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/NCT06031948</url>
    </required_header>
    <id_info>
      <org_study_id>CPLASD2023HNC50</org_study_id>
      <nct_id>NCT06031948</nct_id>
    </id_info>
    <brief_title>pBFS-guided Noninvasive Neuromodulation for Pre-school Children With ASD</brief_title>
    <official_title>Personalized Brain Functional Sectors (pBFS) Guided Noninvasive Neuromodulation Treatment for Pre-school Children With Autism Spectrum Disorder (ASD): a Single-center, Double-blinded, Sham-Controlled, Randomized Clinical Trial Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Changping Laboratory</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Henan Provincial People's Hospital</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Changping Laboratory</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>
        This randomized controlled trial aims to evaluate the efficacy and safeness of the&#xD;
        pBFS-guided rTMS intervention for core symptom relief in pre-school children with autism&#xD;
        spectrum disorder (ASD).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Autism spectrum disorder is a neurodevelopmental disorder, begins early in life. Using the&#xD;
        personalized brain functional sectors (pBFS) technology, investigators could precisely&#xD;
        identify individualized brain function networks based on the functional MRI scan. For each&#xD;
        participant, two personalised TMS intervention targets will be chosen by blinded researcher.&#xD;
        One executive function network target is located in the dorsal lateral prefrontal cortex&#xD;
        (DLPFC) , and the other social function network target is located in the dorsal medial&#xD;
        prefrontal cortex (DMPFC).&#xD;
  &#xD;
        The participants will be equally randomized to the following four groups, active iTBS to the&#xD;
        left DMPFC or the left DLPFC, and sham iTBS to either the left DMPFC or left DLPFC at a ratio&#xD;
        of 2:2:1:1. Later analyses will combine the two sham groups as one control group. Each&#xD;
        participant will receive 1800 pulse active or sham iTBS (100% RMT) in each session, 3&#xD;
        sessions daily, 5 days per week for 8 weeks, as well as background behavioral training&#xD;
        between iTBS sessions. Pre-and post-treatment functional MRI data will be collected under&#xD;
        sedation.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">January 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 1, 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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>ADOS-2 SA change</measure>
      <time_frame>Pre-treatment (baseline), immediately post-treatment</time_frame>
      <description>The social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. Higher scores mean a worse outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>ADOS-2 total score change</measure>
      <time_frame>Pre-treatment (baseline), immediately post-treatment</time_frame>
      <description>The total score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. Higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CBCL score change</measure>
      <time_frame>Pre-treatment (baseline), immediately post-treatment</time_frame>
      <description>Score change of the child behavior checklist (CBCL) from baseline. Higher scores mean a worse outcome.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>SCQ score change</measure>
      <time_frame>Pre-treatment (baseline), immediately post-treatment</time_frame>
      <description>Score change of the Social Communication Questionnaire (SCQ) from baseline. Higher scores mean a worse outcome.</description>
    </other_outcome>
    <other_outcome>
      <measure>SRS-2 score change</measure>
      <time_frame>Pre-treatment (baseline), immediately post-treatment</time_frame>
      <description>Score change of the Social Responsiveness Scale, 2nd edition (SRS-2) from baseline. Higher scores mean a worse outcome.</description>
    </other_outcome>
    <other_outcome>
      <measure>RBS-R score change</measure>
      <time_frame>Pre-treatment (baseline), immediately post-treatment</time_frame>
      <description>Score change of the Repetitive Behavior Scale-Revised (RBS-R) from baseline. Higher scores mean a worse outcome.</description>
    </other_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Autism Spectrum Disorder</condition>
    <arm_group>
      <arm_group_label>DLPFC group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Active iTBS will be delivered to the left DLPFC.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>DMPFC group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Active iTBS will be delivered to the left DMPFC.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham to DLPFC group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Sham iTBS will be delivered to the left DLPFC.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sham to DMPFC group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>Sham iTBS will be delivered to the left DMPFC.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>active iTBS</intervention_name>
      <description>Each participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.</description>
      <arm_group_label>DLPFC group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>active iTBS</intervention_name>
      <description>Each participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.</description>
      <arm_group_label>DMPFC group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>sham iTBS</intervention_name>
      <description>Each participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.</description>
      <arm_group_label>Sham to DLPFC group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>sham iTBS</intervention_name>
      <description>Each participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.</description>
      <arm_group_label>Sham to DMPFC group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  2.5-6 years old&#xD;
  &#xD;
            -  Have the diagnosis of autism spectrum disorder&#xD;
  &#xD;
            -  ADOS-2 score is higher than the ASD cut-offs&#xD;
  &#xD;
            -  Capacity to follow the study procedures, including fMRI scan under sedation,&#xD;
               assessment, and rehabilitation training&#xD;
  &#xD;
            -  Participant's parents or other legal guardians give informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Current or history of psychotic disorders, such as schizophrenia, schizoaffective&#xD;
               disorder, bipolar disorder&#xD;
  &#xD;
            -  Severe self-injury or suicidal behavior presented in the last 1 year&#xD;
  &#xD;
            -  Severe visual, auditory, or motor disability that interferes with any study procedure&#xD;
  &#xD;
            -  Current, history or family history of epilepsy&#xD;
  &#xD;
            -  Known severe physical diseases, such as congenital heart defect, traumatic brain&#xD;
               injury&#xD;
  &#xD;
            -  Metal implantations, which are contradicted by MRI or TMS, such as artificial cardiac&#xD;
               pacemakers, stents, cochlear implants&#xD;
  &#xD;
            -  Received TMS, tCS, FUS, or other neuromodulation treatment in the last 3 months&#xD;
  &#xD;
            -  Currently participating in other clinical trials&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>30 Months</minimum_age>
      <maximum_age>6 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hesheng Liu, Ph.D.</last_name>
      <role>Study Chair</role>
      <affiliation>Changping Laboratory</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Qi Liu, Ph.D.</last_name>
      <phone>010-80726688</phone>
      <email>a0000153@cpl.ac.cn</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>TMS</keyword>
    <keyword>ASD</keyword>
    <keyword>fMRI</keyword>
    <keyword>personalized medicine</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Autism Spectrum 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/NCT06031948
  org study id: CPLASD2023HNC50
  nct id: NCT06031948
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  This randomized controlled trial aims to evaluate the efficacy and safeness of the
        pBFS-guided rTMS intervention for core symptom relief in pre-school children with autism
        spectrum disorder (ASD).
