<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/NCT03015558</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL15_0345</org_study_id>
    <secondary_id>2016-A00022-49</secondary_id>
    <nct_id>NCT03015558</nct_id>
  </id_info>
  <brief_title>Analgesic Effect of Non Invasive Stimulation : Transcranial Direct Current Stimulation of Opercular-insular Cortex</brief_title>
  <acronym>STIM-INSULA</acronym>
  <official_title>Transcranial Direct Current Stimulation (tDCS) for Neuropathic Chronic Pain : Study of the Opercular-insular Cortex Stimulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate, versus placebo, the analgesic efficacy of the&#xD;
      opercular-insular cortex stimulation with Transcranial Direct Current Stimulation (tDCS), in&#xD;
      both healthy subjects and chronic neuropathic pain patients. In healthy subjects analgesia by&#xD;
      tDCS will be assessed using both laser stimuli and cold pressor test. In patients the&#xD;
      assessment regards their chronic pain (ratings for ongoing, evoked and paroxysmal pain, sleep&#xD;
      and fatigue). Opercular-insular stimulation is obtained via a combined 6-electrode montage&#xD;
      and by bi-vestibular stimulation (since vestibular pathways reach the posterior insular&#xD;
      cortex). In patients, three separate conditions (two active and one sham) will be tested in&#xD;
      randomised order. In healthy subjects, two other conditions are added to control for&#xD;
      attention and distraction confounders.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2016</start_date>
  <completion_date type="Actual">March 28, 2018</completion_date>
  <primary_completion_date type="Actual">March 28, 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials with pain scale</measure>
    <time_frame>just before the tDCS session at Day 0</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>In patients : Changes in daily ratings of global pain</measure>
    <time_frame>just before the tDCS session at Day 0</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials</measure>
    <time_frame>just after the tDCS session at Day 0</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>In patients : Changes in daily ratings of global pain</measure>
    <time_frame>just after the tDCS session at Day 0</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>In patients : Changes in daily ratings of global pain</measure>
    <time_frame>at week 1</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ongoing pain with pain scale</measure>
    <time_frame>just before the tDCS session at Day 0</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ongoing pain with pain scale</measure>
    <time_frame>just after the tDCS session at Day 0</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ongoing pain as assessed by daily ratings</measure>
    <time_frame>during one week</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Neuropathic Pain</condition>
  <arm_group>
    <arm_group_label>patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>healthy subjects</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS session</intervention_name>
    <description>transcranial direct current stimulations of opercular-insular cortex. Three sessions separated by a minimum of 2 weeks, with three different conditions: one session with anodal active tDCS, one with active control, and one with sham control.</description>
    <arm_group_label>healthy subjects</arm_group_label>
    <arm_group_label>patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcranial direct current stimulation of opercular-insular cortex - active control session</intervention_name>
    <description>transcranial direct current stimulations of opercular-insular cortex. Three sessions separated by a minimum of 2 weeks, with three different conditions: one session with anodal active tDCS, one with active control, and one with sham control.</description>
    <arm_group_label>healthy subjects</arm_group_label>
    <arm_group_label>patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcranial direct current stimulation of opercular-insular cortex - sham control session.</intervention_name>
    <description>transcranial direct current stimulations of opercular-insular cortex. Three sessions separated by a minimum of 2 weeks, with three different conditions: one session with anodal active tDCS, one with active control, and one with sham control.</description>
    <arm_group_label>healthy subjects</arm_group_label>
    <arm_group_label>patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy subjects aged from 18 to 70 years, male or female, with social security&#xD;
             protection, fully informed and having given their written consent.&#xD;
&#xD;
          -  patients aged from 18 to 80 years, male or female, with social security protection ,&#xD;
             fully informed and having given their written consent.&#xD;
&#xD;
          -  pharmacoresistant neuropathic pain during at least one year,&#xD;
&#xD;
