<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/NCT01703598</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00007508</org_study_id>
    <nct_id>NCT01703598</nct_id>
  </id_info>
  <brief_title>Clinical Outcomes of Deep Brain Stimulator (DBS) Electrodes Placed Using Intraoperative Computed Tomography (CT) and Frameless Stereotaxis</brief_title>
  <official_title>Clinical Outcomes of Deep Brain Stimulator Electrodes Placed Using Intraoperative Computed Tomography and Frameless Stereotaxis Versus Microelectrode Recording and Frame-based Stereotaxis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Oregon Health and Science University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether performing deep brain stimulation surgery&#xD;
      for Parkinson's disease using intraoperative imaging and frameless stereotaxis is noninferior&#xD;
      to using frame-based stereotaxy and microelectrode recording.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background: Frame-based stereotaxis and microelectrode recording (MER) with mapping of target&#xD;
      structures has been the gold standard for deep brain stimulator (DBS) implantation. Though&#xD;
      supported by historical considerations, no Class I or II evidence exists that MER adds&#xD;
      significant value to the DBS implant procedure. With the advent of advanced magnetic&#xD;
      resonance imaging (MRI) and computed tomography (CT) imaging, particularly intra-operative&#xD;
      imaging, the argument for the continued use of MER during DBS implantation has been&#xD;
      substantially weakened. One rationale for pursuing CT-guided intraoperative imaging is due to&#xD;
      presumed increase in patient comfort with this method. DBS implantation with MER requires&#xD;
      that the patient remain awake during the entire procedure. , MER with frame-based stereotaxis&#xD;
      requires the patient to keep their head in a fixed position for a prolonged period of time&#xD;
      during which time they remain awake, causing significant patient discomfort. Furthermore,&#xD;
      Parkinson's disease patients must withhold their PD meds for a minimum of 12 hours prior to&#xD;
      the procedure adding a sometimes significant degree of discomfort and anxiety to the&#xD;
      procedure.&#xD;
&#xD;
      Objective: The goal of this study is to compare the clinical outcomes of DBS electrodes&#xD;
      placed using intraoperative CT and frameless stereotaxis with those placed using MER and&#xD;
      frame-based stereotaxis.&#xD;
&#xD;
      Design: The proposed study will be a prospective non-interventional data collection study.&#xD;
&#xD;
      Setting and Subjects: Subjects for this study will be idiopathic Parkinson's disease patients&#xD;
      identified from the Oregon Health &amp; Science University movement disorder clinic as candidates&#xD;
      for deep brain stimulation therapy. Enrollment will continue until fifty subjects have been&#xD;
      implanted with electrodes using frameless stereotaxis and intraoperative CT. Data regarding&#xD;
      quality of life, motor control, and amount of time during the day without levodopa side&#xD;
      effects will be collected pre-operatively and post-operatively. This data will be compared to&#xD;
      historical controls who have been implanted with DBS electrodes using MER and frame-based&#xD;
      stereotaxis. All surgical procedures will involve only Federal Drug Administration (FDA)&#xD;
      approved stereotactic equipment, used in the manner for which they have been approved. All&#xD;
      clinic procedures are standard of care for movement disorders patients in the deep brain&#xD;
      stimulation program.&#xD;
&#xD;
      Intervention: This study will be a non-interventional data collection study.&#xD;
&#xD;
      Measurements: Data regarding patient age, diagnosis, intracranial target, complications,&#xD;
      Unified Parkinson's Disease Rating Scale UPDRS Parts 3 (motor examination) and 4 (drug side&#xD;
      effects), Parkinson's Disease Quality of life PDQ-39, 3 day motor diary, 3 month falls diary,&#xD;
      neuropsychiatric evaluation and days in hospital following surgery will be collected.&#xD;
&#xD;
      Analysis: The patients will be examined prior to DBS placement both on and off dopaminergic&#xD;
      medications. They will then be examined 3 months and 6 months following DBS placement both on&#xD;
      and off drug with stimulator on after programming parameters have been optimized. The&#xD;
      following measures will be performed:&#xD;
&#xD;
        -  Change in UPDRS Parts 3 and 4&#xD;
&#xD;
        -  Change in PDQ-39&#xD;
&#xD;
        -  Change in amount of time patient is experiencing Parkinson's disease symptoms and/or&#xD;
           side effects of treatment.&#xD;
&#xD;
        -  Change in number of falls&#xD;
&#xD;
        -  Change in neuropsychiatric evaluation, including:&#xD;
&#xD;
        -  Beck Depression Inventory-II (BDI-II)&#xD;
&#xD;
        -  Mattis Dementia Rating Scale-Second Edition (DRS-2)&#xD;
&#xD;
        -  Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)&#xD;
&#xD;
        -  Symptom Checklist-90-Revised (SCL-90-R)&#xD;
&#xD;
        -  Wechsler Abbreviated Scale of Intelligence (WASI) We will also compare the number of&#xD;
           days spent in hospital following surgery. Adverse events related to the surgery will be&#xD;
           captured.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</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>
    <intervention_model_description>Asleep Deep Brain Stimulation</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Motor OFF Ldopa UPDRS</measure>
    <time_frame>Baseline and 6 months</time_frame>
    <description>Change in motor UPDRS in OFF Levodopa state. The range of this outcome is from 0 to 108, a higher number indicated a worse clinical state.&#xD;
The number represents units on this scale.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">69</enrollment>
  <condition>Parkinson's Disease</condition>
  <arm_group>
    <arm_group_label>DBS surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Deep Brain Stimulation</intervention_name>
    <description>Placement of Deep Brain Stimulation electrodes</description>
    <arm_group_label>DBS surgery</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>DBS surgery</intervention_name>
    <description>Placement of DBS electrodes</description>