  Autism spectrum disorder is a neurodevelopmental disorder, begins early in life. Using the
        personalized brain functional sectors (pBFS) technology, investigators could precisely
        identify individualized brain function networks based on the functional MRI scan. For each
        participant, two personalised TMS intervention targets will be chosen by blinded researcher.
        One executive function network target is located in the dorsal lateral prefrontal cortex
        (DLPFC) , and the other social function network target is located in the dorsal medial
        prefrontal cortex (DMPFC).
  
        The participants will be equally randomized to the following four groups, active iTBS to the
        left DMPFC or the left DLPFC, and sham iTBS to either the left DMPFC or left DLPFC at a ratio
        of 2:2:1:1. Later analyses will combine the two sham groups as one control group. Each
        participant will receive 1800 pulse active or sham iTBS (100% RMT) in each session, 3
        sessions daily, 5 days per week for 8 weeks, as well as background behavioral training
        between iTBS sessions. Pre-and post-treatment functional MRI data will be collected under
        sedation.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: ADOS-2 SA change
  time frame: Pre-treatment (baseline), immediately post-treatment
  description: The social affect (SA) dimension score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. Higher scores mean a worse outcome.
  measure: ADOS-2 total score change
  time frame: Pre-treatment (baseline), immediately post-treatment
  description: The total score change of autism diagnostic observation scale, 2nd edition (ADOS-2) from baseline. Higher scores mean a worse outcome.
  measure: CBCL score change
  time frame: Pre-treatment (baseline), immediately post-treatment
  description: Score change of the child behavior checklist (CBCL) from baseline. Higher scores mean a worse outcome.
  measure: SCQ score change
  time frame: Pre-treatment (baseline), immediately post-treatment
  description: Score change of the Social Communication Questionnaire (SCQ) from baseline. Higher scores mean a worse outcome.
  measure: SRS-2 score change
  time frame: Pre-treatment (baseline), immediately post-treatment
  description: Score change of the Social Responsiveness Scale, 2nd edition (SRS-2) from baseline. Higher scores mean a worse outcome.
  measure: RBS-R score change
  time frame: Pre-treatment (baseline), immediately post-treatment
  description: Score change of the Repetitive Behavior Scale-Revised (RBS-R) from baseline. Higher scores mean a worse outcome.
  arm group label: DLPFC group
  arm group type: Experimental
  description: Active iTBS will be delivered to the left DLPFC.
  arm group label: DMPFC group
  arm group type: Experimental
  description: Active iTBS will be delivered to the left DMPFC.
  arm group label: Sham to DLPFC group
  arm group type: Sham Comparator
  description: Sham iTBS will be delivered to the left DLPFC.
  arm group label: Sham to DMPFC group
  arm group type: Sham Comparator
  description: Sham iTBS will be delivered to the left DMPFC.
  intervention type: Device
  intervention name: active iTBS
  description: Each participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.
  arm group label: DLPFC group
  intervention type: Device
  intervention name: active iTBS
  description: Each participant will receive 1800 pulse active iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.
  arm group label: DMPFC group
  intervention type: Device
  intervention name: sham iTBS
  description: Each participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.
  arm group label: Sham to DLPFC group
  intervention type: Device
  intervention name: sham iTBS
  description: Each participant will receive 1800 pulse sham iTBS (100% RMT) in each session, 3 sessions per day, 5 days per week for 8 weeks.
  arm group label: Sham to DMPFC group
  criteria: 
  gender: All
  minimum age: 30 Months
  maximum age: 6 Years
  healthy volunteers: No
  last name: Hesheng Liu, Ph.D.
  role: Study Chair
  affiliation: Changping Laboratory
  last name: Qi Liu, Ph.D.
  phone: 010-80726688
  email: a0000153@cpl.ac.cn
  responsible party type: Sponsor
  mesh term: Autism Spectrum Disorder