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Interest of the T2 * Sequence in MRI for the Diagnosis of Migraine Aura in the Acute Phase. (MARIE)

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ClinicalTrials.gov Identifier: NCT03689361
Recruitment Status : Not yet recruiting
First Posted : September 28, 2018
Last Update Posted : September 28, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Toulouse

Brief Summary:
investigators hypothesize that T2 * vein abnormalities are frequent and are specific to the migraine aura.

Condition or disease Intervention/treatment Phase
Migraine Aura Combination Product: MRI Diagnostic Test: MRI control Other: telephone consultation Phase 4

Detailed Description:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Interest of the T2 * Sequence in MRI for the Diagnosis of Migraine Aura in the Acute Phase.
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : March 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
with migraine aura.
patient with migraine aura detected by MRI, then MRI control 3 month after
Combination Product: MRI
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).

Diagnostic Test: MRI control
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)

without migraine aura
patient without migraine aura detected by MRI, then telephone consultation 3 month after
Other: telephone consultation
telephone consultation




Primary Outcome Measures :
  1. frequency of the presence of visible brain vein abnormalities [ Time Frame: Day 0 ]
    visible brain vein abnormalities on T2 * sequences MRI ,


Secondary Outcome Measures :
  1. perfusion parameters [ Time Frame: Day 0 ]
    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)

  2. asymmetry of visualization of the 3 intracranial arteries [ Time Frame: Day 0 ]
    in MRI TOF



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients aged 18 to 55 years
  • Admitted to the Neuro-Vascular Intensive Care Unit for Acute Focused Neurological Symptoms and MRI

    • less than 4 hours 30 minutes after onset of symptoms if symptoms persist during admission
    • less than two hours after the disappearance of symptoms if the patient arrives asymptomatic
  • Affiliated to a social protection scheme.
  • Having given their informed consent

Exclusion Criteria:

  • Patients with neurological signs pointing to vertebrobasilar localization (vertigo, diplopia) or with a disorder of consciousness
  • 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).
  • 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.
  • Pregnant women - Patients with a contraindication for MRI.
  • Patients benefiting from a system of legal protection (tutelage,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689361


Contacts
Contact: Alain Viguier, PH 0561775609 ext 33 viguier.a@chu-toulouse.fr

Locations
France
Hôpital Pierre Paul Riquet - CHU de Toulouse Not yet recruiting
Toulouse, France, 31049
Contact: Alain Viguier    05 61 77 56 09 ext 33    viguier.a@chu-toulouse.fr   
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Alain Viguier, PH Uuniversity Hospital Toulouse

Responsible Party: University Hospital, Toulouse
ClinicalTrials.gov Identifier: NCT03689361     History of Changes
Other Study ID Numbers: RC31/16/8249
2017-004091-60 ( EudraCT Number )
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 28, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Toulouse:
migraine aura

Additional relevant MeSH terms:
Migraine Disorders
Migraine with Aura
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases