Neuropsychological Evaluation in Intellectual Disability (ENDI)

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age25-65
SponsorCentral Hospital, Nancy, France

About this trial

The goal of this observational study is to evaluate the acceptability ofpatients with trisomy 21 (T21) to perform the full battery of ENDI neurospychological tests and each of the subsets.

In this study, three types of population will be recruted : normotypic volunteers, patients with Intellectual Disability and patients T21carriers.

This study is separated into 2 phases :

* A the preliminary phase : this phase will be used to evaluate subtest design, ergonomics and understanding of instructions, and to identify any malfunctions. The observations gathered will enable the principal investigator to refine the digital design of the battery in collaboration with the publishing company. In this phase, normotypical volunteers and patients with intellectual disabilities will be recruted to perform ENDI test battery. * A main phase : this phase will enable to answer to the main objective. in this phase, patients with Trisomy 21 aged between 25 and 65 will be recruted to perform ENDI test battery.

Eligibility criteria

Qualifiers

Participant who has received full information on the organization of the research and has not objected to his or her participation and to the use of his or her data.

Legal guardian of the participant, if applicable, who has received full information on the organization of the research and has not objected to participation and use of his/her data.

Age at inclusion: ≥ 25 and ≤ 65 years

Notion of intellectual disability in medical records

Disqualifiers

Disabling motor and/or sensory impairments preventing completion of the tests

Insufficient command of the French language to complete the tests

Severe general medical condition or alcoholism (habitual consumption of 3 drinks/day or history of alcohol withdrawal)

History of stroke, severe head trauma, or cancer

Trial design

Treatments tested in this trial

  • ENDI (Neuropsychological Evaluation in Intellectual Disability)

Treatment groups

40 Participants
are divided into 3 treatment groups