<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/NCT03273439</url>
  </required_header>
  <id_info>
    <org_study_id>46694276-1</org_study_id>
    <secondary_id>Szzx201509</secondary_id>
    <nct_id>NCT03273439</nct_id>
  </id_info>
  <brief_title>A Study of rTMS for Cognitive Deficits in Chronic Patients With Schizophrenia</brief_title>
  <official_title>A Randomized, Double-blind Study of Repetitive Transcranial Magnetic Stimulation for Cognitive Deficits in Chronic Patients With Schizophrenia in a Chinese Han Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Suzhou Psychiatric Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Suzhou Psychiatric Hospital</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>
      In this study, we assessed the therapeutic effects and safety of left dorsolateral prefrontal&#xD;
      cortex (DLPFC) high-frequency repetitive transcranial magnetic stimulation (rTMS) on negative&#xD;
      symptoms of schizophrenia. We evaluated the efficacy of rTMS on cognition in patients with&#xD;
      chronic schizophrenia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized, sham-controlled, double-blinded trial. 47 patients diagnosed with&#xD;
      schizophrenia on stable antipsychotic treatment were randomly assigned to active rTMS&#xD;
      treatment group (n=25) or a sham rTMS treatment group (n=22). 25 patients in the active rTMS&#xD;
      group received 10 Hz 110% rTMS, while 22 patients were subjected to sham rTMS, both being&#xD;
      given 4-week treatment (5 days per week). Efficacy of negative symptom was assessed with the&#xD;
      Scale for the Assessment of Negative Symptoms (SANS), the Positive and Negative symptom scale&#xD;
      (PANSS) at baseline, the end of 4 weeks and 8 weeks. The cognitive function was assessed with&#xD;
      CANTAB at baseline, the end of 4 weeks and 8 weeks .The side effects were assessed with&#xD;
      Treatment Emergent Symptoms Scale at baseline and the end of 4 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2012</start_date>
  <completion_date type="Actual">June 30, 2015</completion_date>
  <primary_completion_date type="Actual">February 1, 2014</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 study, we assessed the therapeutic effects and safety of left dorsolateral prefrontal cortex (DLPFC) high-frequency repetitive transcranial magnetic stimulation (rTMS) on negative symptoms of schizophrenia. We evaluated the efficacy of rTMS on cognition in patients with chronic schizophrenia.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>This was a single-institution, randomized controlled, double blinded trial. Participants were randomized to receive, over 4 weeks, 20 sessions of either active or sham rTMS. Clinical assessment was performed at baseline, 4 weeks and 8 weeks by 2 psychiatrists blinded to the treatment assigned. Inter-rater reliability was satisfactory (κa=0.86).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Scale for the Assessment of Negative Symptoms (SANS)</measure>
    <time_frame>4 weeks</time_frame>
    <description>clinical negative symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Positive and Negative symptom scale (PANSS)</measure>
    <time_frame>4 weeks</time_frame>
    <description>Clinical symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CANTAB</measure>
    <time_frame>4 weeks</time_frame>
    <description>cognition</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">47</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>repetitive TMS</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prior to each TMS administration, motor threshold was determined by stimulating the left motor strip with the lowest possible energy to produce, within 10 stimuli, at least 5 evoked potentials Z0.05 . In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 5-s intervals with 30-s intertrain interval. 30 trains were administered each day (MondayFriday) for 4 consecutive weeks (total stimuli=30,000).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham rTMS</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>all procedures were identical except they were the unmagnetized steel cylinders, instead of cylindrical magnets, that were rotated. Participants were, therefore, unable to distinguish between active and sham rTMS.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>repetitive TMS</intervention_name>
    <description>Prior to each TMS administration, motor threshold was determined by stimulating the left motor strip with the lowest possible energy to produce, within 10 stimuli, at least 5 evoked potentials Z0.05 . In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of motor threshold (MT) for 5-s intervals with 30-s intertrain interval. 30 trains were administered each day (MondayFriday) for 4 consecutive weeks (total stimuli=30,000).</description>
    <arm_group_label>repetitive TMS</arm_group_label>
    <other_name>rTMS</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sham rTMS</intervention_name>
    <description>Sham rTMS, without stimulation</description>
    <arm_group_label>Sham rTMS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Right-handed;&#xD;
&#xD;
          2. meeting the diagnosis of schizophrenia for at least 2 years;&#xD;
&#xD;
          3. had been on anti-psychotic medications for more than 12 weeks;&#xD;
&#xD;
          4. with unresolved negative symptoms (SANS&gt;20).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. with substance use disorders ;&#xD;
&#xD;
          2. with cerebral pathologies (e.g. seizure, aneurysm, stroke), intra-cranial metals,&#xD;
             pacemakers, severe cardiovascular diseases;&#xD;
&#xD;
          3. receiving electroconvulsive therapy in the past 3 months.&#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_official>
    <last_name>Guangzhong Yin, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Suzhou Guangji Hospital</affiliation>
  </overall_official>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>March 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>September 5, 2017</last_update_submitted>
  <last_update_submitted_qc>September 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Suzhou Psychiatric Hospital</investigator_affiliation>
    <investigator_full_name>Zhe Li</investigator_full_name>
    <investigator_title>Attending Psychiatrist</investigator_title>
  </responsible_party>
  <keyword>Repetitive transcranial magnetic stimulation</keyword>
  <keyword>Negative symptoms</keyword>
  <keyword>randomized controlled trial</keyword>
  <keyword>Schizophrenia</keyword>
  <keyword>cognition</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Cognition Disorders</mesh_term>
    <mesh_term>Cognitive Dysfunction</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/NCT03273439
org study id: 46694276-1
secondary id: Szzx201509
nct id: NCT03273439
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
In this study, we assessed the therapeutic effects and safety of left dorsolateral prefrontal
      cortex (DLPFC) high-frequency repetitive transcranial magnetic stimulation (rTMS) on negative
      symptoms of schizophrenia. We evaluated the efficacy of rTMS on cognition in patients with
      chronic schizophrenia.
