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

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

Study Overview

• Status: Completed
• Conditions: Migraine Aura
• Intervention / Treatment: Combination product: MRI; Diagnostic test: MRI control; Other: telephone consultation

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
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• France
  • Toulouse, France, 31049
    • Hôpital Pierre Paul Riquet - CHU de Toulouse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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,

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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)
Other: without migraine aura; patient without migraine aura detected by MRI, then telephone consultation 3 month after	Other: telephone consultation; telephone consultation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
frequency of the presence of visible brain vein abnormalities	visible brain vein abnormalities on T2 * sequences MRI ,	Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
perfusion parameters	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)	Day 0
asymmetry of visualization of the 3 intracranial arteries in MRI	in MRI TOF	Day 0

Collaborators and Investigators

• Sponsor: University Hospital, Toulouse
• Investigators: Principal Investigator: Alain Viguier, PH, Uuniversity Hospital Toulouse

Study record dates

Study Major Dates

• Study Start (Actual): December 22, 2018
• Primary Completion (Actual): October 11, 2020
• Study Completion (Actual): December 11, 2020

Study Registration Dates

• First Submitted: September 20, 2018
• First Submitted That Met QC Criteria: September 27, 2018
• First Posted (Actual): September 28, 2018

Study Record Updates

• Last Update Posted (Actual): February 3, 2021
• Last Update Submitted That Met QC Criteria: February 2, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: migraine aura
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders; Migraine with Aura
• Other Study ID Numbers: RC31/16/8249; 2017-004091-60 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No