<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/NCT03269539</url>
  </required_header>
  <id_info>
    <org_study_id>Bio 16-278</org_study_id>
    <nct_id>NCT03269539</nct_id>
  </id_info>
  <brief_title>Assessment of Siemens' GoBrain and DotBrain Software</brief_title>
  <official_title>Assessment of Siemens' GoBrain and DotBrain Software</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Saskatchewan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Saskatchewan</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Our main approach in this research is to collect MR data using both a &quot;Routine&quot; and &quot;Fast&quot;&#xD;
      brain protocol on the 3 Tesla Siemens Skyra scanner using a 20-Channel Head/Neck Coil to&#xD;
      determine if the &quot;Fast&quot; protocol can collect data in less time without compromising patient&#xD;
      care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">May 2018</completion_date>
  <primary_completion_date type="Anticipated">November 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Assessment of Siemens' GoBrain and DotBrain Software</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Headache</condition>
  <arm_group>
    <arm_group_label>Headache Patients</arm_group_label>
    <description>Patients Referred for MRI with History of Headaches</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Motion prone patients</arm_group_label>
    <description>Patients without the ability to remain still for the entire protocol</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>MRI Imaging</intervention_name>
    <arm_group_label>Headache Patients</arm_group_label>
    <arm_group_label>Motion prone patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients referred for MRI with History of Headaches&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients referred for MRI with History of Headaches&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient does not meet MRI safety criteria&#xD;
&#xD;
          -  Patient has known Brain Pathology&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</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>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/NCT03269539
org study id: Bio 16-278
nct id: NCT03269539
lead sponsor: 
has dmc: No
Our main approach in this research is to collect MR data using both a "Routine" and "Fast"
      brain protocol on the 3 Tesla Siemens Skyra scanner using a 20-Channel Head/Neck Coil to
      determine if the "Fast" protocol can collect data in less time without compromising patient
      care.
observational model: Cohort
time perspective: Prospective
measure: Assessment of Siemens' GoBrain and DotBrain Software
time frame: 1 year
arm group label: Headache Patients
description: Patients Referred for MRI with History of Headaches
arm group label: Motion prone patients
description: Patients without the ability to remain still for the entire protocol
intervention type: Other
intervention name: MRI Imaging
arm group label: Headache Patients
arm group label: Motion prone patients
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 7 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Headache
sharing ipd: No