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Clinical Trials/NCT02997566
NCT02997566
Completed
Not Applicable

Autonomic Modulation and Facial Expression in Autism Spectrum Disorder: Cross-sectional Study

Universidade Estadual Paulista Júlio de Mesquita Filho1 site in 1 country55 target enrollmentAugust 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autistic Disorder
Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Enrollment
55
Locations
1
Primary Endpoint
Autonomic evaluation
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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%.

Registry
clinicaltrials.gov
Start Date
August 2016
End Date
December 2017
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Universidade Estadual Paulista Júlio de Mesquita Filho
Responsible Party
Principal Investigator
Principal Investigator

Luiz Carlos Marques Vanderlei

PhD

Universidade Estadual Paulista Júlio de Mesquita Filho

Eligibility Criteria

Inclusion Criteria

  • Children with autistic disorder or typical development.

Exclusion Criteria

  • Participants that do not participant of all evaluations.
  • Participants with an error superior to 5% in the RR intervals series.

Outcomes

Primary Outcomes

Autonomic evaluation

Time Frame: June, 2017

Heart rate variability at rest, during facial expression games and finish at rest.

Secondary Outcomes

  • Childhood Autism Rating Scale (CARS)(June, 2017)
  • Autistic Behavior Checklist(June, 2017)

Study Sites (1)

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