    <arm_group_label>DBS surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Idiopathic Parkinson's disease patients identified by OHSU movement disorders&#xD;
             neurologists as deep brain stimulation surgical candidates&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who have already undergone implantation of DBS electrodes 2.Age &lt; - - 18&#xD;
             years&#xD;
&#xD;
          -  Surgical target site other than subthalamic nucleus or globus pallidus pars interna&#xD;
&#xD;
          -  Subjects who choose to undergo MER and frame-based stereotaxis for the placement of&#xD;
             electrodes.&#xD;
&#xD;
          -  Patients who will receive follow up neurology care and DBS programming at centers&#xD;
             other than OHSU.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew Brodsky, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Oregon Health and Science University</affiliation>
  </overall_official>
  <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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>September 9, 2011</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <results_first_submitted>June 20, 2019</results_first_submitted>
  <results_first_submitted_qc>July 23, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">August 13, 2019</results_first_posted>
  <last_update_submitted>July 23, 2019</last_update_submitted>
  <last_update_submitted_qc>July 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 13, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Oregon Health and Science University</investigator_affiliation>
    <investigator_full_name>Matthew Brodsky</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Parkinson's disease</keyword>
  <keyword>Deep Brain Stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Parkinson Disease</mesh_term>
  </condition_browse>
  <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>October 6, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/98/NCT01703598/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>DBS Surgery</title>
          <description>Single arm&#xD;
Deep Brain Stimulation: Placement of Deep Brain Stimulation electrodes&#xD;
DBS surgery: Placement of DBS electrodes</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="69"/>
              </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>
      <population>The analysis population is the same as the baseline population</population>
      <group_list>
        <group group_id="B1">
          <title>DBS Surgery</title>
          <description>Single arm&#xD;
Deep Brain Stimulation: Placement of Deep Brain Stimulation electrodes&#xD;
DBS surgery: Placement of DBS electrodes</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="69"/>
          </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="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.1" spread="7.61"/>
                  </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="69"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                  </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_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Motor OFF Ldopa UPDRS</title>
        <description>Change in motor UPDRS in OFF Levodopa state. The range of this outcome is from 0 to 108, a higher number indicated a worse clinical state.&#xD;
The number represents units on this scale.</description>
        <time_frame>Baseline and 6 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>DBS Surgery</title>
            <description>Single arm&#xD;
Deep Brain Stimulation: Placement of Deep Brain Stimulation electrodes&#xD;
DBS surgery: Placement of DBS electrodes</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Motor OFF Ldopa UPDRS</title>
          <description>Change in motor UPDRS in OFF Levodopa state. The range of this outcome is from 0 to 108, a higher number indicated a worse clinical state.&#xD;
The number represents units on this scale.</description>
          <units>motor UPDRS</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="69"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14.8" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 years</time_frame>
      <group_list>
        <group group_id="E1">
          <title>DBS Surgery</title>
          <description>Single arm&#xD;
Deep Brain Stimulation: Placement of Deep Brain Stimulation electrodes&#xD;
DBS surgery: Placement of DBS electrodes</description>
        </group>
      </group_list>
      <serious_events>
        <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="69"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="69"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="69"/>
              </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>Matthew Brodsky MD</name_or_title>
      <organization>Oregon Health &amp; Science University</organization>
      <phone>503-494-9054</phone>
      <email>brodskym@ohsu.edu</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/NCT01703598
org study id: IRB00007508
nct id: NCT01703598
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether performing deep brain stimulation surgery
      for Parkinson's disease using intraoperative imaging and frameless stereotaxis is noninferior
      to using frame-based stereotaxy and microelectrode recording.
Background: Frame-based stereotaxis and microelectrode recording (MER) with mapping of target
      structures has been the gold standard for deep brain stimulator (DBS) implantation. Though
      supported by historical considerations, no Class I or II evidence exists that MER adds
      significant value to the DBS implant procedure. With the advent of advanced magnetic
      resonance imaging (MRI) and computed tomography (CT) imaging, particularly intra-operative
      imaging, the argument for the continued use of MER during DBS implantation has been
      substantially weakened. One rationale for pursuing CT-guided intraoperative imaging is due to
      presumed increase in patient comfort with this method. DBS implantation with MER requires
      that the patient remain awake during the entire procedure. , MER with frame-based stereotaxis
      requires the patient to keep their head in a fixed position for a prolonged period of time
      during which time they remain awake, causing significant patient discomfort. Furthermore,
      Parkinson's disease patients must withhold their PD meds for a minimum of 12 hours prior to
      the procedure adding a sometimes significant degree of discomfort and anxiety to the
      procedure.

