<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/NCT03774927</url>
  </required_header>
  <id_info>
    <org_study_id>CASPsy1</org_study_id>
    <nct_id>NCT03774927</nct_id>
  </id_info>
  <brief_title>High Frequency rTMS Treatment for Cognitive Impairments in Chronic Schizophrenia Patients</brief_title>
  <official_title>A Randomized, Double-blind Sham-controlled Trial of High Frequency rTMS for Cognitive Impairments in Chronic Schizophrenia Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing HuiLongGuan Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing HuiLongGuan 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>
      A randomized, double-blind sham-controlled trial of high frequency rTMS treatment for&#xD;
      cognitive impairments in 120 chronic schizophrenia patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      OBJECTIVE: This study aimed to evaluate the efficacy of high-frequency repetitive&#xD;
      transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex in the&#xD;
      treatment of cognitive impairments in 120 chronic patients with schizophrenia.&#xD;
&#xD;
      METHODS:&#xD;
&#xD;
        1. Clinical Trial: The study consists of 8 weeks of treatment.&#xD;
&#xD;
        2. Assessment Procedures:&#xD;
&#xD;
      2.1 Primary Outcome Variable-Psychopathology: The psychopathology of patients was assessed by&#xD;
      three clinical trained staff, who were blind to treatment protocols, using the Positive and&#xD;
      Negative Syndrome Scale (PANSS). Patients are interviewed at screening, at at baseline, 2&#xD;
      weeks, 4 weeks, 6 weeks and 8 weeks.&#xD;
&#xD;
      2.2 Cognitive tests: RBANS was used to assess the cognitive function by three psychologists,&#xD;
      which is comprised of a total score and 5 age-adjusted index scores for attention, language,&#xD;
      delayed and immediate memory and visuospatial/construction. A translated and adapted Chinese&#xD;
      version of RBANS has been evaluated for the test-retest reliability and clinical validity&#xD;
      between schizophrenia patients and control subjects. Cognitive performance was measured at&#xD;
      baseline and at 8-weeks.&#xD;
&#xD;
      2.3 Side Effects: TESS was used to assess the side effect at baseline and every 2 weeks.&#xD;
&#xD;
      2.5 Weight gain measurement: weight gain every week&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">November 30, 2018</completion_date>
  <primary_completion_date type="Actual">October 30, 2018</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Repeatable Battery for the Assessment of Neuropsychological Status for cognition</measure>
    <time_frame>8 weeks</time_frame>
    <description>cognitive performance</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Positive and Negative Syndrome Scale for clinical symptoms</measure>
    <time_frame>8 weeks</time_frame>
    <description>clinical symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatment Emergent Symptoms Scale for side effects</measure>
    <time_frame>8 weeks</time_frame>
    <description>Side effect</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Schizophrenia</condition>
  <arm_group>
    <arm_group_label>10 Hz treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>20 Hz treatment group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In active rTMS, 20 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 20 intervals with 28s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>In sham rTMS, all procedures were identical to 10Hz group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>10 Hz treatment group</intervention_name>
    <description>10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.</description>
    <arm_group_label>10 Hz treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>20 Hz treatment group</intervention_name>
    <description>20 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 20 intervals with 28s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.</description>
    <arm_group_label>20 Hz treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Control Group</intervention_name>
    <description>all procedures were identical to 10Hz group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of schizopherenia by two senior psychiatrists&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Right-handed&#xD;
&#xD;
          -  Between 18 and 60 years and Han Chinese&#xD;
