<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/NCT02263430</url>
  </required_header>
  <id_info>
    <org_study_id>PINS-007</org_study_id>
    <nct_id>NCT02263430</nct_id>
  </id_info>
  <brief_title>PINS Stimulator System for Deep Brain Stimulation in Huntington's Disease</brief_title>
  <official_title>PINS Stimulator System for Deep Brain Stimulation in Huntington'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>
      Deep Brain Stimulation (DBS) of the Globus pallidus internus(GPi) is useful in the treatment&#xD;
      of different forms of chorea, including Huntington's disease (HD).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>December 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 2018</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Unified Huntington's Disease Rating Scale(UHDRS)</measure>
    <time_frame>12 month</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">8</enrollment>
  <condition>Huntington's Disease</condition>
  <arm_group>
    <arm_group_label>Deep Brain Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Stimulation is on.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Stimulation is off.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Deep Brain Stimulation</intervention_name>
    <arm_group_label>Deep Brain Stimulation</arm_group_label>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>Rechargeable Neurostimulator</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject clinically symptomatic and genetically confirmed Huntington Disease (number of&#xD;
             CAG repeats&gt;= 36)&#xD;
&#xD;
          2. Moderate stage of the disease (UHDRS motor&gt;= 30)&#xD;
&#xD;
          3. Predominant movement disorder&#xD;
&#xD;
          4. Compliance of the patient, stable cognition during a 6 months phase prior to inclusion&#xD;
             (Mattis Dementia Rating Scales（MDS）&gt;/= 120)&#xD;
&#xD;
          5. Signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with hearing impairment;&#xD;
&#xD;
          2. Failures of important organs and in severe conditions;&#xD;
&#xD;
          3. Be reluctant or disabled to receive neuropsychological assessments;&#xD;
&#xD;
          4. Participate in other clinical trial;&#xD;
&#xD;
          5. Has a life expectancy of &lt; 1 year.&#xD;
&#xD;
          6. The investigator and/or enrollment review committee, would preclude participation in&#xD;
             the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Li Luming, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Tsinghua University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jia Fumin, PhD</last_name>
    <phone>010-59361265</phone>
    <email>pins_medical@163.com</email>
  </overall_contact>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>September 28, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 13, 2014</study_first_posted>
  <last_update_submitted>October 13, 2016</last_update_submitted>
  <last_update_submitted_qc>October 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 14, 2016</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>Huntington 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/NCT02263430
org study id: PINS-007
nct id: NCT02263430
lead sponsor: 
collaborator: 
has dmc: Yes
Deep Brain Stimulation (DBS) of the Globus pallidus internus(GPi) is useful in the treatment
      of different forms of chorea, including Huntington's disease (HD).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Unified Huntington's Disease Rating Scale(UHDRS)
time frame: 12 month
arm group label: Deep Brain Stimulation
arm group type: Experimental
description: Stimulation is on.
arm group label: Placebo
arm group type: Sham Comparator
description: Stimulation is off.
intervention type: Device
intervention name: Deep Brain Stimulation
arm group label: Deep Brain Stimulation
arm group label: Placebo
other name: Rechargeable Neurostimulator
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Li Luming, PhD
role: Study Chair
affiliation: Tsinghua University
last name: Jia Fumin, PhD
phone: 010-59361265
email: pins_medical@163.com
responsible party type: Sponsor
mesh term: Huntington Disease