<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/NCT04478032</url>
  </required_header>
  <id_info>
    <org_study_id>20194Y0037</org_study_id>
    <nct_id>NCT04478032</nct_id>
  </id_info>
  <brief_title>Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia</brief_title>
  <official_title>Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia: a Double-Blind, Randomized Clinical Trial</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Based on the hypothesis that low-frequency deep transcranial magnetic stimulation(dTMS) on&#xD;
      anterior cingulate cortex （ACC） could down-regulate the glutamate level of ACC and regulate&#xD;
      the acc-related functional network in patients with treatment resistance schizophrenia,this&#xD;
      research plan to utilise multimodal functional magnetic imaging method(including structural&#xD;
      MRI,resting-state functional magnetic resonance imaging and 1H-MRS) to investigate&#xD;
      therapeutic efficacy of low-frequency deep transcranial magnetic stimulation on SZ patients&#xD;
      symptoms,as well as to elucidate the correlation between treatment effects and glutamate&#xD;
      level of ACC&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study includes 20 treatment resistance schizophrenia patients and 20 healthy&#xD;
      controls.This study will investigate 1)abnormalities of the glutamate level of ACC in&#xD;
      patients with schizophrenia compared to healthy controls by using 1H-MRS technique.&#xD;
      2)potential modulation effects of deep transcranial magnetic stimulation(dTMS) on anterior&#xD;
      cingulate cortex function of patients with schizophrenia. 3)the therapeutic efficacy of dTMS&#xD;
      on cognitive impairments and other psychotic symptoms of patients with schizophrenia by&#xD;
      adopting cognitive function and psychotic symptoms evaluation,as well as to explore the&#xD;
      optimal dTMS treatment pattern on cognitive function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 5, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>
    <intervention_model_description>In this research,we combine a cross-sectional case control study and a randomized controlled study.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in Positive and Negative Syndrome Scale(PANSS)</measure>
    <time_frame>baseline,24 hours after the dTMS treatment,30 days</time_frame>
    <description>Change from baseline in Positive and Negative Syndrome Scale(PANSS) after dtms treat 30 days</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from baseline in MATRICS Consensus Cognitive Battery</measure>
    <time_frame>baseline,24 hours after the rTMS treatment,30 days</time_frame>
    <description>MATRICS Consensus Cognitive Battery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of ACC neurogenesis</measure>
    <time_frame>baseline,24 hours after the dTMS treatment</time_frame>
    <description>Quantify neural stem cells in hippocampal by using H1-MRS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in glutamate level</measure>
    <time_frame>baseline,24 hours after the dTMS treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Deep Transcranial Magnetic Stimulation for the Treatment of Treatment Resistance Schizophrenia</condition>
  <arm_group>
    <arm_group_label>sham stimulation</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>20 patients will be randomly allocated into this group,they will receive sham stimulation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>real stimulation dTMS targeting the ACC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 patients will be randomly allocated into this group,they will receive real stimulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>deep transcranial magnetic stimulation with H7 coil</intervention_name>
    <description>low frequency(1Hz) deep transcranial magnetic stimulation on ACC .Duration:20 days.</description>
    <arm_group_label>real stimulation dTMS targeting the ACC</arm_group_label>
    <arm_group_label>sham stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with schizophrenia who meet the dsm-5 diagnostic criteria&#xD;
&#xD;
          -  Aged from 18 to 60&#xD;
&#xD;
          -  After 4 weeks of treatment with a sufficient dose of an antipsychotic (equivalent dose&#xD;
             of 400 ~ 600 mg/ day chlorpromazine (CPZ)), no clinical improvement was achieved (at&#xD;
             least two items in PANSS scale P1,P2,P3,N1,N4,N6,G5 and G9 ≥4 points, or cgi-s ≥4&#xD;
             points)&#xD;
&#xD;
          -  Right-handedness, normal hearing, visual acuity or corrected visual acuity&#xD;
&#xD;
