<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/NCT01733602</url>
  </required_header>
  <id_info>
    <org_study_id>11/188</org_study_id>
    <nct_id>NCT01733602</nct_id>
  </id_info>
  <brief_title>tDCS to Enhance Cognitive Training in Schizophrenia</brief_title>
  <official_title>Does Transcranial Direct Current Stimulation (tDCS) Enhance Outcomes From Computerised Cognitive Remediation in Patients With Schizophrenia?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of New South Wales</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of New South Wales</source>
  <brief_summary>
    <textblock>
      The primary aim for the study is to determine whether transcranial direct current stimulation&#xD;
      (tDCS) enhances training gains on cognitive training (CT) tasks. Secondary aims are to&#xD;
      determine whether tDCS combined with CT causes larger transferable improvements on&#xD;
      non-trained tasks (i.e., generalisation effects) and whether these generalisation effects are&#xD;
      maintained over time (i.e., maintenance effects).&#xD;
&#xD;
      Specific hypotheses are:&#xD;
&#xD;
        1. CT combined with active tDCS will produce greater training gains on CT tasks compared to&#xD;
           a similar control group receiving CT with sham tDCS.&#xD;
&#xD;
        2. CT combined with active tDCS will produce greater generalisation effects on non-trained&#xD;
           cognitive tasks compared to CT with sham tDCS.&#xD;
&#xD;
        3. The cognitive improvements gained by patients from both interventions will be maintained&#xD;
           over 1 month follow-up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <primary_completion_date type="Actual">November 2016</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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression score on cognitive training task.</measure>
    <time_frame>Post treatment</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">52</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>active tDCS and cognitive training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transcranial direct current stimulation combined with cognitive training</description>
  </arm_group>
  <arm_group>
    <arm_group_label>sham tDCD and cognitive training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Sham transcranial direct current stimulation combined with cognitive training</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>transcranial direct current stimulation</intervention_name>
    <arm_group_label>active tDCS and cognitive training</arm_group_label>
    <arm_group_label>sham tDCD and cognitive training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects are 18 years of age or above.&#xD;
&#xD;
          2. Subjects meet criteria for a DSM -IV schizophrenia or schizoaffective disorder but&#xD;
             with a stable mental status as demonstrated by a stable Positive and Negative Symptom&#xD;
             Score (PANSS) score over a period of 2 weeks.&#xD;
&#xD;
          3. Subjects have had no medication changes in the 2 weeks prior to obtaining informed&#xD;
             consent.&#xD;
&#xD;
          4. Subjects are right-handed.&#xD;
&#xD;
          5. Subjects able to give informed consent for the trial.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Drug or alcohol abuse or dependence (preceding 3 months).&#xD;
&#xD;
          2. Concurrent anticonvulsant or long acting benzodiazepine medication, as these&#xD;
             medications may interfere with the effects of tDCS.&#xD;
&#xD;
          3. Subject requires a rapid clinical response due to inanition, psychosis or high suicide&#xD;
             risk.&#xD;
&#xD;
          4. Clinically defined neurological disorder or insult, including history of seizures,&#xD;
             cerebral aneurysm or trauma, significant head trauma with loss of consciousness for ≥&#xD;
             30 minutes.&#xD;
&#xD;
          5. Subject has metal in the cranium, skull defects, or skin lesions on scalp at proposed&#xD;
             electrode sites.&#xD;
&#xD;
          6. Female subject of child bearing age, sexually active and not using reliable&#xD;
             contraception&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Mental Health Rehabilitation Unit (MHRU) at the Sutherland hospital</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2229</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>November 26, 2012</study_first_submitted>
  <study_first_submitted_qc>November 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 27, 2012</study_first_posted>
  <last_update_submitted>August 7, 2017</last_update_submitted>
  <last_update_submitted_qc>August 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of New South Wales</investigator_affiliation>
    <investigator_full_name>Melissa Pigot</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </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/NCT01733602
org study id: 11/188
nct id: NCT01733602
lead sponsor: 
The primary aim for the study is to determine whether transcranial direct current stimulation
      (tDCS) enhances training gains on cognitive training (CT) tasks. Secondary aims are to
      determine whether tDCS combined with CT causes larger transferable improvements on
      non-trained tasks (i.e., generalisation effects) and whether these generalisation effects are
      maintained over time (i.e., maintenance effects).

      Specific hypotheses are:

        1. CT combined with active tDCS will produce greater training gains on CT tasks compared to
           a similar control group receiving CT with sham tDCS.

        2. CT combined with active tDCS will produce greater generalisation effects on non-trained
           cognitive tasks compared to CT with sham tDCS.

        3. The cognitive improvements gained by patients from both interventions will be maintained
           over 1 month follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Progression score on cognitive training task.
time frame: Post treatment
arm group label: active tDCS and cognitive training
arm group type: Experimental
description: Transcranial direct current stimulation combined with cognitive training
arm group label: sham tDCD and cognitive training
arm group type: Active Comparator
description: Sham transcranial direct current stimulation combined with cognitive training
intervention type: Device
intervention name: transcranial direct current stimulation
arm group label: active tDCS and cognitive training
arm group label: sham tDCD and cognitive training
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
facility: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: The University of New South Wales
investigator full name: Melissa Pigot
investigator title: Research Assistant
mesh term: Schizophrenia