<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/NCT03037398</url>
  </required_header>
  <id_info>
    <org_study_id>A4063</org_study_id>
    <nct_id>NCT03037398</nct_id>
  </id_info>
  <brief_title>Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation</brief_title>
  <acronym>CLOVER</acronym>
  <official_title>Closed Loop Programming Evaluation Using External Responses for Deep Brain Stimulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to evaluate the performance of novel DBS programming methods&#xD;
      compared to traditional programming methods.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 11, 2017</start_date>
  <completion_date type="Anticipated">December 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in time to program between the two arms at Programming Visit</measure>
    <time_frame>at least four months post implant</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Novel Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Programming completed by a novel method</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of Care Arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Programming completed as Standard of care</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Vercise Deep Brain Stimulation System</intervention_name>
    <arm_group_label>Novel Arm</arm_group_label>
    <arm_group_label>Standard of Care Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Implanted bilaterally in STN with a Vercise™ DBS system for Parkinson's disease for at&#xD;
             least four months and programming optimized according to standard of care with no&#xD;
             changes to electrode configuration of primary settings for at least four weeks.&#xD;
&#xD;
          -  Able to understand the study requirements and the treatment procedures and provides&#xD;
             written informed consent before any study-specific tests or procedures are performed.&#xD;
&#xD;
          -  Be at least 18 years of age.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any significant psychiatric problems, including unrelated clinically significant&#xD;
             depression as determined by the investigator.&#xD;
&#xD;
          -  Device must be implanted on label.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Natalie Bloom Lyons</last_name>
    <role>Study Director</role>
    <affiliation>Boston Scientific Neuromodulation Corporation</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Heleen Scholtes</last_name>
    <phone>855-213-9890</phone>
    <email>BSNClinicalTrials@bsci.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Diane Keesey</last_name>
    <phone>855-213-9890</phone>
    <email>BSNClinicalTrials@bsci.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Berlin, Charite Virchow Standort, Wedding</name>
      <address>
        <city>Berlin</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinik Eppendorf</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Campus Kiel</name>
      <address>
        <city>Kiel</city>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Boston Scientific Clinical Research Manager</last_name>
      <phone>855-213-9890</phone>
      <email>BSNClinicalTrials@bsci.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 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>
  </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/NCT03037398
org study id: A4063
nct id: NCT03037398
lead sponsor: 
has dmc: No
The objective of this study is to evaluate the performance of novel DBS programming methods
      compared to traditional programming methods.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Difference in time to program between the two arms at Programming Visit
time frame: at least four months post implant
arm group label: Novel Arm
arm group type: Active Comparator
description: Programming completed by a novel method
arm group label: Standard of Care Arm
arm group type: Other
description: Programming completed as Standard of care
intervention type: Device
intervention name: Vercise Deep Brain Stimulation System
arm group label: Novel Arm
arm group label: Standard of Care Arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Natalie Bloom Lyons
role: Study Director
affiliation: Boston Scientific Neuromodulation Corporation
last name: Heleen Scholtes
phone: 855-213-9890
email: BSNClinicalTrials@bsci.com
last name: Diane Keesey
phone: 855-213-9890
email: BSNClinicalTrials@bsci.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Germany
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No