Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-02-11 @ 6:12 AM
Study NCT ID:
NCT02047695
Status:
COMPLETED
Last Update Posted:
2017-04-04
First Post:
2014-01-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Women With Migraine With Aura Neuroimaging Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020325', 'term': 'Migraine with Aura'}, {'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}], 'ancestors': [{'id': 'D051270', 'term': 'Headache Disorders, Primary'}, {'id': 'D020773', 'term': 'Headache Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 345}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-03', 'studyFirstSubmitDate': '2014-01-26', 'studyFirstSubmitQcDate': '2014-01-26', 'lastUpdatePostDateStruct': {'date': '2017-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evidence of white matter hyperintensities or subclinical ischaemic stroke confirmed by MRI', 'timeFrame': 'At time of MRI'}], 'secondaryOutcomes': [{'measure': 'Evidence of other structural and functional changes in brain', 'timeFrame': 'At time of MRI'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['migraine with aura', 'migraine', 'case-control study', 'magnetic resonance imaging', 'brain diseases'], 'conditions': ['Migraine With Aura']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether a particular form of migraine, migraine with aura, is associated with structural changes in the brain'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Selected from a population-based twin registry', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* female\n* case (migraine with aura), co-twin to case, or control (migraine-free)\n* residency in Denmark\n* no severe neurological (vascular, neurodegenerative or neuroinflammatory) disorders, or other somatic or psychiatric disorders\n\nExclusion Criteria:\n\n* male\n* residency outside Denmark\n* registered in Civil Registry as not to be contacted by researchers\n* severe neurological (vascular, neurodegenerative or neuroinflammatory) disorders, or other somatic or psychiatric disorders\n* mobile metal parts or other contraindication for MRI\n* weight of 130+ kilograms\n* pregnancy\n* subjects that wished not to be informed about abnormal findings on MRI\n* chronic tension-type headache, medication overuse headache, or cluster headache (diagnosed through physician interview)\n* frequent tension-type headache (control group only, self-reported or diagnosed through physician interview)'}, 'identificationModule': {'nctId': 'NCT02047695', 'acronym': 'WOMAN', 'briefTitle': 'Women With Migraine With Aura Neuroimaging Study', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Women With Migraine With Aura Neuroimaging (WOMAN) Study: A Population-based Study of Danish Twins', 'orgStudyIdInfo': {'id': 'S-20100126'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Migraine with aura', 'description': 'Participants with migraine with aura (cases), their co-twins, and unrelated migraine-free twins (controls)'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'David Gaist, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, Odense University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Glostrup University Hospital, Copenhagen', 'class': 'OTHER'}, {'name': 'Copenhagen University Hospital, Hvidovre', 'class': 'OTHER'}, {'name': 'University of Southern Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor, consultant', 'investigatorFullName': 'David Gaist', 'investigatorAffiliation': 'Odense University Hospital'}}}}