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/NCT05997667</url>
    </required_header>
    <id_info>
      <org_study_id>LPDBS-2023</org_study_id>
      <nct_id>NCT05997667</nct_id>
    </id_info>
    <brief_title>Study on the Efficacy and Safety of Rechargeable Implantable DBS System in the Treatment of Parkinson's Disease</brief_title>
    <official_title>A Prospective, Multicenter, Randomized Controlled Clinical Study Evaluating the Efficacy and Safety of Rechargeable Implantable Deep Brain Stimulation System for the Treatment of Parkinson's Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lepu Medical Technology (Beijing) Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Lepu Medical Technology (Beijing) 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 clinical trial is to verify the efficacy and safety of rechargeable&#xD;
        implantable deep brain stimulation (DBS) system for the treatment of advanced primary&#xD;
        Parkinson's disease.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study is a prospective, multicenter, randomized controlled superiority clinical study.&#xD;
        According to the unified inclusion and exclusion criteria, 60 eligible subjects are enrolled&#xD;
        in this clinical trial. All subjects are implanted with bilateral deep brain stimulation&#xD;
        leads, and are randomly assigned to the experimental group or control group in a 1:1 ratio.&#xD;
        Within one month after surgery, the DBS system of experimental group is activated and the&#xD;
        stimulation parameters are modulated, whereas the control group is not activated. The primary&#xD;
        endpoint is the change in motor examination scores evaluated using the Movement Disorder&#xD;
        Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part&#xD;
        III (MDS-UPDRS-III) in &quot;med off&quot; state at 3 months after surgery, compared to the baseline.&#xD;
        After primary endpoint evaluation, both groups receive treatment with activated DBS system.&#xD;
        The efficacy in med off/stim on and med on/stim on state and the safety are evaluated at 6&#xD;
        months after surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 20, 2023</start_date>
    <completion_date type="Anticipated">July 20, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 20, 2025</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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in motor examination score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅲ in &quot;med off&quot; state relative to baseline</measure>
      <time_frame>3 months after surgery</time_frame>
      <description>MDS-UPDRS Part Ⅲ (MDS-UPDRS-Ⅲ) scores range from 0 to 132, higher scores mean a worse outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in motor examination score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅲ in &quot;med on&quot; state relative to baseline</measure>
      <time_frame>3 months after surgery</time_frame>
      <description>MDS-UPDRS Part Ⅲ (MDS-UPDRS-Ⅲ) scores range from 0 to 132, higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in motor experiences of daily living score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅱ relative to baseline</measure>
      <time_frame>3 and 6 months after surgery</time_frame>
      <description>MDS-UPDRS Part Ⅱ (MDS-UPDRS-Ⅱ) scores range from 0 to 52, higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in non-motor experiences of daily living score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅰ relative to baseline</measure>
      <time_frame>3 and 6 months after surgery</time_frame>
      <description>MDS-UPDRS Part Ⅰ (MDS-UPDRS-Ⅰ) scores range from 0 to 52, higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in motor complications score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅳ relative to baseline</measure>
      <time_frame>3 and 6 months after surgery</time_frame>
      <description>MDS-UPDRS Part Ⅳ (MDS-UPDRS-Ⅳ) scores range from 0 to 24, higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in &quot;ON&quot; time and &quot;OFF&quot; time relative to the baseline</measure>
      <time_frame>3 and 6 months after surgery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in motor examination score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅲ with stimulation in &quot;med on&quot; and &quot;med off&quot; states relative to baseline</measure>
      <time_frame>6 months after surgery</time_frame>
      <description>MDS-UPDRS Part Ⅲ (MDS-UPDRS-Ⅲ) scores range from 0 to 132, higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in daily levodopa equivalent dose relative to baseline</measure>
      <time_frame>3 and 6 months after surgery</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in the Parkinson's Disease Questionnaire (PDQ-39) score relative to baseline</measure>
      <time_frame>6 months after surgery</time_frame>
      <description>The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item questionnaire designed to measure the specific impact of PD on quality of life. Scores range from 0 to 156, higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Evaluation of equipment operational performance</measure>
      <time_frame>Within surgery, 1 month and 3 months after surgery</time_frame>
      <description>The operational performance of the equipment is evaluated as excellent, good, or poor.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of adverse events</measure>
      <time_frame>up to 6 months after surgery</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Parkinson Disease</condition>
    <arm_group>
      <arm_group_label>experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Subjects in this arm will receive stimulation of DBS system within 1 month after surgery.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Subjects in this arm will receive stimulation of DBS system at 3 months after surgery.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Rechargeable implantable deep brain stimulation system</intervention_name>
      <description>The DBS system will be implanted in subjects in both study arms. Subjects in experimental group will receive stimulation of DBS system within 1 month after surgery.</description>
      <arm_group_label>experimental group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Rechargeable implantable deep brain stimulation system</intervention_name>
