<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/NCT03003156</url>
  </required_header>
  <id_info>
    <org_study_id>SHDC12014111a</org_study_id>
    <nct_id>NCT03003156</nct_id>
  </id_info>
  <brief_title>50 Hz vs. 25 Hz Magnetic Seizure Therapy for Schizophrenia</brief_title>
  <official_title>50 Hz vs. 25 Hz Magnetic Seizure Therapy for Schizophrenia</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 investigate whether the dosage (frequency) has an effect on the&#xD;
      treatment efficacy and cognitive outcomes of magnetic seizure therapy (MST) among&#xD;
      schizophrenia patients. Half of the participants will be recruited to receive 25 Hz MST,&#xD;
      while the other half will be recruited to 50 Hz MST.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Magnetic seizure therapy (MST) is likely to be an alternative options to electroconvulsive&#xD;
      therapy (ECT).Widespread stimulation of cortical and subcortical regions is inevitable for&#xD;
      ECT since the substantial impedance of the scalp and skull shuts most of the electrical&#xD;
      stimulus away from the brain. Nevertheless, magnetic pulses are capable to focus the stimulus&#xD;
      to a specific area of the brain because they can pass the scalp and skull without resistance.&#xD;
      In Addition, electric current will penetrate into deeper structures, while magnetic stimulus&#xD;
      are only capable to reach a depth of a few centimeters. As a consequence, MST are able to&#xD;
      generate focus stimuli on superficial regions of the cortex while ECT can't, which may give&#xD;
      MST the capability to produce comparable therapeutic benefits with the absence of apparent&#xD;
      cognitive side effects. Though high dose (frequency) MST is gaining popularity, there is no&#xD;
      evidences supporting its superiority over low dose (frequency) MST either on efficacy,&#xD;
      safety, or seizure quality.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">February 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 of The Positive and Negative Syndrome Scale (PANSS)</measure>
    <time_frame>At baseline, 4-week follow-up</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes of The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)</measure>
    <time_frame>At baseline and 4-week follow-up</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>seizure duration</measure>
    <time_frame>at each treatment session, up to 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>up to 4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>25 Hz magnetic seizure therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 treatment sessions of 25 Hz 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>50 Hz magnetic seizure therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 treatment sessions of 50 Hz MST, three times per week in the first two weeks, two times per in the following two weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>25 Hz magnetic seizure therapy</intervention_name>
    <description>In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of 25 Hz 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>25 Hz magnetic seizure therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>50 Hz magnetic seizure therapy</intervention_name>
    <description>In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of 50 Hz 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>50 Hz magnetic seizure therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. DSM-5 diagnosis of schizophrenia;&#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)[20] 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 2017</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 26, 2016</study_first_posted>
  <last_update_submitted>May 3, 2017</last_update_submitted>
  <last_update_submitted_qc>May 3, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>magnetic seizure therapy</keyword>
  <keyword>schizophrenia</keyword>
  <keyword>controlled trial</keyword>
  <keyword>cognition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Seizures</mesh_term>
    <mesh_term>Schizophrenia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share IPD data</ipd_description>
  </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/NCT03003156
org study id: SHDC12014111a
nct id: NCT03003156
lead sponsor: 
has dmc: Yes
This trial attempts to investigate whether the dosage (frequency) has an effect on the
      treatment efficacy and cognitive outcomes of magnetic seizure therapy (MST) among
      schizophrenia patients. Half of the participants will be recruited to receive 25 Hz MST,
      while the other half will be recruited to 50 Hz MST.
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. Though high dose (frequency) MST is gaining popularity, there is no
      evidences supporting its superiority over low dose (frequency) MST either on efficacy,
      safety, or seizure quality.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: changes of The Positive and Negative Syndrome Scale (PANSS)
time frame: At baseline, 4-week follow-up
measure: changes of The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
time frame: At baseline and 4-week follow-up
measure: seizure duration
time frame: at each treatment session, up to 4 weeks
measure: Adverse events
time frame: up to 4 weeks
arm group label: 25 Hz magnetic seizure therapy
arm group type: Experimental
description: 10 treatment sessions of 25 Hz MST, three times per week in the first two weeks, two times per in the following two weeks.
arm group label: 50 Hz magnetic seizure therapy
arm group type: Experimental
description: 10 treatment sessions of 50 Hz MST, three times per week in the first two weeks, two times per in the following two weeks.
intervention type: Procedure
intervention name: 25 Hz magnetic seizure therapy
description: In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of 25 Hz 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: 25 Hz magnetic seizure therapy
intervention type: Procedure
intervention name: 50 Hz magnetic seizure therapy
description: In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of 50 Hz 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: 50 Hz 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: Schizophrenia
sharing ipd: No
ipd description: No plan to share IPD data