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/NCT06010966</url>
    </required_header>
    <id_info>
      <org_study_id>IIT20220110C-R2</org_study_id>
      <nct_id>NCT06010966</nct_id>
    </id_info>
    <brief_title>Effect of iTBS on Children With ADHD</brief_title>
    <official_title>Effect of Intermittent TBS on Children With ADHD</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>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Attention Deficit/Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder&#xD;
        characterized by persistent symptoms of attention deficit and/or hyperactivity/impulsivity .&#xD;
        Currently, the first line drugs for treating ADHD are central stimulants such as Tomoxetine&#xD;
        and Guanfaxine. However, there is a risk of drug abuse and misuse, which often affects sleep&#xD;
        and appetite, only 50% of patients can fully tolerate. This project uses the iTBS stimulation&#xD;
        on weekends, children with ADHD finish scale evaluation, magnetic resonance imaging analysis,&#xD;
        and cognitive function before and after stimulation, This study explores its therapeutic&#xD;
        effect on attention deficit in children and adolescents with ADHD.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2025</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>Double (Participant, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>ADHD-RS</measure>
      <time_frame>4 weeks</time_frame>
      <description>Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS), range from 0 to 54 points. The high scores means the worse outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>fMRI</measure>
      <time_frame>4 weeks</time_frame>
      <description>functional magnetic resonance imaging</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Stroop color-wordtask (SCWT)</measure>
      <time_frame>4 weeks</time_frame>
      <description>In the SCWT, the stimuli were two Chinese color words (green and red) presented in matching or contrasting font colors. The participants were asked to respond to the color of the font as quickly and as accurately as possible when a word was presented</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TMT task</measure>
      <time_frame>4 weeks</time_frame>
      <description>trailmaking test,TMT；It is divided into two parts: A and B. Part A requires the participants to connect 25 numbers on the paper in order (Figure 2). Part B includes 1-13 numbers and A-L12 letters, requiring participants to alternately connect these numbers and letters in orde</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">54</enrollment>
    <condition>ADHD</condition>
    <condition>rTMS</condition>
    <arm_group>
      <arm_group_label>sham group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>receive sham itbs</description>
    </arm_group>
    <arm_group>
      <arm_group_label>low-dose group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>receive low dose of itbs</description>
    </arm_group>
    <arm_group>
      <arm_group_label>high-dose group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>receive high dose of itbs</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>rTMS</intervention_name>
      <description>intermittent theta-burst stimulation (iTBS)</description>
      <arm_group_label>high-dose group</arm_group_label>
      <arm_group_label>low-dose group</arm_group_label>
      <arm_group_label>sham group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Clinical diagnosis of ADHD in accordance with DSM-V;&#xD;
  &#xD;
            -  Age 6-12 years old, regardless of gender&#xD;
  &#xD;
            -  Right-handed&#xD;
  &#xD;
            -  Han nationality or born in the Han nationality Ghetto&#xD;
  &#xD;
            -  The course of the disease is greater than 6 months&#xD;
  &#xD;
            -  Webster children's intelligence ≥ 70&#xD;
  &#xD;
            -  The patient's guardian agrees and signs an informed consent form.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Concomitant mental disorders such as anxiety and depression;&#xD;
  &#xD;
            -  Widespread developmental disorders and other neurological developmental related&#xD;
               disorders;&#xD;
  &#xD;
            -  Complication with other important organ diseases such as heart and lungs;&#xD;
  &#xD;
            -  Suffering from diseases such as epilepsy and tic disorder;&#xD;
  &#xD;
            -  Individuals who cannot tolerate rTMS treatment or cannot cooperate with treatment.&#xD;
  &#xD;
            -  Patients taking psychoactive drugs, antipsychotics, antidepressants, or mood&#xD;
               stabilizers 3 months prior to enrollment or during rTMS treatment; In addition to the&#xD;
               minimum effective therapeutic dose of Tomoxetine (1.2-1.4 mg • kg/day), there has been&#xD;
               systematic use of first-line ADHD drugs in clinical practice Webster's intelligence&lt;70&#xD;
  &#xD;
            -  Implantation of metal and electronic components in the body (excluding the oral&#xD;
               cavity), such as pacemakers;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>12 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 24, 2023</last_update_submitted>
    <last_update_submitted_qc>August 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 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>professor</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>individual participant data (IPD) is aviliable from Principal investigator</ipd_description>
    </patient_data>
    <!-- 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/NCT06010966
  org study id: IIT20220110C-R2
  nct id: NCT06010966
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Attention Deficit/Hyperactivity Disorder (ADHD) is a common neurodevelopmental disorder
        characterized by persistent symptoms of attention deficit and/or hyperactivity/impulsivity .
        Currently, the first line drugs for treating ADHD are central stimulants such as Tomoxetine
        and Guanfaxine. However, there is a risk of drug abuse and misuse, which often affects sleep
        and appetite, only 50% of patients can fully tolerate. This project uses the iTBS stimulation
        on weekends, children with ADHD finish scale evaluation, magnetic resonance imaging analysis,
        and cognitive function before and after stimulation, This study explores its therapeutic
        effect on attention deficit in children and adolescents with ADHD.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Investigator)
  measure: ADHD-RS
  time frame: 4 weeks
  description: Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS), range from 0 to 54 points. The high scores means the worse outcome.
  measure: fMRI
  time frame: 4 weeks
  description: functional magnetic resonance imaging
  measure: Stroop color-wordtask (SCWT)
  time frame: 4 weeks
  description: In the SCWT, the stimuli were two Chinese color words (green and red) presented in matching or contrasting font colors. The participants were asked to respond to the color of the font as quickly and as accurately as possible when a word was presented
  measure: TMT task
  time frame: 4 weeks
  description: trailmaking test,TMT；It is divided into two parts: A and B. Part A requires the participants to connect 25 numbers on the paper in order (Figure 2). Part B includes 1-13 numbers and A-L12 letters, requiring participants to alternately connect these numbers and letters in orde
  arm group label: sham group
  arm group type: Sham Comparator
  description: receive sham itbs
  arm group label: low-dose group
  arm group type: Active Comparator
  description: receive low dose of itbs
  arm group label: high-dose group
  arm group type: Active Comparator
  description: receive high dose of itbs
  intervention type: Device
  intervention name: rTMS
  description: intermittent theta-burst stimulation (iTBS)
  arm group label: high-dose group
  arm group label: low-dose group
  arm group label: sham group
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 12 Years
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: First Affiliated Hospital of Zhejiang University
  investigator full name: Hu ShaoHua
  investigator title: professor
  sharing ipd: No
  ipd description: individual participant data (IPD) is aviliable from Principal investigator