<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/NCT03815656</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00100982</org_study_id>
    <secondary_id>UH3NS103468</secondary_id>
    <secondary_id>UH3NS129898</secondary_id>
    <nct_id>NCT03815656</nct_id>
  </id_info>
  <brief_title>Closed Loop DBS Implanted RC+S Study</brief_title>
  <official_title>An Integrated Biomarker Approach to Personalized, Adaptive Deep Brain Stimulation in Parkinson Disease [Formerly: Scalar Closed-Loop STN/GPi DBS Based on Evoked and Spontaneous Potentials (Permanently Implanted Medtronic RC+S Studies)]</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dennis Turner, M.D.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study involves patients who are already planning to have deep brain stimulation (DBS)&#xD;
      surgery to treat the symptoms of severe Parkinson's Disease (PD). The study has two goals:&#xD;
&#xD;
        1. to evaluate the effectiveness of implanting DBS electrodes in the two most common&#xD;
           locations for DBS (subthalamic nucleus (STN), and globus pallidus interna (GPi)),&#xD;
           instead of just one electrode, on each side of the brain; and&#xD;
&#xD;
        2. to develop an adaptive DBS system using brain signals measured from these two&#xD;
           electrodes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this study is a small, first in man, clinical feasibility trial for patients&#xD;
      with severe Parkinson's Disease (PD), who are already clinically eligible for deep brain&#xD;
      stimulation (DBS) with two goals:&#xD;
&#xD;
        1. to compare efficacy from two common sites of DBS (subthalamic nucleus (STN), and globus&#xD;
           pallidus interna (GPi)) through the implantation of dual DBS electrodes on each side of&#xD;
           the brain; and&#xD;
&#xD;
        2. to develop a closed loop DBS system using evoked and spontaneous potentials derived from&#xD;
           these two electrodes.&#xD;
&#xD;
      The study will involve bilateral dual DBS electrode placement in clinically standard&#xD;
      locations (ie, STN and GPi) unilaterally or (more often) bilaterally, the placement of the&#xD;
      RC+S Medtronic research implantable pulse generator (IPG), and a commitment to return for&#xD;
      both extensive postoperative programming and testing to define clinical efficacy and separate&#xD;
      research days to develop the closed loop approach. In addition, patients will undergo&#xD;
      intraoperative research using temporary percutaneous extensions to the DBS electrode(s) and&#xD;
      DBS lead cannula after implantation to confirm the electrode location and to identify what&#xD;
      the signals will look like during later chronic recordings through the research IPG.&#xD;
&#xD;
      The research RC+S IPG includes both ordinary DBS stimulation as well as a recording system&#xD;
      that simultaneously measures the DBS local evoked potential (DLEP) and/or local field&#xD;
      potential (LFP) responses from either the same or a second DBS electrode.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 10, 2019</start_date>
  <completion_date type="Anticipated">January 2027</completion_date>
  <primary_completion_date type="Anticipated">January 2027</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: &quot;on&quot; medication, &quot;on&quot; stimulation at 12 months after IPG implant.</measure>
    <time_frame>baseline and 12 months after IPG implant</time_frame>
    <description>Change in UPDRS score for subject from baseline (pre-surgery) &quot;on&quot; medication state to &quot;on&quot; medication and &quot;on&quot; stimulation state at 12 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. The scores from four subscales (1. Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score. Total scores range from 0 (no disability) to 199 (total disability).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: &quot;on&quot; medication, &quot;on&quot; stimulation at 24 months after IPG implant.</measure>
    <time_frame>baseline and 24 months after IPG implant</time_frame>
    <description>Change in UPDRS score for subject from baseline (pre-surgery) &quot;on&quot; medication state to &quot;on&quot; medication and &quot;on&quot; stimulation state at 24 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. The scores from four subscales (1. Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score. Total scores range from 0 (no disability) to 199 (total disability).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: &quot;on&quot; medication, &quot;on&quot; stimulation at 48 months after IPG implant.</measure>
    <time_frame>baseline and 48 months after IPG implant</time_frame>
    <description>Change in UPDRS score for subject from baseline (pre-surgery) &quot;on&quot; medication state to &quot;on&quot; medication and &quot;on&quot; stimulation state at 48 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. The scores from four subscales (1. Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score. Total scores range from 0 (no disability) to 199 (total disability).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: &quot;on&quot; medication, &quot;on&quot; stimulation at 72 months after IPG implant.</measure>
    <time_frame>baseline and 72 months after IPG implant</time_frame>
