<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/NCT03227250</url>
  </required_header>
  <id_info>
    <org_study_id>GPIFOG</org_study_id>
    <nct_id>NCT03227250</nct_id>
  </id_info>
  <brief_title>Effects of Bilateral GPI DBS on Freezing of Gait in PD</brief_title>
  <acronym>PD GPI DBS</acronym>
  <official_title>Effects of Bilateral Pallidal Deep Brain Stimulation on Freezing of Gait in Parkinson's Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Haiyan Zhou</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ruijin Hospital</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>
      This study aims to evaluate the effect of deep brain stimulation in the the globus pallidus&#xD;
      (Gpi) on freezing of gait in patients with Parkinson's disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 24, 2017</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">July 2020</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>Changs in the score of Stand-Walk-Sit Test</measure>
    <time_frame>baseline, 3month, 6month, 9month, 12 month</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of the scores in UPDRS</measure>
    <time_frame>baseline, 3month, 6month, 9month, 12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the score in PDQ-39</measure>
    <time_frame>baseline, 3month, 6month, 9month, 12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the score in the Freezing of Gait Questionnaire (FOG-Q)</measure>
    <time_frame>baseline, 3month, 6month, 9month, 12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the score in the Gait and Falls Questionnaire (GFQ)</measure>
    <time_frame>baseline, 3month, 6month, 9month, 12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the score in the Mini-Mental State Examination (MMSE)</measure>
    <time_frame>baseline, 3month, 6month, 9month, 12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the score in the Montreal Cognitive Assessment (MoCA) Beijing Version</measure>
    <time_frame>baseline, 3month, 6month, 9month, 12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the score in the Frontal Assessment Battery (FAB)</measure>
    <time_frame>baseline, 3month, 6month, 9month, 12 month</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>GPI DBS</arm_group_label>
    <description>patients who had freezing of gait and underwent deep brain stimulation (DBS) of the globus pallidus interna (GPi)</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with Parkinson's Disease who had freezing of gait and underwent GPI DBS.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt;18 years of age,male or female patients&#xD;
&#xD;
          -  Idiopathic Parkinson's disease with freezing of gait&#xD;
&#xD;
          -  Had GPI deep brain stimulation implant&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with serious diseases such as tumor, sever liver or kidney dysfunction were&#xD;
             not selected in the clinical trials&#xD;
&#xD;
          -  Epilepsy&#xD;
&#xD;
          -  Pregnant female&#xD;
&#xD;
          -  History of severe neuropsychiatric disease&#xD;
&#xD;
          -  Patients are taking part in other clinical trials in recent several months&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haiyan Zhou</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Shengdi Chen</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dianyou Li</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bomin Sun</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wei Hu</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florida</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Haiyan Zhou</last_name>
    <phone>+8602134188108</phone>
    <email>zhaiyan.com@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine</name>
      <address>
        <city>Shanghai</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haiyan Zhou</last_name>
      <phone>+8602134188108</phone>
      <email>zhaiyan.com@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2017</study_first_posted>
  <last_update_submitted>March 10, 2020</last_update_submitted>
  <last_update_submitted_qc>March 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ruijin Hospital</investigator_affiliation>
    <investigator_full_name>Haiyan Zhou</investigator_full_name>
    <investigator_title>attending neurologist</investigator_title>
  </responsible_party>
  <keyword>freezing of gait</keyword>
  <keyword>Parkinson disease</keyword>
  <keyword>GPi</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/NCT03227250
org study id: GPIFOG
nct id: NCT03227250
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This study aims to evaluate the effect of deep brain stimulation in the the globus pallidus
      (Gpi) on freezing of gait in patients with Parkinson's disease.
observational model: Cohort
time perspective: Prospective
measure: Changs in the score of Stand-Walk-Sit Test
time frame: baseline, 3month, 6month, 9month, 12 month
measure: Change of the scores in UPDRS
time frame: baseline, 3month, 6month, 9month, 12 month
measure: Change of the score in PDQ-39
time frame: baseline, 3month, 6month, 9month, 12 month
measure: Change of the score in the Freezing of Gait Questionnaire (FOG-Q)
time frame: baseline, 3month, 6month, 9month, 12 month
measure: Change of the score in the Gait and Falls Questionnaire (GFQ)
time frame: baseline, 3month, 6month, 9month, 12 month
measure: Change of the score in the Mini-Mental State Examination (MMSE)
time frame: baseline, 3month, 6month, 9month, 12 month
measure: Change of the score in the Montreal Cognitive Assessment (MoCA) Beijing Version
time frame: baseline, 3month, 6month, 9month, 12 month
measure: Change of the score in the Frontal Assessment Battery (FAB)
time frame: baseline, 3month, 6month, 9month, 12 month
arm group label: GPI DBS
description: patients who had freezing of gait and underwent deep brain stimulation (DBS) of the globus pallidus interna (GPi)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Haiyan Zhou
role: Principal Investigator
affiliation: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
last name: Shengdi Chen
role: Principal Investigator
affiliation: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
last name: Dianyou Li
role: Principal Investigator
affiliation: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
last name: Bomin Sun
role: Principal Investigator
affiliation: Ruijin Hospital affiliated to Shanghai Jiao Tong University School of Medicine
last name: Wei Hu
role: Principal Investigator
affiliation: University of Florida
last name: Haiyan Zhou
phone: +8602134188108
email: zhaiyan.com@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Ruijin Hospital
investigator full name: Haiyan Zhou
investigator title: attending neurologist
mesh term: Parkinson Disease