<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/NCT02202486</url>
  </required_header>
  <id_info>
    <org_study_id>H-3-2012-073</org_study_id>
    <nct_id>NCT02202486</nct_id>
  </id_info>
  <brief_title>Investigation of the Blood-brain and Blood-dura Barrier Durin Migraine Attacks Using MRI</brief_title>
  <official_title>Investigation of the Blood-brain and Blood-dura Barrier Durin Migraine Attacks Using MRI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Glostrup University Hospital, Copenhagen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Glostrup University Hospital, Copenhagen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Substudy 1 Blood-brain barrier breakdown has been proposed in migraine patients. Our&#xD;
      hypothesis that we will test in this study is that the blood-brain barrier breaks down during&#xD;
      migraine attacks but not out side attacks using MRI.&#xD;
&#xD;
      Substudy 2 Altered cerebral resting-state functional connectivity networks have been reported&#xD;
      in migraine patients outside migraine attacks. What happens during migraine attacks has never&#xD;
      been investigated. The hypothesis we will test is that pain related networks are affected&#xD;
      during spontaneous attacks using functional MRI.&#xD;
&#xD;
      Substudy 3 Old studies report that cerebral blood flow (CBF) is altered in patients with&#xD;
      migraine with aura, but not in those without aura. We hypothesize that CBF is altered&#xD;
      regionally during attacks, which we will investigate in this study using arterial spin&#xD;
      labeling (ASL).&#xD;
&#xD;
      Substudy 4 Structural changes using voxel-based morphometry (VBM) of the brain have been&#xD;
      suggested but never investigated during migraine attacks. Our hypothesis is that pain related&#xD;
      structures show altered VBM during spontaneous migraine attacks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Brain MRI during and outside migraine attacks.&#xD;
&#xD;
      Up to 600 patients will be recruited, who will be given a phone number that they can call&#xD;
      when they get migraine attacks.&#xD;
&#xD;
      The study will continue until 20 patients with migraine with aura, 20 patients without aura,&#xD;
      20 patients with chronic migraine have completed the study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2012</start_date>
  <completion_date type="Anticipated">December 2015</completion_date>
  <primary_completion_date type="Anticipated">July 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Blood-brain barrier alteration during migraine attacks</measure>
    <time_frame>Up to 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Cerebral blood flow alteration during migraine attacks</measure>
    <time_frame>Up to 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Resting-state functional brain connectivity alteration during migraine attacks</measure>
    <time_frame>Up to 1 year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Voxel-based morphometry alteration during migraine attacks</measure>
    <time_frame>Up to 1 year</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Migraine With Aura</condition>
  <condition>Migraine Without Aura</condition>
  <condition>Chronic Migraine</condition>
  <arm_group>
    <arm_group_label>Migraine with aura</arm_group_label>
    <description>Brain MRI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Migraine without aura</arm_group_label>
    <description>Brain MRI</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic migraine</arm_group_label>
    <description>Brain MRI</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Brain MRI</intervention_name>
    <description>Brain MRI with gadolinium contrast</description>
    <arm_group_label>Chronic migraine</arm_group_label>
    <arm_group_label>Migraine with aura</arm_group_label>
    <arm_group_label>Migraine without aura</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Creatinine, blood glucose, potassium, haemoglobin, erytrocyte profile&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Migraine patients.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of migraine with aura, migraine without aura, or chronic migraine according&#xD;
             to the International Headache Society.&#xD;
&#xD;
          -  written informed consent.&#xD;
&#xD;
          -  use of anticonceptive method by women in childbearing age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  tension type headache more than 5/month during last year.&#xD;
&#xD;
          -  tension type headache on the experimental day.&#xD;
&#xD;
          -  use of antimigraine medication or pain-killer on the experimental day before MRI.&#xD;
&#xD;
          -  pregnant or breastfeeding women.&#xD;
&#xD;
          -  contraindications against MRI.&#xD;
&#xD;
          -  history or clinical sign of cardio- or cerebrovascular disease.&#xD;
&#xD;
          -  untreated severe mental disorder or drug abuse.&#xD;
&#xD;
          -  other diseases or disorders interpreted, by the examining doctor, to interfere with&#xD;
             participation in the study.&#xD;
&#xD;
          -  not accepting information about potential accidental finding during experiment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Faisal M Amin, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Danish Headache Center, Glostrup Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Faisal M Amin, MD</last_name>
    <phone>+4538633066</phone>
    <email>faisal.mohammad.amin.01@regionh.dk</email>
  </overall_contact>
  <location>
    <facility>
      <name>Danish Headache Center, Glostrup Hospital</name>
      <address>
        <city>Glostrup</city>
        <state>Copenhagen</state>
        <zip>2600</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Faisal M Amin, MD</last_name>
      <phone>+4538633066</phone>
      <email>faisal.mohammad.amin.01@regionh.dk</email>
    </contact>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 29, 2014</study_first_posted>
  <last_update_submitted>July 25, 2014</last_update_submitted>
  <last_update_submitted_qc>July 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Glostrup University Hospital, Copenhagen</investigator_affiliation>
    <investigator_full_name>Faisal Mohammad Amin</investigator_full_name>
    <investigator_title>medical doctor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
    <mesh_term>Migraine without Aura</mesh_term>
    <mesh_term>Migraine with Aura</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/NCT02202486
org study id: H-3-2012-073
nct id: NCT02202486
lead sponsor: 
has dmc: Yes
Substudy 1 Blood-brain barrier breakdown has been proposed in migraine patients. Our
      hypothesis that we will test in this study is that the blood-brain barrier breaks down during
      migraine attacks but not out side attacks using MRI.

