Ignite Creation Date:
2025-12-24 @ 9:49 PM
Ignite Modification Date:
2025-12-25 @ 7:27 PM
Study NCT ID:
NCT00363532
Status:
COMPLETED
Last Update Posted:
2009-01-28
First Post:
2006-08-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Functional MRI (fMRI) in CGRP Induced Migraine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020326', 'term': 'Migraine without Aura'}], 'ancestors': [{'id': 'D008881', 'term': 'Migraine Disorders'}, {'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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-01-27', 'studyFirstSubmitDate': '2006-08-11', 'studyFirstSubmitQcDate': '2006-08-11', 'lastUpdatePostDateStruct': {'date': '2009-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in BOLD response before and after CGRP infusion.'}, {'measure': 'Changes in BOLD response before and after injection of sumatriptan.'}]}, 'conditionsModule': {'keywords': ['migraine with out aura'], 'conditions': ['Migraine Without Aura']}, 'descriptionModule': {'briefSummary': "In patients known with migraine without aura a migraine headache or migraine like headache will be induced by infusion of calcitonin gene related peptide (CGRP). The patients will then be stimulated with noxious heat via a thermode placed at the forehead. At the same time the Blood-oxygenation-level-dependent (BOLD) response will be measured via functional magnetic resonance imaging (fMRI), to estimate the central-nervous pain response. The regions of interest (ROI) will be thalamic region and medulla oblongata.\n\nThen the patients will be given pain relif in form of injection of sumatriptan and the effect of this will also be registered via measuring the BOLD response at the RIO's previously defined. A 3-Tesla MRI scanner will be used in this trail.\n\nThis study will give us key knowledge of the trigeminal pain pathway and the central processing i.e sensitization during a migraine attach."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients know with migraine without aura.\n* No less then 1 migraine attach pr month and no more then 6 attaches per month.\n* Weight 50-100 kg.\n* Women must be using secure birthcontrol.\n\nExclusion Criteria:\n\n* Tension type headache more then 1 day/month.\n* All other prim. og sec. headache types then migraine without aura.\n* Daily use of medication other then birthcontrol pills.\n* Pregnant and lactation women.\n* Headache on the trail day or 5 days previous to the trail day.\n* Contraindications to MRI-scans.\n* Hypertension or hypotension.\n* Known heart or lung condition.\n* Mental illness or substance abuse.\n* Other considerable conditions judged by the including doctor.'}, 'identificationModule': {'nctId': 'NCT00363532', 'briefTitle': 'Functional MRI (fMRI) in CGRP Induced Migraine', 'organization': {'class': 'OTHER', 'fullName': 'Danish Headache Center'}, 'officialTitle': 'Functional MRI (fMRI) in Patients With Migraine Without Aura Provoked by', 'orgStudyIdInfo': {'id': 'KA-20060083'}}, 'armsInterventionsModule': {'interventions': [{'name': 'infusion of calcitonin gene related peptide (CGRP)', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2770', 'city': 'Glostrup Municipality', 'country': 'Denmark', 'facility': 'Danish Headache Center, Neurological Dep. Glostrup hospital', 'geoPoint': {'lat': 55.6666, 'lon': 12.40377}}], 'overallOfficials': [{'name': 'Messoud Ashina, MD,PH.d', 'role': 'STUDY_CHAIR', 'affiliation': 'Danish Headache Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danish Headache Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Mohammad Sohail Asghar, MD', 'oldOrganization': 'Neurological Dep. University of Copenhagen, Denmark, Glostrup Hospital.'}}}}