xml: <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/NCT05964777</url>
    </required_header>
    <id_info>
      <org_study_id>IIT20230058C-R1</org_study_id>
      <nct_id>NCT05964777</nct_id>
    </id_info>
    <brief_title>rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder</brief_title>
    <official_title>Efficacy and Safety of rTMS-tACS Stimulation on Improving Cognitive Function in Bipolar Disorder: a Randomized, Double-blind, Sham Controlled Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>First Affiliated Hospital of Zhejiang University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>First Affiliated Hospital of Zhejiang University</source>
    <oversight_info>
      <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 individualized positioning technology of diffusion tensor imaging (DTI), the&#xD;
        purpose of this study is to explore a new stimulation target and protocol for the treatment&#xD;
        of bipolar disorder in remission through the repetitive transcranial magnetic&#xD;
        stimulation(rTMS) and transcranial alternating current stimulation（tACS）under&#xD;
        neuronavigation，verify whether there is abnormal functional connectivity and structural&#xD;
        connections between the dorsolateral prefrontal cortex (dlpfc) and the dorsal anterior&#xD;
        cingulate gyrus (dacc) related to cognitive impairment in bipolar disorder in remission,&#xD;
        which will contribute to further understand the relevant neural pathway and mechanism.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 1, 2023</start_date>
    <completion_date type="Anticipated">April 4, 2024</completion_date>
    <primary_completion_date type="Anticipated">March 3, 2024</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>thinc-it</measure>
      <time_frame>0,3week</time_frame>
      <description>THINC-it test suites: Used primarily to assess cognitive dimensions such as executive function, learning and memory, attention, and processing speed in patients with BD. The assessment was conducted before and after treatment, and consisted of five main parts:Spotter,Symbol Check,Code Breaker,Trails test,PDQ-5-D</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">54</enrollment>
    <condition>Bipolar Disorder in Remission</condition>
    <arm_group>
      <arm_group_label>Repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>rTMS and tACS have a profound impact on cognitive impairment.,The damaged neural circuit of DLPFC-DACC may lead to impaired cognitive function in bipolar disorder.We used DTI imaging technology to calculate the stimulus site.Using high-frequency rTMS and high-precision tACS stimulation,thus affect the nerve ring pathway , thereby rapidly, effectively and safely improving cognitive impairment with bipolar disorder in remission.the subjects were subjected to rTMS for 20 minutes per day with the stimulation intensity of 10Hz and 100% of the motion threshold(MT),stimulation time of each sequence was 5 seconds, stimulation interval was 15 seconds, 3000 pulses per day for 15 days, and the total number of pulses was 45000.&#xD;
  tACS has 5 high-precision targets, the total current is 2mA, and the stimulation frequency is 40hz. Under true stimulation, the current fade in and out time is 10 seconds, and the stimulation time is 30 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Repetitive Transcranial magnetic stimulation and sham transcranial alternating current stimulation</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>the subjects were subjected to rTMS for 20 minutes per day with the stimulation intensity of 10Hz and 100% of the motion threshold(MT),stimulation time of each sequence was 5 seconds, stimulation interval was 15 seconds, 3000 pulses per day for 15 days, and the total number of pulses was 45000.&#xD;
  tACS has 5 high-precision targets, the total current is 2mA, and the stimulation frequency is 40hz. Under sham stimulation, the current fade in and out time is 10 seconds, the other 29 minutes and 40 seconds, no real current passes through.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>The stimulus intensity was 20% of MT in the ShamComparator arm, and the remaining parameters were the same as the Active Comparator arm.&#xD;
  tACS has 5 high-precision targets, the total current is 2mA, and the stimulation frequency is 40hz. Under true stimulation, the current fade in and out time is 10 seconds, and the stimulation time is 30 minutes.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation</intervention_name>
      <description>with the rapid development of neuroregulatory technology, rTMS and tACS have a profound impact on cognitive impairment. The damaged neural circuit of DLPFC-DACC may lead to impaired cognitive function in bipolar disorder.We used DTI imaging technology to calculate the DLPFC cortical region corresponding to the strongest point of dlpfc and DACC fiber connection as the stimulus site.Using high-frequency rTMS and high-precision tACS stimulation,thus affect the nerve ring pathway , thereby rapidly, effectively and safely improving cognitive impairment with bipolar disorder in remission.</description>
      <arm_group_label>Repetitive Transcranial magnetic stimulation and sham transcranial alternating current stimulation</arm_group_label>
      <arm_group_label>Repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation</arm_group_label>
