xml: <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/NCT05968703</url>
    </required_header>
    <id_info>
      <org_study_id>70608</org_study_id>
      <secondary_id>UG3NS128150</secondary_id>
      <nct_id>NCT05968703</nct_id>
    </id_info>
    <brief_title>Combined STN and NBM Deep Brain Stimulation for Mild Cognitive Impairment in Parkinson's Disease</brief_title>
    <official_title>Neurostimulation of the Nucleus Basalis of Meynert for the Cognitive-Motor Syndrome in Parkinson's Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Helen M. Bronte-Stewart</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Institute of Neurological Disorders and Stroke (NINDS)</agency>
        <agency_class>NIH</agency_class>
      </collaborator>
    </sponsors>
    <source>Stanford University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to evaluate the safety and tolerability of a novel deep&#xD;
        brain stimulation (DBS) of the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM)&#xD;
        to treat cognitive and cognitive-motor symptoms in individuals with Parkinson's disease. The&#xD;
        main question it aims to answer is:&#xD;
  &#xD;
        Is a combined deep brain stimulation approach targeting the STN and NBM with four DBS leads&#xD;
        safe and tolerable for cognitive and cognitive-motor symptoms in individuals with Parkinson's&#xD;
        disease with Mild Cognitive Impairment. Ten participants are anticipated to be enrolled.&#xD;
  &#xD;
        Participants will undergo a modification of the traditional STN DBS approach for motor&#xD;
        symptoms of PD. In addition to the two leads placed within the STN, two additional leads will&#xD;
        be placed with the NBM for treatment of cognitive and cognitive-motor symptoms. Novel&#xD;
        stimulation patterns will be used within the NBM to target cognitive and cognitive-motor&#xD;
        symptoms using an investigational software. Participants will be followed over two years&#xD;
        while receiving this therapy with assessments at baseline and every six months. Assessments&#xD;
        will include a combination of neuropsychological evaluations, cognitive assessments, motor&#xD;
        tasks (including gait/walking), and questionnaires to evaluate the treatment. Two different&#xD;
        surgical trajectories will be used, with half the cohort randomized to each group. This will&#xD;
        allow comparison of the impact of surgical trajectory on the intervention.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">August 2027</completion_date>
    <primary_completion_date type="Anticipated">August 2027</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>All participants will receive the interventional treatment. Two different surgical trajectories will be used for placing the leads in the NBM. Half the cohort will be randomized to each trajectory.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Adverse Events</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>Any untoward medical occurrence that occurs during this study whether or not considered related to the study device, study procedures, or study requirements that is identified or worsens during the duration of the study</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Swing Time Coefficient of Variation</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>Swing time variability will be measured using the dual force plates in the SIP task and IMUs for TBC. It is defined as the mean swing time coefficient of variation (CV) of both legs.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percent Time Freezing</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>Duration of freezing episodes during SIP will be measured using IMUs and force plates using a validated offline algorithm.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stride Time Coefficient of Variation</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>Stride time coefficient of variation will be measured using the dual force plates in the SIP task and IMUs. Stride time coefficient of variation is defined as the mean stride time coefficient of variation (CV) of both legs. A greater stride time CV is indicative of less rhythmic gait/stepping.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Shank Angular Velocity</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>Shank angular velocity will be measured from IMUs work on the participant's leg/ankle. Reductions in this value are indicative of FOG and gait impairment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tapping Speed</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>The interstrike-interval of alternating tapping will be measured using an engineered piano keyboard. A higher interstrike-interval indicates slower tapping</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tapping Rhythmicity</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>The variability of the interstrike-interval of alternating tapping, as quantified by the coefficient of variation, will be measured using an engineered piano keyboard. A higher coefficient of variation indicates worse rhythmicity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MDS-UPDRS III Score</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>PD symptoms will be assessed clinically using the MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Section III. This is a motor examination to evaluate speech, facial expression, tremor at rest, action or postural tremor of hands, rigidity, finger taps, hand movements, rapid alternating movement of hands, leg agility, arising from chair, posture, gait, freezing of gait, posture, body bradykinesia, and postural stability. Each item is scored on a scale from 0 (normal) to 4 (severe), with the total possible score ranging from 0 to 132.