The Neurocognitive Bases of Trust in Intellectual Disability

NCT07434037 | Not Yet Recruiting

• 2 other identifiers: 69HCL19_02372025-A02283-46
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

This project studies the neurocognitive basis of trust adjustment in intellectual disability (ID), a source of significant vulnerability for these patients, focusing on two target populations chosen for their specific social characteristics: people with Down syndrome, who are often described as being hypersocial, and people with Fragile X syndrome, who are often characterized by a completely opposite social behaviour profile, with a withdrawn attitude and significant social anxiety. The three different types of mechanisms that contribute to the adjustment of interpersonal trust: affective evaluation, trait attribution, and epistemic evaluation of informants, will be studied. Affective evaluation processes recruit subcortical structures such as the amygdala and assess potential social threats in the environment. The second mechanism for selecting whom to trust consists of forming a representation of a person's dispositions, such as benevolence and competence (also known as traits), and using it to predict that person's future behaviour. Trait attribution processes recruit a cortico-cerebellar network comprising the mPFC, CRUS I and posterior lobule VI. The third mechanism, called epistemic vigilance, allows to adjust our trust in what others communicate to us. This mechanism involves linking the assessment of the reliability of individuals who communicate (based on their benevolence and competence) with the reliability of the communicated information. Epistemic assessment involves frontal areas and areas associated with the representation of mental states in order to enable the evaluation of the truthfulness of the communicated information. All of these mechanisms become functional very early on, before a child's sixth birthday. There are reasons to expect that several of these central mechanisms supporting selective trust will behave atypically in intellectual disability.

Conditions

Down Syndrome (Trisomy 21); Fragile X Syndrome (FXS)

Keywords

Trust; Intellectual disability; Eyetracking analysis; Neuroimaging; Down syndrome; Fragile X syndrome

Outcome Measures

Primary Outcomes (3)

• Error rate (percentage) for each of the four paradigms.

  Paradigm 1 /Facial trait assessment : Error rates for each condition (3 levels of difficulty) and 2 types of questions (traits/behaviours) Paradigm 2 / Behaviour assessment: Error rates for each of the three conditions (traits-to-behaviour, behaviour-to-traits, and behaviour-to-behaviour) Paradigm 3/ Assessing informants : error rates for each type of informant Paradigm 4 / Vigilance towards deception: Error rates concerning the location of the pompom, for each of the four conditions: baseline, benevolence, malicious intent, and explicit falsehood of the character.

  Day 1

• Response time (millisecond) for two of the four paradigms.

  Paradigm 1 / Facial trait assessment: Analysis of response times (in milliseconds) for each condition (3 levels of difficulty (easy/moderate/difficult) and 2 types of questions (traits/behaviours) obtained using Presentation® software. Paradigm 2 / Behaviour assessment: Analysis of response times (in milliseconds) for each of the three conditions (traits-to-behaviour, behaviour-to-traits, and behaviour-to-behaviour) using Presentation software.

  Day 1

• Analysis of visual strategies for eye-tracking experiments.

  Paradigm1 / Facial trait assessment: Observation time on different areas of interest (AOI eyes, AOI nose-mouth) obtained using the eye tracker (Tobii ProLab). Paradigm 2 / Behaviour assessment: measurement of time spent on each region of interest corresponding to the task images (in milliseconds) obtained using the eye tracker (Tobii ProLab)

  Day 1

Secondary Outcomes (24)

• Presence of epilepsy (Yes/No)

  Day 1

• Developmental trajectory

  Day 1

• Mental age, in years, [4-12 years] assessed with the Raven's Progressive Matrices test

  Day 1

• Presence of an associated autism spectrum disorder (Yes/No)

  Day 1

• Existence of cardiac malformation (Yes/No).

  Day 1

Study Arms (4)

Down Syndrome patients

Patients aged 13 to 29 years old with a confirmed diagnosis of Down Syndrome

Other: Confidence adjustment assessment; Other: clinical assessment; Other: Cognitive assessment; Other: Executive function assessment; Other: Sociability assessment; Other: Brain MRI (structural and functional)

Fragile X Syndrome patients

Patients aged 13 to 29 years old with a confirmed diagnosis of Fragile X Syndrome

Other: Confidence adjustment assessment; Other: clinical assessment; Other: Cognitive assessment; Other: Executive function assessment; Other: Sociability assessment; Other: Brain MRI (structural and functional)

Chronological age-matched controls

Persons aged 13 to 29 years old with typical development

Other: Confidence adjustment assessment; Other: clinical assessment; Other: Cognitive assessment; Other: Executive function assessment; Other: Sociability assessment; Other: Brain MRI (structural and functional)

Mental age-matched controls

Persons aged 3 to 9 years old with typical development

Other: Confidence adjustment assessment; Other: clinical assessment; Other: Cognitive assessment; Other: Executive function assessment; Other: Sociability assessment

Interventions

Confidence adjustment assessment OTHER

Interpersonal trust assessment including a series of behavioural and eye-tracking studies (Paradigm 1 : Forming impressions using facial cues; Paradigm 2 : Forming impressions using behaviors) and assessment of epistemic trust (Paradigm 3 : assessing informants, Paradigm 4 : vigilance towards deception), will be performed at visit V1.

