Autonomic Modulation and Facial Expression in Autism Spectrum Disorder

NCT02997566 | Completed DMC

• 1 other identifier: 57347916.5.0000.5402
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

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%.

Conditions

Autistic Disorder; Autism Spectrum Disorder

Keywords

Autonomic Nervous System; Sympathetic Nervous System; Heart Rate

Outcome Measures

Primary Outcomes (1)

• Autonomic evaluation

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

  June, 2017

Secondary Outcomes (2)

• Childhood Autism Rating Scale (CARS)

  June, 2017

• Autistic Behavior Checklist

  June, 2017

Study Arms (2)

Autistic Disorder

Age: 3 to 14 years-old Gender: male and female Autism Spectrum Disorder

Other: Autonomic evaluation

Typical

Age: 3 to 14 years-old Gender: male and female Typical

Other: Autonomic evaluation

Interventions

Autonomic evaluation OTHER

Autistic Disorder; Typical

Eligibility Criteria

• Age: 3 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children with autistic disorder or typical development.

You may qualify if:

• Children with autistic disorder or typical development.

You may not qualify if:

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

Sponsors & Collaborators

• Universidade Estadual Paulista Júlio de Mesquita Filho: lead

Study Sites (1)

Universidade Estadual Paulista Júlio de Mesquita Filho

Presidente Prudente, São Paulo, 19060900, Brazil

Location

MeSH Terms

Conditions

Autistic Disorder; Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Luiz Carlos M Vanderlei, PhD

  Universidade Estadual Paulista Júlio de Mesquita Filho

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: December 15, 2016
• First Posted: December 20, 2016
• Study Start: August 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 4, 2020

Record last verified: 2020-06

Locations

BR (1)