<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/NCT03016104</url>
  </required_header>
  <id_info>
    <org_study_id>SHDC12014111b</org_study_id>
    <nct_id>NCT03016104</nct_id>
  </id_info>
  <brief_title>Magnetic Seizure Therapy vs. Electroconvulsive Therapy for Bipolar Mania</brief_title>
  <official_title>Magnetic Seizure Therapy vs. Electroconvulsive Therapy for Bipolar Mania</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shanghai Mental Health Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shanghai Mental Health Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and&#xD;
      its safety for bipolar mania. Half of the participants will receive MST, while the other half&#xD;
      will receive electroconvulsive therapy (ECT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Magnetic seizure therapy (MST) is likely to be an alternative options to electroconvulsive&#xD;
      therapy (ECT).&#xD;
&#xD;
      Widespread stimulation of cortical and subcortical regions is inevitable for ECT since the&#xD;
      substantial impedance of the scalp and skull shuts most of the electrical stimulus away from&#xD;
      the brain. Nevertheless, magnetic pulses are capable to focus the stimulus to a specific area&#xD;
      of the brain because they can pass the scalp and skull without resistance. In Addition,&#xD;
      electric current will penetrate into deeper structures, while magnetic stimulus are only&#xD;
      capable to reach a depth of a few centimeters. As a consequence, MST are able to generate&#xD;
      focus stimuli on superficial regions of the cortex while ECT can't, which may give MST the&#xD;
      capability to produce comparable therapeutic benefits with the absence of apparent cognitive&#xD;
      side effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The problems of MST device&#xD;
  </why_stopped>
  <start_date>November 2016</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">October 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>changes in The Positive and Negative Syndrome Scale (PANSS)</measure>
    <time_frame>At baseline, 4-week follow-up, and 8-week follow-up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in MATRICS Consensus Cognitive Battery (MCCB)</measure>
    <time_frame>At baseline and 4-week follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in Clinical Global Impressions (CGI)</measure>
    <time_frame>At baseline and 4-week follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in motor threshold (MT)</measure>
    <time_frame>At baseline and the day after the first treatment</time_frame>
    <description>using single-pulse Transcranial Magnetic Stimulation (sTMS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in brain gamma-aminobutyric acid （GABA）levels</measure>
    <time_frame>At baseline, the day after the first treatment, and at 4-week follow-up</time_frame>
    <description>measured by Magnetic Resonance Spectroscopy (MRS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in resting state network</measure>
    <time_frame>At baseline, the day after the first treatment, and at 4-week follow-up</time_frame>
    <description>measured by Magnetic Resonance Imaging (MRI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in auditory evoked potential (AEP)</measure>
    <time_frame>At baseline and the day after the first treatment</time_frame>
    <description>measured by electroencephalogram (EEG)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>changes in Novel P300</measure>
    <time_frame>At baseline and the day after the first treatment</time_frame>
    <description>measured by electroencephalogram (EEG)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Bipolar Disorder, Manic</condition>
  <arm_group>
    <arm_group_label>magnetic seizure therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 treatment sessions of MST, three times per week in the first two weeks, two times per in the following two weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>electroconvulsive therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>10 treatment sessions of modified-ECT, three times per week in the first two weeks, two times per in the following two weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Magpro X100 + Option</intervention_name>
    <description>In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of MST in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.</description>
    <arm_group_label>magnetic seizure therapy</arm_group_label>
    <other_name>magnetic seizure therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ThymatronSystem Ⅳ Electroconvulsive System</intervention_name>
    <description>In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of modified ECT in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks</description>
    <arm_group_label>electroconvulsive therapy</arm_group_label>
    <other_name>electroconvulsive therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>treatment as usual (TAU)</intervention_name>
    <description>Participants will engage in their inpatient treatment program as-usual.</description>
    <arm_group_label>electroconvulsive therapy</arm_group_label>
    <arm_group_label>magnetic seizure therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. DSM-5 diagnosis of bipolar I disorder and currently in a manic episode;&#xD;
&#xD;
          2. convulsive therapy clinically indicated, such as severe psychomotor excitement or&#xD;
             retardation, attempts of suicide, being highly aggressive, pharmacotherapy&#xD;
             intolerance, and ineffectiveness of antipsychotics;&#xD;
