<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/NCT03794661</url>
  </required_header>
  <id_info>
    <org_study_id>ABT-CIP-10245</org_study_id>
    <nct_id>NCT03794661</nct_id>
  </id_info>
  <brief_title>Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool</brief_title>
  <acronym>EVIDENT</acronym>
  <official_title>Evaluation of the Infinity Deep Brain Stimulation Electrode Screening Mode Tool</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this clinical investigation is to characterize the clinical performance of&#xD;
      Abbott's Clinician Programmer Electrode Screening Mode tool (InformityTM tool) in programming&#xD;
      InfinityTM deep brain stimulation (DBS) systems for patients with Parkinson's disease (PD) or&#xD;
      essential tremor (ET).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, non-randomized, single-arm, multi-center, post-market clinical&#xD;
      investigation designed to evaluate Abbott's Informity tool for Infinity DBS systems.&#xD;
&#xD;
      This clinical investigation will be conducted at up to 5 centers in the United States.&#xD;
&#xD;
      Up to 40 patients were intended to enroll in the study. However the study was stopped after&#xD;
      enrolling 8 subjects at 3 sites.&#xD;
&#xD;
      Subjects participating in this clinical investigation will be followed for 6 months. The&#xD;
      expected duration of enrollment is 6 months. The total duration of the clinical investigation&#xD;
      is expected to be 18 months. The primary and secondary endpoints will be evaluated when all&#xD;
      subjects have completed their 6 month follow-up visits&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 26, 2019</start_date>
  <completion_date type="Actual">December 16, 2020</completion_date>
  <primary_completion_date type="Actual">December 16, 2020</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>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Outcomes assessor will be masked to subjects' deep brain stimulation programming.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Therapeutic Window Size With Selected Contact at the Informity Programming Visit Compared to Baseline</measure>
    <time_frame>At Day 21 compared to baseline</time_frame>
    <description>Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Therapeutic Window Size With Best Contact at the Informity Programming Visit Compared to Baseline</measure>
    <time_frame>At Day 21 compared to baseline</time_frame>
    <description>Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Therapeutic Electrical Energy Delivered (TEED) With Selected Contact at the Informity Programming Visit Compared to Baseline</measure>
    <time_frame>At Day 21 compared to baseline</time_frame>
    <description>TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Therapeutic Electrical Energy Delivered (TEED) With Best Contact at the Informity Programming Visit Compared to Baseline</measure>
    <time_frame>At Day 21 compared to baseline</time_frame>
    <description>TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 3 Months</measure>
    <time_frame>At 3 months compared to baseline</time_frame>
    <description>Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 3-month follow-up visit compared to baseline. Fahn-Tolosa-Marin tremor rating scale scores are expressed as a percentage of the total score possible (range of 0% to 100%), and lower scores indicate less severe motor symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 6 Months</measure>
    <time_frame>At 6 months compared to baseline</time_frame>
    <description>Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 6-month follow-up visit compared to baseline. Fahn-Tolosa-Marin tremor rating scale scores are expressed as a percentage of the total score possible (range of 0% to 100%), and lower scores indicate less severe motor symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at Baseline</measure>
    <time_frame>At baseline</time_frame>
    <description>Mean quality of life will be measured by the QUEST for ET subjects at baseline. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 3 Months</measure>
    <time_frame>At 3 months</time_frame>
    <description>Mean quality of life will be measured by the QUEST for ET subjects at 3 months follow-up visit. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 6 Months</measure>
    <time_frame>At 6 months</time_frame>
    <description>Mean quality of life will be measured by the QUEST for ET subjects at 6 months follow-up visit. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Duration of Programming</measure>
    <time_frame>At Day 21</time_frame>
    <description>Duration of programming at the Informity programming visit compared to the most recent programming session prior to enrollment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Therapeutic Electrical Energy Delivered (TEED) at 3 Months</measure>
    <time_frame>At 3 months compared to baseline</time_frame>
    <description>Change in TEED at the 3-month follow-up visit compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Therapeutic Electrical Energy Delivered (TEED) at 6 Months</measure>
    <time_frame>At 6 months compared to baseline</time_frame>
    <description>Change in TEED at the 6-month follow-up visit compared to baseline</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Essential Tremor</condition>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>Single Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Clinician programmer electrode screening mode tool</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Clinician programmer electrode screening mode tool</intervention_name>
    <description>Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process</description>
    <arm_group_label>Single Arm</arm_group_label>
    <other_name>Informity tool</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        INCLUSION CRITERIA&#xD;
&#xD;
        Parkinson's disease patients:&#xD;
&#xD;
          1. Patient must provide written informed consent prior to any clinical study related&#xD;
             procedure.&#xD;
&#xD;
          2. Patient is 18 to 80 years of age.&#xD;
&#xD;
          3. Patient is diagnosed with Parkinson's disease for at least 4 years according to&#xD;
             standard practice.&#xD;
&#xD;
          4. Patient is willing to maintain a constant dose of anti-Parkinson's disease medication&#xD;
             indicated as best medical management for at least 1 month prior to study enrollment.&#xD;
&#xD;
          5. Patient is willing and able to comply with the follow-up schedule for the length of&#xD;
             the study.&#xD;
&#xD;
          6. Patient has been implanted with an 8-channel directional Infinity deep brain&#xD;
             stimulation system in the subthalamic nucleus (STN) within the last 12 months.&#xD;
&#xD;
          7. Patient has had stable deep brain stimulation programming settings for at least 1&#xD;
             month prior to study enrollment.&#xD;
&#xD;
        Essential tremor patients:&#xD;
&#xD;
