Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-03-04 @ 10:12 PM
Study NCT ID:
NCT00868556
Status:
COMPLETED
Last Update Posted:
2010-01-05
First Post:
2009-03-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
fMRI of the Brainstem in Migraine Sufferers and Controls. Does Iron Deposition Correlate With Progression of Disease?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-01-04', 'studyFirstSubmitDate': '2009-03-24', 'studyFirstSubmitQcDate': '2009-03-24', 'lastUpdatePostDateStruct': {'date': '2010-01-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assess anatomical changes with emphasis in iron deposition in brainstem structures of migraineurs and controls', 'timeFrame': 'within a month after consent is obtained'}], 'secondaryOutcomes': [{'measure': 'correlate outcomes with headache surrogates (frequency, time since onset and age)', 'timeFrame': 'within one month after enrollment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['fMRI scans', 'episodic migraine sufferers', 'chronic migraine sufferers', 'non migraine sufferers (controls)'], 'conditions': ['Episodic Migraine', 'Chronic Daily Migraine']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Wolff HG. Headache and Other Head Pain, New York: Oxford Univ Press; 1963'}, {'pmid': '11554950', 'type': 'BACKGROUND', 'citation': 'Welch KM, Nagesh V, Aurora SK, Gelman N. Periaqueductal gray matter dysfunction in migraine: cause or the burden of illness? Headache. 2001 Jul-Aug;41(7):629-37. doi: 10.1046/j.1526-4610.2001.041007629.x.'}, {'pmid': '8132434', 'type': 'BACKGROUND', 'citation': 'Siberstein SD, Lipton RB, Solomon S, Mathew NT. Classification of daily and near-daily headaches: proposed revisions to the IHS criteria. Headache. 1994 Jan;34(1):1-7. doi: 10.1111/j.1526-4610.1994.hed3401001.x.'}, {'pmid': '8857711', 'type': 'BACKGROUND', 'citation': 'Silberstein SD, Lipton RB, Sliwinski M. Classification of daily and near-daily headaches: field trial of revised IHS criteria. Neurology. 1996 Oct;47(4):871-5. doi: 10.1212/wnl.47.4.871.'}, {'pmid': '16556250', 'type': 'BACKGROUND', 'citation': 'Bigal ME, Tepper SJ, Sheftell FD, Rapoport AM, Lipton RB. Field testing alternative criteria for chronic migraine. Cephalalgia. 2006 Apr;26(4):477-82. doi: 10.1111/j.1468-2982.2006.01128.x.'}]}, 'descriptionModule': {'briefSummary': 'This is a 2 visit research study for patients with or without a diagnosis of migraine. Participants will be administered informed consent, have a medical history taken and a physical examination performed, and complete 3 questionnaires at the first visit. The participants will have a functional MRI performed after completion of Visit 1. Study stipends will be given for each completed research visit.\n\nThe purpose of this study is to potentially identify risk factors and/or biomarkers (which are differences in the brain structures)by comparing the brain MRI scans of migraine sufferers to brain scans of control persons to attempt to identify migraine progression using the functional MRI scans.', 'detailedDescription': 'At Visit 1, patients in 3 diagnostic arms,(consisting of subjects with episodic migraine, chronic daily migraine or non-migraineurs/controls), of 11 subjects each, will be consented and then have a physical exam, medical history and current medication use documented. Each of these enrolled subjects will have a PRIME MD assessment administered, and will complete the MIDAS and ASC-12 questionnaires.\n\nAt Visit 2 these same subjects will have an fMRI performed.\n\nSubjects will be greater than age 18, have the appropriate diagnoses, be able to be consented and not be pregnant or have an inability to have the fMRI performed (have implanted metal devices, have severe claustrophobia).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '11 episodic migraine sufferers, 11 chronic migraine sufferers, 11 non-migraine sufferers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult episodic, chronic or non-migraine sufferers able to consent\n\nExclusion Criteria:\n\n* contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips, etc\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT00868556', 'briefTitle': 'fMRI of the Brainstem in Migraine Sufferers and Controls. Does Iron Deposition Correlate With Progression of Disease?', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'fMRI of the Brainstem in Migraine Sufferers and Controls. Does Iron Deposition Correlate With Progression of Disease?', 'orgStudyIdInfo': {'id': 'V81708'}, 'secondaryIdInfos': [{'id': 'Merck Grant IISP 36047'}]}, 'armsInterventionsModule': {'armGroups': [{'label': '1 episodic migraine sufferers'}, {'label': '2 chronic migraine sufferers'}, {'label': '3 non migraine sufferers (controls)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Stewart J Tepper, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'oldNameTitle': 'Stewart Tepper MD, PI', 'oldOrganization': 'Cleveland Clinic Foundation'}}}}