<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/NCT02989610</url>
  </required_header>
  <id_info>
    <org_study_id>SJM-CIP-10061</org_study_id>
    <nct_id>NCT02989610</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of the Infinity Deep Brain Stimulation System</brief_title>
  <acronym>PROGRESS</acronym>
  <official_title>Post Market Clinical Follow Up Evaluating the Infinity Deep Brain Stimulation Implantable Pulse Generator System</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Abbott Medical Devices</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Abbott Medical Devices</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this post-market study is to characterize the clinical performance of the&#xD;
      Infinity Deep Brain Stimulation (DBS) system, including the Implantable Pulse Generator&#xD;
      (IPG), directional DBS leads, extensions, iPad clinician programmer, iPod patient controller&#xD;
      and related system components.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2017</start_date>
  <completion_date type="Actual">April 19, 2022</completion_date>
  <primary_completion_date type="Actual">August 7, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Single-arm crossover study, with double-blind, randomized sequence of testing for primary endpoint.&#xD;
Although this was a crossover study, the primary endpoint was a double-blind randomized controlled assessment of therapeutic window during the 3-month clinic visit. Subjects received both directional and omnidirectional stimulation, and the order was randomized.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Single-arm, open-label design for overall study. Primary endpoint is based on double-blind, randomized testing of omnidirectional and directional DBS during three-month follow visit. Participants are blinded to all details of stimulation for first six months, including details of stimulation testing. Outcomes assessor is blinded to stimulation type for primary and secondary endpoints.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Wider Therapeutic Window With Directional Programming (Superiority)</measure>
    <time_frame>3-month follow-up visit after initial programming</time_frame>
    <description>Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. Proportion of subjects with a wider therapeutic window using directional stimulation, compared to a threshold of 60%. Based on randomized, double-blind evaluation using within-subject control.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Wider Therapeutic Window With Directional Programming (Non-inferiority)</measure>
    <time_frame>3-month follow-up visit after initial programming</time_frame>
    <description>Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. The proportion of subjects with wider therapeutic window using directional stimulation will be compared to a performance goal of 60% with a non-inferiority threshold of 40%. Based on randomized, double-blind evaluation using within-subject control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in UPDRS III Score on and Off Stimulation (Medication on) at 3 and 6 Months</measure>
    <time_frame>3-month and 6-month follow-up visits</time_frame>
    <description>Change with stimulation on vs. off in Unified Parkinson's Disease Rating Scale (UPDRS) part III motor examination at 3 months using omnidirectional stimulation, compared to 6 months using directional stimulation. UPDRS part III contains 27 questions used to measures severity of Parkinson's motor symptoms. The range of scores is 0 to 108, with higher score indicating greater symptoms. Subjects are on medication for the assessment.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">234</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Omnidirectional followed by directional DBS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for months 3-6 in all subjects with a directional DBS lead. Primary endpoint is based on double-blind testing of omnidirectional vs. directional DBS in randomized order at 3-month follow-up visit.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Omnidirectional stimulation</intervention_name>
    <description>At the 3-month follow-up, therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional stimulation with the Infinity DBS lead.</description>
    <arm_group_label>Omnidirectional followed by directional DBS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Directional stimulation</intervention_name>
    <description>At the 3-month follow-up, therapeutic window, symptom relief and side effect thresholds are evaluated using directional contacts at the best segmented level of the Infinity DBS lead.</description>
    <arm_group_label>Omnidirectional followed by directional DBS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is able to provide informed consent;&#xD;
&#xD;
          -  Subject is diagnosed with Parkinson's disease (PD) and has been recommended to receive&#xD;
             an Infinity DBS system with a bilateral DBS implant in the Subthalamic Nucleus (STN),&#xD;
             or has received an implant of an Infinity system with bilateral lead implants in the&#xD;
             STN;&#xD;
&#xD;
          -  Subject must be available for follow-up visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is not a surgical candidate;&#xD;
&#xD;
          -  In the investigator's opinion, the subject is unable to tolerate multiple programming&#xD;
             sessions within a single setting;&#xD;
&#xD;
          -  Subject is unable to comply with the follow-up schedule.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alfons Schnitzler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Heinrich-Heine-Universität Düsseldorf, Institute for Clinical Neuroscience</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jan Vesper, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Heinrich-Heine-Universität Düsseldorf, Department of Functional and Stereotactic Neurosurgery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sacramento Medical Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>94229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shands at University of Florida</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami Hospital</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush University, Department of Neurological Sciences</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansas University Medical Center</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johns Hopkins University Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>20814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Robert Wood Johnson University Hospital</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Albany Medical Center</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York University Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital, New York, Department of Neurology</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cleveland Clinic Foundation</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health &amp; Science University</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oregon Health and Science University, Department of Neurology</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Hospital &amp; Health Network</name>
      <address>
        <city>Bethlehem</city>
        <state>Pennsylvania</state>