          -  without any change of the pharmacological treatment since at least one month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        In healthy subjects only:&#xD;
&#xD;
          -  history of chronic pain&#xD;
&#xD;
          -  analgesic medication within 24h before stimulation&#xD;
&#xD;
        For patients only: new analgesic treatment within 1 month before consent&#xD;
&#xD;
        for both:&#xD;
&#xD;
          -  drug addiction, headache, epilepsy&#xD;
&#xD;
          -  ferromagnetic intracranial device&#xD;
&#xD;
          -  implanted stimulator&#xD;
&#xD;
          -  recent neurosurgery and open wound of the scalp.&#xD;
&#xD;
          -  absence of contraceptive method for women of childbearing age&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luis GARCIA-LARREA, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>NeuroPain lab - CRNL (Inserm U1028 - UCBL)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospices Civils de Lyon - NeuroPain lab - CRNL</name>
      <address>
        <city>Bron</city>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>January 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>December 6, 2021</last_update_submitted>
  <last_update_submitted_qc>December 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug Resistance</keyword>
  <keyword>Neuropathic Pain</keyword>
  <keyword>opercular-insular cortex</keyword>
  <keyword>Transcranial Direct Current Stimulation</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>


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/NCT03015558
org study id: 69HCL15_0345
secondary id: 2016-A00022-49
nct id: NCT03015558
lead sponsor: 
has dmc: No
The aim of this study is to evaluate, versus placebo, the analgesic efficacy of the
      opercular-insular cortex stimulation with Transcranial Direct Current Stimulation (tDCS), in
      both healthy subjects and chronic neuropathic pain patients. In healthy subjects analgesia by
      tDCS will be assessed using both laser stimuli and cold pressor test. In patients the
      assessment regards their chronic pain (ratings for ongoing, evoked and paroxysmal pain, sleep
      and fatigue). Opercular-insular stimulation is obtained via a combined 6-electrode montage
      and by bi-vestibular stimulation (since vestibular pathways reach the posterior insular
      cortex). In patients, three separate conditions (two active and one sham) will be tested in
      randomised order. In healthy subjects, two other conditions are added to control for
      attention and distraction confounders.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials with pain scale
time frame: just before the tDCS session at Day 0
measure: In patients : Changes in daily ratings of global pain
time frame: just before the tDCS session at Day 0
measure: In healthy subjects : Change in subjective pain and (when applicable) in cortical evoked potentials
time frame: just after the tDCS session at Day 0
measure: In patients : Changes in daily ratings of global pain
time frame: just after the tDCS session at Day 0
measure: In patients : Changes in daily ratings of global pain
time frame: at week 1
measure: ongoing pain with pain scale
time frame: just before the tDCS session at Day 0
measure: ongoing pain with pain scale
time frame: just after the tDCS session at Day 0
measure: ongoing pain as assessed by daily ratings
time frame: during one week
arm group label: patients
arm group type: Experimental
arm group label: healthy subjects
arm group type: Active Comparator
intervention type: Device
intervention name: transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS session
description: transcranial direct current stimulations of opercular-insular cortex. Three sessions separated by a minimum of 2 weeks, with three different conditions: one session with anodal active tDCS, one with active control, and one with sham control.
arm group label: healthy subjects
arm group label: patients
intervention type: Device
intervention name: transcranial direct current stimulation of opercular-insular cortex - active control session
description: transcranial direct current stimulations of opercular-insular cortex. Three sessions separated by a minimum of 2 weeks, with three different conditions: one session with anodal active tDCS, one with active control, and one with sham control.
arm group label: healthy subjects
arm group label: patients
intervention type: Device
intervention name: transcranial direct current stimulation of opercular-insular cortex - sham control session.
description: transcranial direct current stimulations of opercular-insular cortex. Three sessions separated by a minimum of 2 weeks, with three different conditions: one session with anodal active tDCS, one with active control, and one with sham control.
arm group label: healthy subjects
arm group label: patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Luis GARCIA-LARREA, MD
role: Principal Investigator
affiliation: NeuroPain lab - CRNL (Inserm U1028 - UCBL)
facility: 
country: France
responsible party type: Sponsor
mesh term: Neuralgia
sharing ipd: No