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/NCT06017713</url>
    </required_header>
    <id_info>
      <org_study_id>2023-A01148-37</org_study_id>
      <nct_id>NCT06017713</nct_id>
    </id_info>
    <brief_title>tDCS Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive Disorder</brief_title>
    <acronym>PPSTDCS-TOC</acronym>
    <official_title>Direct Transcranial Stimulation With Direct Current Associated With Symptom Provocation in the Management of Patients With Resistant Obsessive Compulsive</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>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a single-center study about patients with severe resistant OCD.&#xD;
  &#xD;
        We hypothesize that performing 10 tDCS sessions with the anode positioned at the level of the&#xD;
        right orbitofrontal cortex, and the cathode at the level of the supplementary motor area,&#xD;
        associated with the provocation of symptoms before each session is effective in the reduction&#xD;
        in obsessive-compulsive symptoms.&#xD;
  &#xD;
        After the inclusion visit, the treatment period is provided from D1 to D12 (one session per&#xD;
        day from Monday to Friday, for two consecutive weeks, i.e. a total of ten sessions). Each&#xD;
        tDCS session lasts 30 minutes at an intensity of 2 mA and is preceded by symptom provocation&#xD;
        using a standardized procedure performed by trained personnel.&#xD;
  &#xD;
        The patients are then assessed on D42 and D102 (i.e. 1 month and 3 months after the end of&#xD;
        the tDCS sessions).&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">July 2024</completion_date>
    <primary_completion_date type="Anticipated">January 2024</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>YBOCS scale</measure>
      <time_frame>3,5 months</time_frame>
      <description>The primary endpoint corresponds to the change in the score on the YBOCS scale between the inclusion visit (Day 0) and the Day 42 visit.&#xD;
  A score of 0 corresponds to the absence of OCD and a score of 40 to maximum severity.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">25</enrollment>
    <condition>Obsessive-Compulsive Disorder</condition>
    <arm_group>
      <arm_group_label>tDCS + symptoms provocation</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>tDCS + symptoms provocation</intervention_name>
      <description>The treatment consists of 10 sessions of tDCS. Each tDCS session lasts 30 minutes at an intensity of 2mA and is preceded by a provocation of symptoms.</description>
      <arm_group_label>tDCS + symptoms provocation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patient suffering from OCD evolving for at least 2 years diagnosed according to DSM-V&#xD;
               criteria;&#xD;
  &#xD;
            -  Patient with good insight, defined by a score less than or equal to 18 at the&#xD;
               threshold of delusions on the BABS (Brown Assessment of Beliefs Scale) insight scale;&#xD;
  &#xD;
            -  Absence of a current depressive episode (MADRS score &lt; 21) or suicidal risk (MADRS&#xD;
               score item 10 &lt; 3);&#xD;
  &#xD;
            -  Absence of epileptic pathology;&#xD;
  &#xD;
            -  Chronic obsessive-compulsive disorder defined by a total YBOCS score &gt; 20, or a&#xD;
               subscale score &gt; 15;&#xD;
  &#xD;
            -  Drug-resistant obsessive-compulsive disorder despite treatment with:&#xD;
  &#xD;
                 1. at least 2 antidepressants of the IRS type at an effective dose and for a&#xD;
                    sufficient duration&#xD;
  &#xD;
                 2. and/or Behavioral and Cognitive therapy for at least 1 year;&#xD;
  &#xD;
            -  Therapeutic stability (antidepressants) for more than 12 weeks without significant&#xD;
               improvement. This treatment, at a fixed dose, will be maintained during the study;&#xD;
  &#xD;
            -  Patient aged between 18 and 70 included&#xD;
  &#xD;
            -  Patient who has given his/her informed consent after having received written&#xD;
               information on the planned procedure;&#xD;
  &#xD;
            -  Patient benefiting from social security or by benefiting through a third party.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Woman of childbearing age without effective means of contraception&#xD;
               (hormonal/mechanical: oral, injectable, transcutaneous, implantable, intrauterine&#xD;
               device, or surgical: tubal ligation, hysterectomy, total oophorectomy)&#xD;
  &#xD;
            -  Pregnant or nursing woman;&#xD;
  &#xD;
            -  Patient hospitalized under duress (SPDT, SPDRE);&#xD;
  &#xD;
            -  Patient under guardianship or curatorship;&#xD;
  &#xD;
            -  Patient with another DSM-V Axis 1 diagnosis (Schizophrenic Disorder, Bipolar Disorder,&#xD;
               Substance Abuse or Substance Dependence).&#xD;
  &#xD;
          Generalized anxiety disorder, social phobia, nicotine addiction and history of major&#xD;
          depressive episodes are not exclusion criteria. Axis I comorbidity will be explored using&#xD;
          MINI 5.0.0. ;&#xD;
  &#xD;
            -  Patient suffering from a current depressive episode;&#xD;
  &#xD;
            -  Patient at risk of suicide;&#xD;
  &#xD;
            -  Patient with skin lesions on the scalp;&#xD;
  &#xD;
            -  History of head trauma;&#xD;
  &#xD;
            -  Patient with an intracerebral metal object&#xD;
  &#xD;
            -  Patient with a pacemaker;&#xD;
  &#xD;
            -  Presence of epileptic pathology;&#xD;
  &#xD;
            -  Patient in an emergency situation or unable to give personal 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_contact>
      <last_name>Ghina HARIKA-GERMANEAU, Dr</last_name>
      <phone>516526118</phone>
      <phone_ext>0033</phone_ext>
      <email>ghina.harika-germaneau@ch-poitiers.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Centre Hospitalier Henri Laborit</name>
        <address>
          <city>Poitiers</city>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Ghina Harika Germaneau</last_name>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 24, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>
    <!-- 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/NCT06017713
  org study id: 2023-A01148-37
  nct id: NCT06017713
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a single-center study about patients with severe resistant OCD.
  
        We hypothesize that performing 10 tDCS sessions with the anode positioned at the level of the
        right orbitofrontal cortex, and the cathode at the level of the supplementary motor area,
        associated with the provocation of symptoms before each session is effective in the reduction
        in obsessive-compulsive symptoms.
  
        After the inclusion visit, the treatment period is provided from D1 to D12 (one session per
        day from Monday to Friday, for two consecutive weeks, i.e. a total of ten sessions). Each
        tDCS session lasts 30 minutes at an intensity of 2 mA and is preceded by symptom provocation
        using a standardized procedure performed by trained personnel.
  
        The patients are then assessed on D42 and D102 (i.e. 1 month and 3 months after the end of
        the tDCS sessions).
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: YBOCS scale
  time frame: 3,5 months
  description: The primary endpoint corresponds to the change in the score on the YBOCS scale between the inclusion visit (Day 0) and the Day 42 visit.
  A score of 0 corresponds to the absence of OCD and a score of 40 to maximum severity.
  arm group label: tDCS + symptoms provocation
  arm group type: Experimental
  intervention type: Behavioral
  intervention name: tDCS + symptoms provocation
  description: The treatment consists of 10 sessions of tDCS. Each tDCS session lasts 30 minutes at an intensity of 2mA and is preceded by a provocation of symptoms.
  arm group label: tDCS + symptoms provocation
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Ghina HARIKA-GERMANEAU, Dr
  phone: 516526118
  phone ext: 0033
  email: ghina.harika-germaneau@ch-poitiers.fr
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Compulsive Personality Disorder
  mesh term: Obsessive-Compulsive Disorder