<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/NCT03284671</url>
  </required_header>
  <id_info>
    <org_study_id>tDCS-TOC pilote</org_study_id>
    <nct_id>NCT03284671</nct_id>
  </id_info>
  <brief_title>tDCS Stimulation to Treat Patients With Severe and Resistant Obsessive Compulsive Disorder-Pilot Study</brief_title>
  <acronym>tDCS-TOC</acronym>
  <official_title>Transcranial Direct Current Stimulation to Treat Patients With Severe and Resistant Obsessive Compulsive Disorders -Pilot Study (tDCS-TOC Pilot)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Henri Laborit</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Henri Laborit</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose is to show that bifocal tDCS with an anodal stimulation on the orbitofrontal&#xD;
      cortex and cathodic stimulation on supplementary motor areas is an effective treatment for&#xD;
      patients with resistant and severe obsessive compulsive disorders.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 19, 2016</start_date>
  <completion_date type="Actual">May 12, 2017</completion_date>
  <primary_completion_date type="Actual">February 19, 2016</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>The primary outcome measure is used to show that bifocal tDCS with anodal stimulation on OFC and cathodic stimulation on the SMA is an effective treatment</measure>
    <time_frame>Day 14</time_frame>
    <description>Score improvement on the Y-BOCS after 14 days compared to the baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluate the persistence of therapeutic response at 45 days</measure>
    <time_frame>Day 45</time_frame>
    <description>Score improvement on the Y-BOCS after 45 days compared to the baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the persistence of therapeutic response at 105 days</measure>
    <time_frame>Day 105</time_frame>
    <description>Score improvement on the Y-BOCS after 105 days compared to the baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 14 days</measure>
    <time_frame>Day 14</time_frame>
    <description>Score improvement of Hamilton and HDRS scales between the baseline and day 14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 45 days</measure>
    <time_frame>Day 45</time_frame>
    <description>Score improvement of Hamilton and HDRS scales between the baseline and day 45</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 105 days</measure>
    <time_frame>Day 105</time_frame>
    <description>Score improvement of Hamilton and HDRS scales between the baseline and day 105</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effect of tDCS on the quality of life at day 14</measure>
    <time_frame>Day 14</time_frame>
    <description>Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effect of tDCS on the quality of life at day 45</measure>
    <time_frame>Day 45</time_frame>
    <description>Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 45</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effect of tDCS on global functioning at day 14</measure>
    <time_frame>Day 14</time_frame>
    <description>Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effect of tDCS on global functioning at day 45</measure>
    <time_frame>Day 45</time_frame>
    <description>Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 45</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effect of tDCS on social adjustment at day 14</measure>
    <time_frame>Day 14</time_frame>
    <description>Improvement of SAS (Social Adjustment Scale) scale between baseline and day 14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluate the effect of tDCS on social adjustement at day 45</measure>
    <time_frame>Day 45</time_frame>
    <description>Improvement of SAS (Social Adjustment Scale) scale between baseline and day 45</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Obsessive-compulsive Disorders and Symptoms</condition>
  <arm_group>
    <arm_group_label>bifocal stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcranial direct current Bifocal stimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>bifocal stimulation with tDCS</intervention_name>
    <description>Patients will receive an active Treatment with tDCS (10 sessions of 30 mn with an intensity of 2 mA)</description>
    <arm_group_label>bifocal stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Patients must present all of the following criteria in order to be eligible:&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  Meets criteria for obsessive compulsive disorder according to DSM-IV with a &quot;good&#xD;
             insight&quot; (BABS),&#xD;
&#xD;
          -  Age: Participants will be both males and females, 18-70 years of age included.&#xD;
&#xD;
          -  No current depressive and suicidal risks,&#xD;
&#xD;
          -  No epileptic pathology,&#xD;
&#xD;
          -  Chronic evolution ( Total Y-BOCS&gt;20 ),&#xD;
&#xD;
          -  Obsessive compulsive disorder resistant to pharmacology treatment, at least 2&#xD;
