<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/NCT03004313</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00027383</org_study_id>
    <nct_id>NCT03004313</nct_id>
  </id_info>
  <brief_title>Structural and Molecular Neuroplasticity in Migraine</brief_title>
  <official_title>Structural and Molecular Neuroplasticity in Migraine</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Michigan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Michigan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of this study is to integrate novel MRI techniques with positron emission&#xD;
      tomography(PET) for the study of structural and molecular neuroplasticity in the brain of&#xD;
      migraineurs, and its clinical association with changes in pain perception and modulation&#xD;
      (e.g. allodynia). We will attempt to acquire images of the brain that may, in the future,&#xD;
      assist doctors in better understanding how pain is felt and regulated in migraine sufferers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To investigate interictal opioid receptor (MOR) binding potential (BPND) changes in&#xD;
      migraineurs as compared to age/gender-matched healthy controls. To demonstrate that frequency&#xD;
      of the headache attacks and severity of cutaneous allodynia levels in migraineurs experienced&#xD;
      over multiple attacks are correlated with levels of MOR BPND in specific brain regions. To&#xD;
      investigate whether dysfunction of the pain regulatory endogenous opioid system of&#xD;
      migraineurs is correlated with changes in the gray matter thickness in cortical areas&#xD;
      associated with pain perception and modulation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">October 2014</completion_date>
  <primary_completion_date type="Actual">October 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Level of mu-opioid receptor binding potential in the brain of episodic migraineurs during and outside the headache attack and compared to healthy controls.</measure>
    <time_frame>90 min PET scan</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation of migraine attack severity in migraineurs with mu-opioid receptor binding potential</measure>
    <time_frame>90 min PET scan</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Migraine</condition>
  <arm_group>
    <arm_group_label>Migraine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>20 subjects experiencing 1-14 migraines per month will undergo the following:&#xD;
Blood and urine samples will be collected&#xD;
Complete a series of questionnaires; some of which will be completed daily&#xD;
Quantitative Sensory Test (QST)will be performed&#xD;
Magnetic Resonance Imaging (MRI)&#xD;
PET imaging (during and outside of a migraine attack)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 healthy subjects will undergo the following:&#xD;
Blood and urine samples will be collected&#xD;
Complete a series of questionnaires; some of which will be completed daily&#xD;
Quantitative Sensory Test (QST)will be performed&#xD;
Magnetic Resonance Imaging (MRI)&#xD;
PET imaging</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pet Scan</intervention_name>
    <description>Subjects will undergo Pet Scanning for 90 minutes</description>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_label>Migraine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MRI scan</intervention_name>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_label>Migraine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Quantitative Sensory Testing (QST)</intervention_name>
    <arm_group_label>Healthy</arm_group_label>
    <arm_group_label>Migraine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Between 18-45 years of age&#xD;
&#xD;
          -  Between 1-14 migraine attacks per month or healthy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cannot be taking daily migraine medication&#xD;
&#xD;
          -  Healthy subjects cannot be taking hormonal birth control pills or other medication&#xD;
&#xD;
          -  Cannot have chronic pain or a neurologic/psychiatric disorder such as: multiple&#xD;
             sclerosis and bipolar disorder.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alexandre DaSilva, DDS, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan - Michigan Center for Oral Health Research</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>August 30, 2011</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>November 21, 2017</last_update_submitted>
  <last_update_submitted_qc>November 21, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Michigan</investigator_affiliation>
    <investigator_full_name>Alexandre DaSilva, DDS, MS</investigator_full_name>
    <investigator_title>Principal Investigator, Director of Headache and Orofacial Pain Effort</investigator_title>
  </responsible_party>
  <keyword>migraine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</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/NCT03004313
org study id: HUM00027383
nct id: NCT03004313
lead sponsor: 
has dmc: No
The main purpose of this study is to integrate novel MRI techniques with positron emission
      tomography(PET) for the study of structural and molecular neuroplasticity in the brain of
      migraineurs, and its clinical association with changes in pain perception and modulation
      (e.g. allodynia). We will attempt to acquire images of the brain that may, in the future,
      assist doctors in better understanding how pain is felt and regulated in migraine sufferers.
To investigate interictal opioid receptor (MOR) binding potential (BPND) changes in
      migraineurs as compared to age/gender-matched healthy controls. To demonstrate that frequency
      of the headache attacks and severity of cutaneous allodynia levels in migraineurs experienced
      over multiple attacks are correlated with levels of MOR BPND in specific brain regions. To
      investigate whether dysfunction of the pain regulatory endogenous opioid system of
      migraineurs is correlated with changes in the gray matter thickness in cortical areas
      associated with pain perception and modulation.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Level of mu-opioid receptor binding potential in the brain of episodic migraineurs during and outside the headache attack and compared to healthy controls.
time frame: 90 min PET scan
measure: Correlation of migraine attack severity in migraineurs with mu-opioid receptor binding potential
time frame: 90 min PET scan
arm group label: Migraine
arm group type: Experimental
description: 20 subjects experiencing 1-14 migraines per month will undergo the following:
Blood and urine samples will be collected
Complete a series of questionnaires; some of which will be completed daily
Quantitative Sensory Test (QST)will be performed
Magnetic Resonance Imaging (MRI)
PET imaging (during and outside of a migraine attack)
arm group label: Healthy
arm group type: Active Comparator
description: 20 healthy subjects will undergo the following:
Blood and urine samples will be collected
Complete a series of questionnaires; some of which will be completed daily
Quantitative Sensory Test (QST)will be performed
Magnetic Resonance Imaging (MRI)
PET imaging
intervention type: Procedure
intervention name: Pet Scan
description: Subjects will undergo Pet Scanning for 90 minutes
arm group label: Healthy
arm group label: Migraine
intervention type: Procedure
intervention name: MRI scan
arm group label: Healthy
arm group label: Migraine
intervention type: Procedure
intervention name: Quantitative Sensory Testing (QST)
arm group label: Healthy
arm group label: Migraine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Alexandre DaSilva, DDS, MS
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Michigan
investigator full name: Alexandre DaSilva, DDS, MS
investigator title: Principal Investigator, Director of Headache and Orofacial Pain Effort
mesh term: Migraine Disorders