Autism Spectrum DisorderVisioTEDNCT02827279
Study of the Visual Perception During Emotional States on Subjects With an Intrusive Disorder of the Development
A study testing emotional induction in people with Autism Spectrum Disorder, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The Pervasive Developmental Disorders (PDD) are severe neurodevelopmental disorders, affecting nearly 1% of the general population. The disorder of social interaction has often been described as resulting from poor emotion recognition, or a bad perception of biological motion. Read more about this study
- Who is it for?
- Ages 8 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- emotional induction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2013to 3 Apr 2017
- Phase
- Interventional
- 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 8 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Diagnosis of Asperger syndrome or infantile autism (F84.0 et F84.5, classification CIM10, 1992).
- Total score in the algorithm of ADI and ADOS > at the threshold required for the diagnosis of disorders(confusions) of the autistic spectre
- Intelligence quotient verbal (IQ) upper to 70 in the various tests psychométriques
- Chronological age from 8 to 12 years
- Written consent signed by the parents and the child
- Affiliation or recipient with the mode of social security.
Who cannot join
- Consent refusal of the child or parents
- Presence of neurovisual disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Strategies of Visual Perception of Social Scenes During Emotional States Induced to Subjects With an Intrusive Disorder of the Development: Pilot Study
The Pervasive Developmental Disorders (PDD) are severe neurodevelopmental disorders, affecting nearly 1% of the general population. The disorder of social interaction has often been described as resulting from poor emotion recognition, or a bad perception of biological motion. However, the results of studies on these issues are very divergent. The PDD also been described as a disorder of emotion regulation, but few studies address the emotional feelings of individuals with ASD and their neuropsychological implications.
The main objective is to study the effect of induced emotion in the children with ASD on his visual exploration strategies.
This is a comparative exploratory pilot study. We'll look at using the eye-tracking, policy terms of the look in a group of children with ASD, in a context of emotional induction (joy, fear, sadness or anger) using of sound stimuli.
Read the detailed description
Context: The Pervasive Developmental Disorders (PDD) are severe neurodevelopmental disorders, affecting nearly 1% of the general population. The disorder of social interaction has often been described as resulting from poor emotion recognition, or a bad perception of biological motion. However, the results of studies on these issues are very divergent. The PDD also been described as a disorder of emotion regulation, but few studies address the emotional feelings of individuals with ASD and their neuropsychological implications. Many studies analyzing the effect of emotions induced - or felt - in healthy subjects. The effect of emotion on cognitive or attentional process is often called "emotional effect of interference." As has already been demonstrated, an emotion (eg induced by music or film) results in a change in visual perception of the environment strategies. These non-conscious mechanisms promote interactive synchrony with the surrounding world, especially during social interactions. We then assumed that the alteration of these perceptual-emotional regulation processes in PDD contribute to disorders of social interactions. In the absence of sufficient data in the literature, we wish to establish an exploratory study using the Eye-tracking, to objectify the links between emotional and perceptual processing in PDD.
Objectives: The main objective is to study the effect of induced emotion in the children with ASD on his visual exploration strategies. We assume that the direction of gaze to photographs of different emotional valences in individuals with ASD is not changed by the emotional state in which they are located. We will compare a population of children with PDD in a control population matched for age, sex. Our secondary goal is to study the link between 1) the socio adaptive level (measured by the Vineland 2) the intensity of autistic symptoms (score ADI) and gaze orientation towards social subjects with visual stimuli.
Methods: This is a comparative exploratory pilot study. We'll look at using the eye-tracking, policy terms of the look in a group of children with ASD, in a context of emotional induction (joy, fear, sadness or anger) using of sound stimuli.
Conclusion: This study would better characterize the emotional processing in ASD and generate hypotheses that could be tested in other neurophysiological studies. Moreover, it can contribute to the development of new supported techniques.
- Conditions
- Autism Spectrum Disorder
- Being tested
- emotional induction
- Keywords
- Autism Spectrum Disorder, Emotion
- Medical subject headings
- Autism Spectrum Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
emotional inductionOther
The eye-tracking mesure the reaction at emotional induction using of sound stimuli in a group of children with or without ASD, in a context of
| Study group | Role | What they receive |
|---|---|---|
| Patients | Other | Mesure of emotional induction by eye tracking on Patient with Pervasive Developmental Disorders (PDD) Receives: Other: emotional induction |
| Healthy volunteers | Other | Mesure of emotional induction by eye tracking on People without disorders Receives: Other: emotional induction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio corresponding to the relative change in visual orientation
mesured by eye tracking before and after each emotional induction
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2016 (estimated)
- Study start4 Mar 2013
- Primary completion3 Apr 2017
- Study completion3 Apr 2017
Why it stopped: end of inclusion period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent Henry, MD, Principal investigator, CHU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02827279
- Sponsor's protocol ID
- 8991
- Acronym
- VisioTED
- Status last verified
- Dec 2021
- First submitted
- 6 Jul 2016
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Strategies of Visual Perception of Social Scenes During Emotional States Induced to Subjects With an Intrusive Disorder of the Development: Pilot Study
- ClinicalTrials.gov ID
- NCT02827279
- Acronym / sponsor ID
- VisioTED / 8991
- Conditions
- Autism Spectrum Disorder
- Keywords
- Autism Spectrum Disorder, Emotion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: end of inclusion period
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 4 Mar 2013 (actual)
- Primary completion
- 3 Apr 2017 (actual)
- Study completion
- 3 Apr 2017 (actual)
- First posted
- 11 Jul 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.
