- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02160119
Emotional and Change-related Attention in Autism (AUTATTEN)
August 27, 2021 updated by: Institut National de la Santé Et de la Recherche Médicale, France
Several studies seem to indicate that emotional attention and change-related attention are impaired in ASD.
The goal of this study is to identify the relationships between those two types of automatic attention in visual and auditory modalities in subjects with ASD compared to healthy controls and also, over the course of development (children, adults).
In order to achieve this goal, the investigators will use complementary techniques (EEG and MRI-based techniques (fMRI, DTI)).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Autism Spectrum Disorders (ASD) are characterized by major handicap in social interaction and in daily life adaptation.
The orienting response towards potentially relevant events involves automatic attentional mechanisms that would be elicited mainly by two classes of biologically important stimulations: novel stimuli and emotional stimuli.
The neural basis of emotional and change-related attention in ASD will be explored by investigating brain reactivity in both visual and auditory modalities, during tasks mixing emotional and non emotional stimuli.
Study Type
Observational
Enrollment (Actual)
120
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
-
-
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Tours, France, 37044
- University Hospital
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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
Ages Eligible for Study
5 years to 45 years (Child, Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Children/ adults with ASD and healthy children/ adults
Description
Inclusion Criteria:
- No past history of central nervous system disorders
- Written consent
- Affiliated to the National Health Insurance
- Do not participate to another biomedical research
- For ASD group: Children with autism spectrum disorder (DSM-V criteria) and adults with high-functioning autism
- For healthy subjects: No past history of difficulties in early childhood for acquisition of walk, language or reading and no psychiatric disorders
Exclusion Criteria:
- Abnormal corrected vision
- Abnormal audition
- Not stabilized psychoactive treatment or treatment that can modify electrogenesis
- Infectious or metabolic diseases
- Epilepsies
- Impossibility to participate to the whole study
- For subjects participating to the MRI recordings: MRI counter-indications (pace-makers ...), claustrophobia or a positive pregnancy test
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 |
Intervention / Treatment |
---|---|
Healthy Controls
|
fMRI, DTI
Other Names:
ERP
Other Names:
|
Autism Spectrum Disorders
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fMRI, DTI
Other Names:
ERP
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neural responses to neutral and emotional stimuli
Time Frame: 1 day
|
ERP (Event-related potential), fMRI and DTI
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Frédérique BONNET-BRILHAULT, MD,PhD, Institut National de la Santé Et de la Recherche Médicale, France
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)
May 27, 2014
Primary Completion (Actual)
May 1, 2018
Study Completion (Actual)
May 27, 2018
Study Registration Dates
First Submitted
June 3, 2014
First Submitted That Met QC Criteria
June 6, 2014
First Posted (Estimate)
June 10, 2014
Study Record Updates
Last Update Posted (Actual)
August 30, 2021
Last Update Submitted That Met QC Criteria
August 27, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C13-26
- 2013-A01315-40 (Registry Identifier: IDRCB)
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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