NCT04025398 A Computer-based Cognitive Remediation Program for Adults With Intellectual Disability
| NCT ID | NCT04025398 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hôpital le Vinatier |
| Condition | Intellectual Disability |
| Study Type | INTERVENTIONAL |
| Enrollment | 116 participants |
| Start Date | 2020-06-17 |
| Primary Completion | 2026-06-17 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 116 participants in total. It began in 2020-06-17 with a primary completion date of 2026-06-17.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Adults with intellectual disabilities have great difficulty in adapting to social situations and relationships. Cognitive impairment associated with intellectual disability are important factors to understand their difficulties in processing social information. In the field of recognition of facial emotions in particular, basic cognitive processes such as visuospatial and attentional functions, are heavily involved. Cognitive remediation is a management tool widely used by practitioners to help patients who experience cognitive difficulties. Currently, no program can meet specific and validated the problems are adults with intellectual disabilities manner in their daily functioning
Eligibility Criteria
Inclusion Criteria: * Adults aged 18 to 45 inclusive; * Behavioral disorders corresponding to a total score on the ABC scale \> 15 * Presence of a family caregiver (parent, friend) or professional (reeducator, professional of the medico-social sector) stakeholder of the project; * Diagnosis of mild to moderate intellectual disability (assessed by WAIS-IV battery and VABS-II less than 3 years ago; * French or secondary mother tongue; * Psychoactive treatment unchanged during the month prior to inclusion; * Adult or legal representative who has given written and informed consent to participate in the study. By default, the adult's oral agreement will be collected (as well as the written consent of the legal representative); * Affiliation to the social security scheme or beneficiary of such a scheme. Exclusion Criteria: * Neurological disorders of vascular, infectious or neurodegenerative origin; * Taking medications for general medical purposes with a neurological or psychiatric impact (eg corticosteroids); * Simultaneous participation in any other cognitive remediation program targeting attentional, visuospatial and social cognition; * Refusal of participation of the person and/or his/her legal representative; * Not family or professional caregiver; * Presence of Autistic Spectrum Disorders (evaluated by ADOS and ADI if necessary according to the assessment of the investigator)
Contact & Investigator
DEMILY CAROLINE, MD Ph
PRINCIPAL INVESTIGATOR
Centre Hospitalier le Vinatier
Frequently Asked Questions
Who can join the NCT04025398 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Intellectual Disability. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04025398 currently recruiting?
Yes, NCT04025398 is actively recruiting participants. Contact the research team at caroline.demily@ch-le-vinatier.fr for enrollment information.
Where is the NCT04025398 trial being conducted?
This trial is being conducted at Lyon, France.
Who is sponsoring the NCT04025398 clinical trial?
NCT04025398 is sponsored by Hôpital le Vinatier. The principal investigator is DEMILY CAROLINE, MD Ph at Centre Hospitalier le Vinatier. The trial plans to enroll 116 participants.