Autonomic Modulation and Facial Expression in Autism Spectrum Disorder

Completed

• Conditions: Autism Spectrum Disorder; Autistic Disorder
• Interventions: Other: Autonomic evaluation

• Registration Number: NCT02997566
• Lead Sponsor: Universidade Estadual Paulista Júlio de Mesquita Filho

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%.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-12-15
• Study First Submitted QC: 2016-12-19
• Study First Posted: 2016-12-20
• Primary Completion: 2017-06
• Study Completion: 2017-12
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-02
• Last Update Posted: 2020-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Typical	Autonomic evaluation	Age: 3 to 14 years-old Gender: male and female Typical
Autistic Disorder	Autonomic evaluation	Age: 3 to 14 years-old Gender: male and female Autism Spectrum Disorder

Primary Outcome Measures

Name	Time	Method
Autonomic evaluation	June, 2017	Heart rate variability at rest, during facial expression games and finish at rest.

Secondary Outcome Measures

Name	Time	Method
Childhood Autism Rating Scale (CARS)	June, 2017
Autistic Behavior Checklist	June, 2017

Trial Locations

Locations (1)

Universidade Estadual Paulista Júlio de Mesquita Filho; 🇧🇷 Presidente Prudente, São Paulo, Brazil