      Objective: The goal of this study is to compare the clinical outcomes of DBS electrodes
      placed using intraoperative CT and frameless stereotaxis with those placed using MER and
      frame-based stereotaxis.

      Design: The proposed study will be a prospective non-interventional data collection study.

      Setting and Subjects: Subjects for this study will be idiopathic Parkinson's disease patients
      identified from the Oregon Health & Science University movement disorder clinic as candidates
      for deep brain stimulation therapy. Enrollment will continue until fifty subjects have been
      implanted with electrodes using frameless stereotaxis and intraoperative CT. Data regarding
      quality of life, motor control, and amount of time during the day without levodopa side
      effects will be collected pre-operatively and post-operatively. This data will be compared to
      historical controls who have been implanted with DBS electrodes using MER and frame-based
      stereotaxis. All surgical procedures will involve only Federal Drug Administration (FDA)
      approved stereotactic equipment, used in the manner for which they have been approved. All
      clinic procedures are standard of care for movement disorders patients in the deep brain
      stimulation program.

      Intervention: This study will be a non-interventional data collection study.

      Measurements: Data regarding patient age, diagnosis, intracranial target, complications,
      Unified Parkinson's Disease Rating Scale UPDRS Parts 3 (motor examination) and 4 (drug side
      effects), Parkinson's Disease Quality of life PDQ-39, 3 day motor diary, 3 month falls diary,
      neuropsychiatric evaluation and days in hospital following surgery will be collected.

      Analysis: The patients will be examined prior to DBS placement both on and off dopaminergic
      medications. They will then be examined 3 months and 6 months following DBS placement both on
      and off drug with stimulator on after programming parameters have been optimized. The
      following measures will be performed:

        -  Change in UPDRS Parts 3 and 4

        -  Change in PDQ-39

        -  Change in amount of time patient is experiencing Parkinson's disease symptoms and/or
           side effects of treatment.

        -  Change in number of falls

        -  Change in neuropsychiatric evaluation, including:

        -  Beck Depression Inventory-II (BDI-II)

        -  Mattis Dementia Rating Scale-Second Edition (DRS-2)

        -  Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

        -  Symptom Checklist-90-Revised (SCL-90-R)

        -  Wechsler Abbreviated Scale of Intelligence (WASI) We will also compare the number of
           days spent in hospital following surgery. Adverse events related to the surgery will be
           captured.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Asleep Deep Brain Stimulation
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Motor OFF Ldopa UPDRS
time frame: Baseline and 6 months
description: Change in motor UPDRS in OFF Levodopa state. The range of this outcome is from 0 to 108, a higher number indicated a worse clinical state.
The number represents units on this scale.
arm group label: DBS surgery
arm group type: Experimental
description: Single arm
intervention type: Device
intervention name: Deep Brain Stimulation
description: Placement of Deep Brain Stimulation electrodes
arm group label: DBS surgery
intervention type: Procedure
intervention name: DBS surgery
description: Placement of DBS electrodes
arm group label: DBS surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Matthew Brodsky, MD
role: Principal Investigator
affiliation: Oregon Health and Science University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Oregon Health and Science University
investigator full name: Matthew Brodsky
investigator title: Principal Investigator
mesh term: Parkinson Disease
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 