          1. Patient must provide written informed consent prior to any clinical study related&#xD;
             procedure.&#xD;
&#xD;
          2. Patient is 18 to 80 years of age.&#xD;
&#xD;
          3. Patient is diagnosed with essential tremor for at least 4 years according to standard&#xD;
             practice.&#xD;
&#xD;
          4. Patient is willing to maintain a constant dose of anti-tremor medication indicated as&#xD;
             best medical management for at least 1 month prior to study enrollment.&#xD;
&#xD;
          5. Patient is willing and able to comply with the follow-up schedule for the length of&#xD;
             the study.&#xD;
&#xD;
          6. Patient has been implanted with an 8-channel directional Infinity deep brain&#xD;
             stimulation system in the ventral intermediate (Vim) thalamus within the last 12&#xD;
             months.&#xD;
&#xD;
          7. Patient has had stable deep brain stimulation programming settings for at least 1&#xD;
             month prior to study enrollment.&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
          1. Individuals unable to make the decision to participate in a clinical investigation on&#xD;
             their own.&#xD;
&#xD;
          2. Patient is currently programmed with segmented electrodes, and cannot tolerate&#xD;
             omnidirectional programming.&#xD;
&#xD;
          3. Patient is being evaluated for a lead revision.&#xD;
&#xD;
          4. Patient has untreated clinically significant depression.&#xD;
&#xD;
          5. Patient has dementia that interferes with their ability to co-operate or comply with&#xD;
             study requirements or comprehend the informed consent, as determined by the&#xD;
             investigator.&#xD;
&#xD;
          6. Patient abuses drugs or alcohol.&#xD;
&#xD;
          7. Patient is currently enrolled or plans to enroll in another concurrent study that may&#xD;
             confound the results of this clinical investigation.&#xD;
&#xD;
          8. Patient has a confirmation of diagnosis of a terminal illness associated with survival&#xD;
             &lt;12 months.&#xD;
&#xD;
          9. Presence of other anatomic or comorbid conditions, or other medical, social, or&#xD;
             psychological conditions that, in the investigator's opinion, could limit the&#xD;
             patient's ability to participate in the clinical study or to comply with follow-up&#xD;
             requirements, or impact the scientific soundness of the clinical study results.&#xD;
&#xD;
         10. Pregnant or nursing patients and those who plan pregnancy during the clinical study&#xD;
             follow-up period.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bradley White</last_name>
    <role>Study Chair</role>
    <affiliation>Abbott</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Binith Cheeran</last_name>
    <role>Study Director</role>
    <affiliation>Abbott Medical Devices Neuromodulation</affiliation>
  </overall_official>
  <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>The University of Texas Health Science at San Antonio</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inland Northwest Research</name>
      <address>
        <city>Spokane</city>
        <state>Washington</state>
        <zip>99202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>January 2, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 7, 2019</study_first_posted>
  <results_first_submitted>December 6, 2021</results_first_submitted>
  <results_first_submitted_qc>March 28, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">March 31, 2022</results_first_posted>
  <last_update_submitted>March 28, 2022</last_update_submitted>
  <last_update_submitted_qc>March 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 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>
    <mesh_term>Essential Tremor</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>April 8, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/61/NCT03794661/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>The study enrolled a total of 8 subjects at 3 investigation sites. Of which seven subjects were diagnosed with Essential Tremor and one subject with Parkinson's Disease. The first subject enrollment was on June 26, 2019.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Single Arm</title>
          <description>Clinician programmer electrode screening mode tool&#xD;
Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Single Arm</title>
          <description>Clinician programmer electrode screening mode tool&#xD;
Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
          </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="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="64" spread="9"/>
                  </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="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </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="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Essential Tremor</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="8"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Parkinson's Disease</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="8"/>
                  </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>Years of essential tremor symptoms</title>
          <population>Of the total 8 subjects enrolled, 7 subjects were diagnosed with Essential Tremor and 1 subject with Parkinson's Disease.</population>
          <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="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26" spread="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Years since initial diagnosis of essential tremor</title>
          <population>Of the total 8 subjects enrolled, 7 subjects were diagnosed with Essential Tremor and 1 subject with Parkinson's Disease.</population>
          <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="7"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Therapeutic Window Size With Selected Contact at the Informity Programming Visit Compared to Baseline</title>
        <description>Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing.</description>
        <time_frame>At Day 21 compared to baseline</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Clinician programmer electrode screening mode tool&#xD;
Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Therapeutic Window Size With Selected Contact at the Informity Programming Visit Compared to Baseline</title>
          <description>Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>milliampere (mA)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.37" spread="1.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Informity Programming</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.80" spread="1.35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Therapeutic Window Size With Best Contact at the Informity Programming Visit Compared to Baseline</title>
        <description>Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing.</description>