      <arm_group_label>Sham repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. Age 14-45 years old, regardless of gender] 2.Meet DSM-V diagnostic criteria for&#xD;
               bipolar depressive in remission 3.Young Mania Rating Scale (YMRS) ≤ 6 points;&#xD;
               4.Hamilton Depression Scale(HAMD-17)≤7 points; 5.Cognitive deficit questionnaire&#xD;
               PDQ≥17 points; 6.Han nationality, right-handed; 7.More than 9 years of education.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. History of severe somatic or brain organic diseases and craniocerebral trauma;&#xD;
  &#xD;
            2. Abnormal brain structure or any MRI contraindications were found by magnetic resonance&#xD;
               examination;&#xD;
  &#xD;
            3. Those who do not cooperate or cannot effectively complete the experiment;&#xD;
  &#xD;
            4. Drug, alcohol or other psychoactive substance abusers;&#xD;
  &#xD;
            5. Pregnant, lactating or planned pregnancy;&#xD;
  &#xD;
            6. ECT or rTMS or tACS treatment was performed within six months.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>14 Years</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>ShaoHua Hu, MD</last_name>
      <role>Study Director</role>
      <affiliation>Zhejiang University</affiliation>
    </overall_official>
    <overall_official>
      <last_name>China Zhejiang</last_name>
      <role>Study Director</role>
      <affiliation>The First Affiliated Hospital of Zhejiang University [Recruiting] Hangzhou, Zhejiang, China, 310000 Contact: ShaoHua Hu, MD 13957162903 dorhushaoh</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>ShaoHua Hu, MD</last_name>
      <phone>13357169115</phone>
      <phone_ext>86</phone_ext>
      <email>dorhushaohua@zju.deu.cn</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Xiaomei Zhang</last_name>
      <phone>13757275095</phone>
      <phone_ext>86</phone_ext>
      <email>zxm11982012@sina.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of Psychiatry, First Affiliated Hospital of Zhejiang University</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310000</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hu ShaoHua, MD</last_name>
        <phone>13957162903</phone>
        <email>dorhushaohua@zju.edu.cn</email>
      </contact>
      <contact_backup>
        <last_name>Xiaomei Zhang</last_name>
        <phone>zxm11982012@sina.com</phone>
        <email>zxm11982012@sina.com</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 20, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 20, 2023</last_update_submitted>
    <last_update_submitted_qc>July 20, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>First Affiliated Hospital of Zhejiang University</investigator_affiliation>
      <investigator_full_name>Hu ShaoHua</investigator_full_name>
      <investigator_title>Head of Department of Psychaitry , First Affiliated Hospital of Zhejiang University</investigator_title>
    </responsible_party>
    <keyword>repetitive transcranial magnetic stimulation，Transcranial alternating current stimulation，diffusion tensor imaging，bipolar disorder</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Bipolar Disorder</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05964777
  org study id: IIT20230058C-R1
  nct id: NCT05964777
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Based on the individualized positioning technology of diffusion tensor imaging (DTI), the
        purpose of this study is to explore a new stimulation target and protocol for the treatment
        of bipolar disorder in remission through the repetitive transcranial magnetic
        stimulation(rTMS) and transcranial alternating current stimulation（tACS）under
        neuronavigation，verify whether there is abnormal functional connectivity and structural
        connections between the dorsolateral prefrontal cortex (dlpfc) and the dorsal anterior
        cingulate gyrus (dacc) related to cognitive impairment in bipolar disorder in remission,
        which will contribute to further understand the relevant neural pathway and mechanism.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: thinc-it
  time frame: 0,3week
  description: THINC-it test suites: Used primarily to assess cognitive dimensions such as executive function, learning and memory, attention, and processing speed in patients with BD. The assessment was conducted before and after treatment, and consisted of five main parts:Spotter,Symbol Check,Code Breaker,Trails test,PDQ-5-D
  arm group label: Repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation
  arm group type: Active Comparator
  description: rTMS and tACS have a profound impact on cognitive impairment.,The damaged neural circuit of DLPFC-DACC may lead to impaired cognitive function in bipolar disorder.We used DTI imaging technology to calculate the stimulus site.Using high-frequency rTMS and high-precision tACS stimulation,thus affect the nerve ring pathway , thereby rapidly, effectively and safely improving cognitive impairment with bipolar disorder in remission.the subjects were subjected to rTMS for 20 minutes per day with the stimulation intensity of 10Hz and 100% of the motion threshold(MT),stimulation time of each sequence was 5 seconds, stimulation interval was 15 seconds, 3000 pulses per day for 15 days, and the total number of pulses was 45000.