    <description>Change in UPDRS score for subject from baseline (pre-surgery) &quot;on&quot; medication state to &quot;on&quot; medication and &quot;on&quot; stimulation state at 72 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. The scores from four subscales (1. Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score. Total scores range from 0 (no disability) to 199 (total disability).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: &quot;off&quot; medication, &quot;on&quot; stimulation at 12 months after IPG implant.</measure>
    <time_frame>baseline and 12 months after IPG implant</time_frame>
    <description>Change in UPDRS-III (Motor Evaluation) score from baseline (pre-surgery) &quot;off&quot; medication state to &quot;off&quot; medication and &quot;on&quot; stimulation state at 12 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. Subscale III, Motor Examination, scores range from 0 (no disability) to 108 (total disability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: &quot;off&quot; medication, &quot;on&quot; stimulation at 24 months after IPG implant.</measure>
    <time_frame>baseline and 24 months after IPG implant</time_frame>
    <description>Change in UPDRS-III (Motor Evaluation) score from baseline (pre-surgery) &quot;off&quot; medication state to &quot;off&quot; medication and &quot;on&quot; stimulation state at 24 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. Subscale III, Motor Examination, scores range from 0 (no disability) to 108 (total disability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: &quot;off&quot; medication, &quot;on&quot; stimulation at 48 months after IPG implant.</measure>
    <time_frame>baseline and 48 months after IPG implant</time_frame>
    <description>Change in UPDRS-III (Motor Evaluation) score from baseline (pre-surgery) &quot;off&quot; medication state to &quot;off&quot; medication and &quot;on&quot; stimulation state at 48 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. Subscale III, Motor Examination, scores range from 0 (no disability) to 108 (total disability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: &quot;off&quot; medication, &quot;on&quot; stimulation at 72 months after IPG implant.</measure>
    <time_frame>baseline and 72 months after IPG implant</time_frame>
    <description>Change in UPDRS-III (Motor Evaluation) score from baseline (pre-surgery) &quot;off&quot; medication state to &quot;off&quot; medication and &quot;on&quot; stimulation state at 72 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. Subscale III, Motor Examination, scores range from 0 (no disability) to 108 (total disability).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in percentage of waking hours with good &quot;on&quot; time at 12 months after IPG implant.</measure>
    <time_frame>baseline and 12 months after IPG implant</time_frame>
    <description>Change in percentage of waking hours subject experienced &quot;on&quot; time without troubling dyskinesias, based on 3-day motor diary, compared to pre-surgery baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in percentage of waking hours with good &quot;on&quot; time at 24 months after IPG implant.</measure>
    <time_frame>baseline and 24 months after IPG implant</time_frame>
    <description>Change in percentage of waking hours subject experienced &quot;on&quot; time without troubling dyskinesias, based on 3-day motor diary, compared to pre-surgery baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in percentage of waking hours with good &quot;on&quot; time at 48 months after IPG implant.</measure>
    <time_frame>baseline and 48 months after IPG implant</time_frame>
    <description>Change in percentage of waking hours subject experienced &quot;on&quot; time without troubling dyskinesias, based on 3-day motor diary, compared to pre-surgery baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in percentage of waking hours with good &quot;on&quot; time at 72 months after IPG implant.</measure>
    <time_frame>baseline and 72 months after IPG implant</time_frame>
    <description>Change in percentage of waking hours subject experienced &quot;on&quot; time without troubling dyskinesias, based on 3-day motor diary, compared to pre-surgery baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 12 months after IPG implant.</measure>
    <time_frame>baseline and 12 months after IPG implant</time_frame>
    <description>Change in PDQ-39 score compared to pre-surgery baseline. The PDQ-39 is a 39-item self-reporting questionnaire to assess the impact of Parkinson's Disease on quality of life. The PDQ-39 is divided into 8 dimensions (1. Mobility, 2. Activities of Daily Life, 3. Emotional Well-being, 4. Stigma, 5. Social Support, 6. Cognition, 7. Communication, and 8. Bodily Discomfort). The total score is the sum of the dimension total scores divided by 8. Scores range from 0 (better quality of life) to 100 (worse quality of life).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 24 months after IPG implant.</measure>
    <time_frame>baseline and 24 months after IPG implant</time_frame>
    <description>Change in PDQ-39 score compared to pre-surgery baseline. The PDQ-39 is a 39-item self-reporting questionnaire to assess the impact of Parkinson's Disease on quality of life. The PDQ-39 is divided into 8 dimensions (1. Mobility, 2. Activities of Daily Life, 3. Emotional Well-being, 4. Stigma, 5. Social Support, 6. Cognition, 7. Communication, and 8. Bodily Discomfort). The total score is the sum of the dimension total scores divided by 8. Scores range from 0 (better quality of life) to 100 (worse quality of life).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 48 months after IPG implant.</measure>