        <time_frame>At Day 21 compared to baseline</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Clinician programmer electrode screening mode tool&#xD;
Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Therapeutic Window Size With Best Contact at the Informity Programming Visit Compared to Baseline</title>
          <description>Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>milliampere (mA)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.37" spread="1.48"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Informity Programming</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.34" spread="1.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Therapeutic Electrical Energy Delivered (TEED) With Selected Contact at the Informity Programming Visit Compared to Baseline</title>
        <description>TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing.</description>
        <time_frame>At Day 21 compared to baseline</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Clinician programmer electrode screening mode tool&#xD;
Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Therapeutic Electrical Energy Delivered (TEED) With Selected Contact at the Informity Programming Visit Compared to Baseline</title>
          <description>TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>microjoule (μJ)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.6" spread="30.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Informity Programming</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.6" spread="94.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Change in Therapeutic Electrical Energy Delivered (TEED) With Best Contact at the Informity Programming Visit Compared to Baseline</title>
        <description>TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing.</description>
        <time_frame>At Day 21 compared to baseline</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Clinician programmer electrode screening mode tool&#xD;
Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Therapeutic Electrical Energy Delivered (TEED) With Best Contact at the Informity Programming Visit Compared to Baseline</title>
          <description>TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing.</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>microjoule (μJ)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="46.6" spread="30.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Informity Programming</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="31.4" spread="23.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 3 Months</title>
        <description>Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 3-month follow-up visit compared to baseline. Fahn-Tolosa-Marin tremor rating scale scores are expressed as a percentage of the total score possible (range of 0% to 100%), and lower scores indicate less severe motor symptoms.</description>
        <time_frame>At 3 months compared to baseline</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Clinician programmer electrode screening mode tool&#xD;
Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process</description>
          </group>
        </group_list>
        <measure>
          <title>Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 3 Months</title>
          <description>Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 3-month follow-up visit compared to baseline. Fahn-Tolosa-Marin tremor rating scale scores are expressed as a percentage of the total score possible (range of 0% to 100%), and lower scores indicate less severe motor symptoms.</description>
          <population>The number of participants analyzed includes subjects who 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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.6" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.6" spread="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 6 Months</title>
        <description>Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 6-month follow-up visit compared to baseline. Fahn-Tolosa-Marin tremor rating scale scores are expressed as a percentage of the total score possible (range of 0% to 100%), and lower scores indicate less severe motor symptoms.</description>
        <time_frame>At 6 months compared to baseline</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Clinician programmer electrode screening mode tool&#xD;
Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process</description>
          </group>
        </group_list>
        <measure>
          <title>Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 6 Months</title>
          <description>Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 6-month follow-up visit compared to baseline. Fahn-Tolosa-Marin tremor rating scale scores are expressed as a percentage of the total score possible (range of 0% to 100%), and lower scores indicate less severe motor symptoms.</description>
          <population>The number of participants analyzed includes subjects who 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="5"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.6" spread="9.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.2" spread="10.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at Baseline</title>
        <description>Mean quality of life will be measured by the QUEST for ET subjects at baseline. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.</description>
        <time_frame>At baseline</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Clinician programmer electrode screening mode tool&#xD;
Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at Baseline</title>
          <description>Mean quality of life will be measured by the QUEST for ET subjects at baseline. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.</description>
          <population>The number of participants analyzed includes subjects who 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="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Communication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work / Finance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="17" spread="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hobbies / Leisure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="35" spread="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36" spread="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychosocial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 3 Months</title>
        <description>Mean quality of life will be measured by the QUEST for ET subjects at 3 months follow-up visit. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.</description>
        <time_frame>At 3 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Clinician programmer electrode screening mode tool&#xD;
Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 3 Months</title>
          <description>Mean quality of life will be measured by the QUEST for ET subjects at 3 months follow-up visit. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.</description>