      <description>The DBS system will be implanted in subjects in both study arms. Subjects in control group will receive stimulation of DBS system at 3 months after surgery.</description>
      <arm_group_label>control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. 18-75 years old, male or female;.&#xD;
  &#xD;
            2. Primary PD (according to the UK Parkinson's Disease Society Brain Bank clinical&#xD;
               diagnostic criteria for primary PD or Chinese diagnostic criteria for primary PD),&#xD;
               with a duration of PD ≥ 4 years, and the improvement rate after an acute levodopa&#xD;
               challenge test ≥ 30%; or primary PD, mainly characterized by tremor, the improvement&#xD;
               of tremor by standardized drug treatment is not satisfactory and tremor is severe,&#xD;
               which affects the patients' quality of life, after evaluation, duration can be relaxed&#xD;
               to 3 years, the improvement rate of acute levodopa challenge test can be&lt;30%.&#xD;
  &#xD;
            3. The use of levodopa once had good effects, but currently cannot satisfactorily control&#xD;
               symptoms (significant decrease in efficacy or occurrence of fluctuations in motor&#xD;
               function or motor dysfunction), which affects quality of life.&#xD;
  &#xD;
            4. Good compliance, patients and their families have the willingness to participate in&#xD;
               the clinical trial of &quot;bilateral implantation surgery of nervous stimulation system&quot;,&#xD;
               voluntarily participate in this trial and sign informed consent form, patients can&#xD;
               follow up regularly, and can accurately complete of assessment items, or the family&#xD;
               members, guardians, or caregivers may assist the patients.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Severe cognitive impairment (MMSE score: illiterate&lt;17, elementary school&lt;20, junior&#xD;
               high school or above&lt;24), poor compliance due to dementia, and/or inability to sign&#xD;
               informed consent form&#xD;
  &#xD;
            2. Patients with a history of severe mental illness and a Hamilton Depression Scale&#xD;
               (HAMD) score&gt;24&#xD;
  &#xD;
            3. Seizure history in the last 1 year&#xD;
  &#xD;
            4. Patients with severe heart, liver and kidney diseases, severe hypertension and severe&#xD;
               orthostatic hypotension that affect their health status.&#xD;
  &#xD;
            5. Patients with severe diabetes or serious cardiovascular and cerebrovascular diseases&#xD;
               that affect their health status&#xD;
  &#xD;
            6. Confirmed malignant tumor&#xD;
  &#xD;
            7. Patients with surgical contraindications (e.g., the presence of active implants&#xD;
               (whether turned on or not), or the presence of non-active implants that may affect the&#xD;
               deep brain stimulation system, stereotactic nucleus lesioning, etc.), or other&#xD;
               surgical procedures within six months that the researchers believe have an impact on&#xD;
               this trial, or other neurosurgery contraindications&#xD;
  &#xD;
            8. Patients who have suffered a previous cranial neurological injury&#xD;
  &#xD;
            9. Women who are pregnant or preparing for pregnancy&#xD;
  &#xD;
           10. Patients with severe alcohol dependence and drug abuse&#xD;
  &#xD;
           11. Patients who received electric shock therapy within 30 days before surgery&#xD;
  &#xD;
           12. Patients who are abnormally sensitive to temperature or who are allergic to heat&#xD;
  &#xD;
           13. Subjects who are currently participating in other clinical trials or have participated&#xD;
               in other clinical studies that have not reached the primary endpoint within three&#xD;
               months.&#xD;
  &#xD;
           14. Patients who are not suitable to participate in this clinical study in the opinion of&#xD;
               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>Ting Zhang</last_name>
      <phone>+86-010-80120666</phone>
      <email>ting_zhang@lepumedical.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Xuanwu Hospital Capital Medical University</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100053</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Yuqing Zhang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Fujian Medical University</name>
        <address>
          <city>Fuzhou</city>
          <state>Fujian</state>
          <zip>350004</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Lianghong Yu</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>ZhuJiang Hospital of Southern Medical University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510260</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Shizhong Zhang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>Renmin Hospital of Wuhan University</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430060</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Baohui Liu</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital of Air Force Medical University</name>
        <address>
          <city>Xi'an</city>
          <state>Shaanxi</state>
          <zip>524001</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Xuelian Wang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>West China Hospital of Sichuan University</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <zip>610044</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Huifang Shang</last_name>
      </contact>
    </location>
    <location>
      <facility>
        <name>The Second Affiliated Hospital Zhejiang University School of Medicine</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310003</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Not yet recruiting</status>
      <contact>
        <last_name>Junming Zhu</last_name>
      </contact>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 15, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Rechargeable implantable deep brain stimulation (DBS) system</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>
    </condition_browse>
    <!-- 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/NCT05997667
  org study id: LPDBS-2023
  nct id: NCT05997667
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this clinical trial is to verify the efficacy and safety of rechargeable
        implantable deep brain stimulation (DBS) system for the treatment of advanced primary
        Parkinson's disease.
