<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/NCT03795935</url>
  </required_header>
  <id_info>
    <org_study_id>H17-00672</org_study_id>
    <nct_id>NCT03795935</nct_id>
  </id_info>
  <brief_title>Relief From Side Effects: Clinical Use of Electrodes With Direction</brief_title>
  <acronym>RESCUED</acronym>
  <official_title>Relief From Side Effects: Clinical Use of Electrodes With Direction: a Prospective, Open Label, Clinical Trial for Thalamic Deep Brain Stimulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Deep Brain Stimulation (DBS) uses electrical pulses sent through a lead (insulated wire) to&#xD;
      help stop unwanted symptoms in a variety of brain diseases, including the tremor seen in&#xD;
      patients with Essential Tremor (ET). The current standard lead allows this stimulation to&#xD;
      spread out uniformly in all directions. As these diseases progress, however, the amount of&#xD;
      electrical stimulation required to stop the symptom usually increases. This may become&#xD;
      problematic because the increased electrical stimulation required for advanced symptoms may&#xD;
      spread outside the desired targeted area, and effect other parts of the brain and causing&#xD;
      unwanted side effects. A new type of DBS lead has been developed which can steer, or focus,&#xD;
      the electrical stimulation in a given direction toward the desired target area and away from&#xD;
      areas that would cause side effects. We would like to quantify the benefit seen in patients&#xD;
      who have been switched from the traditional lead to this new directional lead.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients implanted with a DBS may experience unwanted side effects such as motor&#xD;
      contractures, paresthesia, or dysarthria. This occurs when the electrical field of the&#xD;
      stimulation spreads out beyond the targeted area. This is especially common in patients whose&#xD;
      disease has progressed, and must use increasingly higher currents in order to regain control&#xD;
      of their tremor. Unfortunately, because the electrical field affects neurons in a symmetrical&#xD;
      sphere around the DBS, it is often impossible to reach the additional desired neuronal&#xD;
      elements without simultaneously affecting equidistant brain regions responsible for side&#xD;
      effects. For many of our advanced patients, this means choosing between a debilitating tremor&#xD;
      or disabling side effects.The directional lead is a FDA and Health Canada approved DBS lead&#xD;
      which features radially segmented electrodes which can selectively steer the electrical field&#xD;
      in a predefined direction, orthogonal to the lead trajectory. This will allow DBS clinicians&#xD;
      to steer current towards desired structural areas, while avoiding locations, which produce&#xD;
      negative side effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 17, 2018</start_date>
  <completion_date type="Anticipated">August 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2019</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Tremor Control</measure>
    <time_frame>Assessed once all tests performed - 1 to 2 months post-operatively</time_frame>
    <description>Maximum percentage change in tremor (as measured by the Tremor Rating Scale) without side-effects (comparing DBS &quot;on&quot; versus &quot;off&quot;) in each patient using the standard lead compared to the directional lead.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of life based on participant's best real life setting</measure>
    <time_frame>Assessed during study visits - The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured</time_frame>
    <description>Quality of life will be based on each participant's subjective opinion using the Short Form 36 (SF36) (a patient-reported survey focusing on health and quality of life) assessment form.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life based on tremor management participant's best real life setting</measure>
    <time_frame>Assessed during study visits - The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured</time_frame>
    <description>Quality of life will be based on each participant's subjective opinion using the Quality of Life in Essential Tremor Questionare.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life based on voice handicap with participant's best real life setting</measure>
    <time_frame>Assessed during study visits - The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured</time_frame>
    <description>Quality of life will be based on each participant's subjective opinion using the Vocal handicap Index scale.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">6</enrollment>
  <condition>Deep Brain Stimulation</condition>
  <condition>Directional Lead</condition>
  <condition>Essential Tremor</condition>
  <arm_group>