        <zip>18018</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pennsylvania Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thomas Jefferson University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegheny General Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Neurology Consultants of Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75251</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI St. Luke's Health Baylor College</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abbott, Medical and Clinical Affairs</name>
      <address>
        <city>Plano</city>
        <state>Texas</state>
        <zip>75024</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Alexandra Hospital</name>
      <address>
        <city>Brisbane</city>
        <zip>4102</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Melbourne Hospital, Department of Neurology</name>
      <address>
        <city>Melbourne</city>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Melbourne Hospital</name>
      <address>
        <city>Melbourne</city>
        <zip>3050</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Westmead Hospital</name>
      <address>
        <city>Richmond</city>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johannes Gutenberg University of Mainz, Department of Neurosurgery</name>
      <address>
        <city>Mainz,</city>
        <state>Mainz</state>
        <zip>55126</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Carl Gustav Carus Dresden</name>
      <address>
        <city>Dresden</city>
        <zip>1815</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heinrich Heine University of Düsseldorf, Department of Neurology</name>
      <address>
        <city>Düsseldorf,</city>
        <zip>40210</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heinrich Heine University of Düsseldorf, Department of Neurology</name>
      <address>
        <city>Düsseldorf</city>
        <zip>40210</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heinrich Heine University of Düsseldorf, Department of Neurosurgery</name>
      <address>
        <city>Düsseldorf</city>
        <zip>40210</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heinrich Heine University of Düsseldorf, Department of Neurology</name>
      <address>
        <city>Düsseldorf</city>
        <zip>40225</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Einrichtungen der Universität Düsseldorf</name>
      <address>
        <city>Düsseldorf</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Centre Hamburg, Department of Neurology,</name>
      <address>
        <city>Hamburg</city>
        <zip>20251</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UKE Hamburg</name>
      <address>
        <city>Hamburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johannes Gutenberg-University of Mainz</name>
      <address>
        <city>Mainz</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinikum der Universität Regensburg</name>
      <address>
        <city>Regensburg</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IRCCS Istituto Ortopedico Galeazzi</name>
      <address>
        <city>Milano</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Istituto Neurologico Nazionale C. Mondino</name>
      <address>
        <city>Pavia</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria S Maria della Misericordia</name>
      <address>
        <city>Udine</city>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Copernicus Hospital, Department of Neurosurgery,</name>
      <address>
        <city>Gdańsk</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute of Psychiatry and Neurology</name>
      <address>
        <city>Warsaw</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Trias i Pujol, Department of Neurology</name>
      <address>
        <city>Badalona</city>
        <zip>08917</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Trias i Pujol</name>
      <address>
        <city>Badalona</city>
        <zip>08917</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Central de Asturias</name>
      <address>
        <city>Oviedo</city>
        <zip>32762</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Central de Asturias, Department of Neurology,</name>
      <address>
        <city>Oviedo</city>
        <zip>33011</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocío, Department of Neurology</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen del Rocío, Department of Neurology</name>
      <address>
        <city>Sevilla</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Belgium</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2022</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <results_first_submitted>September 4, 2020</results_first_submitted>
  <results_first_submitted_qc>October 28, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">November 19, 2020</results_first_posted>
  <last_update_submitted>June 28, 2022</last_update_submitted>
  <last_update_submitted_qc>June 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2022</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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 23, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/10/NCT02989610/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The PROGRESS study enrolled a total of 234 participants between January 2017 and January 2019 at 37 sites in Europe, the U.S. and Australia. Of which 195 participants completed 6 months follow-up visit.</recruitment_details>
      <pre_assignment_details>Of the 234 enrolled participants, there were 230 participants who had initial study programming. Out of 212 participants who completed the 3-month visit, there were 202 with complete primary endpoint data. After the 3-month visit, 17 were withdrawn or lost to follow-up, leaving the number of participants completed as of 195 participants.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Omnidirectional Followed by Directional DBS</title>
          <description>Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for the following three months up to 6 months, unless not tolerated. At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="234"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="195"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Withdrawal/Other reasons</title>
              <participants_list>
                <participants group_id="P1" count="39"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Omnidirectional Followed by Directional DBS</title>
          <description>Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for the following three months up to 6 months, unless not tolerated.&#xD;
At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="234"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.7" spread="8.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Germany</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of Parkinson Symptoms</title>
          <units>Years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="234"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11.7" spread="7.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Wider Therapeutic Window With Directional Programming (Superiority)</title>
        <description>Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. Proportion of subjects with a wider therapeutic window using directional stimulation, compared to a threshold of 60%. Based on randomized, double-blind evaluation using within-subject control.</description>
        <time_frame>3-month follow-up visit after initial programming</time_frame>
        <population>The number of participants analyzed includes subjects for whom data were available at that time of analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Omnidirectional Followed by Directional DBS</title>
