<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/NCT02263417</url>
  </required_header>
  <id_info>
    <org_study_id>PINS-005</org_study_id>
    <nct_id>NCT02263417</nct_id>
  </id_info>
  <brief_title>A Randomized Controlled Trail Comparing Subthalamic and Pallidal Deep Brain Stimulation for Dystonia</brief_title>
  <official_title>The Safety and Efficacy of Long-term Treatment of PINS Stimulator System for Patients With Dystonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Pins Medical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking Union Medical College 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>
      The purpose of this study was to compare the subthalamic nucleus(STN) with the globus&#xD;
      pallidus internus(GPi) as a stimulation target for deep brian stimulation(DBS) for medically&#xD;
      refractory dystonia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this prospective randomized controlled study,elecrodes were bilaterally implanted in STN&#xD;
      and Gpi of 40 patients with dystonia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2015</start_date>
  <completion_date type="Actual">June 2020</completion_date>
  <primary_completion_date type="Actual">December 2019</primary_completion_date>
  <phase>Phase 4</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>Burke-Fahn-Marsden Scale (BFM)</measure>
    <time_frame>Change from baseline in BMF at 1, 3 months and 6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life (SF-36)</measure>
    <time_frame>Change from baseline in SF-36 at 1, 3 months and 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Psychiatric assessment (HADS-D and PANSS)</measure>
    <time_frame>Change from baseline in HADS-D and PANSS at 1, 3 months and 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">70</enrollment>
  <condition>Dystonia</condition>
  <arm_group>
    <arm_group_label>Deep Brain Stimulation</arm_group_label>
    <arm_group_type>Active Comparator</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 (DBS) of Gpi</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>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Deep Brain Stimulation (DBS) of STN</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 is aged 18 to 75 years old, male or female.&#xD;
&#xD;
          2. Diagnosed with cervical dystonia by a movement disorders neurologist.&#xD;
&#xD;
          3. Has cervical dystonia alone, not generalized or multifocal.&#xD;
&#xD;
          4. Has had adequate trials of medical therapy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Cognitive impairment.&#xD;
&#xD;
          2. Abnormalities on pre-operative magnetic resonance imaging (MRI).&#xD;
&#xD;
          3. Medical conditions precluding general anaesthetic or surgery.&#xD;
&#xD;
          4. Unstable psychiatric disease.&#xD;
&#xD;
          5. Previous brain lesions to treat cervical dystonia.&#xD;
&#xD;
          6. Attended some other trials within three month.&#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_official>
    <last_name>Li Luming, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Tsinghua University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking union medical college hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 27, 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>February 27, 2023</last_update_submitted>
  <last_update_submitted_qc>February 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 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>Dystonia</mesh_term>
    <mesh_term>Dystonic Disorders</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/NCT02263417
org study id: PINS-005
nct id: NCT02263417
lead sponsor: 
collaborator: 
has dmc: Yes
The purpose of this study was to compare the subthalamic nucleus(STN) with the globus
      pallidus internus(GPi) as a stimulation target for deep brian stimulation(DBS) for medically
      refractory dystonia.
In this prospective randomized controlled study,elecrodes were bilaterally implanted in STN
      and Gpi of 40 patients with dystonia.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Burke-Fahn-Marsden Scale (BFM)
time frame: Change from baseline in BMF at 1, 3 months and 6 months
measure: Quality of life (SF-36)
time frame: Change from baseline in SF-36 at 1, 3 months and 6 months
measure: Psychiatric assessment (HADS-D and PANSS)
time frame: Change from baseline in HADS-D and PANSS at 1, 3 months and 6 months
arm group label: Deep Brain Stimulation
arm group type: Active Comparator
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 (DBS) of Gpi
arm group label: Deep Brain Stimulation
arm group label: Placebo
other name: Rechargeable Neurostimulator
intervention type: Device
intervention name: Deep Brain Stimulation (DBS) of STN
arm group label: Deep Brain Stimulation
arm group label: Placebo
other name: Rechargeable Neurostimulator
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Li Luming, PhD
role: Study Chair
affiliation: Tsinghua University
facility: 
country: China
responsible party type: Sponsor
mesh term: Dystonia
mesh term: Dystonic Disorders