<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/NCT03297411</url>
  </required_header>
  <id_info>
    <org_study_id>HC17286</org_study_id>
    <nct_id>NCT03297411</nct_id>
  </id_info>
  <brief_title>Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling</brief_title>
  <official_title>Clinical Outcomes With Electroconvulsive Therapy: Insights From Computational Modelling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of New South Wales</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wesley Mission</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>The University of New South Wales</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 study will generate new information on how to optimise brain targets with ECT&#xD;
      stimulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will differentiate the brain regions which are related to the effectiveness of&#xD;
      electroconvulsive therapy (ECT) as a treatment, from the brain regions associated with memory&#xD;
      impairment, with ECT stimulation. This will be done by 1) testing effects on memory of 4&#xD;
      different forms of ECT, which stimulate the brain differently; 2) in a subset of&#xD;
      participants, use computer modelling to assess the pattern of brain stimulation with the 4&#xD;
      forms of ECT, and match these results to memory outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">October 10, 2017</start_date>
  <completion_date type="Anticipated">June 22, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 22, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <intervention_model_description>Each participant will be randomly allocated to a sequence of treatments using designs for crossover studies with fewer periods (3) than treatments (4) involving two sets of ECT electrode placements and two sets of pulse width.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Both participants and the outcome assessor will be blinded.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>HVLT-R</measure>
    <time_frame>Approximately 30 min after ECT treatment</time_frame>
    <description>Hopkins Verbal Learning Test-Revised</description>
  </primary_outcome>
  <primary_outcome>
    <measure>BVMT-R</measure>
    <time_frame>Approximately 30 min after ECT treatment</time_frame>
    <description>Brief Visual Memory Test-Revised</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Depression</condition>
  <arm_group>
    <arm_group_label>Brief Temporoparietal ECT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Brief Pulse Temporoparietal ECT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ultrabrief Temporoparietal ECT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ultrabrief Pulse Temporoparietal ECT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Brief Frontoparietal ECT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Brief Pulse Frontoparietal ECT</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ultrabrief Frontoparietal ECT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ultrabrief Pulse Frontoparietal ECT</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Brief Temporoparietal ECT</intervention_name>
    <description>Electroconvulsive Therapy (Brief pulse width, Temporoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.</description>
    <arm_group_label>Brief Temporoparietal ECT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrabrief Temporoparietal ECT</intervention_name>
    <description>Electroconvulsive Therapy (Ultrabrief pulse width, Temporoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.</description>
    <arm_group_label>Ultrabrief Temporoparietal ECT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Brief Frontoparietal ECT</intervention_name>
    <description>Electroconvulsive Therapy (Brief pulse width, Frontoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.</description>
    <arm_group_label>Brief Frontoparietal ECT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrabrief Frontoparietal ECT</intervention_name>
    <description>Electroconvulsive Therapy (Ultrabrief pulse width, Frontoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.</description>
    <arm_group_label>Ultrabrief Frontoparietal ECT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged ≥18 years; right-handed&#xD;
&#xD;
          -  DSM-5 Major Depressive Episode&#xD;
&#xD;
          -  Prescribed with a course of ECT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosis (as defined by DSM-V) of psychotic disorder (apart from Major Depressive&#xD;
             Episode with Psychotic features), current drug or alcohol abuse or dependence;&#xD;
&#xD;
          -  ECT treatments in last 3 months from a prior course of ECT;&#xD;
&#xD;
          -  Score &lt;23 on the Montreal Cognitive Assessment Battery (MoCA);&#xD;
&#xD;
          -  Past or current neurological illness or injury, medical illness which may&#xD;
             significantly affect neuropsychological function;&#xD;
&#xD;
          -  Inability to give informed consent or comply with study procedures; or&#xD;
&#xD;
          -  Not having worked or studied in an English speaking background (to ensure validity of&#xD;
             neuropsychological testing).&#xD;
&#xD;
          -  Not be claustrophobic (if having an MRI brain scan).&#xD;
&#xD;
          -  Not have any metal in your head or body (if having an MRI brain scan).&#xD;
&#xD;
          -  Likely non response to RUL forms of ECT, as indicated by past non response to RUL ECT&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Colleen Loo, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>The University of New South Wales</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Feng Lin, MD</last_name>
    <phone>+612 9382 8318</phone>
    <email>feng.lin@student.unsw.edu.au</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Colleen Loo, MBBS</last_name>
    <phone>+612 9113 2039</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Wesley Hospital Kogarah</name>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2217</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Feng Lin, MD</last_name>
      <phone>+612 9383 8318</phone>
    </contact>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>September 14, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 29, 2017</study_first_posted>
  <last_update_submitted>May 15, 2018</last_update_submitted>
  <last_update_submitted_qc>May 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 16, 2018</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>Colleen Loo</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>electroconvulsive therapy</keyword>
  <keyword>computer modelling</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</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/NCT03297411
org study id: HC17286
nct id: NCT03297411
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will generate new information on how to optimise brain targets with ECT
      stimulation.