            <description>Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for the following three months up to 6 months, unless not tolerated. At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Wider Therapeutic Window With Directional Programming (Superiority)</title>
          <description>Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. Proportion of subjects with a wider therapeutic window using directional stimulation, compared to a threshold of 60%. Based on randomized, double-blind evaluation using within-subject control.</description>
          <population>The number of participants analyzed includes subjects for whom data were available at that time of analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Proportion with wider therapeutic window using directional stimulation was compared to a performance goal of 60%.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <non_inferiority_desc>Superiority hypothesis was that 95% lower confidence bound on proportion exceeded a threshold of 60%.</non_inferiority_desc>
            <p_value>&lt;0.01</p_value>
            <method>Clopper-Pearson method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Wider Therapeutic Window With Directional Programming (Non-inferiority)</title>
        <description>Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. The proportion of subjects with wider therapeutic window using directional stimulation will be compared to a performance goal of 60% with a non-inferiority threshold of 40%. Based on randomized, double-blind evaluation using within-subject control.</description>
        <time_frame>3-month follow-up visit after initial programming</time_frame>
        <population>The number of participants analyzed includes subjects for whom data were available at that time of analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Omnidirectional Followed by Directional DBS</title>
            <description>Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for the following three months up to 6 months, unless not tolerated. At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Wider Therapeutic Window With Directional Programming (Non-inferiority)</title>
          <description>Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. The proportion of subjects with wider therapeutic window using directional stimulation will be compared to a performance goal of 60% with a non-inferiority threshold of 40%. Based on randomized, double-blind evaluation using within-subject control.</description>
          <population>The number of participants analyzed includes subjects for whom data were available at that time of analysis.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Proportion with wider therapeutic window using directional stimulation was compared to a performance goal of 60%.</groups_desc>
            <non_inferiority_type>Non-Inferiority</non_inferiority_type>
            <non_inferiority_desc>Non-inferiority hypothesis was that 95% lower confidence bound on proportion exceeded a threshold of 40%.</non_inferiority_desc>
            <p_value>&lt;0.01</p_value>
            <method>Clopper-Pearson method</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in UPDRS III Score on and Off Stimulation (Medication on) at 3 and 6 Months</title>
        <description>Change with stimulation on vs. off in Unified Parkinson's Disease Rating Scale (UPDRS) part III motor examination at 3 months using omnidirectional stimulation, compared to 6 months using directional stimulation. UPDRS part III contains 27 questions used to measures severity of Parkinson's motor symptoms. The range of scores is 0 to 108, with higher score indicating greater symptoms. Subjects are on medication for the assessment.</description>
        <time_frame>3-month and 6-month follow-up visits</time_frame>
        <population>The number of participants analyzed includes subjects for whom data were available at that time of analysis.</population>
        <group_list>
          <group group_id="O1">
            <title>Omnidirectional Followed by Directional DBS</title>
            <description>Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for the following three months up to 6 months, unless not tolerated. At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in UPDRS III Score on and Off Stimulation (Medication on) at 3 and 6 Months</title>
          <description>Change with stimulation on vs. off in Unified Parkinson's Disease Rating Scale (UPDRS) part III motor examination at 3 months using omnidirectional stimulation, compared to 6 months using directional stimulation. UPDRS part III contains 27 questions used to measures severity of Parkinson's motor symptoms. The range of scores is 0 to 108, with higher score indicating greater symptoms. Subjects are on medication for the assessment.</description>
          <population>The number of participants analyzed includes subjects for whom data were available at that time of analysis.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="66"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Omnidirectional stimulation (3 months)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.6" spread="9.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Directional stimulation (6 months)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8" spread="12.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Comparison of UPDRS part III on medication from 3 months using omnidirectional stimulation to 6 months using directional stimulation.</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.14</p_value>
            <method>t-test, 1 sided</method>
            <method_desc>Paired t-test.</method_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 Months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Omnidirectional Followed by Directional DBS</title>
          <description>Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for the following three months up to 6 months, unless not tolerated.&#xD;
At the three and twelve month follow-up visit therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional and directional stimulation with the Infinity DBS lead.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 11.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="234"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Mitral valve replacement</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Endocrinological issues</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Appendicitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Umbilical hernia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Falls requiring hospitalization</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Sepsis secondary to influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Battery depletion resulting in hospitalization</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Cognitive impairment: Confusion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Cognitive impairment: Disorientation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Edema near site of lead</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Erosion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Extension breakage in a swimmer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Lead fracture due to trauma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Loss of therapeutic benefit: Lead migration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Speech or language impairment: Aphasia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Speech or language impairment: Dysphagia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Worsening of Parkinson's motor symptoms: Tremor</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Knee operation</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Basal cell carcinoma and squamous cell carcinoma</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Coma related to drowning</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Dopamine dysregulation syndrome</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Transient loss of consciousness</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Depression</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Erosion related to dermatological disorder</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Spinal cord canal stenosis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 11.