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

Primary Purpose

Migraine Aura

Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
MRI
MRI control
telephone consultation
Sponsored by
University Hospital, Toulouse
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Migraine Aura focused on measuring migraine aura

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Hôpital Pierre Paul Riquet - CHU de Toulouse

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

with migraine aura.

without migraine aura

Arm Description

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

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

Outcomes

Primary Outcome Measures

frequency of the presence of visible brain vein abnormalities
visible brain vein abnormalities on T2 * sequences MRI ,

Secondary Outcome Measures

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)
asymmetry of visualization of the 3 intracranial arteries in MRI
in MRI TOF

Full Information

First Posted
September 20, 2018
Last Updated
February 2, 2021
Sponsor
University Hospital, Toulouse
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1. Study Identification

Unique Protocol Identification Number
NCT03689361
Brief Title
Interest of the T2 * Sequence in MRI for the Diagnosis of Migraine Aura in the Acute Phase.
Acronym
MARIE
Official Title
Interest of the T2 * Sequence in MRI for the Diagnosis of Migraine Aura in the Acute Phase.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
December 22, 2018 (Actual)
Primary Completion Date
October 11, 2020 (Actual)
Study Completion Date
December 11, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Toulouse

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Aura
Keywords
migraine aura

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
with migraine aura.
Arm Type
Other
Arm Description
patient with migraine aura detected by MRI, then MRI control 3 month after
Arm Title
without migraine aura
Arm Type
Other
Arm Description
patient without migraine aura detected by MRI, then telephone consultation 3 month after
Intervention Type
Combination Product
Intervention Name(s)
MRI
Intervention 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).
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI control
Intervention 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)
Intervention Type
Other
Intervention Name(s)
telephone consultation
Intervention Description
telephone consultation
Primary Outcome Measure Information:
Title
frequency of the presence of visible brain vein abnormalities
Description
visible brain vein abnormalities on T2 * sequences MRI ,
Time Frame
Day 0
Secondary Outcome Measure Information:
Title
perfusion parameters
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)
Time Frame
Day 0
Title
asymmetry of visualization of the 3 intracranial arteries in MRI
Description
in MRI TOF
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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,
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alain Viguier, PH
Organizational Affiliation
Uuniversity Hospital Toulouse
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Pierre Paul Riquet - CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31049
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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