', 'description': 'The investigators evaluate acute medication intake at baseline, during the treatment and 2 months after its end.'}, {'measure': 'Attack duration', 'timeFrame': '6 months', 'description': 'The investigators evaluate attack duration at baseline, during the treatment and 2 months after its end.'}, {'measure': 'Score on psychological scales', 'timeFrame': '6 Months', 'description': 'The investigators evaluate score on psychological scales at baseline, during the treatment and 2 months after its end.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Sporadic Migraine']}, 'descriptionModule': {'briefSummary': 'Anodal tDCS increases the excitability of the cerebral cortex and its daily application during intercritical phase, may have a therapeutic effect in episodic migraine.', 'detailedDescription': 'During the interictal phase, the cerebral cortex is characterised by hyperresponsiveness to repeated sensory stimuli, manifested by a lack of habituation or adaptation of cortical evoked responses. Such habituation deficit can be shown in the visual cortex by the study of visual evoked potentials (VEP) and it is possibly explained by a reduction in the cortical pre-activation level due to thalamo-cortical dysrhythmia. In healthy subjects and in migraineurs between attacks, anodal tDCS increases VEP habituation and 1st block amplitude. In a proof-of-concept trial, the investigators have shown in 10 episodic migraine without aura patients that 2 weekly 15-minute sessions for 8 weeks of anodal tDCS over the visual cortex significantly decreased attack frequency, migraine days, attack duration and acute medication intake for more than 4 weeks after the last treatment session.\n\nThis randomized trial was designed to prove the preventive effect in episodic migraine of anodal tDCS over the visual cortex compared to sham stimulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosis of episodic migraine with (ICHD III beta 1.2.1) or without aura (ICHD III beta 1.1)\n\nExclusion Criteria:\n\n* preventive treatment\n* others diseases or contraindications to tDCS (epilepsy, pacemaker, metal prosthetics)'}, 'identificationModule': {'nctId': 'NCT02122757', 'acronym': 'ANODEM', 'briefTitle': 'Anodal Transcranial Direct Current Stimulation of the Visual Cortex Versus Sham Stimulation in the Episodic Migraine', 'organization': {'class': 'OTHER', 'fullName': 'University of Liege'}, 'officialTitle': 'Randomised Sham-controlled Trial of Anodal Transcranial Direct Current Stimulation (tDCS) for the Prevention of Episodic Migraine', 'orgStudyIdInfo': {'id': 'CB-1300'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Sham Anodal Cefaly tDCS', 'description': '2 mA placebo anodal tDCS (the direct current is delivered just for 30 seconds) is applied over the visual cortex for 20 minutes, everyday for 2 months, in 15 patients', 'interventionNames': ['Device: sham Cefaly tDCS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Anodal Cefaly tDCS', 'description': '2 mA anodal tDCS is delivered over the visual cortex, for 20 minutes, everyday for 2 months, in 15 patients.', 'interventionNames': ['Device: Cefaly tDCS']}], 'interventions': [{'name': 'Cefaly tDCS', 'type': 'DEVICE', 'description': 'Cefaly tDCS (transcranial direct current stimulation) is able to modify cortical excitability, in particular anodal tDCS increases it. The side effects of tDCS are minor, especially sensations of itching and scalp paresthesias.', 'armGroupLabels': ['Anodal Cefaly tDCS']}, {'name': 'sham Cefaly tDCS', 'type': 'DEVICE', 'description': '2mA during 30sec', 'armGroupLabels': ['Sham Anodal Cefaly tDCS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Liège', 'country': 'Belgium', 'facility': 'Roberta Baschi', 'geoPoint': {'lat': 50.63373, 'lon': 5.56749}}], 'overallOfficials': [{'name': 'Delphine Magis, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Liege'}, {'name': 'Jean Schoenen, MD,PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Liege'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liege', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Honorary Full Professor', 'investigatorFullName': 'Jean Schoenen', 'investigatorAffiliation': 'University of Liege'}}}}