    <arm_group_label>Treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients who were previously implanted with a traditional DBS lead and have subsequently developed stimulation induced side effects will gain significantly more tremor control without side effects when re-implanted with a directional DBS lead. We expect these patients' quality of life will improve. These patients typically will have had significant tremor relief (greater than 75% reduction from preoperative tremor rating scale) without side effects at their one year post operative follow-up. With the expected disease progression they will have had to increase their DBS stimulation to the degree that their DBS now causes side effects in order to block their tremor</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No side-effect stimulator settings with directional lead</intervention_name>
    <description>Individuals in this arm will have their stimulator settings programmed to the point in which they have maximum tremor control with no side effects.</description>
    <arm_group_label>Treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must have been implanted with the DBS&#xD;
&#xD;
          -  Participants must have been diagnosed with Essential Tremor&#xD;
&#xD;
          -  Participants must experience negative side effects from their DBS which limit control&#xD;
             over their tremor&#xD;
&#xD;
          -  Participants must be able to receive benefit from their stimulator, but at the cost of&#xD;
             negative side effects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  All individuals who meet criteria outlined in &quot;inclusion criteria&quot; may be eligible for&#xD;
             this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Christopher Honey, DPhil</last_name>
    <phone>6048755894</phone>
    <email>chris.honey@telus.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Natasha Sarai, BSN</last_name>
    <phone>6048754111</phone>
    <phone_ext>69584</phone_ext>
    <email>natasha.sarai@vch.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Vancouver General Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E3</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>Toader E, Decre MM, Martens HC. Steering deep brain stimulation fields using a high resolution electrode array. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:2061-4. doi: 10.1109/IEMBS.2010.5626472.</citation>
    <PMID>21096152</PMID>
  </reference>
  <reference>
    <citation>Reinacher PC, Kruger MT, Coenen VA, Shah M, Roelz R, Jenkner C, Egger K. Determining the Orientation of Directional Deep Brain Stimulation Electrodes Using 3D Rotational Fluoroscopy. AJNR Am J Neuroradiol. 2017 Jun;38(6):1111-1116. doi: 10.3174/ajnr.A5153. Epub 2017 Apr 6.</citation>
    <PMID>28385887</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>September 17, 2018</study_first_submitted>
  <study_first_submitted_qc>January 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 8, 2019</study_first_posted>
  <last_update_submitted>January 6, 2019</last_update_submitted>
  <last_update_submitted_qc>January 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 8, 2019</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>Neurosurgeon, Professor of Surgery (Neurosurgery), Director of Surgical Centre for Movement Disorders</investigator_title>
  </responsible_party>
  <keyword>Deep Brain Stimulation</keyword>
  <keyword>Directional Lead</keyword>
  <keyword>Essential Tremor</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tremor</mesh_term>
    <mesh_term>Essential Tremor</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>October 26, 2020</submitted>
    <returned>November 19, 2020</returned>
    <submitted>November 20, 2020</submitted>
    <returned>December 18, 2020</returned>
    <submitted>January 8, 2021</submitted>
    <returned>January 28, 2021</returned>
    <submitted>April 26, 2021</submitted>
    <returned>May 21, 2021</returned>
  </pending_results>
  <!-- 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/NCT03795935
org study id: H17-00672
nct id: NCT03795935
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Deep Brain Stimulation (DBS) uses electrical pulses sent through a lead (insulated wire) to
      help stop unwanted symptoms in a variety of brain diseases, including the tremor seen in
      patients with Essential Tremor (ET). The current standard lead allows this stimulation to
      spread out uniformly in all directions. As these diseases progress, however, the amount of
      electrical stimulation required to stop the symptom usually increases. This may become
      problematic because the increased electrical stimulation required for advanced symptoms may
      spread outside the desired targeted area, and effect other parts of the brain and causing
      unwanted side effects. A new type of DBS lead has been developed which can steer, or focus,
      the electrical stimulation in a given direction toward the desired target area and away from
      areas that would cause side effects. We would like to quantify the benefit seen in patients
      who have been switched from the traditional lead to this new directional lead.