    <time_frame>baseline and 48 months after IPG implant</time_frame>
    <description>Change in PDQ-39 score compared to pre-surgery baseline. The PDQ-39 is a 39-item self-reporting questionnaire to assess the impact of Parkinson's Disease on quality of life. The PDQ-39 is divided into 8 dimensions (1. Mobility, 2. Activities of Daily Life, 3. Emotional Well-being, 4. Stigma, 5. Social Support, 6. Cognition, 7. Communication, and 8. Bodily Discomfort). The total score is the sum of the dimension total scores divided by 8. Scores range from 0 (better quality of life) to 100 (worse quality of life).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 72 months after IPG implant.</measure>
    <time_frame>baseline and 72 months after IPG implant</time_frame>
    <description>Change in PDQ-39 score compared to pre-surgery baseline. The PDQ-39 is a 39-item self-reporting questionnaire to assess the impact of Parkinson's Disease on quality of life. The PDQ-39 is divided into 8 dimensions (1. Mobility, 2. Activities of Daily Life, 3. Emotional Well-being, 4. Stigma, 5. Social Support, 6. Cognition, 7. Communication, and 8. Bodily Discomfort). The total score is the sum of the dimension total scores divided by 8. Scores range from 0 (better quality of life) to 100 (worse quality of life).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>Implanted RC+S</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implanted Medtronic RC+S IPG with dual DBS electrodes in STN and GPi. DBS stimulation will be administered to: 1) STN alone, 2) GPi alone, 3) cooperative STN + GPi, and 4) adaptive, closed-loop stimulation of STN and/or GPi.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>STN alone</intervention_name>
    <description>DBS stimulation of STN alone</description>
    <arm_group_label>Implanted RC+S</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GPi alone</intervention_name>
    <description>DBS stimulation of GPi alone</description>
    <arm_group_label>Implanted RC+S</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>STN + GPi</intervention_name>
    <description>cooperative DBS stimulation of STN and GPi sites</description>
    <arm_group_label>Implanted RC+S</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Closed-loop stimulation</intervention_name>
    <description>adaptive DBS stimulation of STN and/or GPi sites</description>
    <arm_group_label>Implanted RC+S</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  able to give informed consent&#xD;
&#xD;
          -  diagnosed with Parkinson's Disease and is considered a surgical candidate for DBS&#xD;
&#xD;
          -  has medication-related side effects from levodopa (i.e., dyskinesias, on-off&#xD;
             fluctuations)&#xD;
&#xD;
          -  has off-on improvement with levodopa of at least 30%&#xD;
&#xD;
          -  is available for follow-up visits for length of study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  is not safe surgical candidate for DBS&#xD;
&#xD;
          -  has severe neurological injury or disease other than Parkinson's Disease&#xD;
&#xD;
          -  has condition requiring repeated MRI scans&#xD;
&#xD;
          -  has untreated, clinically significant depression&#xD;
&#xD;
          -  has an electrical or electromagnetic implant&#xD;
&#xD;
          -  had a prior thalamotomy or surgical ablation procedure&#xD;
&#xD;
          -  has dementia interfering with ability to comply with study requirements or give&#xD;
             informed consent&#xD;
&#xD;
          -  abuses drugs or alcohol&#xD;
&#xD;
          -  has a history of seizures&#xD;
&#xD;
          -  has any metallic implants&#xD;
&#xD;
          -  is pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dennis A Turner, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Medical Center</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>March 9, 2023</last_update_submitted>
  <last_update_submitted_qc>March 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Duke University</investigator_affiliation>
    <investigator_full_name>Dennis Turner, M.D.</investigator_full_name>
    <investigator_title>Professor of Neurosurgery</investigator_title>
  </responsible_party>
  <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>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>April 30, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT03815656/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03815656
org study id: Pro00100982
secondary id: UH3NS103468
secondary id: UH3NS129898
nct id: NCT03815656
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
This study involves patients who are already planning to have deep brain stimulation (DBS)
      surgery to treat the symptoms of severe Parkinson's Disease (PD). The study has two goals:

        1. to evaluate the effectiveness of implanting DBS electrodes in the two most common
           locations for DBS (subthalamic nucleus (STN), and globus pallidus interna (GPi)),
           instead of just one electrode, on each side of the brain; and

        2. to develop an adaptive DBS system using brain signals measured from these two
           electrodes.
