Brain and Eye Markers of Facial Expression Recognition an... | NCT05635812

Studies
Brain and Eye Markers of Facial Expression Recognition and Disorders Associated with Autistic Symptoms

NCT05635812

Sponsor

Centre Hospitalier Universitaire Dijon

Status

Recruiting

Last Update Posted

Oct 4, 2024Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Brain Markers

Interventions

Neuropsychological assessment
EEG experimentation
Oculometry experimentation

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 6, 2023Actual

Primary Completion Date

Jul 2026Estimated

Completion Date

Jul 2026Estimated

First Submitted Date

Nov 23, 2022

First Submission Date that Met QC Criteria

Nov 23, 2022

First Posted Date

Dec 2, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2024

Last Update Posted Date

Oct 4, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In everyday life, it is necessary to adjust one's behavior and reactions in order to interact and communicate with others in an appropriate manner. This adaptation is done by taking into account the emotions of the people with whom we interact. This reading of emotions is done by using visible clues on the face, in particular by observing the eye area of the interlocutor.

The aim of the study is to investigate how processes such as attention or memory influence emotion recognition, as well as (i) their alteration in the disease, and (ii) their link with the emergence of autistic and/or psychotic symptoms. We also want to study the implementation of compensatory strategies (used to compensate for difficulties in recognizing or perceiving emotions) and the link between the correct use of these strategies and the emergence of autistic and/or psychotic symptoms.

The present project plans to include a total of 120 participants: 30 participants with ASD, 30 patients with a particular genetic deletion 22q11.2 and 60 control participants.

After the inclusion visit, participation in the study will be divided into two half-days in order to perform a neuropsychological assessment, an EEG study and an oculometry study.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Participants Autism Spectrum Disorders (ASD)	ASD according to DSM-5 criteria	Other: Neuropsychological assessment Other: EEG experimentation Other: Oculometry experimentation
Participants 22q11.2	Participants with a genetic syndrome diagnosed by FISH or CGH-array	Other: Neuropsychological assessment Other: EEG experimentation Other: Oculometry experimentation
Neurotypical participants	Neurotypical development	Other: Neuropsychological assessment Other: EEG experimentation Other: Oculometry experimentation

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neuropsychological assessment	Other	neuropsychological assessment and clinical scales duration: 3 hours	Neurotypical participants Participants 22q11.2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Electrical brain activity in response to visual stimulation measured by electroencephalography		at baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Person, and if necessary his or her legal representative, who has given his or her non-objection
Person whose mother tongue is French.
Person aged between 7 and 50 years old.
Person diagnosed with ASD according to DSM-5 criteria, person with a genetic syndrome diagnosed by FISH or CGH array (22q11 deletion), person with typical development matched in age and gender.
Psychotropic treatment unchanged for one month and stable symptomatology.

Exclusion Criteria:

Recent addiction according to DSM-5 criteria, excluding tobacco.
Pregnant women.
Uncorrected visual acuity disorder.
Use of somatic or psychic medication that may alter brain/psychic functioning (e.g. corticosteroids).
Neurological disorder of vascular/infectious or neurodegenerative origin.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

50 Years

Standard Ages

ChildAdult

Study Population

ASD, 22q11.2 and neurotypical participants

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Jean-Michel PINOIT	Contact	03 80 29 34 60		jean-michel.pinoit@chu-dijon.fr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chu Dijon Bourogne	Recruiting	Dijon		21000	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D009483	Neuropsychological Tests

Ancestor Terms

ID	Term
D011581	Psychological Tests
D004191	Behavioral Disciplines and Activities

Browse Leaves

Not provided

Browse Branches

Not provided