<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/NCT02982304</url>
  </required_header>
  <id_info>
    <org_study_id>H14-03185</org_study_id>
    <nct_id>NCT02982304</nct_id>
  </id_info>
  <brief_title>Multi-Target Pallidal and Thalamic Deep Brain Stimulation for Hemi-Dystonia</brief_title>
  <official_title>Multi-Target Pallidal and Thalamic Deep Brain Stimulation for Hemi-Dystonia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dystonia is increasingly being considered as a multi-nodal network disorder involving both&#xD;
      basal ganglia and cerebellar dysfunction. The aim of this study is to determine if&#xD;
      &quot;Multi-Target&quot; Thalamic and Pallidal Deep Brain Stimulation improves hemi-dystonia patients&#xD;
      who are receiving inadequate therapy from GPi DBS.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2015</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Burke Fahn Marsden Disability Rating Scale (BFMDRS)</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>SF-36 Quality of Life Scale</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse effects of Vim or Vim + GPi Neuromodulation</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">4</enrollment>
  <condition>Dystonia</condition>
  <condition>Dystonia, Secondary</condition>
  <arm_group>
    <arm_group_label>Pallidal (GPi) Deep Brain Stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>GPi is the standard target for treating most dystonia. This setting will be the active comparator</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Thalamic (Vim) Deep Brain Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Vim is the standard target to treat cerebellar dysfunction in movement disorders. It is not routinely used in secondary dystonia</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GPi + Vim (Multi-Target) Deep Brain Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Combined stimulation of GPi and Vim stimulation (both electrodes ON)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Deep Brain Stimulation</intervention_name>
    <description>Deep Brain Stimulation Electrode</description>
    <arm_group_label>GPi + Vim (Multi-Target) Deep Brain Stimulation</arm_group_label>
    <arm_group_label>Pallidal (GPi) Deep Brain Stimulation</arm_group_label>
    <arm_group_label>Thalamic (Vim) Deep Brain Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosed with hemi-dystonia secondary to stroke&#xD;
&#xD;
          2. Candidate for GPi DBS&#xD;
&#xD;
          3. Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of intracranial pathology (such as multiple sclerosis, tumors, or aneurysms)&#xD;
             that may account for dystonia or essential tremor.&#xD;
&#xD;
          2. History or evidence of ongoing psychiatric or neurodegenerative disorders (such as&#xD;
             Parkinson's disease, Alzheimer's disease).&#xD;
&#xD;
          3. Incompetent adults or those unable to communicate.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chris Honey, MD,DPhil,FRCSC</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Chris Honey, MD,DPhil,FRCSC</last_name>
    <phone>604-875-5894</phone>
    <email>chris.honey@telus.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Leah Polyhronopoulos, BSc</last_name>
    <phone>778-938-6127</phone>
    <email>leahpoly@mail.ubc.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Vancouver General Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christopher R Honey, MD, DPhil</last_name>
      <phone>604.875.5894</phone>
      <email>chris.honey@telus.net</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Slotty PJ, Poologaindran A, Honey CR. A prospective, randomized, blinded assessment of multitarget thalamic and pallidal deep brain stimulation in a case of hemidystonia. Clin Neurol Neurosurg. 2015 Nov;138:16-9. doi: 10.1016/j.clineuro.2015.07.012. Epub 2015 Jul 29.</citation>
    <PMID>26241157</PMID>
  </reference>
  <reference>
    <citation>Prudente CN, Hess EJ, Jinnah HA. Dystonia as a network disorder: what is the role of the cerebellum? Neuroscience. 2014 Feb 28;260:23-35. doi: 10.1016/j.neuroscience.2013.11.062. Epub 2013 Dec 11.</citation>
    <PMID>24333801</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 30, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>October 29, 2020</last_update_submitted>
  <last_update_submitted_qc>October 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Christopher Honey</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </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/NCT02982304
org study id: H14-03185
nct id: NCT02982304
lead sponsor: 
has dmc: No
Dystonia is increasingly being considered as a multi-nodal network disorder involving both
      basal ganglia and cerebellar dysfunction. The aim of this study is to determine if
      "Multi-Target" Thalamic and Pallidal Deep Brain Stimulation improves hemi-dystonia patients
      who are receiving inadequate therapy from GPi DBS.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Burke Fahn Marsden Disability Rating Scale (BFMDRS)
time frame: 3 months
measure: SF-36 Quality of Life Scale
time frame: 3 months
measure: Adverse effects of Vim or Vim + GPi Neuromodulation
time frame: 3 months
arm group label: Pallidal (GPi) Deep Brain Stimulation
arm group type: Active Comparator
description: GPi is the standard target for treating most dystonia. This setting will be the active comparator
arm group label: Thalamic (Vim) Deep Brain Stimulation
arm group type: Experimental
description: Vim is the standard target to treat cerebellar dysfunction in movement disorders. It is not routinely used in secondary dystonia
arm group label: GPi + Vim (Multi-Target) Deep Brain Stimulation
arm group type: Experimental
description: Combined stimulation of GPi and Vim stimulation (both electrodes ON)
intervention type: Device
intervention name: Deep Brain Stimulation
description: Deep Brain Stimulation Electrode
arm group label: GPi + Vim (Multi-Target) Deep Brain Stimulation
arm group label: Pallidal (GPi) Deep Brain Stimulation
arm group label: Thalamic (Vim) Deep Brain Stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Chris Honey, MD,DPhil,FRCSC
role: Principal Investigator
affiliation: University of British Columbia
last name: Chris Honey, MD,DPhil,FRCSC
phone: 604-875-5894
email: chris.honey@telus.net
last name: Leah Polyhronopoulos, BSc
phone: 778-938-6127
email: leahpoly@mail.ubc.ca
facility: 
status: Recruiting
contact: 
country: Canada
citation: Slotty PJ, Poologaindran A, Honey CR. A prospective, randomized, blinded assessment of multitarget thalamic and pallidal deep brain stimulation in a case of hemidystonia. Clin Neurol Neurosurg. 2015 Nov;138:16-9. doi: 10.1016/j.clineuro.2015.07.012. Epub 2015 Jul 29.
PMID: 26241157
citation: Prudente CN, Hess EJ, Jinnah HA. Dystonia as a network disorder: what is the role of the cerebellum? Neuroscience. 2014 Feb 28;260:23-35. doi: 10.1016/j.neuroscience.2013.11.062. Epub 2013 Dec 11.
PMID: 24333801
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Christopher Honey
investigator title: Principal Investigator
mesh term: Dystonia
mesh term: Dystonic Disorders