  This study is a prospective, multicenter, randomized controlled superiority clinical study.
        According to the unified inclusion and exclusion criteria, 60 eligible subjects are enrolled
        in this clinical trial. All subjects are implanted with bilateral deep brain stimulation
        leads, and are randomly assigned to the experimental group or control group in a 1:1 ratio.
        Within one month after surgery, the DBS system of experimental group is activated and the
        stimulation parameters are modulated, whereas the control group is not activated. The primary
        endpoint is the change in motor examination scores evaluated using the Movement Disorder
        Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part
        III (MDS-UPDRS-III) in "med off" state at 3 months after surgery, compared to the baseline.
        After primary endpoint evaluation, both groups receive treatment with activated DBS system.
        The efficacy in med off/stim on and med on/stim on state and the safety are evaluated at 6
        months after surgery.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in motor examination score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅲ in "med off" state relative to baseline
  time frame: 3 months after surgery
  description: MDS-UPDRS Part Ⅲ (MDS-UPDRS-Ⅲ) scores range from 0 to 132, higher scores mean a worse outcome.
  measure: Change in motor examination score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅲ in "med on" state relative to baseline
  time frame: 3 months after surgery
  description: MDS-UPDRS Part Ⅲ (MDS-UPDRS-Ⅲ) scores range from 0 to 132, higher scores mean a worse outcome.
  measure: Change in motor experiences of daily living score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅱ relative to baseline
  time frame: 3 and 6 months after surgery
  description: MDS-UPDRS Part Ⅱ (MDS-UPDRS-Ⅱ) scores range from 0 to 52, higher scores mean a worse outcome.
  measure: Change in non-motor experiences of daily living score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅰ relative to baseline
  time frame: 3 and 6 months after surgery
  description: MDS-UPDRS Part Ⅰ (MDS-UPDRS-Ⅰ) scores range from 0 to 52, higher scores mean a worse outcome.
  measure: Change in motor complications score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅳ relative to baseline
  time frame: 3 and 6 months after surgery
  description: MDS-UPDRS Part Ⅳ (MDS-UPDRS-Ⅳ) scores range from 0 to 24, higher scores mean a worse outcome.
  measure: Change in "ON" time and "OFF" time relative to the baseline
  time frame: 3 and 6 months after surgery
  measure: Change in motor examination score evaluated using the Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part Ⅲ with stimulation in "med on" and "med off" states relative to baseline
  time frame: 6 months after surgery
  description: MDS-UPDRS Part Ⅲ (MDS-UPDRS-Ⅲ) scores range from 0 to 132, higher scores mean a worse outcome.
  measure: Change in daily levodopa equivalent dose relative to baseline
  time frame: 3 and 6 months after surgery
  measure: Change in the Parkinson's Disease Questionnaire (PDQ-39) score relative to baseline
  time frame: 6 months after surgery
  description: The Parkinson's Disease Questionnaire (PDQ-39) is a 39-item questionnaire designed to measure the specific impact of PD on quality of life. Scores range from 0 to 156, higher scores mean a worse outcome.
  measure: Evaluation of equipment operational performance
  time frame: Within surgery, 1 month and 3 months after surgery
  description: The operational performance of the equipment is evaluated as excellent, good, or poor.
  measure: Incidence of adverse events
  time frame: up to 6 months after surgery
  arm group label: experimental group
  arm group type: Experimental
  description: Subjects in this arm will receive stimulation of DBS system within 1 month after surgery.
  arm group label: control group
  arm group type: Other
  description: Subjects in this arm will receive stimulation of DBS system at 3 months after surgery.
  intervention type: Device
  intervention name: Rechargeable implantable deep brain stimulation system
  description: The DBS system will be implanted in subjects in both study arms. Subjects in experimental group will receive stimulation of DBS system within 1 month after surgery.
  arm group label: experimental group
  intervention type: Device
  intervention name: Rechargeable implantable deep brain stimulation system
  description: The DBS system will be implanted in subjects in both study arms. Subjects in control group will receive stimulation of DBS system at 3 months after surgery.
  arm group label: control group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Ting Zhang
  phone: +86-010-80120666
  email: ting_zhang@lepumedical.com
  facility: 
  status: Recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  facility: 
  status: Not yet recruiting
  contact: 
  country: China
  responsible party type: Sponsor
  mesh term: Parkinson Disease