          -  Written informed consent of the patient and his/her family&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who are currently taking clozapine or who have failed to respond to a full&#xD;
             course of treatment with clozapine&#xD;
&#xD;
          -  Current or past neurological illness,severe physical illness,substance abuse or&#xD;
             addiction,alcohol dependence,mental retardation,pregnancy or lactation,extreme&#xD;
             agitation, stupor, negative suicide,or those who can not cooperate&#xD;
&#xD;
          -  A history of MECT within 6 months,or those with contraindications to MRI,rTMS&#xD;
&#xD;
          -  Medically unstable for at least 1 month (PANSS score fluctuation&gt;10%)&#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_contact>
    <last_name>Dengtang Liu, M.D.</last_name>
    <phone>8618017311138</phone>
    <email>erliu110@126.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Shanghai Mental Health Center</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dengtang LIU</last_name>
      <phone>8618017311138</phone>
      <email>erliu110@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>September 12, 2021</last_update_submitted>
  <last_update_submitted_qc>September 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Treatment Resistance Schizophrenia</keyword>
  <keyword>Deep Transcranial Magnetic Stimulation</keyword>
  <keyword>anterior cingulate cortex</keyword>
  <keyword>glutamate</keyword>
  <keyword>H7 coil</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</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/NCT04478032
org study id: 20194Y0037
nct id: NCT04478032
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Based on the hypothesis that low-frequency deep transcranial magnetic stimulation(dTMS) on
      anterior cingulate cortex （ACC） could down-regulate the glutamate level of ACC and regulate
      the acc-related functional network in patients with treatment resistance schizophrenia,this
      research plan to utilise multimodal functional magnetic imaging method(including structural
      MRI,resting-state functional magnetic resonance imaging and 1H-MRS) to investigate
      therapeutic efficacy of low-frequency deep transcranial magnetic stimulation on SZ patients
      symptoms,as well as to elucidate the correlation between treatment effects and glutamate
      level of ACC
This study includes 20 treatment resistance schizophrenia patients and 20 healthy
      controls.This study will investigate 1)abnormalities of the glutamate level of ACC in
      patients with schizophrenia compared to healthy controls by using 1H-MRS technique.
      2)potential modulation effects of deep transcranial magnetic stimulation(dTMS) on anterior
      cingulate cortex function of patients with schizophrenia. 3)the therapeutic efficacy of dTMS
      on cognitive impairments and other psychotic symptoms of patients with schizophrenia by
      adopting cognitive function and psychotic symptoms evaluation,as well as to explore the
      optimal dTMS treatment pattern on cognitive function.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In this research,we combine a cross-sectional case control study and a randomized controlled study.
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change from baseline in Positive and Negative Syndrome Scale(PANSS)
time frame: baseline,24 hours after the dTMS treatment,30 days
description: Change from baseline in Positive and Negative Syndrome Scale(PANSS) after dtms treat 30 days
measure: Change from baseline in MATRICS Consensus Cognitive Battery
time frame: baseline,24 hours after the rTMS treatment,30 days
description: MATRICS Consensus Cognitive Battery
measure: Change of ACC neurogenesis
time frame: baseline,24 hours after the dTMS treatment
description: Quantify neural stem cells in hippocampal by using H1-MRS
measure: Change in glutamate level
time frame: baseline,24 hours after the dTMS treatment
arm group label: sham stimulation
arm group type: Sham Comparator
description: 20 patients will be randomly allocated into this group,they will receive sham stimulation.
arm group label: real stimulation dTMS targeting the ACC
arm group type: Active Comparator
description: 20 patients will be randomly allocated into this group,they will receive real stimulation.
intervention type: Device
intervention name: deep transcranial magnetic stimulation with H7 coil
description: low frequency(1Hz) deep transcranial magnetic stimulation on ACC .Duration:20 days.
arm group label: real stimulation dTMS targeting the ACC
arm group label: sham stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Dengtang Liu, M.D.
phone: 8618017311138
email: erliu110@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor
mesh term: Schizophrenia
sharing ipd: No