AzTrials
AzTrials

Autism Spectrum DisorderPREDEMAUTNCT04069676

Emotional Proactive Brain Study in Adults With Autism Spectrum Condition

An observational study of Autism Spectrum Disorder, run by University Hospital, Grenoble at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for
Autism Spectrum Disorder
What is being tested?
EEG
How many people
94 participants
Where
1 siteFrance
Study dates
17 Sep 2020to 12 Jul 2021
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 18 to 50 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

France1 site

  • Chu Grenoble Alpes

    Grenoble, 38043

Other trials in France

About this study

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
Read the 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.

Being tested
EEG
Keywords
Autism Spectrum Condition, predictive coding, visual perception, electroencephalography, autonomous nervous system, heart rate variability, electrodermal reactivity
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.

  • EEGOther

    Also called ECG, EDR

    EEG, ECG and EDR record during a behavioral task

Study groups in NCT04069676
Study groupRoleWhat they receive
Autism Spectrum Condition (ASC)Adults males and females with a formal autism diagnosis, without intellectual disability
Receives: Other: EEG
Typically developped (TD)Adults males and females without any neurodevelopemental issue (or health issue which could impaired task performances)
Receives: Other: EEG

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 55 minutes recording

  2. 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.

    Measured: 55 minutes (same recording as before)

Secondary outcomes (4)

  1. 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.

    Measured: 55 minutes (same record as before)

  2. 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.

    Measured: 55 minutes (same record as before)

  3. 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.

    Measured: 55 minutes (same record as before)

  4. 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.

    Measured: 55 minutes (same record as before)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start17 Sep 2020
  3. Primary completion12 Jul 2021
  4. Study completion12 Jul 2021

Resources

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
Cohort
Time perspective
Prospective
Enrolment
94 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04069676
Sponsor's protocol ID
38RC19.131
Other IDs
2019-A01145-52
Acronym
PREDEMAUT
Status last verified
May 2022
First submitted
23 Aug 2019
Last updated
9 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 17548232

  • 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.

    PubMed 27752088

  • 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.

    PubMed 21968196

  • 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.

    PubMed 20044901

  • 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.

    PubMed 22940643

  • 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.

    PubMed 25288765

  • 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.

    PubMed 22178086

Questions about this trial

What is this clinical trial studying?

An observational study of Autism Spectrum Disorder, run by University Hospital, Grenoble 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 7 inclusion and 5 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 9 May 2022. 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 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?

Differences between autistic and typically developed participants in evoked potentials related to prediction mechanisms during visual processing (time frame: 55 minutes recording). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04069676, which also lists 7 linked publications.

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 9 May 2022.

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