The Pervasive Developmental Disorders (PDD) are severe neurodevelopmental disorders, affecting nearly 1% of the general population. The disorder of social interaction has often been described as resulting from poor emotion recognition, or a bad perception of biological motion. However, the results of studies on these issues are very divergent. The PDD also been described as a disorder of emotion regulation, but few studies address the emotional feelings of individuals with ASD and their neuropsychological implications.
The main objective is to study the effect of induced emotion in the children with ASD on his visual exploration strategies.
This is a comparative exploratory pilot study. We'll look at using the eye-tracking, policy terms of the look in a group of children with ASD, in a context of emotional induction (joy, fear, sadness or anger) using of sound stimuli.
Detailed description
Context: The Pervasive Developmental Disorders (PDD) are severe neurodevelopmental disorders, affecting nearly 1% of the general population. The disorder of social interaction has often been described as resulting from poor emotion recognition, or a bad perception of biological motion. However, the results of studies on these issues are very divergent. The PDD also been described as a disorder of emotion regulation, but few studies address the emotional feelings of individuals with ASD and their neuropsychological implications. Many studies analyzing the effect of emotions induced - or felt - in healthy subjects. The effect of emotion on cognitive or attentional process is often called "emotional effect of interference." As has already been demonstrated, an emotion (eg induced by music or film) results in a change in visual perception of the environment strategies. These non-conscious mechanisms promote interactive synchrony with the surrounding world, especially during social interactions. We then assumed that the alteration of these perceptual-emotional regulation processes in PDD contribute to disorders of social interactions. In the absence of sufficient data in the literature, we wish to establish an exploratory study using the Eye-tracking, to objectify the links between emotional and perceptual processing in PDD.
Objectives: The main objective is to study the effect of induced emotion in the children with ASD on his visual exploration strategies. We assume that the direction of gaze to photographs of different emotional valences in individuals with ASD is not changed by the emotional state in which they are located. We will compare a population of children with PDD in a control population matched for age, sex. Our secondary goal is to study the link between 1) the socio adaptive level (measured by the Vineland 2) the intensity of autistic symptoms (score ADI) and gaze orientation towards social subjects with visual stimuli.
Methods: This is a comparative exploratory pilot study. We'll look at using the eye-tracking, policy terms of the look in a group of children with ASD, in a context of emotional induction (joy, fear, sadness or anger) using of sound stimuli.
Conclusion: This study would better characterize the emotional processing in ASD and generate hypotheses that could be tested in other neurophysiological studies. Moreover, it can contribute to the development of new supported techniques.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Other | Other: emotional inductionMesure of emotional induction by eye tracking on Patient with Pervasive Developmental Disorders (PDD) |
| Healthy volunteers | Other | Other: emotional inductionMesure of emotional induction by eye tracking on People without disorders |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Diagnosis of Asperger syndrome or infantile autism (F84.0 et F84.5, classification CIM10, 1992).
- Total score in the algorithm of ADI and ADOS > at the threshold required for the diagnosis of disorders(confusions) of the autistic spectre
- Intelligence quotient verbal (IQ) upper to 70 in the various tests psychométriques
- Chronological age from 8 to 12 years
- Written consent signed by the parents and the child
Key exclusion criteria (2 listed)
- Consent refusal of the child or parents
- Presence of neurovisual disorder
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 |
|---|---|---|
| emotional inductionThe eye-tracking mesure the reaction at emotional induction using of sound stimuli in a group of children with or without ASD, in a context of | Other | Healthy volunteers, Patients |
Primary outcome
Ratio corresponding to the relative change in visual orientation
Time frame: 1 hour
mesured by eye tracking before and after each emotional induction
Results and safety
The study was stopped early (reason given: end of inclusion period). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- Individual participant dataSharing planned: No
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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.
Vincent Henry, MD principal investigator
CHU de Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing emotional induction in people with Autism Spectrum Disorder, run by University Hospital, Montpellier at 1 site in France.
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 6 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: stopped early, as of the sponsor's last update on 28 Dec 2021. 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 France. 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 was stopped early (reason given: end of inclusion period). Results are not available in the source record.
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?
Ratio corresponding to the relative change in visual orientation (time frame: 1 hour). 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 28 Dec 2021.