          <population>The number of participants analyzed includes subjects who 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="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Communication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19" spread="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work / Finance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14" spread="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hobbies / Leisure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25" spread="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28" spread="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychosocial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 6 Months</title>
        <description>Mean quality of life will be measured by the QUEST for ET subjects at 6 months follow-up visit. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.</description>
        <time_frame>At 6 months</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Clinician programmer electrode screening mode tool&#xD;
Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 6 Months</title>
          <description>Mean quality of life will be measured by the QUEST for ET subjects at 6 months follow-up visit. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.</description>
          <population>The number of participants analyzed includes subjects who 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="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Communication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15" spread="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Work / Finance</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" spread="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hobbies / Leisure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" spread="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Physical</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="41" spread="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Psychosocial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Mean Duration of Programming</title>
        <description>Duration of programming at the Informity programming visit compared to the most recent programming session prior to enrollment</description>
        <time_frame>At Day 21</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Clinician programmer electrode screening mode tool&#xD;
Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Duration of Programming</title>
          <description>Duration of programming at the Informity programming visit compared to the most recent programming session prior to enrollment</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Last programming session</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76" spread="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Informity programming session</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="85" spread="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Therapeutic Electrical Energy Delivered (TEED) at 3 Months</title>
        <description>Change in TEED at the 3-month follow-up visit compared to baseline</description>
        <time_frame>At 3 months compared to baseline</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Clinician programmer electrode screening mode tool&#xD;
Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Therapeutic Electrical Energy Delivered (TEED) at 3 Months</title>
          <description>Change in TEED at the 3-month follow-up visit compared to baseline</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>milliampere (mA)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.8" spread="32.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="75.1" spread="70.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Therapeutic Electrical Energy Delivered (TEED) at 6 Months</title>
        <description>Change in TEED at the 6-month follow-up visit compared to baseline</description>
        <time_frame>At 6 months compared to baseline</time_frame>
        <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Single Arm</title>
            <description>Clinician programmer electrode screening mode tool&#xD;
Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Therapeutic Electrical Energy Delivered (TEED) at 6 Months</title>
          <description>Change in TEED at the 6-month follow-up visit compared to baseline</description>
          <population>The number of participants analyzed includes subjects who were available at that time of analysis</population>
          <units>milliampere (mA)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="44.8" spread="32.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="76.0" spread="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Single Arm</title>
          <description>Clinician programmer electrode screening mode tool&#xD;
Clinician programmer electrode screening mode tool: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process</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="8"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Extension malfunction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Spine fracture</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </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="1" subjects_at_risk="8"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Persistent pain, tightness, or discomfort around the implanted parts</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </event>
              <event>
                <sub_title>Initial jolt, or tingling stimulation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="8"/>
              </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>
    </certain_agreements>
    <limitations_and_caveats>Subjects enrolled at the experienced centers in this study already had individually tailored therapy at the baseline visit.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Binith Cheeran</name_or_title>
      <organization>Abbott Medical Devices Neuromodulation</organization>
      <phone>+15122864262</phone>
      <email>binith.cheeran@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/NCT03794661
org study id: ABT-CIP-10245
nct id: NCT03794661
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The objective of this clinical investigation is to characterize the clinical performance of
      Abbott's Clinician Programmer Electrode Screening Mode tool (InformityTM tool) in programming
      InfinityTM deep brain stimulation (DBS) systems for patients with Parkinson's disease (PD) or
      essential tremor (ET).
This is a prospective, non-randomized, single-arm, multi-center, post-market clinical
      investigation designed to evaluate Abbott's Informity tool for Infinity DBS systems.

      This clinical investigation will be conducted at up to 5 centers in the United States.

      Up to 40 patients were intended to enroll in the study. However the study was stopped after
      enrolling 8 subjects at 3 sites.

