<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/NCT03231241</url>
  </required_header>
  <id_info>
    <org_study_id>SunStar</org_study_id>
    <nct_id>NCT03231241</nct_id>
  </id_info>
  <brief_title>Analysis of Headache Chronification With Imaging, Deep Phenotyping, and Proteomics</brief_title>
  <official_title>SunStar Project to Explore the Chronification Process in Headache Through Functional Imaging, Deep Phenotyping, and Analysis of CSF of Blood Products</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Stanford University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Stanford University</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>
      Study is aimed at determining why some patients with episodic headache proceed to chronic&#xD;
      daily or near daily headaches. The Investigators seek to discover differences in brain&#xD;
      anatomy and function, composition of cerebrospinal fluid, blood products, genetics, and&#xD;
      patient phenotypes that might help explain this process.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of our study is to better understand disease processes and risk factors involved&#xD;
      in onset of chronic daily headaches/Chronic Migraines. Further, The Investigators hopes to&#xD;
      learn more about the etiology and disease mechanisms to optimize treatment strategies and&#xD;
      determine prophylactic measures.&#xD;
&#xD;
      Participation in this research study, will include online questionnaires, a blood sample, a&#xD;
      lumbar puncture, and a magnetic resonance imaging (MRI) scan without contrast to measure&#xD;
      brain activity. Participant may select to participate in a magnetic resonance imaging (MRI)&#xD;
      scan and/ or lumbar puncture. participating in atleast 3 procedures is required (blood draw,&#xD;
      online questionnaires , MRI and/or Spinal Tap.&#xD;
&#xD;
      The study recruits participants with headache ( any type of headaches), and patients with no&#xD;
      headaches ( or less than 2/year). Participants do not need to have a specified headache type.&#xD;
      All participants are asked to complete an on-line survey to characterize a number of&#xD;
      phenotypic features felt to be relevant by the Investigators. Three independent study groups&#xD;
      (imaging, proteomics/genetics, and phenotyping) analyze data independently and stratify the&#xD;
      data. Then, by group analysis, correlation among the different modalities is sought to&#xD;
      identify features that distinguish common elements that might help elucidate features that&#xD;
      could predict which patients with episodic headache are likely to progress to chronic, and&#xD;
      which patients without headache might be at greater risk to develop new daily persistent&#xD;
      headache.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 12, 2014</start_date>
  <completion_date type="Anticipated">September 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">August 15, 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Prediction of chronification of headache</measure>
    <time_frame>five years</time_frame>
    <description>Brain Imaging, Phenotyping and Proteomics data will be combined to learn headache mechanisms.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">700</enrollment>
  <condition>Chronic Daily Headache</condition>
  <condition>Chronic Migraine</condition>
  <arm_group>
    <arm_group_label>Episodic Headache</arm_group_label>
    <description>Participants experiencing headache of any type more than twice per year but less than 15 days per month. No interventions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic Headache</arm_group_label>
    <description>Participants experiencing headache more than 15 days per month for at least three consecutive months. No interventions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Participants reporting fewer than two headaches per year. No interventions</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Cerebrospinal Fluid and Blood are collected and stored for analysis.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Anybody above 18 years of age regardless of their race, gender will be able to participate&#xD;
        in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects must agree to sign informed consent.&#xD;
&#xD;
          -  Subject must be able to or at least with some help willing to complete online&#xD;
             questionnaires in English .&#xD;
&#xD;
          -  Willing to comply with study instructions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        * Understand English.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Robert Cowan, MD, FAAN</last_name>
    <role>Principal Investigator</role>
    <affiliation>Stanford University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Bharati Sanjanwala, M.Sc.</last_name>
    <phone>650-721-2830</phone>
    <email>bharatis@stanford.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anthony Bet, B.S.</last_name>
    <phone>650-683-5823</phone>
    <email>abet0915@stanford.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Stanford University School of Medicine</name>
      <address>
        <city>Stanford</city>
        <state>California</state>
        <zip>94304</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bharati Sanjanwala, M.Sc.</last_name>
      <phone>650-721-2830</phone>
      <email>bharatis@stanford.edu</email>
    </contact>
    <contact_backup>
      <last_name>Anthony Bet, B.S.</last_name>
      <phone>650-683-5823</phone>
      <email>abet0915@stanford.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 14, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2017</study_first_posted>
  <last_update_submitted>August 4, 2022</last_update_submitted>
  <last_update_submitted_qc>August 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Stanford University</investigator_affiliation>
    <investigator_full_name>Robert Cowan</investigator_full_name>
    <investigator_title>Director and Chief, Division of Headache Medicine</investigator_title>
  </responsible_party>
  <keyword>Headaches</keyword>
  <keyword>Tension-Type Headache</keyword>
  <keyword>New Daily Persistent Headache (NDPH)</keyword>
  <keyword>Migraine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Headache Disorders</mesh_term>
    <mesh_term>Headache</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03231241
org study id: SunStar
nct id: NCT03231241
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Study is aimed at determining why some patients with episodic headache proceed to chronic
      daily or near daily headaches. The Investigators seek to discover differences in brain
      anatomy and function, composition of cerebrospinal fluid, blood products, genetics, and
      patient phenotypes that might help explain this process.
The purpose of our study is to better understand disease processes and risk factors involved
      in onset of chronic daily headaches/Chronic Migraines. Further, The Investigators hopes to
      learn more about the etiology and disease mechanisms to optimize treatment strategies and
      determine prophylactic measures.

      Participation in this research study, will include online questionnaires, a blood sample, a
      lumbar puncture, and a magnetic resonance imaging (MRI) scan without contrast to measure
      brain activity. Participant may select to participate in a magnetic resonance imaging (MRI)
      scan and/ or lumbar puncture. participating in atleast 3 procedures is required (blood draw,
      online questionnaires , MRI and/or Spinal Tap.

      The study recruits participants with headache ( any type of headaches), and patients with no
      headaches ( or less than 2/year). Participants do not need to have a specified headache type.
      All participants are asked to complete an on-line survey to characterize a number of
      phenotypic features felt to be relevant by the Investigators. Three independent study groups
      (imaging, proteomics/genetics, and phenotyping) analyze data independently and stratify the
      data. Then, by group analysis, correlation among the different modalities is sought to
      identify features that distinguish common elements that might help elucidate features that
      could predict which patients with episodic headache are likely to progress to chronic, and
      which patients without headache might be at greater risk to develop new daily persistent
      headache.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: Prediction of chronification of headache
time frame: five years
description: Brain Imaging, Phenotyping and Proteomics data will be combined to learn headache mechanisms.
arm group label: Episodic Headache
description: Participants experiencing headache of any type more than twice per year but less than 15 days per month. No interventions
arm group label: Chronic Headache
description: Participants experiencing headache more than 15 days per month for at least three consecutive months. No interventions
arm group label: Control
description: Participants reporting fewer than two headaches per year. No interventions
Cerebrospinal Fluid and Blood are collected and stored for analysis.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Robert Cowan, MD, FAAN
role: Principal Investigator
affiliation: Stanford University
last name: Bharati Sanjanwala, M.Sc.
phone: 650-721-2830
email: bharatis@stanford.edu
last name: Anthony Bet, B.S.
phone: 650-683-5823
email: abet0915@stanford.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Stanford University
investigator full name: Robert Cowan
investigator title: Director and Chief, Division of Headache Medicine
mesh term: Headache Disorders
mesh term: Headache
sharing ipd: No