<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/NCT04409977</url>
  </required_header>
  <id_info>
    <org_study_id>2018-02389</org_study_id>
    <nct_id>NCT04409977</nct_id>
  </id_info>
  <brief_title>Circadian Changes of the Hypothalamic Activity in Patients Suffering From Cluster Headache</brief_title>
  <official_title>Circadian Changes of the Hypothalamic Activity in Patients Suffering From Cluster Headache</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Zurich</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zurich</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>
      Cluster headache attacks do not occur randomly throughout the day, but have a clear circadian&#xD;
      rhythmicity. The aim of this study is to investigate circadian changes of the brain, the&#xD;
      autonomic nervous system and pain processing systems.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Cluster headache attacks do not occur randomly throughout the day, but have a clear circadian&#xD;
      rhythmicity. The aim of this study is to investigate circadian changes in the functional&#xD;
      connectivity, spectroscopy, iron deposition and perfusion of the brain. In addition, we plan&#xD;
      to investigate circadian changes in the pain threshold of the brain using quantitative&#xD;
      sensory testing (QST). Finally, we will investigate changes in the autonomic nervous system&#xD;
      measuring the pupillary response.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 26, 2019</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 30, 2020</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>Circadian rhythmicity of the functional connectivity of the brain</measure>
    <time_frame>Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.</time_frame>
    <description>Changes from baseline in functional connectivity of the brain using whole-brain fMRI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Circadian rhythmicity of the pain threshold</measure>
    <time_frame>Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.</time_frame>
    <description>Changes from baseline of the pain threshold in the face using quantitative sensory testing (QST)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circadian changes in the perfusion of the brain.</measure>
    <time_frame>Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.</time_frame>
    <description>Changes from baseline in perfusion of the brain using Arterial Spin Labeled MRI Perfusion Imaging and vascular space occupancy sequences</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circadian rhythmicity of the autonomic system</measure>
    <time_frame>Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.</time_frame>
    <description>Changes from baseline in the pupillary response (measured using pupillometry)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circadian rhythmicity of the spectroscopy of the hypothalamus</measure>
    <time_frame>Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.</time_frame>
    <description>Changes from baseline in the spectroscopy of the hypothalamus</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Circadian rhythmicity of the spectroscopy of the hypothalamus</measure>
    <time_frame>Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.</time_frame>
    <description>Changes from baseline in the iron concentration of the brain using quantitative susceptibility mapping</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Cluster Headache</condition>
  <arm_group>
    <arm_group_label>Patient group</arm_group_label>
    <description>Patients suffering from cluster headache will be included in this group. When analysing the data, the investigators will distinguish those in the in-bout period from those in the out-bout period. People in this group may participate twice: once in the in-bout and once in the out-bout period.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Participants not suffering from cluster headache will be included in this group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI examination</intervention_name>
    <description>Patient will be scanned in the MRI twice, once at noon (+/- 1 hour), once at 1 a.m. (+/- 1 hour). The investigators will search for any changes in functional connectivity, particular regarding the connection between the hypothalamus and pain-processing networks.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Patient group</arm_group_label>
    <other_name>quantitative sensory testing (QST)</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients suffering from cluster headache.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of cluster headache (CH) may enter the patient group, patients not suffering&#xD;
             from CH may enter the control group.&#xD;
&#xD;
          -  knowledge of the german language suffices to understand the information sheet and&#xD;
             consent form&#xD;
&#xD;
          -  having read, understood and signed the consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  contraindications for the MRI scan (particularly metal splinters, ferromagnetic&#xD;
             devices and implants)&#xD;
&#xD;
          -  claustrophobia&#xD;
&#xD;
          -  obesity (MRI &gt; 35 kg/m2)&#xD;
&#xD;
          -  shift working (last night shift must date back more than one week)&#xD;
&#xD;
          -  jet lag (last travel over more than two time zones must date back more than one week)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Heiko Pohl, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Zurich</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Heiko Pohl, MD</last_name>
    <phone>+41 44 255 1856</phone>
    <email>heiko.pohl@usz.ch</email>
  </overall_contact>
  <location>
    <facility>
      <name>University hospital Zurich</name>
      <address>
        <city>Zürich</city>
        <state>Zurich</state>
        <zip>8091</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heiko Pohl, MD</last_name>
      <phone>+41 44 255 1856</phone>
      <email>heiko.pohl@usz.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>June 26, 2019</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>May 26, 2020</last_update_submitted>
  <last_update_submitted_qc>May 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Primary Headache</keyword>
  <keyword>Trigeminal autonomic cephalgia</keyword>
  <keyword>functional connectivity</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cluster Headache</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/NCT04409977
org study id: 2018-02389
nct id: NCT04409977
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Cluster headache attacks do not occur randomly throughout the day, but have a clear circadian
      rhythmicity. The aim of this study is to investigate circadian changes of the brain, the
      autonomic nervous system and pain processing systems.
Cluster headache attacks do not occur randomly throughout the day, but have a clear circadian
      rhythmicity. The aim of this study is to investigate circadian changes in the functional
      connectivity, spectroscopy, iron deposition and perfusion of the brain. In addition, we plan
      to investigate circadian changes in the pain threshold of the brain using quantitative
      sensory testing (QST). Finally, we will investigate changes in the autonomic nervous system
      measuring the pupillary response.
observational model: Case-Control
time perspective: Prospective
measure: Circadian rhythmicity of the functional connectivity of the brain
time frame: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
description: Changes from baseline in functional connectivity of the brain using whole-brain fMRI
measure: Circadian rhythmicity of the pain threshold
time frame: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
description: Changes from baseline of the pain threshold in the face using quantitative sensory testing (QST)
measure: Circadian changes in the perfusion of the brain.
time frame: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
description: Changes from baseline in perfusion of the brain using Arterial Spin Labeled MRI Perfusion Imaging and vascular space occupancy sequences
measure: Circadian rhythmicity of the autonomic system
time frame: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
description: Changes from baseline in the pupillary response (measured using pupillometry)
measure: Circadian rhythmicity of the spectroscopy of the hypothalamus
time frame: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
description: Changes from baseline in the spectroscopy of the hypothalamus
measure: Circadian rhythmicity of the spectroscopy of the hypothalamus
time frame: Measurements will be made at noon and at 1 a.m. (+/- 2 hours); we will compare these measurements to identify changes.
description: Changes from baseline in the iron concentration of the brain using quantitative susceptibility mapping
arm group label: Patient group
description: Patients suffering from cluster headache will be included in this group. When analysing the data, the investigators will distinguish those in the in-bout period from those in the out-bout period. People in this group may participate twice: once in the in-bout and once in the out-bout period.
arm group label: Control group
description: Participants not suffering from cluster headache will be included in this group.
intervention type: Diagnostic Test
intervention name: MRI examination
description: Patient will be scanned in the MRI twice, once at noon (+/- 1 hour), once at 1 a.m. (+/- 1 hour). The investigators will search for any changes in functional connectivity, particular regarding the connection between the hypothalamus and pain-processing networks.
arm group label: Control group
arm group label: Patient group
other name: quantitative sensory testing (QST)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Heiko Pohl, MD
role: Principal Investigator
affiliation: University of Zurich
last name: Heiko Pohl, MD
phone: +41 44 255 1856
email: heiko.pohl@usz.ch
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Sponsor
mesh term: Cluster Headache
mesh term: Headache