Autonomic Modulation and Facial Expression in Autism Spectrum Disorder

NCT ID: NCT02997566

Last Updated: 2020-06-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 55 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2017-12-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Autistic Disorder

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

Autonomic evaluation

Intervention Type: OTHER

Typical

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

Autonomic evaluation

Intervention Type: OTHER

Interventions

Autonomic evaluation

Intervention Type: OTHER

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Universidade Estadual Paulista Júlio de Mesquita Filho

OTHER

Sponsor Role: lead

Responsible Party

Luiz Carlos Marques Vanderlei

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luiz Carlos M Vanderlei, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidade Estadual Paulista Júlio de Mesquita Filho

Locations

Universidade Estadual Paulista Júlio de Mesquita Filho

Presidente Prudente, São Paulo, Brazil

Countries

Brazil

Other Identifiers

57347916.5.0000.5402

Identifier Type: -

Identifier Source: org_study_id