<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/NCT01696812</url>
  </required_header>
  <id_info>
    <org_study_id>DELAS-201209</org_study_id>
    <secondary_id>DELAS</secondary_id>
    <nct_id>NCT01696812</nct_id>
  </id_info>
  <brief_title>Web-based International Multi-Center Clinical Study for Parkinson's Disease</brief_title>
  <official_title>Web-based International Multi-Center Clinical Study for Parkinson's Disease; the Evaluation of Clinical Outcome Based on the Electrode Position Estimated From the Fused Images of Preoperative MRI and Postoperative CT After Bilateral STN DBS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objectives of this study are (1) to compare the clinical outcome in correlation with the&#xD;
      electrode positions estimated by web-based image fusion of the preoperative MRI and the&#xD;
      postoperative brain CT taken at a stable period after surgery using mutual information&#xD;
      technique in the patients with advanced Parkinson's disease (PD) after bilateral STN DBS and&#xD;
      (2) to examine whether the documentation of the electrode position by using mutual&#xD;
      information technique at a stable period after unilateral or bilateral STN stimulation&#xD;
      provides useful information for the postoperative programming.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>November 2014</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To determine the electrode positions with the relationship of the STN from the fused images of the preoperative MRI and the postoperative CT</measure>
    <time_frame>at 1 month after surgery</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>UPDRS, H&amp;Y, ADL scores, LEDD</measure>
    <time_frame>at 6 and 12 months after surgery</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">136</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>electrode position, STN DBS, Parkinson' disease</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>To determine the electrode positions with the relationship of the STN from the fused images of the preoperative MRI and the postoperative CT via web-site.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>electrode position</intervention_name>
    <arm_group_label>electrode position, STN DBS, Parkinson' disease</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Advanced Parkinson Disease patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The patients who have experienced any perioperative or postoperative complications&#xD;
&#xD;
          -  The patients with severe cognitive impairment, ongoing psychiatric problems, an&#xD;
             unsatisfactory general condition for evaluation, or an inability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sun Ha Paek, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Neurosurgery, Seoul National University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Neurosurgery, Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>110-744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <contact>
      <last_name>Sun Ha Paek, M.D., Ph.D.</last_name>
      <phone>82-2-2072-3993</phone>
      <email>paeksh@snu.ac.kr</email>
    </contact>
    <investigator>
      <last_name>Sun Ha Paek, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>September 18, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>November 25, 2015</last_update_submitted>
  <last_update_submitted_qc>November 25, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>electrodeposition</keyword>
  <keyword>Subthalamic Nucleus</keyword>
  <keyword>Deep Brain Stimulation</keyword>
  <keyword>Parkinson 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>


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/NCT01696812
org study id: DELAS-201209
secondary id: DELAS
nct id: NCT01696812
lead sponsor: 
has dmc: Yes
The objectives of this study are (1) to compare the clinical outcome in correlation with the
      electrode positions estimated by web-based image fusion of the preoperative MRI and the
      postoperative brain CT taken at a stable period after surgery using mutual information
      technique in the patients with advanced Parkinson's disease (PD) after bilateral STN DBS and
      (2) to examine whether the documentation of the electrode position by using mutual
      information technique at a stable period after unilateral or bilateral STN stimulation
      provides useful information for the postoperative programming.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: To determine the electrode positions with the relationship of the STN from the fused images of the preoperative MRI and the postoperative CT
time frame: at 1 month after surgery
measure: UPDRS, H&Y, ADL scores, LEDD
time frame: at 6 and 12 months after surgery
arm group label: electrode position, STN DBS, Parkinson' disease
arm group type: Experimental
description: To determine the electrode positions with the relationship of the STN from the fused images of the preoperative MRI and the postoperative CT via web-site.
intervention type: Procedure
intervention name: electrode position
arm group label: electrode position, STN DBS, Parkinson' disease
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: No
last name: Sun Ha Paek, M.D., Ph.D.
role: Principal Investigator
affiliation: Department of Neurosurgery, Seoul National University Hospital
facility: 
contact: 
investigator: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Parkinson Disease