Autonomic Modulation and Facial Expression in Autism Spectrum Disorder

Sponsor

Universidade Estadual Paulista Júlio de Mesquita Filho (Other)

Overall Status

Completed

CT.gov ID

NCT02997566

Collaborator

(none)

Enrollment

Location

Actual Duration (Months)

3.4

Patients Per Site Per Month

Study Details

Study Description

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%.

Condition or Disease	Intervention/Treatment	Phase
Autistic Disorder Autism Spectrum Disorder	Other: Autonomic evaluation

Study Design

Study Type:

Observational

Actual Enrollment :

55 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Aug 1, 2016

Actual Primary Completion Date :

Jun 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
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

Arm

Intervention/Treatment

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

Outcome Measures

Primary Outcome Measures

Autonomic evaluation [June, 2017]
Heart rate variability at rest, during facial expression games and finish at rest.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 14 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidade Estadual Paulista Júlio de Mesquita Filho	Presidente Prudente	São Paulo	Brazil	19060900

Sponsors and Collaborators

Universidade Estadual Paulista Júlio de Mesquita Filho

Investigators

Principal Investigator: Luiz Carlos M Vanderlei, PhD, Universidade Estadual Paulista Júlio de Mesquita Filho

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Luiz Carlos Marques Vanderlei, PhD, Universidade Estadual Paulista Júlio de Mesquita Filho

ClinicalTrials.gov Identifier:

NCT02997566

Other Study ID Numbers:

57347916.5.0000.5402

First Posted:

Dec 20, 2016

Last Update Posted:

Jun 4, 2020

Last Verified:

Jun 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Keywords provided by Luiz Carlos Marques Vanderlei, PhD, Universidade Estadual Paulista Júlio de Mesquita Filho

Autonomic Nervous System

Sympathetic Nervous System

Heart Rate

Additional relevant MeSH terms:

Disease

Autistic Disorder

Autism Spectrum Disorder

Child Development Disorders, Pervasive

Study Results

No Results Posted as of Jun 4, 2020