&#xD;
          3. the positive and negative syndrome scale (PANSS) score ≥ 60;&#xD;
&#xD;
          4. informed consent in written form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. diagnosis of other mental disorders;&#xD;
&#xD;
          2. severe physical diseases, such as stroke, heart failure, liver failure, neoplasm, and&#xD;
             immune deficiency;&#xD;
&#xD;
          3. present with a laboratory abnormality that could impact on efficacy of treatments or&#xD;
             safety of participants;&#xD;
&#xD;
          4. failure to respond to an adequate trial of ECT lifetime;&#xD;
&#xD;
          5. are pregnant or intend to get pregnant during the study;&#xD;
&#xD;
          6. other conditions that investigators consider to be inappropriate to participate in&#xD;
             this trial.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chunbo Li, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Shanghai Mental Health Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Shanghai Mental Health Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 21, 2016</study_first_submitted>
  <study_first_submitted_qc>January 8, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>May 5, 2022</last_update_submitted>
  <last_update_submitted_qc>May 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>magnetic seizure therapy</keyword>
  <keyword>electroconvulsive therapy</keyword>
  <keyword>bipolar mania</keyword>
  <keyword>cognition</keyword>
  <keyword>controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Seizures</mesh_term>
    <mesh_term>Bipolar Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03016104
org study id: SHDC12014111b
nct id: NCT03016104
lead sponsor: 
has dmc: Yes
This trial attempts to evaluate the treatment efficacy of magnetic seizure therapy (MST) and
      its safety for bipolar mania. Half of the participants will receive MST, while the other half
      will receive electroconvulsive therapy (ECT).
Magnetic seizure therapy (MST) is likely to be an alternative options to electroconvulsive
      therapy (ECT).

      Widespread stimulation of cortical and subcortical regions is inevitable for ECT since the
      substantial impedance of the scalp and skull shuts most of the electrical stimulus away from
      the brain. Nevertheless, magnetic pulses are capable to focus the stimulus to a specific area
      of the brain because they can pass the scalp and skull without resistance. In Addition,
      electric current will penetrate into deeper structures, while magnetic stimulus are only
      capable to reach a depth of a few centimeters. As a consequence, MST are able to generate
      focus stimuli on superficial regions of the cortex while ECT can't, which may give MST the
      capability to produce comparable therapeutic benefits with the absence of apparent cognitive
      side effects.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: changes in The Positive and Negative Syndrome Scale (PANSS)
time frame: At baseline, 4-week follow-up, and 8-week follow-up
measure: changes in MATRICS Consensus Cognitive Battery (MCCB)
time frame: At baseline and 4-week follow-up
measure: changes in Clinical Global Impressions (CGI)
time frame: At baseline and 4-week follow-up
measure: changes in motor threshold (MT)
time frame: At baseline and the day after the first treatment
description: using single-pulse Transcranial Magnetic Stimulation (sTMS)
measure: changes in brain gamma-aminobutyric acid （GABA）levels
time frame: At baseline, the day after the first treatment, and at 4-week follow-up
description: measured by Magnetic Resonance Spectroscopy (MRS)
measure: changes in resting state network
time frame: At baseline, the day after the first treatment, and at 4-week follow-up
description: measured by Magnetic Resonance Imaging (MRI)
measure: changes in auditory evoked potential (AEP)
time frame: At baseline and the day after the first treatment
description: measured by electroencephalogram (EEG)
measure: changes in Novel P300
time frame: At baseline and the day after the first treatment
description: measured by electroencephalogram (EEG)
arm group label: magnetic seizure therapy
arm group type: Experimental
description: 10 treatment sessions of MST, three times per week in the first two weeks, two times per in the following two weeks.
arm group label: electroconvulsive therapy
arm group type: Active Comparator
description: 10 treatment sessions of modified-ECT, three times per week in the first two weeks, two times per in the following two weeks.
intervention type: Device
intervention name: Magpro X100 + Option
description: In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of MST in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.
arm group label: magnetic seizure therapy
other name: magnetic seizure therapy
intervention type: Device
intervention name: ThymatronSystem Ⅳ Electroconvulsive System
description: In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of modified ECT in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks
arm group label: electroconvulsive therapy
other name: electroconvulsive therapy
intervention type: Other
intervention name: treatment as usual (TAU)
description: Participants will engage in their inpatient treatment program as-usual.
arm group label: electroconvulsive therapy
arm group label: magnetic seizure therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Chunbo Li, PHD
role: Principal Investigator
affiliation: Shanghai Mental Health Center
facility: 
country: China
responsible party type: Sponsor
mesh term: Seizures
mesh term: Bipolar Disorder
sharing ipd: No