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>SAT Score</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>Each trial of the SAT will be categorized as a Hit (H), Miss (M), or False Alarm (FA). The SAT score is defined as ((H - FA) / [2× (H + FA) - (H + FA)2]), which ranges from - 1.0 (100% incorrect performance; all misses and false alarms) to +1.0 (100% correct performance; all hits and correct rejections).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent False Positives</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>The percent of false positives during the SAT.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percent Misses</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>The percent of misses of total trials during the SAT</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Average + standard deviation of response time</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>The average and standard deviation of the response time during the SAT.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Goal-directed focus of attention</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>Hit rate during the first minute in the no- distractor condition for the CTET.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sustained attention</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>Hit rate change slope in no-distractor condition for the CTET.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Distractibility</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>Hit rate difference between no-distractor and distractor conditions for the CTET.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parkinson's Disease - Cognitive Rating Scale (PD-CRS)</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>Cognitive scale composed of 9 tasks that assesses the full range of cognitive dysfunction in PD. It is a scale of 0 to 134, with 134 being the best score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Montreal Cognitive Assessment (MoCA)</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>Total score to assess of this rapid screening test of different cognitive domains. It is a scale of 0 to 30, with 30 being the best score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trails A</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>The time it takes to complete the task and errors.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Trails B</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>The time it takes to complete the task and errors.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Symbol Digit Modalities (SDMT) Oral and Written</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>The summation of the number of correct substitutions within the 90 second interval.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>visual puzzles from the Wechsler Adult Intelligence Scale-IV (WAIS-IV)</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>Percentile of performance on visual puzzles for participant's demographic.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Judgement of Line Orientation</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>Percentile of performance on judgement of line orientation for participant's demographic.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Patient Health Questionnaire-9 (PHQ-9)</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>Total score on questionnaire regarding participant's mood the last 2 weeks. The scale ranges from 0 to 27 with a score of 27 indicating the most severe symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General Anxiety Disorder-7 (GAD-7)</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>Total score on questionnaire regarding participant's anxiety the last two weeks.The scale ranges from 0 to 21 with a score of 21 indicating the most severe symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MDS-UPDRS I</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>Total score evaluating the non-motor aspects of experiences of daily living. It is a scale from 0 to 52 with 52 being the most severe symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MDS-UPDRS II</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>Total score evaluating the motor aspects of experiences of daily living. It is a scale from 0 to 52 with 52 being the most severe symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>MDS-UPDRS IV</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>Total score of motor complications experienced by the participant. It is a scale from 0 to 24 with 24 being the most severe symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Neuropsychiatric Inventory (NPI)</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>Total score for symptom severity and distress via questionnaire. It is a scale from 0 to 60 with 60 indicating worse symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parkinson's Disease Questionnaire-39 (PDQ-39)</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>Total score for Parkinson's disease-specific health related quality over the last month across 8 quality of life dimensions assessed via questionnaire. Score ranges from 0 to 100 with 100 indicating more symptoms and problems.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Caregiver Burden Assessment</measure>
      <time_frame>From baseline to 1 year into treatment</time_frame>
      <description>Total score on caregiver self-report to assess the stress-levels of family caregivers. It is a scale from 0 to 88 with higher scores indicating greater or worse burden.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Parkinson's Disease</condition>
