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/NCT05992701</url>
    </required_header>
    <id_info>
      <org_study_id>PINS-DBS-2101</org_study_id>
      <nct_id>NCT05992701</nct_id>
    </id_info>
    <brief_title>Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease</brief_title>
    <official_title>Effectiveness and Safety of Directional Deep Brain Stimulation for Parkinson's Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Beijing Pins Medical Co., Ltd</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Beijing Tiantan Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Changhai Hospital, the Second Military Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Shenzhen Second People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Wuhan University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>West China Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>First Affiliated Hospital of Kunming Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Nanjing Medical University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Tianjin Medical University General Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Beijing Pins Medical Co., Ltd</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to demonstrate the safety and effectiveness of the PINS Deep&#xD;
        Brain Stimulation (DBS) system, including the G107R/G107 IPG, L305/L306 directional leads,&#xD;
        E204 extensions and related system components.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a prospective, open label, non-randomized study. The study will evaluate the clinical&#xD;
        outcome and possible adverse effects of the directional DBS treatment. The following data&#xD;
        will be collected: therapeutic window, Movement Disorder Society-Sponsored Revision of the&#xD;
        Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores, Parkinson's Disease&#xD;
        Questionnaire (PDQ-39) summary scores, total electrical energy delivered, the dosage of&#xD;
        anti-parkinsonian medications, on time(h/d) without troublesome dyskinesia, and adverse&#xD;
        events.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 28, 2021</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2024</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>Therapeutic Window</measure>
      <time_frame>1 month post the device implanted</time_frame>
      <description>Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Motor Function</measure>
      <time_frame>3 months post device-activation</time_frame>
      <description>Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Quality of Life</measure>
      <time_frame>3 months post device-activation</time_frame>
      <description>Change in Parkinson's Disease Questionnaire (PDQ-39) summary score.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total Electrical Energy Delivered(TEED)</measure>
      <time_frame>3 months post device-activation</time_frame>
      <description>TEED=(Voltage^2×frequency×pulse width)/impedance×1 s</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The dosage of anti-parkinsonian medications</measure>
      <time_frame>3 months post device-activation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>On time(h/d) without troublesome dyskinesia</measure>
      <time_frame>3 months post device-activation</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse events</measure>
      <time_frame>3 months post device-activation</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">28</enrollment>
    <condition>Parkinson's Disease</condition>
    <arm_group>
      <arm_group_label>Directional deep brain stimulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Directional deep brain stimualtion</intervention_name>
      <description>Directional deep brain stimualtion in the treatment of Parkinson's disease using L305/L306 leads and G107R/G107 implanted pulse generators (Beijing Pins Medical Co.).</description>
      <arm_group_label>Directional deep brain stimulation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Age at the time of enrollment: 18 ~ 75;&#xD;
  &#xD;
            2. Idiopathic Parkinson's disease;&#xD;
  &#xD;
            3. Patient whose symptoms are not adequately controlled by best medical therapy;&#xD;
  &#xD;
            4. Hoehn and Yahr stage≥2.5;&#xD;
  &#xD;
            5. Patient whose symptoms are improved by at least 30% with levodopa challenge test;&#xD;
  &#xD;
            6. Must be an appropriate candidate for the surgical procedures required for bilateral&#xD;
               DBS;&#xD;
  &#xD;
            7. Is willing and able to comply with all visits and study related procedures;&#xD;
  &#xD;
            8. Patient understands the study requirements and the treatment procedures and provides&#xD;
               written informed consent before any study-specific tests or procedures are performed.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Had received lesioning surgical treatment;&#xD;
  &#xD;
            2. A female who is breastfeeding or of child-bearing potential with a positive urine&#xD;
               pregnancy test or not using adequate contraception;&#xD;
  &#xD;
            3. Any current drug or alcohol abuse;&#xD;
  &#xD;
            4. Cognitive impairment (MMSE≦17 for primary school education or MMSE≦24 for middle&#xD;
               school education and above);&#xD;
  &#xD;
            5. Any significant psychiatric problems, including unrelated clinically significant&#xD;
               depression;&#xD;
  &#xD;
            6. Any history of craniocerebral injury, tumor, or severe cerebrovascular disease;&#xD;
  &#xD;
            7. Severe brain atrophy (confirmed by CT or MRI);&#xD;
  &#xD;
            8. A condition requiring or likely to require the use of diathermy;&#xD;
  &#xD;
            9. Abnormal blood routine or biochemical test, coagulation dysfunction, serious abnormal&#xD;
