Brain Perfusion Assessment in the Acute Phase of Migraine Aura (PERCAM)

Brain Perfusion Assessment in the Acute Phase of Migraine Aura.

The aim of the study is to determine the proportion of patients with change in brain perfusion during the acute phase of migraine attack with aura.

Study Overview

• Status: Terminated
• Conditions: Emergencies
• Intervention / Treatment: Other: the difference of care management and prognosis, an early distinction of migraine aura based on imaging techniques will have a particular interest

Detailed Description

Migraine is a benign and frequent disorder. Migraine aura consists in reversible focal neurological symptoms developing gradually during attack. Its diagnosis relies mainly on patient's history, clinical examination and exclusion of other possible secondary causes to explain transient neurological signs. Thus it can be difficult particularly during first attack or during attack without headache to differentiate migraine aura from transient ischemic stroke. Considering the difference of care management and prognosis, an early distinction of migraine aura based on imaging techniques will have a particular interest. MRI with diffusion, SWI, Flair 2D, ARM 3D TOF, ASL sequences' are routinely performed for the management of acute neurological deficit. Arterial spin labeling (ASL), as a MR perfusion method, will be used to describe brain perfusion during migraine aura. The study hypothesis is that hyperperfusion occurs in brain territories corresponding to the neurological symptoms during migraine aura.

• Study Type: Observational
• Enrollment (Actual): 25

Contacts and Locations

Study Locations

• France
  • Nantes, France, 44000
    • CHU Nantes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to the hospital with neurological deficit and final clinical diagnosis of migraine with aura (certain probable as defined by The International Classification of Headache Disorders)

Description

Inclusion Criteria:

• Age between greater than or equal to 18
• Able to undergo MRI during migraine aura

Exclusion Criteria:

• Pregnant females
• Contraindications towards MRI scanning
• History of epilepsy, psychiatric disease, or any other neurologic disease (brain tumors, stroke..).
• Presence of abnormalities on the MRI that could explain the neurological deficit.
• Adults under guardianship or trusteeship

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perfusion pattern of concerned brain areas	Presence or absence of hypo-hyperperfusion using arterial spin labeling. Visual assessments and comparison between hemispheres	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pattern of perfusion and aura duration	Change in brain perfusion in relation to neurological deficits (migraine aura) duration.	12 month

Collaborators and Investigators

• Sponsor: Nantes University Hospital
• Investigators: Principal Investigator: Solene de Gaalon, Dr, CHU Nantes

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): June 22, 2021
• Study Completion (Actual): July 22, 2021

Study Registration Dates

• First Submitted: January 4, 2019
• First Submitted That Met QC Criteria: January 28, 2019
• First Posted (Actual): January 30, 2019

Study Record Updates

• Last Update Posted (Actual): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: migraine; perfusion arterial; aura brain
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease Attributes; Headache Disorders, Primary; Headache Disorders; Emergencies; Migraine Disorders
• Other Study ID Numbers: RC18_0373

Drug and device information, study documents

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