<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03821584</url>
  </required_header>
  <id_info>
    <org_study_id>RC18_0373</org_study_id>
    <nct_id>NCT03821584</nct_id>
  </id_info>
  <brief_title>Brain Perfusion Assessment in the Acute Phase of Migraine Aura</brief_title>
  <acronym>PERCAM</acronym>
  <official_title>Brain Perfusion Assessment in the Acute Phase of Migraine Aura.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nantes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Nantes University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to determine the proportion of patients with change in brain&#xD;
      perfusion during the acute phase of migraine attack with aura.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Migraine is a benign and frequent disorder. Migraine aura consists in reversible focal&#xD;
      neurological symptoms developing gradually during attack. Its diagnosis relies mainly on&#xD;
      patient's history, clinical examination and exclusion of other possible secondary causes to&#xD;
      explain transient neurological signs. Thus it can be difficult particularly during first&#xD;
      attack or during attack without headache to differentiate migraine aura from transient&#xD;
      ischemic stroke. Considering the difference of care management and prognosis, an early&#xD;
      distinction of migraine aura based on imaging techniques will have a particular interest. MRI&#xD;
      with diffusion, SWI, Flair 2D, ARM 3D TOF, ASL sequences' are routinely performed for the&#xD;
      management of acute neurological deficit. Arterial spin labeling (ASL), as a MR perfusion&#xD;
      method, will be used to describe brain perfusion during migraine aura. The study hypothesis&#xD;
      is that hyperperfusion occurs in brain territories corresponding to the neurological symptoms&#xD;
      during migraine aura.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Recruiting terminated&#xD;
  </why_stopped>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Actual">July 22, 2021</completion_date>
  <primary_completion_date type="Actual">June 22, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Perfusion pattern of concerned brain areas</measure>
    <time_frame>1 hour</time_frame>
    <description>Presence or absence of hypo-hyperperfusion using arterial spin labeling. Visual assessments and comparison between hemispheres</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pattern of perfusion and aura duration</measure>
    <time_frame>12 month</time_frame>
    <description>Change in brain perfusion in relation to neurological deficits (migraine aura) duration.</description>
  </secondary_outcome>
  <enrollment type="Actual">25</enrollment>
  <condition>Emergencies</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>the difference of care management and prognosis, an early distinction of migraine aura based on imaging techniques will have a particular interest</intervention_name>
    <description>the difference of care management and prognosis, an early distinction of migraine aura based on imaging techniques will have a particular interest</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to the hospital with neurological deficit and final clinical diagnosis of&#xD;
        migraine with aura (certain probable as defined by The International Classification of&#xD;
        Headache Disorders)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between greater than or equal to 18&#xD;
&#xD;
          -  Able to undergo MRI during migraine aura&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant females&#xD;
&#xD;
          -  Contraindications towards MRI scanning&#xD;
&#xD;
          -  History of epilepsy, psychiatric disease, or any other neurologic disease (brain&#xD;
             tumors, stroke..).&#xD;
&#xD;
          -  Presence of abnormalities on the MRI that could explain the neurological deficit.&#xD;
&#xD;
          -  Adults under guardianship or trusteeship&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Solene de Gaalon, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Nantes</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Nantes</name>
      <address>
        <city>Nantes</city>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>January 4, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>September 10, 2021</last_update_submitted>
  <last_update_submitted_qc>September 10, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>migraine</keyword>
  <keyword>perfusion arterial</keyword>
  <keyword>aura brain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03821584
org study id: RC18_0373
nct id: NCT03821584
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
observational model: Other
time perspective: Prospective
measure: Perfusion pattern of concerned brain areas
time frame: 1 hour
description: Presence or absence of hypo-hyperperfusion using arterial spin labeling. Visual assessments and comparison between hemispheres
measure: Pattern of perfusion and aura duration
time frame: 12 month
description: Change in brain perfusion in relation to neurological deficits (migraine aura) duration.
intervention type: Other
intervention name: the difference of care management and prognosis, an early distinction of migraine aura based on imaging techniques will have a particular interest
description: the difference of care management and prognosis, an early distinction of migraine aura based on imaging techniques will have a particular interest
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Solene de Gaalon, Dr
role: Principal Investigator
affiliation: CHU Nantes
facility: 
country: France
responsible party type: Sponsor
mesh term: Migraine Disorders
mesh term: Emergencies