&#xD;
          -  Duration of symptoms at least 60 months&#xD;
&#xD;
          -  Received stable doses of antipsychotic drugs at least 12 months&#xD;
&#xD;
          -  With unresolved negative symptoms (Negative scale of PANSS ≥20 and positive scale of&#xD;
             PANSS &lt; 24)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A DSM-IV Axis I diagnosis other than schizophrenia&#xD;
&#xD;
          -  Documented disease of physical diseases including, but not limited to seizure,&#xD;
             epilepsy, aneurysm brain tumor, and stroke, dementia, parkinson's disease,&#xD;
             Huntington's disease, multiple sclerosis&#xD;
&#xD;
          -  Acute, unstable and/or significant and untreated medical illness (e.g., infection,&#xD;
             unstable diabetes, uncontrolled hypertension)&#xD;
&#xD;
          -  Severe headache for unknown reasons and cardiovascular diseases, intra-cranial metals,&#xD;
             pacemakers, severe and those receiving electroconvulsive therapy in the past 3 months&#xD;
&#xD;
          -  Past history of autoimmune and allergies, hypertension, lung disease, diabetes or&#xD;
             cerebrovascular disease), past history of neurological illness (head trauma with loss&#xD;
             of consciousness for more than 5 minutes) or family history of epilepsy increasing the&#xD;
             risk of seizures&#xD;
&#xD;
          -  Education level less than 5 years by subject report,&#xD;
&#xD;
          -  Receiving or planning to start the psychotherapy during the rTMS treatment or past&#xD;
             received psychotherapy 6 months before the current study&#xD;
&#xD;
          -  Subjects who suffered from alcohol or illegal drug abuse/dependence&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hengyong Guan, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hebei Province Veteran Psychiatric Hospital</affiliation>
  </overall_official>
  <reference>
    <citation>Dlabac-de Lange JJ, Liemburg EJ, Bais L, Renken RJ, Knegtering H, Aleman A. Effect of rTMS on brain activation in schizophrenia with negative symptoms: A proof-of-principle study. Schizophr Res. 2015 Oct;168(1-2):475-82. doi: 10.1016/j.schres.2015.06.018. Epub 2015 Jul 14.</citation>
    <PMID>26187147</PMID>
  </reference>
  <results_reference>
    <citation>Mogg A, Purvis R, Eranti S, Contell F, Taylor JP, Nicholson T, Brown RG, McLoughlin DM. Repetitive transcranial magnetic stimulation for negative symptoms of schizophrenia: a randomized controlled pilot study. Schizophr Res. 2007 Jul;93(1-3):221-8. doi: 10.1016/j.schres.2007.03.016. Epub 2007 May 2.</citation>
    <PMID>17478080</PMID>
  </results_reference>
  <results_reference>
    <citation>Wobrock T, Guse B, Cordes J, Wolwer W, Winterer G, Gaebel W, Langguth B, Landgrebe M, Eichhammer P, Frank E, Hajak G, Ohmann C, Verde PE, Rietschel M, Ahmed R, Honer WG, Malchow B, Schneider-Axmann T, Falkai P, Hasan A. Left prefrontal high-frequency repetitive transcranial magnetic stimulation for the treatment of schizophrenia with predominant negative symptoms: a sham-controlled, randomized multicenter trial. Biol Psychiatry. 2015 Jun 1;77(11):979-88. doi: 10.1016/j.biopsych.2014.10.009. Epub 2014 Oct 23.</citation>
    <PMID>25582269</PMID>
  </results_reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>April 28, 2019</last_update_submitted>
  <last_update_submitted_qc>April 28, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing HuiLongGuan Hospital</investigator_affiliation>
    <investigator_full_name>Xiang Yang Zhang</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>schizophrenia</keyword>
  <keyword>rTMS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Schizophrenia</mesh_term>
    <mesh_term>Cognitive Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data with be available on request</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/NCT03774927
org study id: CASPsy1
nct id: NCT03774927
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
A randomized, double-blind sham-controlled trial of high frequency rTMS treatment for
      cognitive impairments in 120 chronic schizophrenia patients
OBJECTIVE: This study aimed to evaluate the efficacy of high-frequency repetitive
      transcranial magnetic stimulation (rTMS) over left dorsolateral prefrontal cortex in the
      treatment of cognitive impairments in 120 chronic patients with schizophrenia.