The purpose of this study is a small, first in man, clinical feasibility trial for patients
      with severe Parkinson's Disease (PD), who are already clinically eligible for deep brain
      stimulation (DBS) with two goals:

        1. to compare efficacy from two common sites of DBS (subthalamic nucleus (STN), and globus
           pallidus interna (GPi)) through the implantation of dual DBS electrodes on each side of
           the brain; and

        2. to develop a closed loop DBS system using evoked and spontaneous potentials derived from
           these two electrodes.

      The study will involve bilateral dual DBS electrode placement in clinically standard
      locations (ie, STN and GPi) unilaterally or (more often) bilaterally, the placement of the
      RC+S Medtronic research implantable pulse generator (IPG), and a commitment to return for
      both extensive postoperative programming and testing to define clinical efficacy and separate
      research days to develop the closed loop approach. In addition, patients will undergo
      intraoperative research using temporary percutaneous extensions to the DBS electrode(s) and
      DBS lead cannula after implantation to confirm the electrode location and to identify what
      the signals will look like during later chronic recordings through the research IPG.

      The research RC+S IPG includes both ordinary DBS stimulation as well as a recording system
      that simultaneously measures the DBS local evoked potential (DLEP) and/or local field
      potential (LFP) responses from either the same or a second DBS electrode.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 12 months after IPG implant.
time frame: baseline and 12 months after IPG implant
description: Change in UPDRS score for subject from baseline (pre-surgery) "on" medication state to "on" medication and "on" stimulation state at 12 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. The scores from four subscales (1. Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score. Total scores range from 0 (no disability) to 199 (total disability).
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 24 months after IPG implant.
time frame: baseline and 24 months after IPG implant
description: Change in UPDRS score for subject from baseline (pre-surgery) "on" medication state to "on" medication and "on" stimulation state at 24 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. The scores from four subscales (1. Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score. Total scores range from 0 (no disability) to 199 (total disability).
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 48 months after IPG implant.
time frame: baseline and 48 months after IPG implant
description: Change in UPDRS score for subject from baseline (pre-surgery) "on" medication state to "on" medication and "on" stimulation state at 48 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. The scores from four subscales (1. Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score. Total scores range from 0 (no disability) to 199 (total disability).
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) score: "on" medication, "on" stimulation at 72 months after IPG implant.
time frame: baseline and 72 months after IPG implant
description: Change in UPDRS score for subject from baseline (pre-surgery) "on" medication state to "on" medication and "on" stimulation state at 72 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. The scores from four subscales (1. Mentation, Behavior and Mood, 2. Activities of Daily Living, 3. Motor Examination, and 4. Complications of Therapy) are summed to determine the total UPDRS score. Total scores range from 0 (no disability) to 199 (total disability).
measure: Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 12 months after IPG implant.
time frame: baseline and 12 months after IPG implant
description: Change in UPDRS-III (Motor Evaluation) score from baseline (pre-surgery) "off" medication state to "off" medication and "on" stimulation state at 12 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. Subscale III, Motor Examination, scores range from 0 (no disability) to 108 (total disability).
measure: Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 24 months after IPG implant.
time frame: baseline and 24 months after IPG implant
description: Change in UPDRS-III (Motor Evaluation) score from baseline (pre-surgery) "off" medication state to "off" medication and "on" stimulation state at 24 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. Subscale III, Motor Examination, scores range from 0 (no disability) to 108 (total disability).
measure: Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 48 months after IPG implant.
time frame: baseline and 48 months after IPG implant
description: Change in UPDRS-III (Motor Evaluation) score from baseline (pre-surgery) "off" medication state to "off" medication and "on" stimulation state at 48 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. Subscale III, Motor Examination, scores range from 0 (no disability) to 108 (total disability).
measure: Change in Unified Parkinson's Disease Rating Scale, subscale III: Motor Evaluation (UPDRS-III) score: "off" medication, "on" stimulation at 72 months after IPG implant.
time frame: baseline and 72 months after IPG implant
description: Change in UPDRS-III (Motor Evaluation) score from baseline (pre-surgery) "off" medication state to "off" medication and "on" stimulation state at 72 months after IPG implant. The UPDRS is a scale to measure the degree of a patient's disability due to Parkinson's Disease. Subscale III, Motor Examination, scores range from 0 (no disability) to 108 (total disability).
measure: Change in percentage of waking hours with good "on" time at 12 months after IPG implant.
time frame: baseline and 12 months after IPG implant
description: Change in percentage of waking hours subject experienced "on" time without troubling dyskinesias, based on 3-day motor diary, compared to pre-surgery baseline.
