<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/NCT02255643</url>
  </required_header>
  <id_info>
    <org_study_id>H14-01258</org_study_id>
    <nct_id>NCT02255643</nct_id>
  </id_info>
  <brief_title>Motor Threshold and Motor Cortex Stimulation</brief_title>
  <official_title>The Relationship Between Motor Threshold and Effective Stimulation Threshold During Motor Cortex Stimulation</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>
      Motor cortex stimulation (MCS) is a form of brain stimulation for patients with neuropathic&#xD;
      pain not responsive to medication. An electrode is placed on the surface of the brain and&#xD;
      connected to a programmable battery in the chest.&#xD;
&#xD;
      The strength of stimulation can be individually adjusted by changing the voltage of&#xD;
      stimulation. A too high voltage will produce side effects (e.g. seizures) while a too low&#xD;
      voltage will not provide pain control. The aim of this study is to analyze the optimal&#xD;
      stimulation parameters in patients already implanted with a motor cortex stimulation who have&#xD;
      received good pain relief. The actual voltage may vary widely between patients but the&#xD;
      investigators feel that there may be an &quot;ideal&quot; voltage if it is measured as a percentage of&#xD;
      motor threshold (PMT). If motor threshold is the stimulation voltage that can evoke a muscle&#xD;
      contraction then a PMT = 80% would be a voltage that was eighty percent of that value.&#xD;
      Although the actual voltage may be widely different between patients, the percentage needed&#xD;
      may be very similar. The investigators therefore plan to measure the effect of different&#xD;
      percentages of PMT in patients already being treated with motor cortex stimulation.&#xD;
&#xD;
      Systematic analysis of the findings of this study might help the individual participant and&#xD;
      future patients to better programming and less side effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Motor cortex stimulation (MCS) is a form of brain stimulation for patients with medically&#xD;
      refractory neuropathic pain. The strength of stimulation can be individually adjusted by&#xD;
      changing the voltage of stimulation. Too high voltage will produce side effects (e.g.&#xD;
      seizures) while too low voltage will not provide pain control. The aim of this study is to&#xD;
      analyze the optimal stimulation parameters in patients already implanted with a motor cortex&#xD;
      stimulation who have received good pain relief. The actual voltage may vary widely between&#xD;
      patients (because of the individual variations in tissue resistance) but the investigators&#xD;
      feel that there may be an &quot;ideal&quot; voltage if it is measured as a percentage of motor&#xD;
      threshold (PMT).&#xD;
&#xD;
      If motor threshold is the voltage that can evoke a muscle contraction then a PMT = 80% would&#xD;
      be a voltage that was eighty percent of that value. Although the actual voltage may be&#xD;
      different between patients, the effective PMT may be similar since it represents a more&#xD;
      physiologic measure of stimulation.&#xD;
&#xD;
      Systematic analysis of the findings of this study might help the individual participant and&#xD;
      future patients by reducing voltage to the lowest effective setting and reducing the chance&#xD;
      of seizures.&#xD;
&#xD;
      Motor cortex stimulation is used in the treatment of neuropathic pain since 1991 but still no&#xD;
      guidelines for programming exist and programming is therefore mainly bases on trial and&#xD;
      error. This is mostly due to many variables influencing the choice of stimulation parameters&#xD;
      and significant individual differences in susceptibility to stimulation. Routinely the motor&#xD;
      threshold is determined during programming to identify the superior limit of voltage at which&#xD;
      twitching is induced. No stimulation above the motor threshold should be performed as this is&#xD;
      known to cause seizures. The voltage of simulation that will be effective for an individual&#xD;
      is unknown at the beginning of the treatment.&#xD;
&#xD;
      The investigators try to find the lowest effective voltage because that will reduce the risk&#xD;
      of stimulation-induced seizures and prolong the life of the pacemaker.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</primary_completion_date>
  <phase>N/A</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pain measured on the Visual Analogue Scale with different PMT Settings</measure>