      METHODS:

        1. Clinical Trial: The study consists of 8 weeks of treatment.

        2. Assessment Procedures:

      2.1 Primary Outcome Variable-Psychopathology: The psychopathology of patients was assessed by
      three clinical trained staff, who were blind to treatment protocols, using the Positive and
      Negative Syndrome Scale (PANSS). Patients are interviewed at screening, at at baseline, 2
      weeks, 4 weeks, 6 weeks and 8 weeks.

      2.2 Cognitive tests: RBANS was used to assess the cognitive function by three psychologists,
      which is comprised of a total score and 5 age-adjusted index scores for attention, language,
      delayed and immediate memory and visuospatial/construction. A translated and adapted Chinese
      version of RBANS has been evaluated for the test-retest reliability and clinical validity
      between schizophrenia patients and control subjects. Cognitive performance was measured at
      baseline and at 8-weeks.

      2.3 Side Effects: TESS was used to assess the side effect at baseline and every 2 weeks.

      2.5 Weight gain measurement: weight gain every week
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Repeatable Battery for the Assessment of Neuropsychological Status for cognition
time frame: 8 weeks
description: cognitive performance
measure: Positive and Negative Syndrome Scale for clinical symptoms
time frame: 8 weeks
description: clinical symptoms
measure: Treatment Emergent Symptoms Scale for side effects
time frame: 8 weeks
description: Side effect
arm group label: 10 Hz treatment group
arm group type: Experimental
description: In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.
arm group label: 20 Hz treatment group
arm group type: Experimental
description: In active rTMS, 20 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 20 intervals with 28s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.
arm group label: Control Group
arm group type: Sham Comparator
description: In sham rTMS, all procedures were identical to 10Hz group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.
intervention type: Device
intervention name: 10 Hz treatment group
description: 10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.
arm group label: 10 Hz treatment group
intervention type: Device
intervention name: 20 Hz treatment group
description: 20 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 20 intervals with 28s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.
arm group label: 20 Hz treatment group
intervention type: Device
intervention name: Control Group
description: all procedures were identical to 10Hz group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.
arm group label: Control Group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Hengyong Guan, Doctor
role: Principal Investigator
affiliation: Hebei Province Veteran Psychiatric Hospital
citation: Dlabac-de Lange JJ, Liemburg EJ, Bais L, Renken RJ, Knegtering H, Aleman A. Effect of rTMS on brain activation in schizophrenia with negative symptoms: A proof-of-principle study. Schizophr Res. 2015 Oct;168(1-2):475-82. doi: 10.1016/j.schres.2015.06.018. Epub 2015 Jul 14.
PMID: 26187147
citation: Mogg A, Purvis R, Eranti S, Contell F, Taylor JP, Nicholson T, Brown RG, McLoughlin DM. Repetitive transcranial magnetic stimulation for negative symptoms of schizophrenia: a randomized controlled pilot study. Schizophr Res. 2007 Jul;93(1-3):221-8. doi: 10.1016/j.schres.2007.03.016. Epub 2007 May 2.
PMID: 17478080
citation: Wobrock T, Guse B, Cordes J, Wolwer W, Winterer G, Gaebel W, Langguth B, Landgrebe M, Eichhammer P, Frank E, Hajak G, Ohmann C, Verde PE, Rietschel M, Ahmed R, Honer WG, Malchow B, Schneider-Axmann T, Falkai P, Hasan A. Left prefrontal high-frequency repetitive transcranial magnetic stimulation for the treatment of schizophrenia with predominant negative symptoms: a sham-controlled, randomized multicenter trial. Biol Psychiatry. 2015 Jun 1;77(11):979-88. doi: 10.1016/j.biopsych.2014.10.009. Epub 2014 Oct 23.
PMID: 25582269
responsible party type: Principal Investigator
investigator affiliation: Beijing HuiLongGuan Hospital
investigator full name: Xiang Yang Zhang
investigator title: Professor
mesh term: Schizophrenia
mesh term: Cognitive Dysfunction
sharing ipd: No
ipd description: Data with be available on request