measure: Change in percentage of waking hours with good "on" time at 24 months after IPG implant.
time frame: baseline and 24 months after IPG implant
description: Change in percentage of waking hours subject experienced "on" time without troubling dyskinesias, based on 3-day motor diary, compared to pre-surgery baseline.
measure: Change in percentage of waking hours with good "on" time at 48 months after IPG implant.
time frame: baseline and 48 months after IPG implant
description: Change in percentage of waking hours subject experienced "on" time without troubling dyskinesias, based on 3-day motor diary, compared to pre-surgery baseline.
measure: Change in percentage of waking hours with good "on" time at 72 months after IPG implant.
time frame: baseline and 72 months after IPG implant
description: Change in percentage of waking hours subject experienced "on" time without troubling dyskinesias, based on 3-day motor diary, compared to pre-surgery baseline.
measure: Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 12 months after IPG implant.
time frame: baseline and 12 months after IPG implant
description: Change in PDQ-39 score compared to pre-surgery baseline. The PDQ-39 is a 39-item self-reporting questionnaire to assess the impact of Parkinson's Disease on quality of life. The PDQ-39 is divided into 8 dimensions (1. Mobility, 2. Activities of Daily Life, 3. Emotional Well-being, 4. Stigma, 5. Social Support, 6. Cognition, 7. Communication, and 8. Bodily Discomfort). The total score is the sum of the dimension total scores divided by 8. Scores range from 0 (better quality of life) to 100 (worse quality of life).
measure: Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 24 months after IPG implant.
time frame: baseline and 24 months after IPG implant
description: Change in PDQ-39 score compared to pre-surgery baseline. The PDQ-39 is a 39-item self-reporting questionnaire to assess the impact of Parkinson's Disease on quality of life. The PDQ-39 is divided into 8 dimensions (1. Mobility, 2. Activities of Daily Life, 3. Emotional Well-being, 4. Stigma, 5. Social Support, 6. Cognition, 7. Communication, and 8. Bodily Discomfort). The total score is the sum of the dimension total scores divided by 8. Scores range from 0 (better quality of life) to 100 (worse quality of life).
measure: Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 48 months after IPG implant.
time frame: baseline and 48 months after IPG implant
description: Change in PDQ-39 score compared to pre-surgery baseline. The PDQ-39 is a 39-item self-reporting questionnaire to assess the impact of Parkinson's Disease on quality of life. The PDQ-39 is divided into 8 dimensions (1. Mobility, 2. Activities of Daily Life, 3. Emotional Well-being, 4. Stigma, 5. Social Support, 6. Cognition, 7. Communication, and 8. Bodily Discomfort). The total score is the sum of the dimension total scores divided by 8. Scores range from 0 (better quality of life) to 100 (worse quality of life).
measure: Change in Parkinson's Disease Questionnaire-39 (PDQ-39) patient satisfaction score at 72 months after IPG implant.
time frame: baseline and 72 months after IPG implant
description: Change in PDQ-39 score compared to pre-surgery baseline. The PDQ-39 is a 39-item self-reporting questionnaire to assess the impact of Parkinson's Disease on quality of life. The PDQ-39 is divided into 8 dimensions (1. Mobility, 2. Activities of Daily Life, 3. Emotional Well-being, 4. Stigma, 5. Social Support, 6. Cognition, 7. Communication, and 8. Bodily Discomfort). The total score is the sum of the dimension total scores divided by 8. Scores range from 0 (better quality of life) to 100 (worse quality of life).
arm group label: Implanted RC+S
arm group type: Experimental
description: Implanted Medtronic RC+S IPG with dual DBS electrodes in STN and GPi. DBS stimulation will be administered to: 1) STN alone, 2) GPi alone, 3) cooperative STN + GPi, and 4) adaptive, closed-loop stimulation of STN and/or GPi.
intervention type: Device
intervention name: STN alone
description: DBS stimulation of STN alone
arm group label: Implanted RC+S
intervention type: Device
intervention name: GPi alone
description: DBS stimulation of GPi alone
arm group label: Implanted RC+S
intervention type: Device
intervention name: STN + GPi
description: cooperative DBS stimulation of STN and GPi sites
arm group label: Implanted RC+S
intervention type: Device
intervention name: Closed-loop stimulation
description: adaptive DBS stimulation of STN and/or GPi sites
arm group label: Implanted RC+S
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Dennis A Turner, M.D.
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Duke University
investigator full name: Dennis Turner, M.D.
investigator title: Professor of Neurosurgery
mesh term: Parkinson Disease
provided document: 