<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/NCT01677793</url>
  </required_header>
  <id_info>
    <org_study_id>201105115RC</org_study_id>
    <nct_id>NCT01677793</nct_id>
  </id_info>
  <brief_title>Developmental Trajectory of Brain Structural Connectivity and Cognitive Function From Childhood to Adulthood</brief_title>
  <official_title>Developmental Trajectory of Brain Structural Connectivity and Cognitive Function From Childhood to Adulthood</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Health Research Institutes, Taiwan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Magnetic resonance imaging (MRI) is a premier modality to investigate structures and&#xD;
      functions of human brain. In studies of children and adolescents, noninvasiveness of MRI&#xD;
      makes it especially applicable. Developmental trajectory of gray matter volume and cortical&#xD;
      thickness has been well studied in western countries. However, significant variability of&#xD;
      brain structure has been reported between Chinese and Caucasian, and the variation may also&#xD;
      exist in developmental trajectory of the brain. However, the maturation processes of neural&#xD;
      fiber tracts in white matter are less understood. Diffusion tensor imaging (DTI), which has&#xD;
      been frequently used to investigate the integrity of fibertracts in the literature, is&#xD;
      limited in dealing with crossing fibers. Diffusion spectrum imaging (DSI) is a newly&#xD;
      developed technique to improve the resolution of crossing fibers, and it is more suitable for&#xD;
      detailed tractography assessment. In addition to establishing the template of brain structure&#xD;
      (T1 and T2) and structural connectivity of our child, adolescent, and young adult population,&#xD;
      the study has the following three aims.&#xD;
&#xD;
        1. To describe gender effect and developmental change of brain volume of different cortical&#xD;
           and subcortical regions, thickness of cortex brain, and structural connectivity (e.g.,&#xD;
           frono-striatal, fronto-pareital, fronto-temporal and fronto-cerebeller tracts and&#xD;
           superior longitudinal fasciculus II) across childhood through adolescent to adulthood;&#xD;
&#xD;
        2. To examine the gender effects and developmental change of attention, executive function&#xD;
           and visual memory from childhood to adulthood and whether gender moderates these&#xD;
           developmental changes; and&#xD;
&#xD;
        3. To correlate the structural connectivity and brain size and neuropsychological function&#xD;
           within the same subjects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators plan to recruit 140 healthy volunteers (70 males and 70 females), ages 8-21&#xD;
      without current and past history of any psychiatric disorder and autistic symptoms. All the&#xD;
      participants will receive psychiatric interviews (K-SADS-E/SADS) and complete the Chinese AQ&#xD;
      or SRS to screen for any psychiatric disorder or autistic symptoms. They will receive the&#xD;
      WAIS-III or WISC-III (depending on their age) first to ensure their full-scale IQ greater&#xD;
      than 80, followed by the CPT and CANTAB for a wide range assessments of attention, executive&#xD;
      functions, and memory. The MRI assessments (T1 and T2 imaging, DSI, and resting-state fMRI)&#xD;
      will be subsequently arranged within 2 weeks after psychiatric/neuropsychological&#xD;
      assessments.&#xD;
&#xD;
      The investigators anticipate that this study (1) will establish the first template of brain&#xD;
      anatomy and structural connectivity of children and adolescents in our population, (2) will&#xD;
      be the first report on the developmental trajectory of brain of Chinese in both brain gross&#xD;
      anatomy and tractography; (3) will provide evidence about how these development in brain&#xD;
      structures associated with maturation in cognitive functions.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2012</start_date>
  <completion_date type="Actual">December 31, 2014</completion_date>
  <primary_completion_date type="Actual">December 31, 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">140</enrollment>
  <condition>Brain Structural Connectivity</condition>
  <condition>Cognitive Function</condition>
  <arm_group>
    <arm_group_label>Child and adolescent population</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The sample consists of 140 healthy volunteers (70 males and 70 females). The ranges of age&#xD;
        are 8-21 (around 5 males and 5 females in each age group). They will be recruited from&#xD;
        schools and colleges.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages 8-21 without current and past history of any psychiatric disorder and autistic&#xD;
             symptoms.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current symptoms or lifetime history of DSM-IV-TR diagnosis of&#xD;
             attention-deficit/hyperactivity disorder, pervasive developmental disorder,&#xD;
             schizophrenia, schizoaffective disorder, delusional disorder, other psychotic&#xD;
             disorder, organic psychosis, bipolar disorder, depression, severe anxiety disorders or&#xD;
             substance use.&#xD;
&#xD;
          -  With neurodegenerative disorder, epilepsy, involuntary movement disorder, congenital&#xD;
             metabolic disorder, brain tumor, history of severe head trauma, and history of&#xD;
             craniotomy.&#xD;
&#xD;
          -  With major systemic disease.&#xD;
&#xD;
          -  Full-scale IQ &lt; 80.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>8 Years</minimum_age>
    <maximum_age>21 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Susan Shur-Fen Gau, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital &amp; College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan Univeristy Hospital</name>
      <address>
        <city>Taipei</city>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>August 2021</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 31, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_first_posted>
  <last_update_submitted>September 1, 2021</last_update_submitted>
  <last_update_submitted_qc>September 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Taiwan University Hospital</investigator_affiliation>
    <investigator_full_name>Statistical Center, NTUHCTC</investigator_full_name>
    <investigator_title>Susan Shur-Fen Gau</investigator_title>
  </responsible_party>
  <!-- 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/NCT01677793
org study id: 201105115RC
nct id: NCT01677793
lead sponsor: 
collaborator: 
has dmc: Yes
Magnetic resonance imaging (MRI) is a premier modality to investigate structures and
      functions of human brain. In studies of children and adolescents, noninvasiveness of MRI
      makes it especially applicable. Developmental trajectory of gray matter volume and cortical
      thickness has been well studied in western countries. However, significant variability of
      brain structure has been reported between Chinese and Caucasian, and the variation may also
      exist in developmental trajectory of the brain. However, the maturation processes of neural
      fiber tracts in white matter are less understood. Diffusion tensor imaging (DTI), which has
      been frequently used to investigate the integrity of fibertracts in the literature, is
      limited in dealing with crossing fibers. Diffusion spectrum imaging (DSI) is a newly
      developed technique to improve the resolution of crossing fibers, and it is more suitable for
      detailed tractography assessment. In addition to establishing the template of brain structure
      (T1 and T2) and structural connectivity of our child, adolescent, and young adult population,
      the study has the following three aims.

