Ignite Creation Date:
2025-12-24 @ 1:07 PM
Ignite Modification Date:
2026-02-06 @ 4:50 AM
Study NCT ID:
NCT03689361
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2018-09-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interest of the T2 * Sequence in MRI for the Diagnosis of Migraine Aura in the Acute Phase.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020325', 'term': 'Migraine with 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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-02', 'studyFirstSubmitDate': '2018-09-20', 'studyFirstSubmitQcDate': '2018-09-27', 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'frequency of the presence of visible brain vein abnormalities', 'timeFrame': 'Day 0', 'description': 'visible brain vein abnormalities on T2 \\* sequences MRI ,'}], 'secondaryOutcomes': [{'measure': 'perfusion parameters', 'timeFrame': 'Day 0', 'description': 'in MRI , Overall visual assessment: presence or absence of hypoperfusion (presence or not in each anterior, middle and posterior territory) each lobe: Frontal, Temporal, Parietal, Occipital)'}, {'measure': 'asymmetry of visualization of the 3 intracranial arteries in MRI', 'timeFrame': 'Day 0', 'description': 'in MRI TOF'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['migraine aura'], 'conditions': ['Migraine Aura']}, 'descriptionModule': {'briefSummary': 'investigators hypothesize that T2 \\* vein abnormalities are frequent and are specific to the migraine aura.', 'detailedDescription': 'The diagnosis of migraine aura is now based solely on clinical criteria and the assertion of the diagnosis on these clinical criteria alone proves difficult in the acute phase. Added to this difficulty, the symptomatology of a migraine aura can sometimes be similar to that of a stroke, so a diagnosis can be poorly established, resulting in poor patient care. The possibility of making the positive diagnosis of migraine aura on a routine MRI sequence, T2 \\*, would be an important advance for the management of these patients'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18 to 55 years\n* Admitted to the Neuro-Vascular Intensive Care Unit for Acute Focused Neurological Symptoms and MRI\n\n * less than 4 hours 30 minutes after onset of symptoms if symptoms persist during admission\n * less than two hours after the disappearance of symptoms if the patient arrives asymptomatic\n* Affiliated to a social protection scheme.\n* Having given their informed consent\n\nExclusion Criteria:\n\n* Patients with neurological signs pointing to vertebrobasilar localization (vertigo, diplopia) or with a disorder of consciousness\n* Presence of recent explanatory abnormalities on the MRI to make a diagnosis compatible with the initial neurological symptomatology (visible stroke in diffusion, cerebral hemorrhage, tumor, arteriovenous malformations).\n* Potential strong cause of stroke known or discovered at the arrival of the patient, in particular stenosis of a cervical or intracranial artery upstream of the cerebral zone may correspond to the symptoms and emboligenic heart disease type atrial fibrillation.\n* Pregnant women - Patients with a contraindication for MRI.\n* Patients benefiting from a system of legal protection (tutelage,'}, 'identificationModule': {'nctId': 'NCT03689361', 'acronym': 'MARIE', 'briefTitle': 'Interest of the T2 * Sequence in MRI for the Diagnosis of Migraine Aura in the Acute Phase.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Interest of the T2 * Sequence in MRI for the Diagnosis of Migraine Aura in the Acute Phase.', 'orgStudyIdInfo': {'id': 'RC31/16/8249'}, 'secondaryIdInfos': [{'id': '2017-004091-60', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'with migraine aura.', 'description': 'patient with migraine aura detected by MRI, then MRI control 3 month after', 'interventionNames': ['Combination Product: MRI', 'Diagnostic Test: MRI control']}, {'type': 'OTHER', 'label': 'without migraine aura', 'description': 'patient without migraine aura detected by MRI, then telephone consultation 3 month after', 'interventionNames': ['Other: telephone consultation']}], 'interventions': [{'name': 'MRI', 'type': 'COMBINATION_PRODUCT', 'description': 'Routine MRI with all the sequences performed for the management of acute neurological deficit in the Toulouse Neuro Vascular Unit (diffusion, FLAIR, T2 \\*, vascular sequences (AngioRM and TOF) and perfusion).', 'armGroupLabels': ['with migraine aura.']}, {'name': 'MRI control', 'type': 'DIAGNOSTIC_TEST', 'description': 'MRI with all the sequences performed for the management of acute neurological deficit in the Toulouse Neuro Vascular Unit (diffusion, FLAIR, T2 \\*, vascular sequences (AngioRM and TOF) and perfusion)', 'armGroupLabels': ['with migraine aura.']}, {'name': 'telephone consultation', 'type': 'OTHER', 'description': 'telephone consultation', 'armGroupLabels': ['without migraine aura']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31049', 'city': 'Toulouse', 'country': 'France', 'facility': 'Hôpital Pierre Paul Riquet - CHU de Toulouse', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'overallOfficials': [{'name': 'Alain Viguier, PH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Uuniversity Hospital Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}