             antidepressants (type IRS) or cognitive and comportment therapy since at least one&#xD;
             year,&#xD;
&#xD;
          -  Stability treatment (antidepressants) for more than 12 weeks without significant&#xD;
             improvement,&#xD;
&#xD;
          -  Affiliation to a social security system (recipient or assignee),&#xD;
&#xD;
          -  Signed written inform consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Female subject who is pregnant, or of child-bearing age, sexually active and not using&#xD;
             reliable contraception or who is nursing,&#xD;
&#xD;
          -  Patient under curators&#xD;
&#xD;
          -  Meets another diagnosis of axe 1 of DSM-IV,&#xD;
&#xD;
          -  Current depressive or suicidal risks,&#xD;
&#xD;
          -  Patient with a benzodiazepine treatment,&#xD;
&#xD;
          -  Patient with any form of metal in the cranium, a pacemaker, skull defects, or skin&#xD;
             lesions to the scalp (cuts, abrasions, rash) ,&#xD;
&#xD;
          -  Epileptic patient,&#xD;
&#xD;
          -  Patient with a medical history of cranial trauma,&#xD;
&#xD;
          -  Patient unable to give his or hers informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nematollah JAAFARI, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Centre Hospitalier Henri Laborit</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier Henri Laborit</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 7, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Transcranial Direct Current Stimulation</keyword>
  <keyword>Supplementary motor area</keyword>
  <keyword>Orbitofrontal cortex</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Compulsive Personality Disorder</mesh_term>
    <mesh_term>Obsessive-Compulsive Disorder</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/NCT03284671
org study id: tDCS-TOC pilote
nct id: NCT03284671
lead sponsor: 
has dmc: No
The purpose is to show that bifocal tDCS with an anodal stimulation on the orbitofrontal
      cortex and cathodic stimulation on supplementary motor areas is an effective treatment for
      patients with resistant and severe obsessive compulsive disorders.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: The primary outcome measure is used to show that bifocal tDCS with anodal stimulation on OFC and cathodic stimulation on the SMA is an effective treatment
time frame: Day 14
description: Score improvement on the Y-BOCS after 14 days compared to the baseline
measure: Evaluate the persistence of therapeutic response at 45 days
time frame: Day 45
description: Score improvement on the Y-BOCS after 45 days compared to the baseline
measure: Evaluate the persistence of therapeutic response at 105 days
time frame: Day 105
description: Score improvement on the Y-BOCS after 105 days compared to the baseline
measure: Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 14 days
time frame: Day 14
description: Score improvement of Hamilton and HDRS scales between the baseline and day 14
measure: Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 45 days
time frame: Day 45
description: Score improvement of Hamilton and HDRS scales between the baseline and day 45
measure: Evaluate the therapeutic effect of tDCS on the depressive and anxious symptoms associated with Obsessive compulsive disorder at 105 days
time frame: Day 105
description: Score improvement of Hamilton and HDRS scales between the baseline and day 105
measure: Evaluate the effect of tDCS on the quality of life at day 14
time frame: Day 14
description: Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 14
measure: Evaluate the effect of tDCS on the quality of life at day 45
time frame: Day 45
description: Improvement of MOS SF-36 scale (Medical Outcome Study, Short Form) between baseline and day 45
measure: Evaluate the effect of tDCS on global functioning at day 14
time frame: Day 14
description: Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 14
measure: Evaluate the effect of tDCS on global functioning at day 45
time frame: Day 45
description: Improvement of GAF (Global Assessment of Functioning) scale between baseline and day 45
measure: Evaluate the effect of tDCS on social adjustment at day 14
time frame: Day 14
description: Improvement of SAS (Social Adjustment Scale) scale between baseline and day 14
measure: Evaluate the effect of tDCS on social adjustement at day 45
time frame: Day 45
description: Improvement of SAS (Social Adjustment Scale) scale between baseline and day 45
arm group label: bifocal stimulation
arm group type: Experimental
description: Transcranial direct current Bifocal stimulation
intervention type: Other
intervention name: bifocal stimulation with tDCS
description: Patients will receive an active Treatment with tDCS (10 sessions of 30 mn with an intensity of 2 mA)
arm group label: bifocal stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Nematollah JAAFARI, Professor
role: Study Director
affiliation: Centre Hospitalier Henri Laborit
facility: 
country: France
responsible party type: Sponsor
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder
sharing ipd: No