This is a randomized, sham-controlled, double-blinded trial. 47 patients diagnosed with
      schizophrenia on stable antipsychotic treatment were randomly assigned to active rTMS
      treatment group (n=25) or a sham rTMS treatment group (n=22). 25 patients in the active rTMS
      group received 10 Hz 110% rTMS, while 22 patients were subjected to sham rTMS, both being
      given 4-week treatment (5 days per week). Efficacy of negative symptom was assessed with the
      Scale for the Assessment of Negative Symptoms (SANS), the Positive and Negative symptom scale
      (PANSS) at baseline, the end of 4 weeks and 8 weeks. The cognitive function was assessed with
      CANTAB at baseline, the end of 4 weeks and 8 weeks .The side effects were assessed with
      Treatment Emergent Symptoms Scale at baseline and the end of 4 weeks.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In this study, we assessed the therapeutic effects and safety of left dorsolateral prefrontal cortex (DLPFC) high-frequency repetitive transcranial magnetic stimulation (rTMS) on negative symptoms of schizophrenia. We evaluated the efficacy of rTMS on cognition in patients with chronic schizophrenia.
primary purpose: Treatment
masking: Single (Participant)
masking description: This was a single-institution, randomized controlled, double blinded trial. Participants were randomized to receive, over 4 weeks, 20 sessions of either active or sham rTMS. Clinical assessment was performed at baseline, 4 weeks and 8 weeks by 2 psychiatrists blinded to the treatment assigned. Inter-rater reliability was satisfactory (κa=0.86).
measure: Scale for the Assessment of Negative Symptoms (SANS)
time frame: 4 weeks
description: clinical negative symptoms
measure: Positive and Negative symptom scale (PANSS)
time frame: 4 weeks
description: Clinical symptoms
measure: CANTAB
time frame: 4 weeks
description: cognition
arm group label: repetitive TMS
arm group type: Experimental
description: Prior to each TMS administration, motor threshold was determined by stimulating the left motor strip with the lowest possible energy to produce, within 10 stimuli, at least 5 evoked potentials Z0.05 . In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 5-s intervals with 30-s intertrain interval. 30 trains were administered each day (MondayFriday) for 4 consecutive weeks (total stimuli=30,000).
arm group label: Sham rTMS
arm group type: Sham Comparator
description: all procedures were identical except they were the unmagnetized steel cylinders, instead of cylindrical magnets, that were rotated. Participants were, therefore, unable to distinguish between active and sham rTMS.
intervention type: Device
intervention name: repetitive TMS
description: Prior to each TMS administration, motor threshold was determined by stimulating the left motor strip with the lowest possible energy to produce, within 10 stimuli, at least 5 evoked potentials Z0.05 . In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of motor threshold (MT) for 5-s intervals with 30-s intertrain interval. 30 trains were administered each day (MondayFriday) for 4 consecutive weeks (total stimuli=30,000).
arm group label: repetitive TMS
other name: rTMS
intervention type: Device
intervention name: Sham rTMS
description: Sham rTMS, without stimulation
arm group label: Sham rTMS
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Guangzhong Yin, MD
role: Study Chair
affiliation: Suzhou Guangji Hospital
responsible party type: Principal Investigator
investigator affiliation: Suzhou Psychiatric Hospital
investigator full name: Zhe Li
investigator title: Attending Psychiatrist
mesh term: Schizophrenia
mesh term: Cognition Disorders
mesh term: Cognitive Dysfunction
sharing ipd: No