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

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ClinicalTrials.gov Identifier: NCT03821584
Recruitment Status : Not yet recruiting
First Posted : January 30, 2019
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment
Emergencies 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
Estimated Enrollment : 25 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Brain Perfusion Assessment in the Acute Phase of Migraine Aura.
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : October 22, 2021
Estimated Study Completion Date : October 22, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine


Intervention Details:
  • Other: the difference of care management and prognosis, an early distinction of migraine aura based on imaging techniques will have a particular interest
    the difference of care management and prognosis, an early distinction of migraine aura based on imaging techniques will have a particular interest


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


Secondary Outcome Measures :
  1. Pattern of perfusion and aura duration [ Time Frame: 12 month ]
    Change in brain perfusion in relation to neurological deficits (migraine aura) duration.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821584


Contacts
Contact: Solene de Gaalon, Dr (33)240165212 Solene.degaalon@chu-nantes.fr

Locations
France
CHU Nantes Not yet recruiting
Nantes, France, 44000
Contact: Solène de Gaalon, Dr    02(33)2 40 16 52 12    Solene.degaalon@chu-nantes.fr   
Principal Investigator: Solène de Gaalon, Dr         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Solene de Gaalon, Dr CHU Nantes

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT03821584     History of Changes
Other Study ID Numbers: RC18_0373
First Posted: January 30, 2019    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: January 2019

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nantes University Hospital:
migraine
perfusion arterial
aura brain

Additional relevant MeSH terms:
Emergencies
Migraine Disorders
Migraine with Aura
Disease Attributes
Pathologic Processes
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases