xml: <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/NCT05984329</url>
    </required_header>
    <id_info>
      <org_study_id>IRBN872022/CHUSTE</org_study_id>
      <nct_id>NCT05984329</nct_id>
    </id_info>
    <brief_title>Tonic Versus Burst DR(TM) Epidural Motor Cortex Stimulation for Neuropathic Pain</brief_title>
    <official_title>Tonic Versus Burst DR(TM) Epidural Motor Cortex Stimulation for Neuropathic Pain : a Double-blind, Crossover, Comparative Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire de Saint Etienne</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>
        Epidural stimulation of the primary motor cortex (PMC) is indicated for the relief of&#xD;
        neuropathic pain refractory to pharmacological treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The main objective of this study is to compare the analgesic effect of two distinct waveforms&#xD;
        (i.e. tonic versus Burst DR(TM)) delivered by an epidural stimulator of the (primary) motor&#xD;
        cortex in patients suffering from neuropathic pain resistant to the best pharmacological&#xD;
        treatment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 15, 2022</start_date>
    <completion_date type="Anticipated">August 2023</completion_date>
    <primary_completion_date type="Anticipated">August 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of pain relief</measure>
      <time_frame>6 months</time_frame>
      <description>Percentage of analgesic relief compared with baseline (i.e. preoperative pain level)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Antalgic drugs intake</measure>
      <time_frame>6 months</time_frame>
      <description>Modification of pharmacological treatment doses (analgesics)</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Neuropathic Pain</condition>
    <arm_group>
      <arm_group_label>Tonic then Burst DR(TM)</arm_group_label>
      <description>Tonic Motor Cortex Stimulation (MCS) for 3 months then Burst DR(TM) MCS for 3 months</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Burst DR(TM) then tonic</arm_group_label>
      <description>Burst DR(TM) MCS for 3 months then tonic MCS for 3 months</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Retrospective analysis of patients' choice</intervention_name>
      <description>Retrospective analysis of patients' choice of tonic or Burst DR(TM) waves for their analgesic effect.</description>
      <arm_group_label>Burst DR(TM) then tonic</arm_group_label>
      <arm_group_label>Tonic then Burst DR(TM)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          MCS patients.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients suffering from neuropathic pain refractory to best pharmacological treatment,&#xD;
               operated on for MCS with an internal pulse generator (IPG) capable of delivering both&#xD;
               tonic and Burst DR(TM) stimulation waveforms.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients under 18 years old ; pregnancy&#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>François VASSAL, MD PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHU Saint-Etienne</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>François VASSAL, MD PhD</last_name>
      <phone>(0)477127538</phone>
      <phone_ext>+33</phone_ext>
      <email>francois.vassal@chu-st-etienne.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Chu Saint-Etienne</name>
        <address>
          <city>Saint-Étienne</city>
          <zip>42000</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>François VASSAL, MD PhD</last_name>
        <phone>(0)477127538</phone>
        <phone_ext>+33</phone_ext>
        <email>francois.vassal@chu-st-etienne.fr</email>
      </contact>
      <investigator>
        <last_name>François VASSAL, MD PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Motor cortex stimulation</keyword>
    <keyword>neuropathic pain</keyword>
    <keyword>Burst DR(TM) waveform</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Neuralgia</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05984329
  org study id: IRBN872022/CHUSTE
  nct id: NCT05984329
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Epidural stimulation of the primary motor cortex (PMC) is indicated for the relief of
        neuropathic pain refractory to pharmacological treatment.
  The main objective of this study is to compare the analgesic effect of two distinct waveforms
        (i.e. tonic versus Burst DR(TM)) delivered by an epidural stimulator of the (primary) motor
        cortex in patients suffering from neuropathic pain resistant to the best pharmacological
        treatment.
  observational model: Case-Crossover
  time perspective: Retrospective
  measure: Percentage of pain relief
  time frame: 6 months
  description: Percentage of analgesic relief compared with baseline (i.e. preoperative pain level)
  measure: Antalgic drugs intake
  time frame: 6 months
  description: Modification of pharmacological treatment doses (analgesics)
  arm group label: Tonic then Burst DR(TM)
  description: Tonic Motor Cortex Stimulation (MCS) for 3 months then Burst DR(TM) MCS for 3 months
  arm group label: Burst DR(TM) then tonic
  description: Burst DR(TM) MCS for 3 months then tonic MCS for 3 months
  intervention type: Other
  intervention name: Retrospective analysis of patients' choice
  description: Retrospective analysis of patients' choice of tonic or Burst DR(TM) waves for their analgesic effect.
  arm group label: Burst DR(TM) then tonic
  arm group label: Tonic then Burst DR(TM)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: François VASSAL, MD PhD
  role: Principal Investigator
  affiliation: CHU Saint-Etienne
  last name: François VASSAL, MD PhD
  phone: (0)477127538
  phone ext: +33
  email: francois.vassal@chu-st-etienne.fr
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Neuralgia
  sharing ipd: No