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

NCT03689361 | Completed Phase 4

• 2 other identifiers: RC31/16/82492017-004091-60
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Migraine Aura

Keywords

migraine aura

Outcome Measures

Primary Outcomes (1)

• frequency of the presence of visible brain vein abnormalities

  visible brain vein abnormalities on T2 \* sequences MRI ,

  Day 0

Secondary Outcomes (2)

• perfusion parameters

  Day 0

• asymmetry of visualization of the 3 intracranial arteries in MRI

  Day 0

Study Arms (2)

with migraine aura.

OTHER

patient with migraine aura detected by MRI, then MRI control 3 month after

Combination Product: MRI; Diagnostic Test: MRI control

without migraine aura

OTHER

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

Other: telephone consultation

Interventions

MRI COMBINATION_PRODUCT

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).

with migraine aura.

MRI control DIAGNOSTIC_TEST

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)

with migraine aura.

telephone consultation OTHER

telephone consultation

without migraine aura

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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,

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

Hôpital Pierre Paul Riquet - CHU de Toulouse

Toulouse, 31049, France

Location

MeSH Terms

Conditions

Migraine with Aura

Condition Hierarchy (Ancestors)

Migraine Disorders; Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Alain Viguier, PH

  Uuniversity Hospital Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 28, 2018
• Study Start: December 22, 2018
• Primary Completion: October 11, 2020
• Study Completion: December 11, 2020
• Last Updated: February 3, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)