<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/NCT02227563</url>
  </required_header>
  <id_info>
    <org_study_id>Meiron 2013-3</org_study_id>
    <nct_id>NCT02227563</nct_id>
  </id_info>
  <brief_title>tDCS &amp; Auditory Hallucinations in Schizophrenia</brief_title>
  <official_title>tDCS &amp; Auditory Hallucinations in Schizophrenia (AVH-SZ)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Herzog Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Herzog Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate tDCS effects on schizophrenia symptoms, particularly on&#xD;
      auditory verbal hallucinations. tDCS applied with cathodal (inhibitory) electrode over the&#xD;
      left temporal parietal junction and anodal (excitatory) electrode over the left dorsolateral&#xD;
      prefrontal cortex.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of participants that fit inclusion criteria&#xD;
  </why_stopped>
  <start_date>March 2014</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change from baseline in auditory hallucination rating scale</measure>
    <time_frame>1 week post-treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>change in self-report quality of life scale from baseline</measure>
    <time_frame>1 week post treatment</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>change from baseline in auditory event related potentials (ERP)</measure>
    <time_frame>change in auditory ERP from baseline at 1 week</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>Active tDCS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>active tDCS</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>sham (placebo) tDCS condition</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Active tDCS</intervention_name>
    <description>repetitive daily tDCS sessions for a period of one week</description>
    <arm_group_label>Active tDCS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>control</intervention_name>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 18-60&#xD;
&#xD;
          -  Primary diagnosis of Diagnostic and Statistical Manual, fifth edition, schizophrenia&#xD;
&#xD;
          -  Persistent auditory verbal hallucinations&#xD;
&#xD;
          -  Right handed&#xD;
&#xD;
          -  Under stable doses of antipsychotic medication for ≥4 weeks&#xD;
&#xD;
          -  Normal hearing by self-report and physical exam&#xD;
&#xD;
          -  Use of effective method of birth control for women of childbearing capacity&#xD;
&#xD;
          -  Capable to provide informed consent. For patients judged to be incapable to provide&#xD;
             informed consent the legal guardian of the patient must agree to participation in the&#xD;
             study and provide signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current or past history of substance dependence or abuse (excluding nicotine)&#xD;
&#xD;
          -  Other current Axis I disorders&#xD;
&#xD;
          -  History of seizure, epilepsy in self or first degree relatives, stoke, brain surgery,&#xD;
             head injury, intracranial metal implants, known structural brain lesion, devices that&#xD;
             may be affected by tDCS (pacemaker, medication pump, cochlear implant, implanted brain&#xD;
             stimulator)&#xD;
&#xD;
          -  Frequent and persistent migraines&#xD;
&#xD;
          -  History of adverse reaction to neurostimulation&#xD;
&#xD;
          -  Participation in study of investigational medication within 6 weeks&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Women who are breast-feeding&#xD;
&#xD;
          -  Current significant laboratory abnormality&#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>Oded Meiron, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sarah Herzog Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Herzog Hospital</name>
      <address>
        <city>Jerusalem</city>
        <zip>9103702</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <reference>
    <citation>Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091. Erratum In: Am J Psychiatry. 2012 Dec 1;169(12):1321.</citation>
    <PMID>22581236</PMID>
  </reference>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>May 20, 2014</study_first_submitted>
  <study_first_submitted_qc>August 27, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>November 1, 2016</last_update_submitted>
  <last_update_submitted_qc>November 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 2, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dorsolateral prefrontal cortex</keyword>
  <keyword>left superior temporal gyrus</keyword>
  <keyword>auditory hallucinations</keyword>
  <keyword>transcranial direct current stimulation (tDCS)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hallucinations</mesh_term>
    <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/NCT02227563
org study id: Meiron 2013-3
nct id: NCT02227563
lead sponsor: 
has dmc: Yes
The aim of this study is to evaluate tDCS effects on schizophrenia symptoms, particularly on
      auditory verbal hallucinations. tDCS applied with cathodal (inhibitory) electrode over the
      left temporal parietal junction and anodal (excitatory) electrode over the left dorsolateral
      prefrontal cortex.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: change from baseline in auditory hallucination rating scale
time frame: 1 week post-treatment
measure: change in self-report quality of life scale from baseline
time frame: 1 week post treatment
measure: change from baseline in auditory event related potentials (ERP)
time frame: change in auditory ERP from baseline at 1 week
arm group label: Active tDCS
arm group type: Experimental
description: active tDCS
arm group label: control
arm group type: Sham Comparator
description: sham (placebo) tDCS condition
intervention type: Device
intervention name: Active tDCS
description: repetitive daily tDCS sessions for a period of one week
arm group label: Active tDCS
intervention type: Device
intervention name: control
arm group label: control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Oded Meiron, PhD
role: Principal Investigator
affiliation: Sarah Herzog Memorial Hospital
facility: 
country: Israel
citation: Brunelin J, Mondino M, Gassab L, Haesebaert F, Gaha L, Suaud-Chagny MF, Saoud M, Mechri A, Poulet E. Examining transcranial direct-current stimulation (tDCS) as a treatment for hallucinations in schizophrenia. Am J Psychiatry. 2012 Jul;169(7):719-24. doi: 10.1176/appi.ajp.2012.11071091. Erratum In: Am J Psychiatry. 2012 Dec 1;169(12):1321.
PMID: 22581236
responsible party type: Sponsor
mesh term: Hallucinations
mesh term: Schizophrenia