- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02997566
Autonomic Modulation and Facial Expression in Autism Spectrum Disorder
June 2, 2020 updated by: Luiz Carlos Marques Vanderlei, Universidade Estadual Paulista Júlio de Mesquita Filho
Autonomic Modulation and Facial Expression in Autism Spectrum Disorder: Cross-sectional Study
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%.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
55
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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São Paulo
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Presidente Prudente, São Paulo, Brazil, 19060900
- Universidade Estadual Paulista Julio de Mesquita Filho
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 14 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Children with autistic disorder or typical development.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Autistic Disorder
Age: 3 to 14 years-old Gender: male and female Autism Spectrum Disorder
|
|
|
Typical
Age: 3 to 14 years-old Gender: male and female Typical
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Autonomic evaluation
Time Frame: June, 2017
|
Heart rate variability at rest, during facial expression games and finish at rest.
|
June, 2017
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Childhood Autism Rating Scale (CARS)
Time Frame: June, 2017
|
June, 2017
|
|
Autistic Behavior Checklist
Time Frame: June, 2017
|
June, 2017
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Luiz Carlos M Vanderlei, PhD, Universidade Estadual Paulista Julio de Mesquita Filho
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 1, 2016
Primary Completion (Actual)
June 1, 2017
Study Completion (Actual)
December 1, 2017
Study Registration Dates
First Submitted
December 15, 2016
First Submitted That Met QC Criteria
December 19, 2016
First Posted (Estimate)
December 20, 2016
Study Record Updates
Last Update Posted (Actual)
June 4, 2020
Last Update Submitted That Met QC Criteria
June 2, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 57347916.5.0000.5402
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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