  tACS has 5 high-precision targets, the total current is 2mA, and the stimulation frequency is 40hz. Under true stimulation, the current fade in and out time is 10 seconds, and the stimulation time is 30 minutes.
  arm group label: Repetitive Transcranial magnetic stimulation and sham transcranial alternating current stimulation
  arm group type: Placebo Comparator
  description: the subjects were subjected to rTMS for 20 minutes per day with the stimulation intensity of 10Hz and 100% of the motion threshold(MT),stimulation time of each sequence was 5 seconds, stimulation interval was 15 seconds, 3000 pulses per day for 15 days, and the total number of pulses was 45000.
  tACS has 5 high-precision targets, the total current is 2mA, and the stimulation frequency is 40hz. Under sham stimulation, the current fade in and out time is 10 seconds, the other 29 minutes and 40 seconds, no real current passes through.
  arm group label: Sham repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation
  arm group type: Placebo Comparator
  description: The stimulus intensity was 20% of MT in the ShamComparator arm, and the remaining parameters were the same as the Active Comparator arm.
  tACS has 5 high-precision targets, the total current is 2mA, and the stimulation frequency is 40hz. Under true stimulation, the current fade in and out time is 10 seconds, and the stimulation time is 30 minutes.
  intervention type: Device
  intervention name: Repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation
  description: with the rapid development of neuroregulatory technology, rTMS and tACS have a profound impact on cognitive impairment. The damaged neural circuit of DLPFC-DACC may lead to impaired cognitive function in bipolar disorder.We used DTI imaging technology to calculate the DLPFC cortical region corresponding to the strongest point of dlpfc and DACC fiber connection as the stimulus site.Using high-frequency rTMS and high-precision tACS stimulation,thus affect the nerve ring pathway , thereby rapidly, effectively and safely improving cognitive impairment with bipolar disorder in remission.
  arm group label: Repetitive Transcranial magnetic stimulation and sham transcranial alternating current stimulation
  arm group label: Repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation
  arm group label: Sham repetitive Transcranial magnetic stimulation and transcranial alternating current stimulation
  criteria: 
  gender: All
  minimum age: 14 Years
  maximum age: 45 Years
  healthy volunteers: No
  last name: ShaoHua Hu, MD
  role: Study Director
  affiliation: Zhejiang University
  last name: China Zhejiang
  role: Study Director
  affiliation: The First Affiliated Hospital of Zhejiang University [Recruiting] Hangzhou, Zhejiang, China, 310000 Contact: ShaoHua Hu, MD 13957162903 dorhushaoh
  last name: ShaoHua Hu, MD
  phone: 13357169115
  phone ext: 86
  email: dorhushaohua@zju.deu.cn
  last name: Xiaomei Zhang
  phone: 13757275095
  phone ext: 86
  email: zxm11982012@sina.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: First Affiliated Hospital of Zhejiang University
  investigator full name: Hu ShaoHua
  investigator title: Head of Department of Psychaitry , First Affiliated Hospital of Zhejiang University
  mesh term: Bipolar Disorder