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/NCT06012461</url>
    </required_header>
    <id_info>
      <org_study_id>CDBS_PD_2023</org_study_id>
      <nct_id>NCT06012461</nct_id>
    </id_info>
    <brief_title>Closed-loop DBS in Parkinson's Disease</brief_title>
    <official_title>Safety and Effectiveness of Closed-loop DBS in Parkinson's Disease: A Long-term Follow-up Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Tsinghua University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>National Engineering Research Center of Neuromodulation, Tsinghua University</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Beijing Tiantan Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Beijing Pins Medical Co., Ltd</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Tsinghua University</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Closed-loop DBS is an emerging neuromodulation pattern in Parkinson's disease with dyanmic&#xD;
        adjustment of stimulation parameters to patients' disease fluctuations and state of activity.&#xD;
        The purpose of this study is to verify the long-term safety and effectiveness of closed-loop&#xD;
        DBS. Through comparing with open-loop DBS, the study also determine whether closed-loop DBS&#xD;
        is more effective than conventional open-loop DBS on PD treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 30, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">December 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>Movement disorders evaluation</measure>
      <time_frame>1-3 days</time_frame>
      <description>Using MDS-UPDRS III rating scale （0-132, the higher score means a worse outcome） and Rush dyskinesia rating scale （0-12, the higher score means a worse outcome） combined with IMU to evaluate the motor function improvement under both closed-loop DBS and open-loop DBS condition</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Sleep Structure Evaluation</measure>
      <time_frame>1-3 nights</time_frame>
      <description>Using polysomnography evaluation （sleep efficiency，N1/N2/N3/REM/Wake after sleep onset duration and percentage，arousal index） and subjuective sleep quality rating scale to evaluate the sleep improvement under both closed-loop DBS and open-loop DBS condition</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Diary Outcomes in Parkinson's Disease</measure>
      <time_frame>1-3days</time_frame>
      <description>Using SCOPA-DC （0-87, the higher score means a worse outcome） to evaluate the diary outcomes under both closed-loop DBS and open-loop DBS condition</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Safety (Stimulation-related AEs) and Subjective Satisfactory</measure>
      <time_frame>1-3days</time_frame>
      <description>Number of modulation related Adverse Events or abnormal vital signs.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total Electrical Energy Delivered to patients</measure>
      <time_frame>1-3days</time_frame>
      <description>To evaluate the energy changes in closed-loop DBS and open-loop DBS modualtion</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Neurophysiological changes of STN-LFP in daytime and sleep</measure>
      <time_frame>at 3,6,9,12,15 months compared to baseline</time_frame>
      <description>Changes of the power and entropy features of delta, theta, alpha, beta and gamma oscillations</description>
    </other_outcome>
    <other_outcome>
      <measure>Functional connectivity changes during long-term DBS modulation</measure>
      <time_frame>at 3,6,9,12,15 months compared to baseline</time_frame>
      <description>Changes of subcortical and cortical functional connectivity</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">10</enrollment>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>Bilateral STN DBS Modulation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will be implanted with bilateral STN DBS using PINS 106RS system. DBS stimulation will be initiated one month post surgery. Follow-up visits will be conducted 1/3/6/9/12/15 months post surgery with clinical evaluation, STN LFP recording and resting state functional MRI testing. During the 6-15 month's visit, short-term closed-loop DBS modulation (from 24hours to 72hours ) will be conducted to test the safety and efficacy of closed-loop DBS therapy.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Closed-loop DBS stimulation for 24 hours</intervention_name>
      <description>Continuous closed-loop modulation for 24 hours</description>
      <arm_group_label>Bilateral STN DBS Modulation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Open-loop DBS stimulation for 24 hours</intervention_name>
      <description>Continuous open-loop modulation for 24 hours</description>
      <arm_group_label>Bilateral STN DBS Modulation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Closed-loop DBS stimulation for 72 hours</intervention_name>
      <description>Continuous closed-loop modulation for 72 hours</description>
      <arm_group_label>Bilateral STN DBS Modulation</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Open-loop DBS stimulation for 72 hours</intervention_name>
      <description>Continuous open-loop modulation for 72 hours</description>
      <arm_group_label>Bilateral STN DBS Modulation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Diagnosis of primary Parkinson's disease: Diagnosis of primary Parkinson's disease&#xD;
               should meet the diagnostic criteria outlined in the &quot;Diagnosis Standards for&#xD;
               Parkinson's Disease in China&quot; published in 2016 or the diagnostic criteria for primary&#xD;
               Parkinson's disease by the International Parkinson and Movement Disorder Society (MDS)&#xD;
               published in 2015.&#xD;
  &#xD;
            2. Good response to levodopa combination therapy.&#xD;
  &#xD;
            3. Significant reduction in drug efficacy or significant impact on the patient's quality&#xD;
