Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2026-02-20 @ 12:37 PM
Study NCT ID:
NCT01896167
Status:
COMPLETED
Last Update Posted:
2015-02-12
First Post:
2013-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow by Hypoxia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006261', 'term': 'Headache'}, {'id': 'D008881', 'term': 'Migraine Disorders'}, {'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-02', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-11', 'studyFirstSubmitDate': '2013-06-21', 'studyFirstSubmitQcDate': '2013-07-08', 'lastUpdatePostDateStruct': {'date': '2015-02-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Headache and aura', 'timeFrame': '24 h', 'description': 'Comparison between hypoxia and placebo (atmospheric air)'}], 'secondaryOutcomes': [{'measure': 'artery circumference', 'timeFrame': 'Baseline, 120 and 200 min', 'description': 'Hypoxia induced changes in intra- and extracranial circumference'}, {'measure': 'Cerebral blood flow', 'timeFrame': 'Baseline, 120 and 200 min', 'description': 'Hypoxia induced changes in cerebral blood flow'}, {'measure': 'BOLD response in visual cortex', 'timeFrame': 'Baseline, 170 min and 220 min', 'description': 'Hypoxia induced changes in BOLD response'}, {'measure': 'Brain metabolism', 'timeFrame': 'Baseline, 180 min and 230 min post hypoxia', 'description': 'Hypoxia induced changes in brain metabolism'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Headache', 'Migraine', 'Aura', 'Cerebral hemodynamics'], 'conditions': ['Headache', 'Migraine', 'Aura']}, 'descriptionModule': {'briefSummary': 'In this study the investigators will investigate the following hypothesis\n\n* that hypoxia induce migraine headache and migraine aura\n* the aura phase is associated with a spreading reduction in cerebral blood flow\n* the migraine headache is associated with dilatation of intra- and extracerebral arteries\n* the migraine headache is associated with changes in brain metabolism\n* the pre-ictal stage of a migraine attack with aura is associated with specific patterns in neural activity.', 'detailedDescription': 'To investigate migraine with aura symptoms during and after hypoxia.\n\nWith magnetic resonance imaging the investigators will investigate changes in\n\n* regional cerebral blood flow (rCBF)\n* resting state functional connectivity\n* circumference of the middle cerebral artery(MCA), internal carotic artery, superficial temporal artery, medial meningeal artery, external carotic artery\n* brain metabolism\n\nAnd compare these changes with a aged match healthy control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMigraine with aura patients and Helthy volunteers as controls:\n\n* Aged 18-40\n* 50-100 kg\n\nExclusion Criteria:\n\n* Tension type headache more than 5 days/month\n* Other primary headaches\n* Daily medication except contraceptives\n* Drug taken within 4 times the halflife for the specific drug except contraceptives\n* Pregnant or lactating women\n* Headache or migraine attack within the last 48 hours before start of trial\n* Hypertension\n* Hypotension\n* Respiratory or cardiac disease\n* smoking\n\nExtra exclusion Criteria for healthy volunteers:\n\n* migraine at present or earlier in life\n* parents, sibling or children who suffer or have suffered from migraine'}, 'identificationModule': {'nctId': 'NCT01896167', 'briefTitle': 'Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries and Blood Flow by Hypoxia', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': 'Study of Migraine With Aura Inducing Characteristics and Effects on the Cerebral Arteries by Hypoxia in a Humane Experimental Migraine Model', 'orgStudyIdInfo': {'id': 'H-4-2012-182'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Hypoxia', 'description': 'Inhalation of air with 8-12% oxygen content', 'interventionNames': ['Other: Hypoxia']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Atmospheric air', 'description': 'Inhalation of atmospheric air, with oxygen content at 21%', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Hypoxia', 'type': 'OTHER', 'description': 'Inhalation of hypoxic air (8-12% oxygen content)', 'armGroupLabels': ['Hypoxia']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Inhalation of atmospheric air', 'armGroupLabels': ['Atmospheric air']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2600', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Nanna Arngrim', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}], 'overallOfficials': [{'name': 'Nanna Arngrim, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology, Glostrup Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, medical doctors', 'investigatorFullName': 'Nanna Arngrim', 'investigatorAffiliation': 'Danish Headache Center'}}}}