<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/NCT02232464</url>
  </required_header>
  <id_info>
    <org_study_id>201312144RINB</org_study_id>
    <nct_id>NCT02232464</nct_id>
  </id_info>
  <brief_title>Disturbed Structural Connectivity of Frontostriatal and Frontoparietal Networks in Adults With ADHD</brief_title>
  <official_title>Disturbed Structural Connectivity of Frontostriatal and Frontoparietal Networks in Adults With Attention-deficit Hyperactivity Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Attention deficit/hyperactivity disorder (ADHD) is a common, impairing, childhood onset&#xD;
      neuropsychiatric disorder with executive dysfunctions. The ADHD symptoms and executive&#xD;
      deficits may last to adulthood. Our previous studies, like western results, have shown that&#xD;
      children with ADHD have disrupted microstructural integrity of frontostriatal fiber pathways&#xD;
      and impaired brain activity in frontoparietal network. However, there is lack of data with&#xD;
      regards to whether adults with ADHD also demonstrate structural and functional&#xD;
      disconnectivity of frontostriatal and frontoparietal networks as compared to healthy controls&#xD;
      without ADHD in Asian population and no study has been done to correlate a wide range of&#xD;
      executive functions with the connectivity of these two networks.&#xD;
&#xD;
      Specific Aims:&#xD;
&#xD;
        1. to compare the executive functions, and structural and functional connectivity in&#xD;
           frontostriatal and frontoparietal circuitries between adults with ADHD and healthy&#xD;
           controls without ADHD;&#xD;
&#xD;
        2. to correlate the data from structural and functional connectivity, executive functions,&#xD;
           and ADHD core symptoms stratifying by the ADHD and controls; and&#xD;
&#xD;
        3. to explore other circuitries that may involve in ADHD by using whole brain tractography&#xD;
           analyses.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Structural neuroimaging</measure>
    <time_frame>one day</time_frame>
    <description>Using diffusing spectrum imaging (DSI) to assess the structural connectivity in frontostriatal, frontoparietal and other circuitries.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Functional connectivity of the brain circuits</measure>
    <time_frame>one day</time_frame>
    <description>Using resting-state functional MRI (rsfMRI) to assess the functional connectivity in frontostriatal, frontoparietal and other circuitries.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">90</enrollment>
  <condition>Attention Deficit Hyperactivity Disorder</condition>
  <arm_group>
    <arm_group_label>ADHD group</arm_group_label>
    <description>Adults with clinical diagnosis of ADHD according to the DSM-IV criteria</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>Age-, sex-, and IQ-matched healthy controls without lifetime diagnosis with ADHD</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The sample consists of 50 adults (ages 18-45) with clinical diagnosis of ADHD according to&#xD;
        the DSM-IV criteria and 50 age-, sex-, and IQ-matched healthy controls without lifetime&#xD;
        diagnosis with ADHD.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects aged 18-45, who have clinical diagnosis of a ADHD according to the DSM-IV&#xD;
             criteria.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subjects will be excluded from the study if they meet any of the following&#xD;
             criteria: (1) Comorbidity with diagnoses of autism spectrum disorder, schizophrenia,&#xD;
             schizoaffective disorder, delusional disorder, other psychotic disorder, organic&#xD;
             psychosis, schizotypal personality disorder, bipolar disorder, depression, severe&#xD;
             anxiety disorders or substance use; (2) With neurodegenerative disorder, epilepsy,&#xD;
             involuntary movement disorder, congenital metabolic disorder, brain tumor, history of&#xD;
             severe head trauma, and history of craniotomy; (3)With visual or hearing impairments,&#xD;
             or motor disability which may influence the process of MRI assessment; and (4)&#xD;
             Full-scale IQ lower than 80.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 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>March 2015</verification_date>
  <study_first_submitted>August 27, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>March 16, 2015</last_update_submitted>
  <last_update_submitted_qc>March 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 18, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Adult ADHD</keyword>
  <keyword>diffusion spectrum imaging</keyword>
  <keyword>resting-state fMRI</keyword>
  <keyword>frontostriatal circuitries</keyword>
  <keyword>frontoparietal circuitries</keyword>
  <keyword>executive function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperkinesis</mesh_term>
    <mesh_term>Attention Deficit Disorder with Hyperactivity</mesh_term>
  </condition_browse>
  <!-- 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/NCT02232464
org study id: 201312144RINB
nct id: NCT02232464
lead sponsor: 
has dmc: Yes
Attention deficit/hyperactivity disorder (ADHD) is a common, impairing, childhood onset
      neuropsychiatric disorder with executive dysfunctions. The ADHD symptoms and executive
      deficits may last to adulthood. Our previous studies, like western results, have shown that
      children with ADHD have disrupted microstructural integrity of frontostriatal fiber pathways
      and impaired brain activity in frontoparietal network. However, there is lack of data with
      regards to whether adults with ADHD also demonstrate structural and functional
      disconnectivity of frontostriatal and frontoparietal networks as compared to healthy controls
      without ADHD in Asian population and no study has been done to correlate a wide range of
      executive functions with the connectivity of these two networks.

      Specific Aims:

        1. to compare the executive functions, and structural and functional connectivity in
           frontostriatal and frontoparietal circuitries between adults with ADHD and healthy
           controls without ADHD;

        2. to correlate the data from structural and functional connectivity, executive functions,
           and ADHD core symptoms stratifying by the ADHD and controls; and

        3. to explore other circuitries that may involve in ADHD by using whole brain tractography
           analyses.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Structural neuroimaging
time frame: one day
description: Using diffusing spectrum imaging (DSI) to assess the structural connectivity in frontostriatal, frontoparietal and other circuitries.
measure: Functional connectivity of the brain circuits
time frame: one day
description: Using resting-state functional MRI (rsfMRI) to assess the functional connectivity in frontostriatal, frontoparietal and other circuitries.
arm group label: ADHD group
description: Adults with clinical diagnosis of ADHD according to the DSM-IV criteria
arm group label: Control group
description: Age-, sex-, and IQ-matched healthy controls without lifetime diagnosis with ADHD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 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: Sponsor
mesh term: Hyperkinesis
mesh term: Attention Deficit Disorder with Hyperactivity