               of life due to prominent motor complications.&#xD;
  &#xD;
            4. Intolerable adverse reactions to medication affecting its efficacy.&#xD;
  &#xD;
            5. Presence of uncontrollable tremors despite medication.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients who have undergone pallidotomy or other brain surgeries.&#xD;
  &#xD;
            2. Patients with secondary Parkinson syndromes or Parkinson plus syndromes.&#xD;
  &#xD;
            3. Patients with concurrent central nervous system and peripheral nervous system&#xD;
               diseases.&#xD;
  &#xD;
            4. Patients with severe systemic diseases, unstable vital signs, or those who cannot&#xD;
               tolerate clinical assessments.&#xD;
  &#xD;
            5. Patients with severe psychiatric disorders.&#xD;
  &#xD;
            6. Patients who are unable to provide informed consent due to cognitive or communication&#xD;
               impairments or those who refuse to sign the informed consent form.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Weizhi Pan, B.S.</last_name>
      <phone>+86-010-62796172</phone>
      <email>neln@mail.tsinghua.edu.cn</email>
    </overall_contact>
    <location>
      <facility>
        <name>National Engineering Research Center of Neuromodulation</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100084</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Huiling Yu, M.D.</last_name>
        <phone>86-010-62794952</phone>
        <email>hellokittylene@163.com</email>
      </contact>
      <investigator>
        <last_name>Luming Li, Ph.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 30, 2023</last_update_submitted>
    <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Tsinghua University</investigator_affiliation>
      <investigator_full_name>Luming Li</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <keyword>Parkinson Disease</keyword>
    <keyword>Deep Brain Stimulation</keyword>
    <keyword>Closed-loop DBS</keyword>
    <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/NCT06012461
  org study id: CDBS_PD_2023
  nct id: NCT06012461
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Closed-loop DBS is an emerging neuromodulation pattern in Parkinson's disease with dyanmic
        adjustment of stimulation parameters to patients' disease fluctuations and state of activity.
        The purpose of this study is to verify the long-term safety and effectiveness of closed-loop
        DBS. Through comparing with open-loop DBS, the study also determine whether closed-loop DBS
        is more effective than conventional open-loop DBS on PD treatment.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Movement disorders evaluation
  time frame: 1-3 days
  description: Using MDS-UPDRS III rating scale （0-132, the higher score means a worse outcome） and Rush dyskinesia rating scale （0-12, the higher score means a worse outcome） combined with IMU to evaluate the motor function improvement under both closed-loop DBS and open-loop DBS condition
  measure: Sleep Structure Evaluation
  time frame: 1-3 nights
  description: Using polysomnography evaluation （sleep efficiency，N1/N2/N3/REM/Wake after sleep onset duration and percentage，arousal index） and subjuective sleep quality rating scale to evaluate the sleep improvement under both closed-loop DBS and open-loop DBS condition
  measure: Diary Outcomes in Parkinson's Disease
  time frame: 1-3days
  description: Using SCOPA-DC （0-87, the higher score means a worse outcome） to evaluate the diary outcomes under both closed-loop DBS and open-loop DBS condition
  measure: Safety (Stimulation-related AEs) and Subjective Satisfactory
  time frame: 1-3days
  description: Number of modulation related Adverse Events or abnormal vital signs.
  measure: Total Electrical Energy Delivered to patients
  time frame: 1-3days
  description: To evaluate the energy changes in closed-loop DBS and open-loop DBS modualtion
  measure: Neurophysiological changes of STN-LFP in daytime and sleep
  time frame: at 3,6,9,12,15 months compared to baseline
  description: Changes of the power and entropy features of delta, theta, alpha, beta and gamma oscillations
  measure: Functional connectivity changes during long-term DBS modulation
  time frame: at 3,6,9,12,15 months compared to baseline
  description: Changes of subcortical and cortical functional connectivity
  arm group label: Bilateral STN DBS Modulation
  arm group type: Experimental
  description: Participants will be implanted with bilateral STN DBS using PINS 106RS system. DBS stimulation will be initiated one month post surgery. Follow-up visits will be conducted 1/3/6/9/12/15 months post surgery with clinical evaluation, STN LFP recording and resting state functional MRI testing. During the 6-15 month's visit, short-term closed-loop DBS modulation (from 24hours to 72hours ) will be conducted to test the safety and efficacy of closed-loop DBS therapy.
  intervention type: Other
  intervention name: Closed-loop DBS stimulation for 24 hours
  description: Continuous closed-loop modulation for 24 hours
  arm group label: Bilateral STN DBS Modulation
  intervention type: Other
  intervention name: Open-loop DBS stimulation for 24 hours
  description: Continuous open-loop modulation for 24 hours
  arm group label: Bilateral STN DBS Modulation
  intervention type: Other
  intervention name: Closed-loop DBS stimulation for 72 hours
  description: Continuous closed-loop modulation for 72 hours
  arm group label: Bilateral STN DBS Modulation
  intervention type: Other
  intervention name: Open-loop DBS stimulation for 72 hours
  description: Continuous open-loop modulation for 72 hours
  arm group label: Bilateral STN DBS Modulation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Weizhi Pan, B.S.
  phone: +86-010-62796172
  email: neln@mail.tsinghua.edu.cn
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Tsinghua University
  investigator full name: Luming Li
  investigator title: Professor
  mesh term: Parkinson Disease
  sharing ipd: No