<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/NCT03772860</url>
  </required_header>
  <id_info>
    <org_study_id>HYMC-113-18</org_study_id>
    <nct_id>NCT03772860</nct_id>
  </id_info>
  <brief_title>Defining the Sympathetic Skin Response of Migraineurs in the Facial Area</brief_title>
  <official_title>Defining the Sympathetic Skin Response of Migraineurs in the Facial Area During the Interictal State: Comparison of Migraine Patients Who Suffer Dominant Left/Right/Bilateral Pain.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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 this study is to define the sympathetic skin response of migraineurs in the facial&#xD;
      area. This will be achieved by exposing healthy volunteers and migraine patients to various&#xD;
      stress stimuli (pain, visual stimulation, auditory stimulation and a mathematical challenge),&#xD;
      and recording sympathetic skin response in the facial area.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</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>Defining sympathetic skin response in migraineurs</measure>
    <time_frame>One year</time_frame>
    <description>Outcome will be presented as mean sympathetic response values for all the different stimuli and then separately for each stimuli</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Defining differences between sympathetic skin response in migraineurs</measure>
    <time_frame>One year</time_frame>
    <description>Outcome will be presented as mean sympathetic response values for all the different stimuli and then separately for each stimuli</description>
  </secondary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Migraine Disorders</condition>
  <arm_group>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <description>Healthy volunteers will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Left headache</arm_group_label>
    <description>Migraine patients with mostly left sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Right headache</arm_group_label>
    <description>Migraine patients with mostly right sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bilateral headache</arm_group_label>
    <description>Migraine patients without a dominant side headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pain stimulation</intervention_name>
    <description>Pain will be simulated with an electric shock 25 mlAMP over the median nerve</description>
    <arm_group_label>Bilateral headache</arm_group_label>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Left headache</arm_group_label>
    <arm_group_label>Right headache</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Visual stimulation</intervention_name>
    <description>Visual stimulation will be performed by a flicker of light on a computer screen at 15 Hrz for 0.3 seconds</description>
    <arm_group_label>Bilateral headache</arm_group_label>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Left headache</arm_group_label>
    <arm_group_label>Right headache</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Auditory stimulation</intervention_name>
    <description>Auditory stimulation will be delivered through headphones with a sound at 500 Hrz at 85 decibels for 0.3 seconds</description>
    <arm_group_label>Bilateral headache</arm_group_label>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Left headache</arm_group_label>
    <arm_group_label>Right headache</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mental stress</intervention_name>
    <description>A mathematical challenge will be displayed on a computer screen that must be quickly solved</description>
    <arm_group_label>Bilateral headache</arm_group_label>
    <arm_group_label>Healthy volunteers</arm_group_label>
    <arm_group_label>Left headache</arm_group_label>
    <arm_group_label>Right headache</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffering migraine attending our Neurology Clinic and healthy volunteers&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy volunteers with no history of any kind of recurrent headache&#xD;
&#xD;
          -  Migraine patients according to ICH3 criteria&#xD;
&#xD;
          -  Migraine patients with more than 1 attack per month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with other heart or neurologic diseases&#xD;
&#xD;
          -  Patients with hearing or visual decline&#xD;
&#xD;
          -  Patients taking medication that effects the sympathetic system (except those taking&#xD;
             beta blockers for migraine treatment)&#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>Yaron River, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hillel Yaffe Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Erel Domany, MD</last_name>
    <phone>972-52-6134235</phone>
    <email>erel.domany@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hillel Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Erel Domany, MD</last_name>
      <email>erel.domany@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 5, 2018</study_first_submitted>
  <study_first_submitted_qc>December 10, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 10, 2018</last_update_submitted>
  <last_update_submitted_qc>December 10, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 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>
  </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/NCT03772860
org study id: HYMC-113-18
nct id: NCT03772860
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to define the sympathetic skin response of migraineurs in the facial
      area. This will be achieved by exposing healthy volunteers and migraine patients to various
      stress stimuli (pain, visual stimulation, auditory stimulation and a mathematical challenge),
      and recording sympathetic skin response in the facial area.
observational model: Case-Control
time perspective: Prospective
measure: Defining sympathetic skin response in migraineurs
time frame: One year
description: Outcome will be presented as mean sympathetic response values for all the different stimuli and then separately for each stimuli
measure: Defining differences between sympathetic skin response in migraineurs
time frame: One year
description: Outcome will be presented as mean sympathetic response values for all the different stimuli and then separately for each stimuli
arm group label: Healthy volunteers
description: Healthy volunteers will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress
arm group label: Left headache
description: Migraine patients with mostly left sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress
arm group label: Right headache
description: Migraine patients with mostly right sided headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress
arm group label: Bilateral headache
description: Migraine patients without a dominant side headache will be exposed to pain stimulation, visual stimulation, auditory stimulation and mental stress
intervention type: Other
intervention name: Pain stimulation
description: Pain will be simulated with an electric shock 25 mlAMP over the median nerve
arm group label: Bilateral headache
arm group label: Healthy volunteers
arm group label: Left headache
arm group label: Right headache
intervention type: Other
intervention name: Visual stimulation
description: Visual stimulation will be performed by a flicker of light on a computer screen at 15 Hrz for 0.3 seconds
arm group label: Bilateral headache
arm group label: Healthy volunteers
arm group label: Left headache
arm group label: Right headache
intervention type: Other
intervention name: Auditory stimulation
description: Auditory stimulation will be delivered through headphones with a sound at 500 Hrz at 85 decibels for 0.3 seconds
arm group label: Bilateral headache
arm group label: Healthy volunteers
arm group label: Left headache
arm group label: Right headache
intervention type: Other
intervention name: Mental stress
description: A mathematical challenge will be displayed on a computer screen that must be quickly solved
arm group label: Bilateral headache
arm group label: Healthy volunteers
arm group label: Left headache
arm group label: Right headache
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Yaron River, MD
role: Study Director
affiliation: Hillel Yaffe Medical Center
last name: Erel Domany, MD
phone: 972-52-6134235
email: erel.domany@gmail.com
facility: 
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Migraine Disorders
sharing ipd: No