NCT03821584

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2019

Completed
26 days until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2021

Completed
Last Updated

September 17, 2021

Status Verified

July 1, 2021

Enrollment Period

2.3 years

First QC Date

January 4, 2019

Last Update Submit

September 10, 2021

Conditions

Keywords

migraineperfusion arterialaura brain

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Pattern of perfusion and aura duration

    12 month

Interventions

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Nantes

Nantes, 44000, France

Location

MeSH Terms

Conditions

EmergenciesMigraine Disorders

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHeadache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Solene de Gaalon, Dr

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2019

First Posted

January 30, 2019

Study Start

March 1, 2019

Primary Completion

June 22, 2021

Study Completion

July 22, 2021

Last Updated

September 17, 2021

Record last verified: 2021-07

Locations