xml: <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/NCT05962489</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY00018981</org_study_id>
      <nct_id>NCT05962489</nct_id>
    </id_info>
    <brief_title>DBS and Sleep Outcomes</brief_title>
    <official_title>Sleep Outcomes With DBS Therapy in Parkinson's Disease and Dystonia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Minnesota</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Minnesota</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The objective of this study is to describe how activation of distinct pathways in and around&#xD;
        the subthalamic nucleus (STN) and internal segment of the globus pallidus (GPi) correlate to&#xD;
        changes in sleep outcomes in movement disorders patients after deep brain stimulation (DBS)&#xD;
        surgery targeting these structures.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2027</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2026</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Only</observational_model>
      <time_perspective>Other</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>pallidopeduncular and pedunculopallidal pathway activation</measure>
      <time_frame>6 months post DBS surgery</time_frame>
      <description>Percent of pallidopeduncular and pedunculopallidal pathway activation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>pallidopeduncular and pedunculopallidal pathway activation</measure>
      <time_frame>12 months post DBS surgery</time_frame>
      <description>Percent of pallidopeduncular and pedunculopallidal pathway activation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>GPe activation</measure>
      <time_frame>6 months post DBS surgery</time_frame>
      <description>percent of GPe activation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>GPe activation</measure>
      <time_frame>12 months post DBS surgery</time_frame>
      <description>percent of GPe activation</description>
    </primary_outcome>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Deep Brain Stimulation</condition>
    <condition>Parkinson's Disease and Parkinsonism</condition>
    <condition>Dystonia</condition>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>DBS</intervention_name>
      <description>deep brain stimulation</description>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with deep brain stimulation, Parkinson's Disease, dystonia&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. At least 21 years old&#xD;
  &#xD;
            2. Existing or planned 7T brain imaging&#xD;
  &#xD;
            3. Surgery at UMN to implant DBS system in GPi or STN is planned as part of routine&#xD;
               clinical care (or has already occurred, as long as the initial programming session is&#xD;
               at least 2 weeks away)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Other significant neurological disorder&#xD;
  &#xD;
            2. History of dementia&#xD;
  &#xD;
            3. Patients with post-operative complications or adverse effects (e.g. ON stimulation&#xD;
               dystonias) that affect patient safety or confound the experiment will be excluded from&#xD;
               further study&#xD;
  &#xD;
            4. Pregnant women&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Luke Johnson, PhD</last_name>
      <phone>612-625-9900</phone>
      <email>joh03032@umn.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>University Of Minnesota</name>
        <address>
          <city>Minneapolis</city>
          <state>Minnesota</state>
          <zip>55455</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Luke Johnson, PhD</last_name>
        <phone>612-625-9900</phone>
        <email>joh03032@umn.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>June 28, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>September 13, 2023</last_update_submitted>
    <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</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>Parkinson Disease</mesh_term>
      <mesh_term>Dystonia</mesh_term>
      <mesh_term>Dystonic Disorders</mesh_term>
      <mesh_term>Parkinsonian Disorders</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05962489
  org study id: STUDY00018981
  nct id: NCT05962489
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The objective of this study is to describe how activation of distinct pathways in and around
        the subthalamic nucleus (STN) and internal segment of the globus pallidus (GPi) correlate to
        changes in sleep outcomes in movement disorders patients after deep brain stimulation (DBS)
        surgery targeting these structures.
  observational model: Case-Only
  time perspective: Other
  measure: pallidopeduncular and pedunculopallidal pathway activation
  time frame: 6 months post DBS surgery
  description: Percent of pallidopeduncular and pedunculopallidal pathway activation
  measure: pallidopeduncular and pedunculopallidal pathway activation
  time frame: 12 months post DBS surgery
  description: Percent of pallidopeduncular and pedunculopallidal pathway activation
  measure: GPe activation
  time frame: 6 months post DBS surgery
  description: percent of GPe activation
  measure: GPe activation
  time frame: 12 months post DBS surgery
  description: percent of GPe activation
  intervention type: Device
  intervention name: DBS
  description: deep brain stimulation
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Luke Johnson, PhD
  phone: 612-625-9900
  email: joh03032@umn.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Sponsor
  mesh term: Parkinson Disease
  mesh term: Dystonia
  mesh term: Dystonic Disorders
  mesh term: Parkinsonian Disorders