        1. To describe gender effect and developmental change of brain volume of different cortical
           and subcortical regions, thickness of cortex brain, and structural connectivity (e.g.,
           frono-striatal, fronto-pareital, fronto-temporal and fronto-cerebeller tracts and
           superior longitudinal fasciculus II) across childhood through adolescent to adulthood;

        2. To examine the gender effects and developmental change of attention, executive function
           and visual memory from childhood to adulthood and whether gender moderates these
           developmental changes; and

        3. To correlate the structural connectivity and brain size and neuropsychological function
           within the same subjects.
The investigators plan to recruit 140 healthy volunteers (70 males and 70 females), ages 8-21
      without current and past history of any psychiatric disorder and autistic symptoms. All the
      participants will receive psychiatric interviews (K-SADS-E/SADS) and complete the Chinese AQ
      or SRS to screen for any psychiatric disorder or autistic symptoms. They will receive the
      WAIS-III or WISC-III (depending on their age) first to ensure their full-scale IQ greater
      than 80, followed by the CPT and CANTAB for a wide range assessments of attention, executive
      functions, and memory. The MRI assessments (T1 and T2 imaging, DSI, and resting-state fMRI)
      will be subsequently arranged within 2 weeks after psychiatric/neuropsychological
      assessments.

      The investigators anticipate that this study (1) will establish the first template of brain
      anatomy and structural connectivity of children and adolescents in our population, (2) will
      be the first report on the developmental trajectory of brain of Chinese in both brain gross
      anatomy and tractography; (3) will provide evidence about how these development in brain
      structures associated with maturation in cognitive functions.
observational model: Other
time perspective: Other
arm group label: Child and adolescent population
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 8 Years
maximum age: 21 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Susan Shur-Fen Gau, MD, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital & College of Medicine
facility: 
country: Taiwan
responsible party type: Principal Investigator
investigator affiliation: National Taiwan University Hospital
investigator full name: Statistical Center, NTUHCTC
investigator title: Susan Shur-Fen Gau