ClinicalTrials.gov record NCT07434037
The Neurocognitive Bases of Trust in Intellectual Disability
The Neurocognitive Bases of Trust in Intellectual Disability: Affective Evaluation, Trait Attribution, and Epistemic Vigilance
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This prospective observational study looks at how people with Down syndrome or Fragile X syndrome form and adjust trust. Participants complete behavioural and eye-tracking tasks, clinical and cognitive assessments, and some may be offered an optional brain MRI. The study compares the roles of emotional evaluation, trait attribution, and epistemic vigilance across participant groups.
What it is studying. The study will examine three brain and cognitive processes involved in deciding whom to trust: affective evaluation (rapid emotional threat assessment, involving subcortical areas like the amygdala), trait attribution (forming judgments about others’ dispositions, involving cortical and cerebellar networks), and epistemic vigilance (assessing the reliability of what others say, involving frontal and mental-state representation areas). It uses behavioural paradigms, eye-tracking, cognitive tests, clinical data, and optional structural and functional MRI to compare these processes in people with Down syndrome, people with Fragile X syndrome, and two types of typically developing control groups.
What the researchers hope to learn. To describe and compare how affective evaluation, trait attribution, and epistemic vigilance contribute to trust adjustment in Down syndrome and Fragile X syndrome; to measure task error rates, response times, and eye-tracking strategies; and to map related brain structure and activity using MRI.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
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people with Fragile X syndrome, who are often characterized by a completely opposite social behaviour profile, with a withdrawn attitude and significant social anxiety.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.
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Other
- Confidence adjustment assessment
- clinical assessment
- Cognitive assessment
- Executive function assessment
- Sociability assessment
- Brain MRI (structural and functional)
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- 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.
- 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 mental age-matched control
- Aged between 3 and 9
- Native French speakers.
- 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
Exclusion criteria
- 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.
- Subject participating in another interventional study with an exclusion period still ongoing at the time of pre-inclusion.
- 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.
- Birth complications requiring admission to a neonatal intensive care unit or prematurity of less than 35 weeks.
- Ongoing treatment with drugs affecting the central nervous system.
- Significant hearing impairment
- Uncorrected visual impairment
- Repeating a school year
- Learning disorders requiring rehabilitation (speech therapy, psychomotor therapy or orthoptics) for more than one year.
- Refusal of the subject and/or legal guardians/representative of the subject to be informed of any abnormalities detected during the neuropsychological assessment.
- Subject participating in another interventional study with an exclusion period still ongoing at the time of pre-inclusion.
- Regarding the neuroimaging (MRI) study (only for chronological age-matched group):
- 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.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴
AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Most participants attend at least one study visit with behavioral tasks and eye-tracking to assess interpersonal trust (four task paradigms), plus clinical and neuropsychological testing (medical/developmental history, cognitive tests such as Raven and Wechsler scales, language and adaptive-behavior questionnaires, executive-function and sociability assessments). Parents or guardians will be interviewed for developmental and adaptive-history measures. An optional separate visit may include structural and functional brain MRI for Down syndrome, Fragile X, and chronological control groups if the participant has no MRI contraindication and can undergo MRI without anaesthesia. Neuropsychological or MRI assessments may reveal clinical abnormalities; participants and/or guardians must agree to be informed of such findings.
How the study is structured. A prospective observational study with one main study visit for behavioural tasks, eye-tracking, clinical history, and cognitive testing. An optional ancillary visit offers structural and functional brain MRI. Four participant groups are included: people with Down syndrome, people with Fragile X syndrome, chronological age-matched controls, and mental age-matched controls. No experimental treatment is given.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
- The listed sites are in France. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on fragile X syndrome
Important dates
- Study start
- Jul 17, 2026
- Primary completion
- January 2030 (estimated)
- Study completion
- January 2030 (estimated)
- Target enrollment
- 112 participants (estimated)
- Last updated on registry
- Aug 5, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Hospices Civils de Lyon
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- CURIE MD AURORE, MD 📞 +33 (0)6.70.62.69.76 ✉ Aurore.curie@chu-lyon.fr
Participating sites (1)
- Reference Center of Rare Disease with Intellectual Disability in Lyon, Woman Mother and Child Hospital, University Hospital of Lyon, Hospices Civils de LyonRecruiting
Bron, 69500 · France
- CURIE AURORE, MD · +33 (0)6.70.62.69.76 · Aurore.curie@chu-lyon.fr
Terms used on this page · explanations by MedicalUpdates.ai
- informed consent form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- interventional study
- A study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
- MRI
- A scan that uses magnets and radio waves, not X-rays, to make detailed pictures of the inside of the body. Some implants and metal objects mean a person cannot have one.
- contraindication
- A reason a particular test or treatment should not be used for a person, for example a metal implant that rules out an MRI scan.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
- Exclusion Criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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