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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04069676
Other study ID # 38RC19.131
Secondary ID 2019-A01145-52
Status Completed
Phase
First received
Last updated
Start date September 17, 2020
Est. completion date July 12, 2021

Study information

Verified date May 2022
Source University Hospital, Grenoble
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date July 12, 2021
Est. primary completion date July 12, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
EEG
EEG, ECG and EDR record during a behavioral task

Locations

Country Name City State
France Chu Grenoble Alpes Grenoble

Sponsors (2)

Lead Sponsor Collaborator
University Hospital, Grenoble Laboratoire de Psychologie et NeuroCognition

Country where clinical trial is conducted

France, 

References & Publications (7)

Bar M. The proactive brain: using analogies and associations to generate predictions. Trends Cogn Sci. 2007 Jul;11(7):280-9. Epub 2007 Jun 4. Erratum in: Trends Cogn Sci. 2007 Sep;11(9):372. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Differences between autistic and typically developed participants in evoked potentials related to prediction mechanisms during visual processing - 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. 55 minutes recording
Primary Differences between autistic and typically developed participants in behavioral responses related to prediction mechanisms during visual processing - 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. 55 minutes (same recording as before)
Secondary Differences between groups in oscillatory activity -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. 55 minutes (same record as before)
Secondary Difference between groups in cerebral connectivity - 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. 55 minutes (same record as before)
Secondary Differences between groups in autonomous activity ECG activity (HRV analysis)
electrodermal activity (EDA) 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 autonomous activity.
55 minutes (same record as before)
Secondary Sex differences - 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. 55 minutes (same record as before)
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