    <time_frame>at the End of each trial period, typically 14 days after changes in PMT Settings</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quality of Life assessment with the SF-36 questionnaire</measure>
    <time_frame>at the end of each trial period, typically at 14 days</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Pain assessment with the McGill pain questionnaire to record impact of pain</measure>
    <time_frame>at the end of each trial period, typically 14 days</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Neuropathic Pain</condition>
  <arm_group>
    <arm_group_label>-10% of effective PMT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients are set to a voltage 10% less than their original PMT at start of study, Changes in PMT settings</description>
  </arm_group>
  <arm_group>
    <arm_group_label>former setting (+/- 0% of PMT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients are set to their original PMT at start of study, Changes in PMT settings</description>
  </arm_group>
  <arm_group>
    <arm_group_label>+10% of effective PMT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients are set to a voltage 10% more than their original PMT at start of study, Changes in PMT settings</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Change of PMT setting</intervention_name>
    <description>The patients current motor threshold is determined and the patient is set to a new PMT (= new treatment arm)</description>
    <arm_group_label>+10% of effective PMT</arm_group_label>
    <arm_group_label>-10% of effective PMT</arm_group_label>
    <arm_group_label>former setting (+/- 0% of PMT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient more than 18 years of age&#xD;
&#xD;
          -  Chronic neuropathic pain effectively treated with motor cortex stimulation&#xD;
&#xD;
          -  Stable medication during the trial&#xD;
&#xD;
          -  Willing and able to comply with the study protocol and to return per the follow-up&#xD;
             visit schedule and able to provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Evidence of an active disruptive psychiatric disorder or other known condition&#xD;
             significant enough to impact the perception of pain, compliance to intervention and/or&#xD;
             ability to evaluate treatment outcome as determined by the investigator&#xD;
&#xD;
          -  Technical malfunction of the MCS device&#xD;
&#xD;
          -  History of seizures&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christopher R Honey, MD, DPhil</last_name>
    <role>Principal Investigator</role>
    <affiliation>UBC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vancouver General Hospital</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 4E3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Tsubokawa T, Katayama Y, Yamamoto T, Hirayama T, Koyama S. Treatment of thalamic pain by chronic motor cortex stimulation. Pacing Clin Electrophysiol. 1991 Jan;14(1):131-4. doi: 10.1111/j.1540-8159.1991.tb04058.x.</citation>
    <PMID>1705329</PMID>
  </reference>
  <reference>
    <citation>Tsubokawa T, Katayama Y, Yamamoto T, Hirayama T, Koyama S. Chronic motor cortex stimulation for the treatment of central pain. Acta Neurochir Suppl (Wien). 1991;52:137-9. doi: 10.1007/978-3-7091-9160-6_37.</citation>
    <PMID>1792954</PMID>
  </reference>
  <reference>
    <citation>Peyron R, Garcia-Larrea L, Deiber MP, Cinotti L, Convers P, Sindou M, Mauguiere F, Laurent B. Electrical stimulation of precentral cortical area in the treatment of central pain: electrophysiological and PET study. Pain. 1995 Sep;62(3):275-286. doi: 10.1016/0304-3959(94)00211-V.</citation>
    <PMID>8657427</PMID>
  </reference>
  <reference>
    <citation>Lima MC, Fregni F. Motor cortex stimulation for chronic pain: systematic review and meta-analysis of the literature. Neurology. 2008 Jun 10;70(24):2329-37. doi: 10.1212/01.wnl.0000314649.38527.93.</citation>
    <PMID>18541887</PMID>
  </reference>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2014</study_first_posted>
  <last_update_submitted>December 16, 2014</last_update_submitted>
  <last_update_submitted_qc>December 16, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 18, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>motor cortex stimulation</keyword>
  <keyword>chronic neuropathic pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neuralgia</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/NCT02255643
org study id: H14-01258
nct id: NCT02255643
lead sponsor: 
has dmc: No
Motor cortex stimulation (MCS) is a form of brain stimulation for patients with neuropathic
      pain not responsive to medication. An electrode is placed on the surface of the brain and
      connected to a programmable battery in the chest.

      The strength of stimulation can be individually adjusted by changing the voltage of
      stimulation. A too high voltage will produce side effects (e.g. seizures) while a too low
      voltage will not provide pain control. The aim of this study is to analyze the optimal
      stimulation parameters in patients already implanted with a motor cortex stimulation who have
      received good pain relief. The actual voltage may vary widely between patients but the
      investigators feel that there may be an "ideal" voltage if it is measured as a percentage of
      motor threshold (PMT). If motor threshold is the stimulation voltage that can evoke a muscle
      contraction then a PMT = 80% would be a voltage that was eighty percent of that value.
      Although the actual voltage may be widely different between patients, the percentage needed
      may be very similar. The investigators therefore plan to measure the effect of different
      percentages of PMT in patients already being treated with motor cortex stimulation.

      Systematic analysis of the findings of this study might help the individual participant and
      future patients to better programming and less side effects.
Motor cortex stimulation (MCS) is a form of brain stimulation for patients with medically
      refractory neuropathic pain. The strength of stimulation can be individually adjusted by
      changing the voltage of stimulation. Too high voltage will produce side effects (e.g.
      seizures) while too low voltage will not provide pain control. The aim of this study is to
      analyze the optimal stimulation parameters in patients already implanted with a motor cortex
      stimulation who have received good pain relief. The actual voltage may vary widely between
      patients (because of the individual variations in tissue resistance) but the investigators
      feel that there may be an "ideal" voltage if it is measured as a percentage of motor
      threshold (PMT).

      If motor threshold is the voltage that can evoke a muscle contraction then a PMT = 80% would
      be a voltage that was eighty percent of that value. Although the actual voltage may be
      different between patients, the effective PMT may be similar since it represents a more
      physiologic measure of stimulation.

      Systematic analysis of the findings of this study might help the individual participant and
      future patients by reducing voltage to the lowest effective setting and reducing the chance
      of seizures.

      Motor cortex stimulation is used in the treatment of neuropathic pain since 1991 but still no
      guidelines for programming exist and programming is therefore mainly bases on trial and
      error. This is mostly due to many variables influencing the choice of stimulation parameters
      and significant individual differences in susceptibility to stimulation. Routinely the motor
      threshold is determined during programming to identify the superior limit of voltage at which
      twitching is induced. No stimulation above the motor threshold should be performed as this is
      known to cause seizures. The voltage of simulation that will be effective for an individual
      is unknown at the beginning of the treatment.

      The investigators try to find the lowest effective voltage because that will reduce the risk
      of stimulation-induced seizures and prolong the life of the pacemaker.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change in Pain measured on the Visual Analogue Scale with different PMT Settings
time frame: at the End of each trial period, typically 14 days after changes in PMT Settings
measure: Quality of Life assessment with the SF-36 questionnaire
time frame: at the end of each trial period, typically at 14 days
measure: Pain assessment with the McGill pain questionnaire to record impact of pain
time frame: at the end of each trial period, typically 14 days
arm group label: -10% of effective PMT
arm group type: Experimental
description: Patients are set to a voltage 10% less than their original PMT at start of study, Changes in PMT settings
arm group label: former setting (+/- 0% of PMT)
arm group type: Active Comparator
description: Patients are set to their original PMT at start of study, Changes in PMT settings
arm group label: +10% of effective PMT
arm group type: Experimental
description: Patients are set to a voltage 10% more than their original PMT at start of study, Changes in PMT settings
intervention type: Device
intervention name: Change of PMT setting
description: The patients current motor threshold is determined and the patient is set to a new PMT (= new treatment arm)
arm group label: +10% of effective PMT
arm group label: -10% of effective PMT
arm group label: former setting (+/- 0% of PMT)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christopher R Honey, MD, DPhil
role: Principal Investigator
affiliation: UBC
facility: 
country: Canada
citation: Tsubokawa T, Katayama Y, Yamamoto T, Hirayama T, Koyama S. Treatment of thalamic pain by chronic motor cortex stimulation. Pacing Clin Electrophysiol. 1991 Jan;14(1):131-4. doi: 10.1111/j.1540-8159.1991.tb04058.x.
PMID: 1705329
citation: Tsubokawa T, Katayama Y, Yamamoto T, Hirayama T, Koyama S. Chronic motor cortex stimulation for the treatment of central pain. Acta Neurochir Suppl (Wien). 1991;52:137-9. doi: 10.1007/978-3-7091-9160-6_37.
PMID: 1792954
citation: Peyron R, Garcia-Larrea L, Deiber MP, Cinotti L, Convers P, Sindou M, Mauguiere F, Laurent B. Electrical stimulation of precentral cortical area in the treatment of central pain: electrophysiological and PET study. Pain. 1995 Sep;62(3):275-286. doi: 10.1016/0304-3959(94)00211-V.
PMID: 8657427
citation: Lima MC, Fregni F. Motor cortex stimulation for chronic pain: systematic review and meta-analysis of the literature. Neurology. 2008 Jun 10;70(24):2329-37. doi: 10.1212/01.wnl.0000314649.38527.93.
PMID: 18541887
responsible party type: Sponsor
mesh term: Neuralgia