<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/NCT02997566</url>
  </required_header>
  <id_info>
    <org_study_id>57347916.5.0000.5402</org_study_id>
    <nct_id>NCT02997566</nct_id>
  </id_info>
  <brief_title>Autonomic Modulation and Facial Expression in Autism Spectrum Disorder</brief_title>
  <official_title>Autonomic Modulation and Facial Expression in Autism Spectrum Disorder: Cross-sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Estadual Paulista Júlio de Mesquita Filho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Estadual Paulista Júlio de Mesquita Filho</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: the autism spectrum disorders (ASD) can be related with abnormalities in cortical&#xD;
      structures and cause behavior imbalances. In addition, as soon as the diagnosis is done, the&#xD;
      better will be the prognosis. In this context, heart rate variability (HRV) stands out, which&#xD;
      is a non-invasive tool representing autonomic modulation, with potential prognostic value.&#xD;
      The literature showed there are no changes in HRV at rest using linear methods of analysis,&#xD;
      but changes can be identified during tasks. Nonlinear methods of HRV are more sensitive and&#xD;
      provide additional information to the linear. Objective: to analyze autonomic modulation&#xD;
      using nonlinear and linear indexes of HRV in children with ASD at rest and during tasks in&#xD;
      comparison to typical children. In addition, to correlate HRV analysis between them, also&#xD;
      between behavior and severity of the disease. Methods: this study involves both typical&#xD;
      children and children with ASD. Autonomic modulation will be performed using nonlinear&#xD;
      indices (extracted from Poincaré plot, detrended fluctuation of tendency analysis and&#xD;
      recurrence plot) and linear indices of HRV in the time (RMSSD e SDNN) and frequency domain&#xD;
      (LF, HF, VLF). The tasks consist in games to identify and recognize faces and facial&#xD;
      expressions. Behavior and severity of the disease will be evaluated using the Autism Behavior&#xD;
      Checklist and the Childhood Autism Rating Scale respectively. Statistical Analysis: to&#xD;
      identify differences between moments and protocols two-way analysis of variance will be used&#xD;
      along with the Bonferroni post-test or Dunn post-test according to the data distribution.&#xD;
      Statistical significance will be set at 5%.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">December 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</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>Autonomic evaluation</measure>
    <time_frame>June, 2017</time_frame>
    <description>Heart rate variability at rest, during facial expression games and finish at rest.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Childhood Autism Rating Scale (CARS)</measure>
    <time_frame>June, 2017</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Autistic Behavior Checklist</measure>
    <time_frame>June, 2017</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">55</enrollment>
  <condition>Autistic Disorder</condition>
  <condition>Autism Spectrum Disorder</condition>
  <arm_group>
    <arm_group_label>Autistic Disorder</arm_group_label>
    <description>Age: 3 to 14 years-old Gender: male and female Autism Spectrum Disorder</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Typical</arm_group_label>
    <description>Age: 3 to 14 years-old Gender: male and female Typical</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Autonomic evaluation</intervention_name>
    <arm_group_label>Autistic Disorder</arm_group_label>
    <arm_group_label>Typical</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Children with autistic disorder or typical development.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with autistic disorder or typical development.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants that do not participant of all evaluations.&#xD;
&#xD;
          -  Participants with an error superior to 5% in the RR intervals series.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luiz Carlos M Vanderlei, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Estadual Paulista Júlio de Mesquita Filho</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade Estadual Paulista Júlio de Mesquita Filho</name>
      <address>
        <city>Presidente Prudente</city>
        <state>São Paulo</state>
        <zip>19060900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>December 15, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Estadual Paulista Júlio de Mesquita Filho</investigator_affiliation>
    <investigator_full_name>Luiz Carlos Marques Vanderlei</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>Autonomic Nervous System</keyword>
  <keyword>Sympathetic Nervous System</keyword>
  <keyword>Heart Rate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autistic Disorder</mesh_term>
    <mesh_term>Autism Spectrum Disorder</mesh_term>
    <mesh_term>Child Development Disorders, Pervasive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02997566
org study id: 57347916.5.0000.5402
nct id: NCT02997566
lead sponsor: 
has dmc: Yes
Background: the autism spectrum disorders (ASD) can be related with abnormalities in cortical
      structures and cause behavior imbalances. In addition, as soon as the diagnosis is done, the
      better will be the prognosis. In this context, heart rate variability (HRV) stands out, which
      is a non-invasive tool representing autonomic modulation, with potential prognostic value.
      The literature showed there are no changes in HRV at rest using linear methods of analysis,
      but changes can be identified during tasks. Nonlinear methods of HRV are more sensitive and
      provide additional information to the linear. Objective: to analyze autonomic modulation
      using nonlinear and linear indexes of HRV in children with ASD at rest and during tasks in
      comparison to typical children. In addition, to correlate HRV analysis between them, also
      between behavior and severity of the disease. Methods: this study involves both typical
      children and children with ASD. Autonomic modulation will be performed using nonlinear
      indices (extracted from Poincaré plot, detrended fluctuation of tendency analysis and
      recurrence plot) and linear indices of HRV in the time (RMSSD e SDNN) and frequency domain
      (LF, HF, VLF). The tasks consist in games to identify and recognize faces and facial
      expressions. Behavior and severity of the disease will be evaluated using the Autism Behavior
      Checklist and the Childhood Autism Rating Scale respectively. Statistical Analysis: to
      identify differences between moments and protocols two-way analysis of variance will be used
      along with the Bonferroni post-test or Dunn post-test according to the data distribution.
      Statistical significance will be set at 5%.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Autonomic evaluation
time frame: June, 2017
description: Heart rate variability at rest, during facial expression games and finish at rest.
measure: Childhood Autism Rating Scale (CARS)
time frame: June, 2017
measure: Autistic Behavior Checklist
time frame: June, 2017
arm group label: Autistic Disorder
description: Age: 3 to 14 years-old Gender: male and female Autism Spectrum Disorder
arm group label: Typical
description: Age: 3 to 14 years-old Gender: male and female Typical
intervention type: Other
intervention name: Autonomic evaluation
arm group label: Autistic Disorder
arm group label: Typical
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 3 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Luiz Carlos M Vanderlei, PhD
role: Principal Investigator
affiliation: Universidade Estadual Paulista Júlio de Mesquita Filho
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Universidade Estadual Paulista Júlio de Mesquita Filho
investigator full name: Luiz Carlos Marques Vanderlei
investigator title: PhD
mesh term: Autistic Disorder
mesh term: Autism Spectrum Disorder
mesh term: Child Development Disorders, Pervasive
sharing ipd: Undecided