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

Migraine Aura Clinical Trial

— MARIE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03689361
• Other study ID #: RC31/16/8249
• Secondary ID: 2017-004091-60
• Status: Completed
• Phase: Phase 4
• Start date: December 22, 2018
• Est. completion date: December 11, 2020

Study information

• Verified date: February 2021
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 11, 2020
• Est. primary completion date: October 11, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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,

Related Conditions & MeSH terms

• Migraine Aura
• Migraine Disorders
• Migraine with Aura

Intervention

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:
• telephone consultation
telephone consultation

Locations

Country	Name	City	State
France	Hôpital Pierre Paul Riquet - CHU de Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	frequency of the presence of visible brain vein abnormalities	visible brain vein abnormalities on T2 * sequences MRI ,	Day 0
Secondary	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
Secondary	asymmetry of visualization of the 3 intracranial arteries in MRI	in MRI TOF	Day 0