      Subjects participating in this clinical investigation will be followed for 6 months. The
      expected duration of enrollment is 6 months. The total duration of the clinical investigation
      is expected to be 18 months. The primary and secondary endpoints will be evaluated when all
      subjects have completed their 6 month follow-up visits
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
masking description: Outcomes assessor will be masked to subjects' deep brain stimulation programming.
measure: Change in Therapeutic Window Size With Selected Contact at the Informity Programming Visit Compared to Baseline
time frame: At Day 21 compared to baseline
description: Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing.
measure: Change in Therapeutic Window Size With Best Contact at the Informity Programming Visit Compared to Baseline
time frame: At Day 21 compared to baseline
description: Therapeutic window was defined as the electrical current at which the side effect appeared minus the electrical current at which complete therapeutic benefit was obtained. The reported value is the range of current between first side effect appearance and complete therapeutic benefit. The 'Selected contact' is the therapeutic window for the contact configuration selected for the patient's programming. The 'best contact' is the therapeutic window for the contact configuration that showed the widest therapeutic window during Informity testing.
measure: Change in Therapeutic Electrical Energy Delivered (TEED) With Selected Contact at the Informity Programming Visit Compared to Baseline
time frame: At Day 21 compared to baseline
description: TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing.
measure: Change in Therapeutic Electrical Energy Delivered (TEED) With Best Contact at the Informity Programming Visit Compared to Baseline
time frame: At Day 21 compared to baseline
description: TEED measures the total energy delivered by the deep brain stimulation system, and is represented as delivery over a set, arbitrary period of time. TEED is determined by the programmed stimulation parameters and measured system impedance. The 'Selected contact' is the contact configuration selected for the patient's programming. The 'best contact' is the contact configuration with the lowest TEED during Informity testing.
measure: Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 3 Months
time frame: At 3 months compared to baseline
description: Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 3-month follow-up visit compared to baseline. Fahn-Tolosa-Marin tremor rating scale scores are expressed as a percentage of the total score possible (range of 0% to 100%), and lower scores indicate less severe motor symptoms.
measure: Motor Symptom Evaluation for ET Subjects- Change in Fahn Tolosa Marin Tremor Rating Scale (FTM-TRS) Scores at 6 Months
time frame: At 6 months compared to baseline
description: Change in Fahn-Tolosa-Marin tremor rating scale for ET subjects at 6-month follow-up visit compared to baseline. Fahn-Tolosa-Marin tremor rating scale scores are expressed as a percentage of the total score possible (range of 0% to 100%), and lower scores indicate less severe motor symptoms.
measure: Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at Baseline
time frame: At baseline
description: Mean quality of life will be measured by the QUEST for ET subjects at baseline. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.
measure: Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 3 Months
time frame: At 3 months
description: Mean quality of life will be measured by the QUEST for ET subjects at 3 months follow-up visit. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.
measure: Mean Quality of Life for Essential Tremor Subjects as Measured by the Quality of Life in Essential Tremor (QUEST) at 6 Months
time frame: At 6 months
description: Mean quality of life will be measured by the QUEST for ET subjects at 6 months follow-up visit. The QUEST questionnaire consists of 30 items, which are rated from 0 to 4, corresponding to the frequency (from never to always). Those 30 items assess how tremor impacts a function or how it can be associated with feelings or attitudes. The 30 items contribute to five sub scales (number of items contributing to each scale in parentheses): Physical/ADL (9), Psychosocial (9), Communication (3), Hobbies/Leisure (3), and Work/Finances (6). The score on each sub scale is expressed as a percentage of the total score possible, with a higher score indicating greater dissatisfaction with that domain of QOL. Maximal score of 100 indicates worse quality of life, while minimal score 0 corresponds to best quality of life.
measure: Mean Duration of Programming
time frame: At Day 21
description: Duration of programming at the Informity programming visit compared to the most recent programming session prior to enrollment
measure: Change in Therapeutic Electrical Energy Delivered (TEED) at 3 Months
time frame: At 3 months compared to baseline
description: Change in TEED at the 3-month follow-up visit compared to baseline
measure: Change in Therapeutic Electrical Energy Delivered (TEED) at 6 Months
time frame: At 6 months compared to baseline
description: Change in TEED at the 6-month follow-up visit compared to baseline
arm group label: Single Arm
arm group type: Experimental
description: Clinician programmer electrode screening mode tool
intervention type: Device
intervention name: Clinician programmer electrode screening mode tool
description: Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process
arm group label: Single Arm
other name: Informity tool
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Bradley White
role: Study Chair
affiliation: Abbott
last name: Binith Cheeran
role: Study Director
affiliation: Abbott Medical Devices Neuromodulation
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Parkinson Disease
mesh term: Essential Tremor
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Subjects enrolled at the experienced centers in this study already had individually tailored therapy at the baseline visit.
point of contact: 