               liver or kidney function;&#xD;
  &#xD;
           10. Uncontrolled high blood pressure, serious heart disease or serious medical or&#xD;
               respiratory diseases;&#xD;
  &#xD;
           11. Long-term of immunosuppressive or hormone therapy;&#xD;
  &#xD;
           12. Other diseases requiring the stimulators;&#xD;
  &#xD;
           13. A condition requiring or likely to require the use of MRI;&#xD;
  &#xD;
           14. Participated in any other clinical trials within the preceding 3 months;&#xD;
  &#xD;
           15. Unwilling or unable to cooperate with the implantation of DBS system;&#xD;
  &#xD;
           16. Unwilling or unable to cooperate with postoperative follow-up;&#xD;
  &#xD;
           17. Not considered to be applicable by the investigator.&#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_contact>
      <last_name>Jianguang Sun</last_name>
      <phone>010-60736388</phone>
      <email>sunjianguang@pinsmedical.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Beijing Tiantan Hospital, Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Beijing Tsinghua Changgung Hospital, School of Clinical Medicine, Tsinghua University</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>West China Hospital of Sichuan University</name>
        <address>
          <city>Chengdu</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wei Wang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>First Affiliated Hospital of Kunming Medical University</name>
        <address>
          <city>Kunming</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hualin Yu</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Nanjing Brain Hospital Affiliated to Nanjing Medical University</name>
        <address>
          <city>Nanjing</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Wenbin Zhang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Changhai Hospital, the Second Military Medical University</name>
        <address>
          <city>Shanghai</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xi Wu</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Shenzhen Second People's Hospital (the First Affiliated Hospital of Shenzhen University)</name>
        <address>
          <city>Shenzhen</city>
          <country>China</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Tianjin Medical University General Hospital</name>
        <address>
          <city>Tianjin</city>
          <country>China</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location>
      <facility>
        <name>Zhongnan Hospital of Wuhan University</name>
        <address>
          <city>Wuhan</city>
          <country>China</country>
        </address>
      </facility>
      <status>Active, not recruiting</status>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>September 14, 2023</last_update_submitted>
    <last_update_submitted_qc>September 14, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Parkinson Disease</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05992701
  org study id: PINS-DBS-2101
  nct id: NCT05992701
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to demonstrate the safety and effectiveness of the PINS Deep
        Brain Stimulation (DBS) system, including the G107R/G107 IPG, L305/L306 directional leads,
        E204 extensions and related system components.
  This is a prospective, open label, non-randomized study. The study will evaluate the clinical
        outcome and possible adverse effects of the directional DBS treatment. The following data
        will be collected: therapeutic window, Movement Disorder Society-Sponsored Revision of the
        Unified Parkinson's Disease Rating (MDS-UPDRS) Part III scores, Parkinson's Disease
        Questionnaire (PDQ-39) summary scores, total electrical energy delivered, the dosage of
        anti-parkinsonian medications, on time(h/d) without troublesome dyskinesia, and adverse
        events.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Therapeutic Window
  time frame: 1 month post the device implanted
  description: Therapeutic window is the range of stimulation amplitude that produces symptom relief without causing side effects.
  measure: Motor Function
  time frame: 3 months post device-activation
  description: Change in Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating (MDS-UPDRS) Part III score.
  measure: Quality of Life
  time frame: 3 months post device-activation
  description: Change in Parkinson's Disease Questionnaire (PDQ-39) summary score.
  measure: Total Electrical Energy Delivered(TEED)
  time frame: 3 months post device-activation
  description: TEED=(Voltage^2×frequency×pulse width)/impedance×1 s
  measure: The dosage of anti-parkinsonian medications
  time frame: 3 months post device-activation
  measure: On time(h/d) without troublesome dyskinesia
  time frame: 3 months post device-activation
  measure: Adverse events
  time frame: 3 months post device-activation
  arm group label: Directional deep brain stimulation
  arm group type: Experimental
  intervention type: Device
  intervention name: Directional deep brain stimualtion
  description: Directional deep brain stimualtion in the treatment of Parkinson's disease using L305/L306 leads and G107R/G107 implanted pulse generators (Beijing Pins Medical Co.).
  arm group label: Directional deep brain stimulation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Jianguang Sun
  phone: 010-60736388
  email: sunjianguang@pinsmedical.com
  facility: 
  status: Active, not recruiting
  facility: 
  status: Active, not recruiting
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Active, not recruiting
  facility: 
  status: Active, not recruiting
  facility: 
  status: Active, not recruiting
  country: China
  responsible party type: Sponsor
  mesh term: Parkinson Disease
  sharing ipd: No