This study will differentiate the brain regions which are related to the effectiveness of
      electroconvulsive therapy (ECT) as a treatment, from the brain regions associated with memory
      impairment, with ECT stimulation. This will be done by 1) testing effects on memory of 4
      different forms of ECT, which stimulate the brain differently; 2) in a subset of
      participants, use computer modelling to assess the pattern of brain stimulation with the 4
      forms of ECT, and match these results to memory outcomes.
allocation: Randomized
intervention model: Crossover Assignment
intervention model description: Each participant will be randomly allocated to a sequence of treatments using designs for crossover studies with fewer periods (3) than treatments (4) involving two sets of ECT electrode placements and two sets of pulse width.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Both participants and the outcome assessor will be blinded.
measure: HVLT-R
time frame: Approximately 30 min after ECT treatment
description: Hopkins Verbal Learning Test-Revised
measure: BVMT-R
time frame: Approximately 30 min after ECT treatment
description: Brief Visual Memory Test-Revised
arm group label: Brief Temporoparietal ECT
arm group type: Active Comparator
description: Brief Pulse Temporoparietal ECT
arm group label: Ultrabrief Temporoparietal ECT
arm group type: Active Comparator
description: Ultrabrief Pulse Temporoparietal ECT
arm group label: Brief Frontoparietal ECT
arm group type: Active Comparator
description: Brief Pulse Frontoparietal ECT
arm group label: Ultrabrief Frontoparietal ECT
arm group type: Active Comparator
description: Ultrabrief Pulse Frontoparietal ECT
intervention type: Procedure
intervention name: Brief Temporoparietal ECT
description: Electroconvulsive Therapy (Brief pulse width, Temporoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.
arm group label: Brief Temporoparietal ECT
intervention type: Procedure
intervention name: Ultrabrief Temporoparietal ECT
description: Electroconvulsive Therapy (Ultrabrief pulse width, Temporoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.
arm group label: Ultrabrief Temporoparietal ECT
intervention type: Procedure
intervention name: Brief Frontoparietal ECT
description: Electroconvulsive Therapy (Brief pulse width, Frontoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.
arm group label: Brief Frontoparietal ECT
intervention type: Procedure
intervention name: Ultrabrief Frontoparietal ECT
description: Electroconvulsive Therapy (Ultrabrief pulse width, Frontoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.
arm group label: Ultrabrief Frontoparietal ECT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Colleen Loo, MBBS
role: Principal Investigator
affiliation: The University of New South Wales
last name: Feng Lin, MD
phone: +612 9382 8318
email: feng.lin@student.unsw.edu.au
last name: Colleen Loo, MBBS
phone: +612 9113 2039
facility: 
status: Recruiting
contact: 
country: Australia
responsible party type: Principal Investigator
investigator affiliation: The University of New South Wales
investigator full name: Colleen Loo
investigator title: Professor
mesh term: Depression