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

May 6, 2022 updated by: University Hospital, Grenoble

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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
94

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Grenoble, France, 38043
        • Chu Grenoble Alpes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
55 minutes recording
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.
55 minutes (same recording as before)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
55 minutes (same record as before)
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.
55 minutes (same record as before)
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.
55 minutes (same record as before)
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.
55 minutes (same record as before)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Grenoble

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Laboratoire de Psychologie et NeuroCognition

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laurent Vercueil, Doctor, University Hospital, Grenoble

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 12, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 12, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 38RC19.131
  • 2019-A01145-52 (Other Identifier: ID RCB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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