<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/NCT02251808</url>
  </required_header>
  <id_info>
    <org_study_id>PINS-001</org_study_id>
    <nct_id>NCT02251808</nct_id>
  </id_info>
  <brief_title>Satisfaction Survey on PINS Stimulator System for Patients With Parkinson's Disease</brief_title>
  <official_title>Satisfaction Survey on PINS Stimulator System for Patients With 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>
  </sponsors>
  <source>Beijing Pins Medical Co., Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be done because the investigators would like to evaluate product satisfaction&#xD;
      of two PINS products (product A, product B) that are to evaluate the effectiveness of&#xD;
      rechargeable and non-rechargeable Deep Brain Stimulation (at baseline visit and at follow-up&#xD;
      visit) and by evaluating their responses to the product satisfaction survey that will be&#xD;
      given to them by a study coordinator.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Other: IPGs products Patients implanted with the rechargeable IPGs and non-rechargeable were&#xD;
      followed before and 3 months after DBS surgery and completed a systematic survey of&#xD;
      satisfaction with PINS Stimulator System.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Satisfaction as Measured by Giving a Form By PINS Medical.</measure>
    <time_frame>3 months after DBS surgery</time_frame>
    <description>Of 612 patients implanted with the rechargeable IPGs and non-rechargeable (including 306 PD received rechargeable IPGs, 306 PD received non-rechargeable IPGs) were followed before and 3 months after DBS surgery and completed a systematic survey of satisfaction with PINS Stimulator System.</description>
  </primary_outcome>
  <enrollment type="Anticipated">612</enrollment>
  <condition>Parkinson's Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Of 612 patients implanted with the rechargeable IPGs and non-rechargeable (including 306 PD&#xD;
        received rechargeable IPGs, 306 PD received non-rechargeable IPGs) were followed before and&#xD;
        3 months after DBS surgery and completed a systematic survey of satisfaction with PINS&#xD;
        Stimulator System.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is 18 to 80 years of age.&#xD;
&#xD;
          2. Subject has been diagnosed, by a neurologist, with idiopathic Parkinson's disease.&#xD;
&#xD;
          3. The PD patients can recharge the neurostimulator independently, with favourable&#xD;
             compliance and commit to cooperate with the clinical trial study,&#xD;
&#xD;
          4. Subjects are PINS neurostimulator users&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subject were major depression with suicidal thoughts (a score of &gt;25 on the Beck Depression&#xD;
        Inventory II,20 with scoresranging from 0 to 63 and higher scores indicating worse&#xD;
        functioning), tumor, abnormality in routine liver and renal function, cerebral infarction,&#xD;
        hydrocephalus, encephalatrophy, stroke sequela, heart disease, thrombocytopenia,&#xD;
        hyperthermalgesia and any medical or psychological problem that would interfere with the&#xD;
        conduction of the study protocol.Patients with symptoms of the midline at the state of off&#xD;
        medication such as severe language barrier, dysphagia, disequilibrium, slipping-clutch&#xD;
        gaitwere excluded. Patients who had undergone other implantation such as cardiac pacemaker,&#xD;
        artificial cochlea because of the accompanied diseases such as were excluded. Patients with&#xD;
        history of pallidotomy, stereotactic radiofrequency (Gamma Knife) and cell transplantation&#xD;
        were also excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jianguo Zhang, MD</last_name>
    <role>Study Director</role>
    <affiliation>study principal investigator</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Fumin Jia</last_name>
    <phone>010-60736388</phone>
    <email>pins_medical@163.con</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Luming Li</last_name>
    <phone>010-59361265</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Beijing Tiantan Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100050</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianguo Zhang, MD</last_name>
      <phone>010-67096611</phone>
      <email>Limuxin2011@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>September 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 29, 2014</study_first_posted>
  <last_update_submitted>October 12, 2016</last_update_submitted>
  <last_update_submitted_qc>October 12, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 13, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Parkinson's Disease, 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>
  <!-- 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/NCT02251808
org study id: PINS-001
nct id: NCT02251808
lead sponsor: 
collaborator: 
has dmc: Yes
This study will be done because the investigators would like to evaluate product satisfaction
      of two PINS products (product A, product B) that are to evaluate the effectiveness of
      rechargeable and non-rechargeable Deep Brain Stimulation (at baseline visit and at follow-up
      visit) and by evaluating their responses to the product satisfaction survey that will be
      given to them by a study coordinator.
Other: IPGs products Patients implanted with the rechargeable IPGs and non-rechargeable were
      followed before and 3 months after DBS surgery and completed a systematic survey of
      satisfaction with PINS Stimulator System.
observational model: Cohort
time perspective: Prospective
measure: Patient Satisfaction as Measured by Giving a Form By PINS Medical.
time frame: 3 months after DBS surgery
description: Of 612 patients implanted with the rechargeable IPGs and non-rechargeable (including 306 PD received rechargeable IPGs, 306 PD received non-rechargeable IPGs) were followed before and 3 months after DBS surgery and completed a systematic survey of satisfaction with PINS Stimulator System.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jianguo Zhang, MD
role: Study Director
affiliation: study principal investigator
last name: Fumin Jia
phone: 010-60736388
email: pins_medical@163.con
last name: Luming Li
phone: 010-59361265
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Parkinson Disease