      Substudy 2 Altered cerebral resting-state functional connectivity networks have been reported
      in migraine patients outside migraine attacks. What happens during migraine attacks has never
      been investigated. The hypothesis we will test is that pain related networks are affected
      during spontaneous attacks using functional MRI.

      Substudy 3 Old studies report that cerebral blood flow (CBF) is altered in patients with
      migraine with aura, but not in those without aura. We hypothesize that CBF is altered
      regionally during attacks, which we will investigate in this study using arterial spin
      labeling (ASL).

      Substudy 4 Structural changes using voxel-based morphometry (VBM) of the brain have been
      suggested but never investigated during migraine attacks. Our hypothesis is that pain related
      structures show altered VBM during spontaneous migraine attacks.
Brain MRI during and outside migraine attacks.

      Up to 600 patients will be recruited, who will be given a phone number that they can call
      when they get migraine attacks.

      The study will continue until 20 patients with migraine with aura, 20 patients without aura,
      20 patients with chronic migraine have completed the study.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Blood-brain barrier alteration during migraine attacks
time frame: Up to 1 year
measure: Cerebral blood flow alteration during migraine attacks
time frame: Up to 1 year
measure: Resting-state functional brain connectivity alteration during migraine attacks
time frame: Up to 1 year
measure: Voxel-based morphometry alteration during migraine attacks
time frame: Up to 1 year
arm group label: Migraine with aura
description: Brain MRI
arm group label: Migraine without aura
description: Brain MRI
arm group label: Chronic migraine
description: Brain MRI
intervention type: Other
intervention name: Brain MRI
description: Brain MRI with gadolinium contrast
arm group label: Chronic migraine
arm group label: Migraine with aura
arm group label: Migraine without aura
Creatinine, blood glucose, potassium, haemoglobin, erytrocyte profile
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Faisal M Amin, MD
role: Principal Investigator
affiliation: Danish Headache Center, Glostrup Hospital
last name: Faisal M Amin, MD
phone: +4538633066
email: faisal.mohammad.amin.01@regionh.dk
facility: 
status: Recruiting
contact: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Glostrup University Hospital, Copenhagen
investigator full name: Faisal Mohammad Amin
investigator title: medical doctor
mesh term: Migraine Disorders
mesh term: Migraine without Aura
mesh term: Migraine with Aura