<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/NCT02259387</url>
  </required_header>
  <id_info>
    <org_study_id>13-3128</org_study_id>
    <secondary_id>UL1TR001082</secondary_id>
    <nct_id>NCT02259387</nct_id>
  </id_info>
  <brief_title>Adolescents With Migraine: What's Stress Got To Do With It?</brief_title>
  <acronym>Adostress</acronym>
  <official_title>Adolescents With Migraine: What's Stress Got To Do With It?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall objective of this proposal is to better define the relationship between perceived&#xD;
      stress, hair cortisol, and migraine in adolescents. This will be done by creating 2 arms of&#xD;
      the study: those with migraines (cases) and those without migraines or headaches (controls).&#xD;
      Each arm will answer several of the same questionnaires and have hair cortisol samples taken&#xD;
      multiple times over the course of 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The overall objective of this proposal is to better define the relationship between perceived&#xD;
      stress, hair cortisol, and migraine in adolescents. Although adolescents most frequently&#xD;
      report stress as their migraine trigger, stress measurement and treatment are usually beyond&#xD;
      the scope of routine clinical care. Hair cortisol levels may identify stressed adolescents&#xD;
      who need structured stress management, as well as provide objective evidence for the medical&#xD;
      community, migraineurs (i.e. individuals who experience migraines), and their families, who&#xD;
      may be reluctant to accept stress as a migraine factor. The rationale for this research is&#xD;
      that scientific validation of an association between stress and migraine will inform future&#xD;
      prevention studies in the headache field and potentially identify a stress biomarker for&#xD;
      migraine.&#xD;
&#xD;
      This prospective study will enroll 67 adolescents (aged 13-17) with migraine and 33&#xD;
      adolescents without migraine for 12 weeks with the following aims:&#xD;
&#xD;
      Aim 1: Measure the relationship between hair cortisol concentration and perceived stress in&#xD;
      adolescents with and without migraine.&#xD;
&#xD;
      Hypothesis: The association between hair cortisol and perceived stress (3 month averages)&#xD;
      will be a positive in both adolescents with and without migraine.&#xD;
&#xD;
      Aim 2: Measure the relationship between migraine frequency with perceived stress and hair&#xD;
      cortisol concentration in adolescents with migraine.&#xD;
&#xD;
      Hypothesis: The association between migraine frequency with (a) perceived stress and (b) hair&#xD;
      cortisol will be positive in adolescents with migraines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2014</start_date>
  <completion_date type="Actual">October 15, 2017</completion_date>
  <primary_completion_date type="Actual">September 15, 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between hair cortisol and perceived stress</measure>
    <time_frame>12 weeks</time_frame>
    <description>Hair cortisol (a biomarker of stress) will be correlated with perceived stress (as measured by participant-answered questionnaires). We expect a positive correlation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Correlation between headache frequency, perceived stress, and hair cortisol.</measure>
    <time_frame>12 weeks</time_frame>
    <description>Hair cortisol (a biomarker of stress) will be correlated with perceived stress (as measured by participant-answered questionnaires) and headache frequency (as measured by a headache diary, which will measure how many days per month a child has headaches). We expect a positive correlation.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">100</enrollment>
  <condition>Headache, Migraine</condition>
  <arm_group>
    <arm_group_label>Cases</arm_group_label>
    <description>Children with migraines will be placed into this group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Controls</arm_group_label>
    <description>Children without migraines or headaches will be placed into this group.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Hair samples for cortisol.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        The population to be sampled is adolescents (13-17 years old) with migraines, both male and&#xD;
        female. Migraines are common in the pediatric population with a prevalence as high as 10%&#xD;
        in children 5-14 years old,1 and 28% in adolescents 15-19 years old (Split W, 1999).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        For Cases:&#xD;
&#xD;
          -  Diagnosis of Migraine as defined by the ICHD-II&#xD;
&#xD;
          -  At least 1 migraine per month&#xD;
&#xD;
        For Controls:&#xD;
&#xD;
          -  No diagnosis of Migraine as defined by ICHD-II&#xD;
&#xD;
          -  No diagnosis of Primary Headache Disorders as defined by ICHD-II&#xD;
&#xD;
        Exclusion Criteria for Migrainers and Non-migrainers:&#xD;
&#xD;
          -  A secondary headache disorder as defined by ICHD-II&#xD;
&#xD;
          -  A continuous headache (i.e. 24 hours a day every day)&#xD;
&#xD;
          -  An underlying neurological condition such as epilepsy, chiari malformation, or&#xD;
             neurocutaneous disorder&#xD;
&#xD;
          -  A chronic medical illness including those illnesses that require chronic steroid use&#xD;
             such as asthma, cancer or rheumatologic disorders&#xD;
&#xD;
          -  Subject has bleached hair in past 3 months.&#xD;
&#xD;
          -  Pubertal Tanner stage 1 or 2 (Hair cortisol concentration may depend on developmental&#xD;
             stage; 59 Tanner staging will be performed by Dr. Kedia).&#xD;
&#xD;
          -  Subject is pregnant or has a positive pregnancy test.&#xD;
&#xD;
          -  Present psychiatric disease as defined by the Diagnostic and Statistical Manual of&#xD;
             Mental Disorders, 4th Edition (DSM IV) (e.g. psychosis, bipolar disorder, major&#xD;
             depression, generalized anxiety disorder), alcohol or drug dependence, or documented&#xD;
             developmental delays or impairments (e.g., autism, cerebral palsy, or mental&#xD;
             retardation) that, in the opinion of the site investigator, would interfere with&#xD;
             adherence to study requirements or safe participation in the trial&#xD;
&#xD;
          -  Any and all other diagnoses or conditions which in the opinion of the primary&#xD;
             investigator would prevent the patient from being a suitable candidate for the study&#xD;
             or interfere with the medical care needs of the study subject.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sita Kedia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Colorado Children's Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Split W, Neuman W. Epidemiology of migraine among students from randomly selected secondary schools in Lodz. Headache. 1999 Jul-Aug;39(7):494-501. doi: 10.1046/j.1526-4610.1999.3907494.x.</citation>
    <PMID>11279934</PMID>
  </reference>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>October 3, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>June 6, 2018</last_update_submitted>
  <last_update_submitted_qc>June 6, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Migraine Disorders</mesh_term>
    <mesh_term>Headache</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/NCT02259387
org study id: 13-3128
secondary id: UL1TR001082
nct id: NCT02259387
lead sponsor: 
has dmc: No
The overall objective of this proposal is to better define the relationship between perceived
      stress, hair cortisol, and migraine in adolescents. This will be done by creating 2 arms of
      the study: those with migraines (cases) and those without migraines or headaches (controls).
      Each arm will answer several of the same questionnaires and have hair cortisol samples taken
      multiple times over the course of 12 weeks.
The overall objective of this proposal is to better define the relationship between perceived
      stress, hair cortisol, and migraine in adolescents. Although adolescents most frequently
      report stress as their migraine trigger, stress measurement and treatment are usually beyond
      the scope of routine clinical care. Hair cortisol levels may identify stressed adolescents
      who need structured stress management, as well as provide objective evidence for the medical
      community, migraineurs (i.e. individuals who experience migraines), and their families, who
      may be reluctant to accept stress as a migraine factor. The rationale for this research is
      that scientific validation of an association between stress and migraine will inform future
      prevention studies in the headache field and potentially identify a stress biomarker for
      migraine.

