<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/NCT02204787</url>
  </required_header>
  <id_info>
    <org_study_id>9257</org_study_id>
    <nct_id>NCT02204787</nct_id>
  </id_info>
  <brief_title>Treatment of Negative Symptoms and Schizophrenia</brief_title>
  <acronym>STICCS</acronym>
  <official_title>A Double Blind Sham Controlled Trial of tDCS for Treatment of Negative Symptoms in Patients With Schizophrenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the therapeutic efficacy of a neuromodulation technique,&#xD;
      tDCS (transcranial direct current stimulation) used as a complementary treatment on negative&#xD;
      symptoms. 60 patients will be randomized into two groups (active tDCS vs sham tDCS) and will&#xD;
      be assessed after the intervention, 1 and 3 months after.Secondary outcomes shall include&#xD;
      neuropsychological assessment, general symptomatology, extrapyramidal symptoms and social&#xD;
      functioning.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2014</start_date>
  <completion_date type="Actual">October 26, 2018</completion_date>
  <primary_completion_date type="Actual">October 26, 2018</primary_completion_date>
  <phase>Phase 1/Phase 2</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Scale for the Assessment of Negative Symptoms</measure>
    <time_frame>up to 3 months after intervention</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>active tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcranial Direct Current Stimulation : 10 sessions twice a day during 5 days, with a 2 mA intensity during 20 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Transcranial Direct Current Stimulation : 10 sessions twice a day during 5 days, with a sham stimulation during 20 minutes. Initial stimulation followed by turning off the device as to ensure blinding.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcranial direct current stimulation</intervention_name>
    <arm_group_label>Sham tDCS</arm_group_label>
    <arm_group_label>active tDCS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        -  Inclusion Criteria:&#xD;
&#xD;
               -  Schizophrenia with prominent negative symptoms&#xD;
&#xD;
          -  Exclusion Criteria:&#xD;
&#xD;
               -  other psychiatric or neurological diseases&#xD;
&#xD;
               -  specific tDCS limitations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jerome ATTAL, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UH Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UH Montpellier</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>July 29, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 30, 2014</study_first_posted>
  <last_update_submitted>December 13, 2022</last_update_submitted>
  <last_update_submitted_qc>December 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 14, 2022</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>Schizophrenia</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/NCT02204787
org study id: 9257
nct id: NCT02204787
lead sponsor: 
has dmc: Yes
The aim of this study is to evaluate the therapeutic efficacy of a neuromodulation technique,
      tDCS (transcranial direct current stimulation) used as a complementary treatment on negative
      symptoms. 60 patients will be randomized into two groups (active tDCS vs sham tDCS) and will
      be assessed after the intervention, 1 and 3 months after.Secondary outcomes shall include
      neuropsychological assessment, general symptomatology, extrapyramidal symptoms and social
      functioning.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Scale for the Assessment of Negative Symptoms
time frame: up to 3 months after intervention
arm group label: active tDCS
arm group type: Experimental
description: Transcranial Direct Current Stimulation : 10 sessions twice a day during 5 days, with a 2 mA intensity during 20 minutes.
arm group label: Sham tDCS
arm group type: Sham Comparator
description: Transcranial Direct Current Stimulation : 10 sessions twice a day during 5 days, with a sham stimulation during 20 minutes. Initial stimulation followed by turning off the device as to ensure blinding.
intervention type: Device
intervention name: transcranial direct current stimulation
arm group label: Sham tDCS
arm group label: active tDCS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Jerome ATTAL, MD
role: Principal Investigator
affiliation: UH Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Schizophrenia