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Emotional Proactive Brain Study in Adults With Autism Spectrum Condition (PREDEMAUT)

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ClinicalTrials.gov Identifier: NCT04069676
Recruitment Status : Not yet recruiting
First Posted : August 28, 2019
Last Update Posted : March 30, 2020
Sponsor:
Collaborator:
Laboratoire de Psychologie et NeuroCognition
Information provided by (Responsible Party):
University Hospital, Grenoble

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

Condition or disease Intervention/treatment
Autism Spectrum Disorder Other: EEG

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.

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Emotional Proactive Brain Study in Adults With Autism Spectrum Condition
Estimated Study Start Date : October 1, 2020
Estimated Primary Completion Date : October 31, 2022
Estimated Study Completion Date : October 31, 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Autism Spectrum Condition (ASC)
Adults males and females with a formal autism diagnosis, without intellectual disability
Other: EEG
EEG, ECG and EDR record during a behavioral task
Other Names:
  • ECG
  • EDR

Typically developped (TD)
Adults males and females without any neurodevelopemental issue (or health issue which could impaired task performances)
Other: EEG
EEG, ECG and EDR record during a behavioral task
Other Names:
  • ECG
  • EDR




Primary Outcome Measures :
  1. Differences between autistic and typically developed participants in evoked potentials related to prediction mechanisms during visual processing [ Time Frame: 55 minutes recording ]
    - 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.

  2. 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) ]
    - 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.


Secondary Outcome Measures :
  1. Differences between groups in oscillatory activity [ Time Frame: 55 minutes (same record as before) ]
    -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.

  2. Difference between groups in cerebral connectivity [ Time Frame: 55 minutes (same record as before) ]
    - 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.

  3. Differences between groups in autonomous activity [ Time Frame: 55 minutes (same record as before) ]
    • 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.

  4. Sex differences [ Time Frame: 55 minutes (same record as before) ]
    - 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adults autistic males and females without intellectual disability compared to a control group
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04069676


Contacts
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Contact: Laurent Vercueil, Doctor 0476765561 ext +33 LVercueil@chu-grenoble.fr
Contact: Adeline LACROIX 06 63 87 54 15 ext +33 adeline.lacroix@univ-grenoble-alpes.fr

Sponsors and Collaborators
University Hospital, Grenoble
Laboratoire de Psychologie et NeuroCognition
Investigators
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Principal Investigator: Laurent Vercueil, Doctor University Hospital, Grenoble
Publications:

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Responsible Party: University Hospital, Grenoble
ClinicalTrials.gov Identifier: NCT04069676    
Other Study ID Numbers: 38RC19.131
2019-A01145-52 ( Other Identifier: ID RCB )
First Posted: August 28, 2019    Key Record Dates
Last Update Posted: March 30, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Grenoble:
Autism Spectrum Condition
predictive coding
visual perception
electroencephalography
autonomous nervous system
heart rate variability
electrodermal reactivity
Additional relevant MeSH terms:
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Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders