<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/NCT03267550</url>
  </required_header>
  <id_info>
    <org_study_id>DBS telemedicine</org_study_id>
    <nct_id>NCT03267550</nct_id>
  </id_info>
  <brief_title>The Safety of Remote DBS Programming System</brief_title>
  <official_title>A Pilot Study to Investigating Safety of A Remote and Wireless Deep Brain Stimulation Programming System for Parkinson's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruijin Hospital</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>
      Remote programming has significant advantages over conventional programming methods on some&#xD;
      issues. This research will test the safety of SceneRay remote and wireless DBS programming&#xD;
      system.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Programming is a crucial aspect of deep brain stimulation (DBS), directly influences the&#xD;
      final success of DBS. Optimal programming helps patients achieve maximized control of&#xD;
      clinical symptoms and higher life quality. However, there are a number of inadequacies in&#xD;
      conventional programming methods. First, the programming probe must come into close contact&#xD;
      with the implantable pulse generator (IPG) and test stimulator to complete programming. And&#xD;
      during initial postoperative programming, only the parameters of one patient can be&#xD;
      ascertained. In addition, the same frequency is typically used in the left and right brain&#xD;
      for dual channel IPG. The patient also need to repeatedly travel between their home and the&#xD;
      hospital, leading to increased time and expense. Therefore, the investigators developed the&#xD;
      SceneRay wireless and remote DBS system to address the outline issues. This system has&#xD;
      significant advantages over conventional programming methods on all the issues above. This&#xD;
      research will test the safety of this remote and wireless DBS programming system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The sponsor terminated industrial support&#xD;
  </why_stopped>
  <start_date type="Actual">August 8, 2017</start_date>
  <completion_date type="Anticipated">March 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2018</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>Device Feasibility</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The Unified Parkinson's Disease Rating Scale III&amp;IV</measure>
    <time_frame>Through study completion, an average of 4 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Deep Brain Stimulation Programming parameter</measure>
    <time_frame>Through study completion, an average of 4 months</time_frame>
    <description>Contact selection</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Deep Brain Stimulation Programming parameter</measure>
    <time_frame>Through study completion, an average of 4 months</time_frame>
    <description>Pulse width</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Deep Brain Stimulation Programming parameter</measure>
    <time_frame>Through study completion, an average of 4 months</time_frame>
    <description>Frequency</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Deep Brain Stimulation Programming parameter</measure>
    <time_frame>Through study completion, an average of 4 months</time_frame>
    <description>Amplitude</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Serious Adverse Event</measure>
    <time_frame>Through study completion, an average of 4 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Parkinson Disease</condition>
  <arm_group>
    <arm_group_label>remote programming system</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SceneRay wireless and remote DBS system</intervention_name>
    <description>Implement therapeutic programming in patients with network coverage at home</description>
    <arm_group_label>remote programming system</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary PD patients volunteered to receive DBS surgery with SceneRay wireless and&#xD;
             remote DBS system,&#xD;
&#xD;
          -  Age 18-75 years,&#xD;
&#xD;
          -  Achieved optimal control of clinical symptoms after coventional programming for 3-12&#xD;
             months,&#xD;
&#xD;
          -  Significant difference in motor function when DBS is switched on/off,&#xD;
&#xD;
          -  Good compliance and easy to follow-up,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No significant improvement or clinical efficacy in symptoms after surgery,&#xD;
&#xD;
          -  Severe cognitive impairment due to dementia (Mini-Mental State Examination score:&#xD;
             illiteracy &lt;17, elementary school &lt;20, junior high school or above &lt;24) or inability&#xD;
             to accurately record in a diary,&#xD;
&#xD;
          -  Active psychosis or a history of psychosis,&#xD;
&#xD;
          -  Serious heart, liver, or kidney diseases,&#xD;
&#xD;
          -  Severe hypertension or orthostatic hypotension, severe diabetes, or diabetes&#xD;
             accompanied by brain and cardiovascular diseases,&#xD;
&#xD;
          -  Malignant cancer, brain injuries, epilepsy, or other unstable medical conditions,&#xD;
&#xD;
          -  Severe alcohol dependence or drug abuse,&#xD;
&#xD;
          -  Any situation that may jeopardize the patient's safety or lead to a failure to&#xD;
             participate in the study (medical, psychological, social, or georational factors) at&#xD;
             present or in the future,&#xD;
&#xD;
          -  Participating in other clinical trials,&#xD;
&#xD;
          -  Other factors that researchers think may not be suitable for research.&#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>Zhang Chencheng, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ruijin Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Ruijin Hospital Functional Neurosurgery</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200025</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Li D, Zhang C, Gault J, Wang W, Liu J, Shao M, Zhao Y, Zeljic K, Gao G, Sun B. Remotely Programmed Deep Brain Stimulation of the Bilateral Subthalamic Nucleus for the Treatment of Primary Parkinson Disease: A Randomized Controlled Trial Investigating the Safety and Efficacy of a Novel Deep Brain Stimulation System. Stereotact Funct Neurosurg. 2017;95(3):174-182. doi: 10.1159/000475765. Epub 2017 Jun 2.</citation>
    <PMID>28571034</PMID>
  </reference>
  <reference>
    <citation>Zhang C, Li D, Zeljic K, Tan H, Ning Y, Sun B. A Remote and Wireless Deep Brain Stimulation Programming System. Neuromodulation. 2016 Jun;19(4):437-9. doi: 10.1111/ner.12448. No abstract available.</citation>
    <PMID>27321195</PMID>
  </reference>
  <reference>
    <citation>Heo MS, Moon HS, Kim HC, Park HW, Lim YH, Paek SH. Fully Implantable Deep Brain Stimulation System with Wireless Power Transmission for Long-term Use in Rodent Models of Parkinson's Disease. J Korean Neurosurg Soc. 2015 Mar;57(3):152-8. doi: 10.3340/jkns.2015.57.3.152. Epub 2015 Mar 20.</citation>
    <PMID>25810853</PMID>
  </reference>
  <reference>
    <citation>Hu WH, Zhang K, Meng FG, Ma Y, Zhang JG. Deep brain stimulation in China: present and future. Neuromodulation. 2012 May-Jun;15(3):251-9; discussion 259. doi: 10.1111/j.1525-1403.2012.00439.x. Epub 2012 Feb 29.</citation>
    <PMID>22376211</PMID>
  </reference>
  <reference>
    <citation>Perlmutter JS, Mink JW. Deep brain stimulation. Annu Rev Neurosci. 2006;29:229-57. doi: 10.1146/annurev.neuro.29.051605.112824.</citation>
    <PMID>16776585</PMID>
  </reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>March 22, 2018</last_update_submitted>
  <last_update_submitted_qc>March 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruijin Hospital</investigator_affiliation>
    <investigator_full_name>Bomin Sun</investigator_full_name>
    <investigator_title>Director of functional neurosurgery department</investigator_title>
  </responsible_party>
  <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/NCT03267550
org study id: DBS telemedicine
nct id: NCT03267550
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Remote programming has significant advantages over conventional programming methods on some
      issues. This research will test the safety of SceneRay remote and wireless DBS programming
      system.
Programming is a crucial aspect of deep brain stimulation (DBS), directly influences the
      final success of DBS. Optimal programming helps patients achieve maximized control of
      clinical symptoms and higher life quality. However, there are a number of inadequacies in
      conventional programming methods. First, the programming probe must come into close contact
      with the implantable pulse generator (IPG) and test stimulator to complete programming. And
      during initial postoperative programming, only the parameters of one patient can be
      ascertained. In addition, the same frequency is typically used in the left and right brain
      for dual channel IPG. The patient also need to repeatedly travel between their home and the
      hospital, leading to increased time and expense. Therefore, the investigators developed the
      SceneRay wireless and remote DBS system to address the outline issues. This system has
      significant advantages over conventional programming methods on all the issues above. This
      research will test the safety of this remote and wireless DBS programming system.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Device Feasibility
masking: None (Open Label)
measure: The Unified Parkinson's Disease Rating Scale III&IV
time frame: Through study completion, an average of 4 months
measure: Deep Brain Stimulation Programming parameter
time frame: Through study completion, an average of 4 months
description: Contact selection
measure: Deep Brain Stimulation Programming parameter
time frame: Through study completion, an average of 4 months
description: Pulse width
measure: Deep Brain Stimulation Programming parameter
time frame: Through study completion, an average of 4 months
description: Frequency
measure: Deep Brain Stimulation Programming parameter
time frame: Through study completion, an average of 4 months
description: Amplitude
measure: Serious Adverse Event
time frame: Through study completion, an average of 4 months
arm group label: remote programming system
arm group type: Experimental
intervention type: Device
intervention name: SceneRay wireless and remote DBS system
description: Implement therapeutic programming in patients with network coverage at home
arm group label: remote programming system
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Zhang Chencheng, MD
role: Principal Investigator
affiliation: Ruijin Hospital
facility: 
country: China
citation: Li D, Zhang C, Gault J, Wang W, Liu J, Shao M, Zhao Y, Zeljic K, Gao G, Sun B. Remotely Programmed Deep Brain Stimulation of the Bilateral Subthalamic Nucleus for the Treatment of Primary Parkinson Disease: A Randomized Controlled Trial Investigating the Safety and Efficacy of a Novel Deep Brain Stimulation System. Stereotact Funct Neurosurg. 2017;95(3):174-182. doi: 10.1159/000475765. Epub 2017 Jun 2.
PMID: 28571034
citation: Zhang C, Li D, Zeljic K, Tan H, Ning Y, Sun B. A Remote and Wireless Deep Brain Stimulation Programming System. Neuromodulation. 2016 Jun;19(4):437-9. doi: 10.1111/ner.12448. No abstract available.
PMID: 27321195
citation: Heo MS, Moon HS, Kim HC, Park HW, Lim YH, Paek SH. Fully Implantable Deep Brain Stimulation System with Wireless Power Transmission for Long-term Use in Rodent Models of Parkinson's Disease. J Korean Neurosurg Soc. 2015 Mar;57(3):152-8. doi: 10.3340/jkns.2015.57.3.152. Epub 2015 Mar 20.
PMID: 25810853
citation: Hu WH, Zhang K, Meng FG, Ma Y, Zhang JG. Deep brain stimulation in China: present and future. Neuromodulation. 2012 May-Jun;15(3):251-9; discussion 259. doi: 10.1111/j.1525-1403.2012.00439.x. Epub 2012 Feb 29.
PMID: 22376211
citation: Perlmutter JS, Mink JW. Deep brain stimulation. Annu Rev Neurosci. 2006;29:229-57. doi: 10.1146/annurev.neuro.29.051605.112824.
PMID: 16776585
responsible party type: Principal Investigator
investigator affiliation: Ruijin Hospital
investigator full name: Bomin Sun
investigator title: Director of functional neurosurgery department
mesh term: Parkinson Disease