    <condition>Mild Cognitive Impairment</condition>
    <arm_group>
      <arm_group_label>Vertical Nuclear Trajectory</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive combined STN + NBM DBS. The lead placed within the NBM will use a vertical trajectory targeting the nucleus itself.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Lateral NBM Bundle Trajectory</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive combined STN + NBM DBS. The lead placed within the NBM will use a lateral trajectory targeting the lateral efferent bundle from the NBM</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Combined STN+NBM DBS</intervention_name>
      <description>This intervention is a 4-lead deep brain stimulation approach targeting the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM)</description>
      <arm_group_label>Lateral NBM Bundle Trajectory</arm_group_label>
      <arm_group_label>Vertical Nuclear Trajectory</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Diagnosis of Parkinson's disease (PD)&#xD;
  &#xD;
            -  Approved (or planning on) for subthalamic nucleus (STN) deep brain stimulation (DBS)&#xD;
  &#xD;
            -  Willingness to withdraw from clinical medication regimen when necessary for research&#xD;
               visits&#xD;
  &#xD;
            -  Ability to provide informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Dementia&#xD;
  &#xD;
            -  Unstable medical, psychiatric conditions including significant untreated depression,&#xD;
               history of suicidal attempt, or current suicide ideation&#xD;
  &#xD;
            -  History of seizures&#xD;
  &#xD;
            -  Pregnant&#xD;
  &#xD;
            -  Requires MRI&#xD;
  &#xD;
            -  Unable to walk 100 feet without an assistive device&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Helen M Bronte-Stewart, MD MSE</last_name>
      <role>Principal Investigator</role>
      <affiliation>Stanford University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Study Coordinator</last_name>
      <phone>650-723-6709</phone>
      <email>bronte-stewart-lab@stanford.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>Stanford Neuroscience Health Center</name>
        <address>
          <city>Stanford</city>
          <state>California</state>
          <zip>94305</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Study Coordinator</last_name>
        <phone>650-723-6709</phone>
        <email>bronte-stewart-lab@stanford.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 19, 2023</study_first_submitted>
    <study_first_submitted_qc>July 27, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 27, 2023</last_update_submitted>
    <last_update_submitted_qc>July 27, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Stanford University</investigator_affiliation>
      <investigator_full_name>Helen M. Bronte-Stewart</investigator_full_name>
      <investigator_title>Professor of Neurology</investigator_title>
    </responsible_party>
    <keyword>deep brain stimulation</keyword>
    <keyword>cognition</keyword>
    <keyword>DBS</keyword>
    <keyword>parkinson's disease</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
      <mesh_term>Cognitive Dysfunction</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>De-identified data will be uploaded to the Data Archive for the BRAIN Initiative (DABI).</ipd_description>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>The IPD is anticipated to be available in approximately three months after study completion</ipd_time_frame>
      <ipd_access_criteria>DABI is openly available</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05968703
  org study id: 70608
  secondary id: UG3NS128150
  nct id: NCT05968703
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  The goal of this clinical trial is to evaluate the safety and tolerability of a novel deep
        brain stimulation (DBS) of the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM)
        to treat cognitive and cognitive-motor symptoms in individuals with Parkinson's disease. The
        main question it aims to answer is:
  
        Is a combined deep brain stimulation approach targeting the STN and NBM with four DBS leads
        safe and tolerable for cognitive and cognitive-motor symptoms in individuals with Parkinson's
        disease with Mild Cognitive Impairment. Ten participants are anticipated to be enrolled.
  
        Participants will undergo a modification of the traditional STN DBS approach for motor
        symptoms of PD. In addition to the two leads placed within the STN, two additional leads will
        be placed with the NBM for treatment of cognitive and cognitive-motor symptoms. Novel
        stimulation patterns will be used within the NBM to target cognitive and cognitive-motor
        symptoms using an investigational software. Participants will be followed over two years
        while receiving this therapy with assessments at baseline and every six months. Assessments
        will include a combination of neuropsychological evaluations, cognitive assessments, motor
        tasks (including gait/walking), and questionnaires to evaluate the treatment. Two different
        surgical trajectories will be used, with half the cohort randomized to each group. This will
        allow comparison of the impact of surgical trajectory on the intervention.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: All participants will receive the interventional treatment. Two different surgical trajectories will be used for placing the leads in the NBM. Half the cohort will be randomized to each trajectory.
