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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03821584
Other study ID # RC18_0373
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date March 1, 2019
Est. completion date July 22, 2021

Study information

Verified date July 2021
Source Nantes University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 25
Est. completion date July 22, 2021
Est. primary completion date June 22, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France CHU Nantes Nantes

Sponsors (1)

Lead Sponsor Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Pattern of perfusion and aura duration Change in brain perfusion in relation to neurological deficits (migraine aura) duration. 12 month
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