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="25" subjects_at_risk="234"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title vocab="MedRA 11.0">Worsening of Parkinson's motor symptoms: Dyskinesia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Worsening of Parkinson's motor symptoms: Tremor</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Decreased therapeutic response</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Cognitive impairment: Emotional lability</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Sensory disturbance or impairment: Neuralgia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Sensory disturbance or impairment: Sensory deficit</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Undesirable changes in stimulation</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Worsening of Parkinson's motor symptoms: Abnormal gait</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Worsening of Parkinson's motor symptoms: Bradykinesia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Cognitive impairment: Hallucination</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Dystonia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Erosion</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Impaired wound healing: Incision site drainage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Sensory disturbance or impairment: Neuropathy</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Speech or language impairment: Dysarthria</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Skull discoloration</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title>Suboptimal placement of lead corrected during IPG implant</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
              <event>
                <sub_title vocab="MedRA 11.0">High impedance</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="234"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Edward Karst, Clinical Research Director</name_or_title>
      <organization>Abbott</organization>
      <phone>+1 9725264663</phone>
      <email>Edward.karst@abbott.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02989610
org study id: SJM-CIP-10061
nct id: NCT02989610
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The purpose of this post-market study is to characterize the clinical performance of the
      Infinity Deep Brain Stimulation (DBS) system, including the Implantable Pulse Generator
      (IPG), directional DBS leads, extensions, iPad clinician programmer, iPod patient controller
      and related system components.
allocation: N/A
intervention model: Crossover Assignment
intervention model description: Single-arm crossover study, with double-blind, randomized sequence of testing for primary endpoint.
Although this was a crossover study, the primary endpoint was a double-blind randomized controlled assessment of therapeutic window during the 3-month clinic visit. Subjects received both directional and omnidirectional stimulation, and the order was randomized.
primary purpose: Treatment
masking: None (Open Label)
masking description: Single-arm, open-label design for overall study. Primary endpoint is based on double-blind, randomized testing of omnidirectional and directional DBS during three-month follow visit. Participants are blinded to all details of stimulation for first six months, including details of stimulation testing. Outcomes assessor is blinded to stimulation type for primary and secondary endpoints.
measure: Percentage of Participants With Wider Therapeutic Window With Directional Programming (Superiority)
time frame: 3-month follow-up visit after initial programming
description: Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. Proportion of subjects with a wider therapeutic window using directional stimulation, compared to a threshold of 60%. Based on randomized, double-blind evaluation using within-subject control.
measure: Percentage of Participants With Wider Therapeutic Window With Directional Programming (Non-inferiority)
time frame: 3-month follow-up visit after initial programming
description: Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects. The proportion of subjects with wider therapeutic window using directional stimulation will be compared to a performance goal of 60% with a non-inferiority threshold of 40%. Based on randomized, double-blind evaluation using within-subject control.
measure: Change in UPDRS III Score on and Off Stimulation (Medication on) at 3 and 6 Months
time frame: 3-month and 6-month follow-up visits
description: Change with stimulation on vs. off in Unified Parkinson's Disease Rating Scale (UPDRS) part III motor examination at 3 months using omnidirectional stimulation, compared to 6 months using directional stimulation. UPDRS part III contains 27 questions used to measures severity of Parkinson's motor symptoms. The range of scores is 0 to 108, with higher score indicating greater symptoms. Subjects are on medication for the assessment.
arm group label: Omnidirectional followed by directional DBS
arm group type: Experimental
description: Omnidirectional DBS is used for the first 3 months in all subjects, unless not tolerated. Directional DBS is used for months 3-6 in all subjects with a directional DBS lead. Primary endpoint is based on double-blind testing of omnidirectional vs. directional DBS in randomized order at 3-month follow-up visit.
intervention type: Device
intervention name: Omnidirectional stimulation
description: At the 3-month follow-up, therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional stimulation with the Infinity DBS lead.
arm group label: Omnidirectional followed by directional DBS
intervention type: Device
intervention name: Directional stimulation
description: At the 3-month follow-up, therapeutic window, symptom relief and side effect thresholds are evaluated using directional contacts at the best segmented level of the Infinity DBS lead.
arm group label: Omnidirectional followed by directional DBS
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Alfons Schnitzler, MD
role: Principal Investigator
affiliation: Heinrich-Heine-Universität Düsseldorf, Institute for Clinical Neuroscience
last name: Jan Vesper, MD
role: Principal Investigator
affiliation: Heinrich-Heine-Universität Düsseldorf, Department of Functional and Stereotactic Neurosurgery
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country: Australia
country: Belgium
country: Germany
country: Italy
country: Poland
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease
sharing ipd: No
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