      This prospective study will enroll 67 adolescents (aged 13-17) with migraine and 33
      adolescents without migraine for 12 weeks with the following aims:

      Aim 1: Measure the relationship between hair cortisol concentration and perceived stress in
      adolescents with and without migraine.

      Hypothesis: The association between hair cortisol and perceived stress (3 month averages)
      will be a positive in both adolescents with and without migraine.

      Aim 2: Measure the relationship between migraine frequency with perceived stress and hair
      cortisol concentration in adolescents with migraine.

      Hypothesis: The association between migraine frequency with (a) perceived stress and (b) hair
      cortisol will be positive in adolescents with migraines.
observational model: Case-Control
time perspective: Prospective
measure: Correlation between hair cortisol and perceived stress
time frame: 12 weeks
description: Hair cortisol (a biomarker of stress) will be correlated with perceived stress (as measured by participant-answered questionnaires). We expect a positive correlation.
measure: Correlation between headache frequency, perceived stress, and hair cortisol.
time frame: 12 weeks
description: Hair cortisol (a biomarker of stress) will be correlated with perceived stress (as measured by participant-answered questionnaires) and headache frequency (as measured by a headache diary, which will measure how many days per month a child has headaches). We expect a positive correlation.
arm group label: Cases
description: Children with migraines will be placed into this group.
arm group label: Controls
description: Children without migraines or headaches will be placed into this group.
Hair samples for cortisol.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 13 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sita Kedia, MD
role: Principal Investigator
affiliation: University of Colorado, Denver
facility: 
country: United States
citation: Split W, Neuman W. Epidemiology of migraine among students from randomly selected secondary schools in Lodz. Headache. 1999 Jul-Aug;39(7):494-501. doi: 10.1046/j.1526-4610.1999.3907494.x.
PMID: 11279934
responsible party type: Sponsor
mesh term: Migraine Disorders
mesh term: Headache