- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04069676
Emotional Proactive Brain Study in Adults With Autism Spectrum Condition (PREDEMAUT)
This project aims:
- to study behavioral and cerebral activity specificity (latency and amplitude of evoked potentials, time frequency maps and cerebral connectivity) in predictive process (top-down regulation) during visual recognition of static and dynamic stimuli in adults participants with autism spectrum conditions compared to typically developed participants.
- to study the relation between predictive process and autonomous response (heart activity and electrodermal activity)
- to explore potential sex differences between autistic males and females
Study Overview
Detailed Description
Once eligibility criteria would have been verified, information on the study will be given and non opposition of the participant will be collected.Then, the participant will be comfortably installed in order to pass the Landolt C task (visual acuity task) on a computer. If his vision is normal, electroencephalogram (EEG), electrocardiogram (ECG) and electrodermal activity (EDA) of participants, will be recorded during visual processing and recognition tasks. Stimuli will include emotional and non emotional pictures and films, filtered in coarse-to-fine versus fine-to-coarse sequences in order to stimulate or not predictive process described by Bar (2007).
The participant will also have to complete an abbreviated version of the Wechsler Adult Intelligence Scale, IVth edition (Wechsler, 2003), and the Autism Spectrum Quotient (Baron-Cohen et al., 2001) if he never did it before. The aim is to pair as much as possible group by IQ and to verify that control participants don't present autistic traits above the Autism Spectrum Quotient cutoff. Groups will also be paired by age and education level.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Grenoble, France, 38043
- Chu Grenoble Alpes
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- affiliation to the french social protection care
- information and non opposition of the participant
- information and non opposition of tutor/curator if the case presented
- normal or corrected to normal vision
- capacity to understand and apply instruction required by the task
- no participation in another research
- for autistic person: formal diagnosis of autism spectrum condition (autism/asperger/PDD-NS) according to CIM-10/DSM-IV/DSM-5 criteria
Exclusion Criteria:
- adults with no ability to express their consent
- adults on judiciary protection
- perceptive/motor/neurological/psychiatric issue
- major health issue (cardiac, metabolic ...)
- alcohol or drug consumption
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Autism Spectrum Condition (ASC)
Adults males and females with a formal autism diagnosis, without intellectual disability
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EEG, ECG and EDR record during a behavioral task
Other Names:
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Typically developped (TD)
Adults males and females without any neurodevelopemental issue (or health issue which could impaired task performances)
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EEG, ECG and EDR record during a behavioral task
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Differences between autistic and typically developed participants in evoked potentials related to prediction mechanisms during visual processing
Time Frame: 55 minutes recording
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- differences in evoked potentials (latency and amplitude) Changes will be assessed between coarse-to-fine and fine-to-coarse sequencies.
It will be used to investigated how predictive mechanism during visual perception are affected in autism regarding cerebral activity.
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55 minutes recording
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Differences between autistic and typically developed participants in behavioral responses related to prediction mechanisms during visual processing
Time Frame: 55 minutes (same recording as before)
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- differences in behavioral responses (reaction time and correct response rate) Changes will be assessed between coarse-to-fine and fine-to-coarse sequencies.
It will be used to investigated how predictive mechanism during visual perception are affected in autism regarding behavioral response.
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55 minutes (same recording as before)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Differences between groups in oscillatory activity
Time Frame: 55 minutes (same record as before)
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-differences in time-frequency maps.
Changes will be assessed between coarse-to-fine and fine-to-coarse sequencies.
It will be used to investigated how predictive mechanism during visual perception are affected in autism regarding cerebral activity.
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55 minutes (same record as before)
|
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Difference between groups in cerebral connectivity
Time Frame: 55 minutes (same record as before)
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- differences in Dynamic Causal Modeling Changes will be assessed between coarse-to-fine and fine-to-coarse sequencies.
It will be used to investigated how predictive mechanism during visual perception are affected in autism regarding cerebral activity.
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55 minutes (same record as before)
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Differences between groups in autonomous activity
Time Frame: 55 minutes (same record as before)
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55 minutes (same record as before)
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Sex differences
Time Frame: 55 minutes (same record as before)
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- sex differences analysis Changes will be assessed between coarse-to-fine and fine-to-coarse sequencies.
It will be used to investigated the existence of sex differences in autism regarding predictive process during visual perception.
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55 minutes (same record as before)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Laurent Vercueil, Doctor, University Hospital, Grenoble
Publications and helpful links
General Publications
- Peyrin C, Michel CM, Schwartz S, Thut G, Seghier M, Landis T, Marendaz C, Vuilleumier P. The neural substrates and timing of top-down processes during coarse-to-fine categorization of visual scenes: a combined fMRI and ERP study. J Cogn Neurosci. 2010 Dec;22(12):2768-80. doi: 10.1162/jocn.2010.21424.
- Thayer JF, Ahs F, Fredrikson M, Sollers JJ 3rd, Wager TD. A meta-analysis of heart rate variability and neuroimaging studies: implications for heart rate variability as a marker of stress and health. Neurosci Biobehav Rev. 2012 Feb;36(2):747-56. doi: 10.1016/j.neubiorev.2011.11.009. Epub 2011 Dec 8.
- Bar M. The proactive brain: using analogies and associations to generate predictions. Trends Cogn Sci. 2007 Jul;11(7):280-9. doi: 10.1016/j.tics.2007.05.005. Epub 2007 Jun 4. Erratum In: Trends Cogn Sci. 2007 Sep;11(9):372.
- Caplette L, Wicker B, Gosselin F. Atypical Time Course of Object Recognition in Autism Spectrum Disorder. Sci Rep. 2016 Oct 18;6:35494. doi: 10.1038/srep35494.
- Gomot M, Wicker B. A challenging, unpredictable world for people with autism spectrum disorder. Int J Psychophysiol. 2012 Feb;83(2):240-7. doi: 10.1016/j.ijpsycho.2011.09.017. Epub 2011 Oct 1.
- Quintana DS, Guastella AJ, Outhred T, Hickie IB, Kemp AH. Heart rate variability is associated with emotion recognition: direct evidence for a relationship between the autonomic nervous system and social cognition. Int J Psychophysiol. 2012 Nov;86(2):168-72. doi: 10.1016/j.ijpsycho.2012.08.012. Epub 2012 Aug 30.
- Sinha P, Kjelgaard MM, Gandhi TK, Tsourides K, Cardinaux AL, Pantazis D, Diamond SP, Held RM. Autism as a disorder of prediction. Proc Natl Acad Sci U S A. 2014 Oct 21;111(42):15220-5. doi: 10.1073/pnas.1416797111. Epub 2014 Oct 6.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 38RC19.131
- 2019-A01145-52 (Other Identifier: ID RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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