Patients implanted with a DBS may experience unwanted side effects such as motor
      contractures, paresthesia, or dysarthria. This occurs when the electrical field of the
      stimulation spreads out beyond the targeted area. This is especially common in patients whose
      disease has progressed, and must use increasingly higher currents in order to regain control
      of their tremor. Unfortunately, because the electrical field affects neurons in a symmetrical
      sphere around the DBS, it is often impossible to reach the additional desired neuronal
      elements without simultaneously affecting equidistant brain regions responsible for side
      effects. For many of our advanced patients, this means choosing between a debilitating tremor
      or disabling side effects.The directional lead is a FDA and Health Canada approved DBS lead
      which features radially segmented electrodes which can selectively steer the electrical field
      in a predefined direction, orthogonal to the lead trajectory. This will allow DBS clinicians
      to steer current towards desired structural areas, while avoiding locations, which produce
      negative side effects.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Tremor Control
time frame: Assessed once all tests performed - 1 to 2 months post-operatively
description: Maximum percentage change in tremor (as measured by the Tremor Rating Scale) without side-effects (comparing DBS "on" versus "off") in each patient using the standard lead compared to the directional lead.
measure: Quality of life based on participant's best real life setting
time frame: Assessed during study visits - The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured
description: Quality of life will be based on each participant's subjective opinion using the Short Form 36 (SF36) (a patient-reported survey focusing on health and quality of life) assessment form.
measure: Quality of life based on tremor management participant's best real life setting
time frame: Assessed during study visits - The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured
description: Quality of life will be based on each participant's subjective opinion using the Quality of Life in Essential Tremor Questionare.
measure: Quality of life based on voice handicap with participant's best real life setting
time frame: Assessed during study visits - The initial assessment will occur during a pre-operative study visit which will be compared post operatively 3 months after outcome 1 has been measured
description: Quality of life will be based on each participant's subjective opinion using the Vocal handicap Index scale.
arm group label: Treatment
arm group type: Experimental
description: Patients who were previously implanted with a traditional DBS lead and have subsequently developed stimulation induced side effects will gain significantly more tremor control without side effects when re-implanted with a directional DBS lead. We expect these patients' quality of life will improve. These patients typically will have had significant tremor relief (greater than 75% reduction from preoperative tremor rating scale) without side effects at their one year post operative follow-up. With the expected disease progression they will have had to increase their DBS stimulation to the degree that their DBS now causes side effects in order to block their tremor
intervention type: Other
intervention name: No side-effect stimulator settings with directional lead
description: Individuals in this arm will have their stimulator settings programmed to the point in which they have maximum tremor control with no side effects.
arm group label: Treatment
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Christopher Honey, DPhil
phone: 6048755894
email: chris.honey@telus.net
last name: Natasha Sarai, BSN
phone: 6048754111
phone ext: 69584
email: natasha.sarai@vch.ca
facility: 
status: Recruiting
contact: 
country: Canada
citation: Toader E, Decre MM, Martens HC. Steering deep brain stimulation fields using a high resolution electrode array. Annu Int Conf IEEE Eng Med Biol Soc. 2010;2010:2061-4. doi: 10.1109/IEMBS.2010.5626472.
PMID: 21096152
citation: Reinacher PC, Kruger MT, Coenen VA, Shah M, Roelz R, Jenkner C, Egger K. Determining the Orientation of Directional Deep Brain Stimulation Electrodes Using 3D Rotational Fluoroscopy. AJNR Am J Neuroradiol. 2017 Jun;38(6):1111-1116. doi: 10.3174/ajnr.A5153. Epub 2017 Apr 6.
PMID: 28385887
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Christopher Honey
investigator title: Neurosurgeon, Professor of Surgery (Neurosurgery), Director of Surgical Centre for Movement Disorders
mesh term: Tremor
mesh term: Essential Tremor
sharing ipd: No
submitted: October 26, 2020
returned: November 19, 2020
submitted: November 20, 2020
returned: December 18, 2020
submitted: January 8, 2021
returned: January 28, 2021
submitted: April 26, 2021
returned: May 21, 2021