Autistic DisorderNCT02997566
Autonomic Modulation and Facial Expression in Autism Spectrum Disorder
An observational study of Autistic Disorder and Autism Spectrum Disorder, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Autistic Disorder, Autism Spectrum Disorder
- What is being tested?
- Autonomic evaluation
- How many people
- 55 participants
- Where
- 1 siteBrazil
- Study dates
- Aug 2016to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children with autistic disorder or typical development.
Who may be able to join
- Children with autistic disorder or typical development.
Who cannot join
- Participants that do not participant of all evaluations.
- Participants with an error superior to 5% in the RR intervals series.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Estadual Paulista Júlio de Mesquita Filho
Presidente Prudente, São Paulo, 19060900
About this study
Official title: 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%.
- Conditions
- Autistic Disorder, Autism Spectrum Disorder
- Being tested
- Autonomic evaluation
- Keywords
- Autonomic Nervous System, Sympathetic Nervous System, Heart Rate
- Medical subject headings
- Autistic Disorder, Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autonomic evaluationOther
| Study group | Role | What they receive |
|---|---|---|
| Autistic Disorder | Age: 3 to 14 years-old Gender: male and female Autism Spectrum Disorder Receives: Other: Autonomic evaluation | |
| Typical | Age: 3 to 14 years-old Gender: male and female Typical Receives: Other: Autonomic evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Autonomic evaluation
Heart rate variability at rest, during facial expression games and finish at rest.
Measured: June, 2017
Secondary outcomes (2)
Childhood Autism Rating Scale (CARS)
Measured: June, 2017
Autistic Behavior Checklist
Measured: June, 2017
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startAug 2016
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autistic DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita Filho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Luiz Carlos Marques Vanderlei, Universidade Estadual Paulista Júlio de Mesquita Filho
- Investigators
- Luiz Carlos M Vanderlei, PhD, Principal investigator, Universidade Estadual Paulista Júlio de Mesquita Filho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997566
- Sponsor's protocol ID
- 57347916.5.0000.5402
- Status last verified
- Jun 2020
- First submitted
- 15 Dec 2016
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autonomic Modulation and Facial Expression in Autism Spectrum Disorder: Cross-sectional Study
- ClinicalTrials.gov ID
- NCT02997566
- Acronym / sponsor ID
- 57347916.5.0000.5402
- Conditions
- Autistic Disorder, Autism Spectrum Disorder
- Keywords
- Autonomic Nervous System, Sympathetic Nervous System, Heart Rate
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Universidade Estadual Paulista Júlio de Mesquita FilhoUniversity, hospital or other
- Study start
- Aug 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 20 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autistic Disorder | – | Other: Autonomic evaluationAge: 3 to 14 years-old Gender: male and female Autism Spectrum Disorder |
| Typical | – | Other: Autonomic evaluationAge: 3 to 14 years-old Gender: male and female Typical |
Who may qualify
- Ages
- 3 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children with autistic disorder or typical development.
Key inclusion criteria (1 listed)
- Children with autistic disorder or typical development.
Key exclusion criteria (2 listed)
- Participants that do not participant of all evaluations.
- Participants with an error superior to 5% in the RR intervals series.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autonomic evaluation | Other | Autistic Disorder, Typical |
Primary outcome
Autonomic evaluation
Time frame: June, 2017
Heart rate variability at rest, during facial expression games and finish at rest.
2 secondary outcomes
Childhood Autism Rating Scale (CARS)
Time frame: June, 2017
Autistic Behavior Checklist
Time frame: June, 2017
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luiz Carlos M Vanderlei, PhD principal investigator
Universidade Estadual Paulista Júlio de Mesquita Filho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autistic Disorder and Autism Spectrum Disorder, run by Universidade Estadual Paulista Júlio de Mesquita Filho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Autonomic evaluation (time frame: June, 2017). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2020.