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  measure: Adverse Events
  time frame: From baseline to 1 year into treatment
  description: Any untoward medical occurrence that occurs during this study whether or not considered related to the study device, study procedures, or study requirements that is identified or worsens during the duration of the study
  measure: Swing Time Coefficient of Variation
  time frame: From baseline to 1 year into treatment
  description: Swing time variability will be measured using the dual force plates in the SIP task and IMUs for TBC. It is defined as the mean swing time coefficient of variation (CV) of both legs.
  measure: Percent Time Freezing
  time frame: From baseline to 1 year into treatment
  description: Duration of freezing episodes during SIP will be measured using IMUs and force plates using a validated offline algorithm.
  measure: Stride Time Coefficient of Variation
  time frame: From baseline to 1 year into treatment
  description: Stride time coefficient of variation will be measured using the dual force plates in the SIP task and IMUs. Stride time coefficient of variation is defined as the mean stride time coefficient of variation (CV) of both legs. A greater stride time CV is indicative of less rhythmic gait/stepping.
  measure: Shank Angular Velocity
  time frame: From baseline to 1 year into treatment
  description: Shank angular velocity will be measured from IMUs work on the participant's leg/ankle. Reductions in this value are indicative of FOG and gait impairment.
  measure: Tapping Speed
  time frame: From baseline to 1 year into treatment
  description: The interstrike-interval of alternating tapping will be measured using an engineered piano keyboard. A higher interstrike-interval indicates slower tapping
  measure: Tapping Rhythmicity
  time frame: From baseline to 1 year into treatment
  description: The variability of the interstrike-interval of alternating tapping, as quantified by the coefficient of variation, will be measured using an engineered piano keyboard. A higher coefficient of variation indicates worse rhythmicity
  measure: MDS-UPDRS III Score
  time frame: From baseline to 1 year into treatment
  description: PD symptoms will be assessed clinically using the MDS-Unified Parkinson's Disease Rating Scale (UPDRS) Section III. This is a motor examination to evaluate speech, facial expression, tremor at rest, action or postural tremor of hands, rigidity, finger taps, hand movements, rapid alternating movement of hands, leg agility, arising from chair, posture, gait, freezing of gait, posture, body bradykinesia, and postural stability. Each item is scored on a scale from 0 (normal) to 4 (severe), with the total possible score ranging from 0 to 132.
  measure: SAT Score
  time frame: From baseline to 1 year into treatment
  description: Each trial of the SAT will be categorized as a Hit (H), Miss (M), or False Alarm (FA). The SAT score is defined as ((H - FA) / [2× (H + FA) - (H + FA)2]), which ranges from - 1.0 (100% incorrect performance; all misses and false alarms) to +1.0 (100% correct performance; all hits and correct rejections).
  measure: Percent False Positives
  time frame: From baseline to 1 year into treatment
  description: The percent of false positives during the SAT.
  measure: Percent Misses
  time frame: From baseline to 1 year into treatment
  description: The percent of misses of total trials during the SAT
  measure: Average + standard deviation of response time
  time frame: From baseline to 1 year into treatment
  description: The average and standard deviation of the response time during the SAT.
  measure: Goal-directed focus of attention
  time frame: From baseline to 1 year into treatment
  description: Hit rate during the first minute in the no- distractor condition for the CTET.
  measure: Sustained attention
  time frame: From baseline to 1 year into treatment
  description: Hit rate change slope in no-distractor condition for the CTET.
  measure: Distractibility
  time frame: From baseline to 1 year into treatment
  description: Hit rate difference between no-distractor and distractor conditions for the CTET.
  measure: Parkinson's Disease - Cognitive Rating Scale (PD-CRS)
  time frame: From baseline to 1 year into treatment
  description: Cognitive scale composed of 9 tasks that assesses the full range of cognitive dysfunction in PD. It is a scale of 0 to 134, with 134 being the best score.
  measure: Montreal Cognitive Assessment (MoCA)
  time frame: From baseline to 1 year into treatment
  description: Total score to assess of this rapid screening test of different cognitive domains. It is a scale of 0 to 30, with 30 being the best score.
  measure: Trails A
  time frame: From baseline to 1 year into treatment
  description: The time it takes to complete the task and errors.
  measure: Trails B
  time frame: From baseline to 1 year into treatment
  description: The time it takes to complete the task and errors.
