NCT04069676

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 28, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

September 17, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2021

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

10 months

First QC Date

August 23, 2019

Last Update Submit

May 6, 2022

Conditions

Keywords

Autism Spectrum Conditionpredictive codingvisual perceptionelectroencephalographyautonomous nervous systemheart rate variabilityelectrodermal reactivity

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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 Outcomes (4)

  • Differences between groups in oscillatory activity

    55 minutes (same record as before)

  • Difference between groups in cerebral connectivity

    55 minutes (same record as before)

  • Differences between groups in autonomous activity

    55 minutes (same record as before)

  • Sex differences

    55 minutes (same record as before)

Study Arms (2)

Autism Spectrum Condition (ASC)

Adults males and females with a formal autism diagnosis, without intellectual disability

Other: EEG

Typically developped (TD)

Adults males and females without any neurodevelopemental issue (or health issue which could impaired task performances)

Other: EEG

Interventions

EEGOTHER

EEG, ECG and EDR record during a behavioral task

Also known as: ECG, EDR
Autism Spectrum Condition (ASC)Typically developped (TD)

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Adults autistic males and females without intellectual disability compared to a control group

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Grenoble Alpes

Grenoble, 38043, France

Location

Related Publications (7)

  • 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.

    PMID: 17548232BACKGROUND
  • 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.

    PMID: 27752088BACKGROUND
  • 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.

    PMID: 21968196BACKGROUND
  • 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.

    PMID: 20044901BACKGROUND
  • 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.

    PMID: 22940643BACKGROUND
  • 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.

    PMID: 25288765BACKGROUND
  • 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.

    PMID: 22178086BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Study Officials

  • Laurent Vercueil, Doctor

    University Hospital, Grenoble

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 23, 2019

First Posted

August 28, 2019

Study Start

September 17, 2020

Primary Completion

July 12, 2021

Study Completion

July 12, 2021

Last Updated

May 9, 2022

Record last verified: 2022-05

Locations