Chronological age-matched controls; Down Syndrome patients; Fragile X Syndrome patients; Mental age-matched controls

clinical assessment OTHER

Clinical assessment including Medical history, developmental trajectory, epilepsy history, clinical examination, presence of autism spectrum disorder, presence of cardiopathy, will be performed at visit V1.

Chronological age-matched controls; Down Syndrome patients; Fragile X Syndrome patients; Mental age-matched controls

Cognitive assessment OTHER

Cognitive assessment including Raven Matrix, Wechsler Scale (WISC-V or WAIS IV), Vineland Adaptive Behavior Scale II, PPVT5, EVT3, will be performed at visit V1.

Chronological age-matched controls; Down Syndrome patients; Fragile X Syndrome patients; Mental age-matched controls

Executive function assessment OTHER

Executive function assessment including Laby 5-12 test, day/night Test, Questionnaire BRIEF-2, will be performed at visit V1.

Chronological age-matched controls; Down Syndrome patients; Fragile X Syndrome patients; Mental age-matched controls

Sociability assessment OTHER

Sociability assessment including Social Responsiveness Scale 2, Revised Preschool Anxiety Scale, two eye-tracking tasks (social scenes and social preference), Perception bias task, Distance adjustment task, Social motivation tasks, Examiner's assistance task, will be performed at visit V1.

Chronological age-matched controls; Down Syndrome patients; Fragile X Syndrome patients; Mental age-matched controls

Brain MRI (structural and functional) OTHER

Optional brain MRI acquisition (structural and functional) will be performed at ancillary visit

Chronological age-matched controls; Down Syndrome patients; Fragile X Syndrome patients

Eligibility Criteria

• Age: 3 Years - 29 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Four groups of participants will be included in the study: * Individuals with Down syndrome * Individuals with Fragile X syndrome * Control subjects with typical development matched for chronological age to individuals with intellectual disability (ID) * Control subjects with typical development matched for mental age to individuals with intellectual disability (ID)

You may qualify if:

• Group of Down Syndrom patients
• Complete chromosomal trisomy of the 21st chromosome confirmed by karyotype analysis
• Aged 13 to 29 (chronological age)
• French as their native language
• Having signed an informed consent form and/or whose legal guardians/patient representatives have signed the informed consent form
• Affiliated with the French health insurance system (social security) or whose legal guardians are affiliated with the French health insurance system
• Group of X-Fragile Syndrome
• Complete mutation of the FMR1 gene by molecular analysis (more than 200 CGG triplet repeats)
• Aged between 13 and 29 (chronological age)
• Native French speakers
• Having signed an informed consent form and/or whose legal guardians/patient representatives have signed the informed consent form
• Affiliated with the French health insurance system (social security) or whose legal guardians are affiliated with the French health insurance system
• Group of chronological age-matched control
• Aged between 13 and 29
• Native French speakers.

You may not qualify if:

• Groups of Down Syndrom and X-Fragiles patients
• Inability to understand tasks
• Significant brain malformation
• Uncontrolled epilepsy
• Significant hearing impairment
• Uncorrected visual impairment
• Refusal of the subject and/or legal guardians/representative of the subject to be informed of any abnormalities detected during the neuropsychological assessment.
• Regarding the neuroimaging (MRI) study:
• Having a contraindication to MRI examination (people using a pacemaker or insulin pump, people with metal prostheses or intracerebral clips, people with metal fragments in their eyes, as well as claustrophobic subjects). A comprehensive list of contraindications is provided in Appendix 5.
• Inability to perform the MRI without anaesthesia.
• Refusal by the subject and/or those exercising parental authority/the subject's representative to be informed of any abnormalities detected during the MRI.
• Groups of typical development persons (chronological age-matched and mental age-matched)
• Known acquired neurological disorders, including epilepsy.
• History of head trauma requiring hospitalisation.
• Known psychiatric disorders.

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Reference Center of Rare Disease with Intellectual Disability in Lyon, Woman Mother and Child Hospital, University Hospital of Lyon, Hospices Civils de Lyon

Bron, 69500, France

Location

MeSH Terms

Conditions

Down Syndrome; Fragile X Syndrome; Intellectual Disability

Interventions

Mental Status and Dementia Tests; Neuropsychological Tests; Functional Status

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Chromosome Disorders; Genetic Diseases, Inborn; X-Linked Intellectual Disability; Sex Chromosome Disorders; Genetic Diseases, X-Linked; Heredodegenerative Disorders, Nervous System; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Psychological Tests; Behavioral Disciplines and Activities; Activities of Daily Living; Rehabilitation; Health Services; Health Care Facilities Workforce and Services; Health Status; Demography; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

CURIE MD AURORE, MD

CONTACT

+33 (0)6.70.62.69.76; Aurore.curie@chu-lyon.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2026
• First Posted: February 25, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

FR (1)