  measure: Symbol Digit Modalities (SDMT) Oral and Written
  time frame: From baseline to 1 year into treatment
  description: The summation of the number of correct substitutions within the 90 second interval.
  measure: visual puzzles from the Wechsler Adult Intelligence Scale-IV (WAIS-IV)
  time frame: From baseline to 1 year into treatment
  description: Percentile of performance on visual puzzles for participant's demographic.
  measure: Judgement of Line Orientation
  time frame: From baseline to 1 year into treatment
  description: Percentile of performance on judgement of line orientation for participant's demographic.
  measure: Patient Health Questionnaire-9 (PHQ-9)
  time frame: From baseline to 1 year into treatment
  description: Total score on questionnaire regarding participant's mood the last 2 weeks. The scale ranges from 0 to 27 with a score of 27 indicating the most severe symptoms.
  measure: General Anxiety Disorder-7 (GAD-7)
  time frame: From baseline to 1 year into treatment
  description: Total score on questionnaire regarding participant's anxiety the last two weeks.The scale ranges from 0 to 21 with a score of 21 indicating the most severe symptoms.
  measure: MDS-UPDRS I
  time frame: From baseline to 1 year into treatment
  description: Total score evaluating the non-motor aspects of experiences of daily living. It is a scale from 0 to 52 with 52 being the most severe symptoms.
  measure: MDS-UPDRS II
  time frame: From baseline to 1 year into treatment
  description: Total score evaluating the motor aspects of experiences of daily living. It is a scale from 0 to 52 with 52 being the most severe symptoms.
  measure: MDS-UPDRS IV
  time frame: From baseline to 1 year into treatment
  description: Total score of motor complications experienced by the participant. It is a scale from 0 to 24 with 24 being the most severe symptoms.
  measure: Neuropsychiatric Inventory (NPI)
  time frame: From baseline to 1 year into treatment
  description: Total score for symptom severity and distress via questionnaire. It is a scale from 0 to 60 with 60 indicating worse symptoms.
  measure: Parkinson's Disease Questionnaire-39 (PDQ-39)
  time frame: From baseline to 1 year into treatment
  description: Total score for Parkinson's disease-specific health related quality over the last month across 8 quality of life dimensions assessed via questionnaire. Score ranges from 0 to 100 with 100 indicating more symptoms and problems.
  measure: Caregiver Burden Assessment
  time frame: From baseline to 1 year into treatment
  description: Total score on caregiver self-report to assess the stress-levels of family caregivers. It is a scale from 0 to 88 with higher scores indicating greater or worse burden.
  arm group label: Vertical Nuclear Trajectory
  arm group type: Experimental
  description: Participants will receive combined STN + NBM DBS. The lead placed within the NBM will use a vertical trajectory targeting the nucleus itself.
  arm group label: Lateral NBM Bundle Trajectory
  arm group type: Experimental
  description: Participants will receive combined STN + NBM DBS. The lead placed within the NBM will use a lateral trajectory targeting the lateral efferent bundle from the NBM
  intervention type: Device
  intervention name: Combined STN+NBM DBS
  description: This intervention is a 4-lead deep brain stimulation approach targeting the Subthalamic Nucleus (STN) and Nucleus Basalis of Meynert (NBM)
  arm group label: Lateral NBM Bundle Trajectory
  arm group label: Vertical Nuclear Trajectory
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 80 Years
  healthy volunteers: No
  last name: Helen M Bronte-Stewart, MD MSE
  role: Principal Investigator
  affiliation: Stanford University
  last name: Study Coordinator
  phone: 650-723-6709
  email: bronte-stewart-lab@stanford.edu
  facility: 
  contact: 
  country: United States
  responsible party type: Sponsor-Investigator
  investigator affiliation: Stanford University
  investigator full name: Helen M. Bronte-Stewart
  investigator title: Professor of Neurology
  mesh term: Parkinson Disease
  mesh term: Cognitive Dysfunction
  sharing ipd: Yes
  ipd description: De-identified data will be uploaded to the Data Archive for the BRAIN Initiative (DABI).
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: The IPD is anticipated to be available in approximately three months after study completion
  ipd access criteria: DABI is openly available