Outcomes Measures in Intellectual Disability (EVALDI)

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Attention Deficit in Intellectual Disability

Treatments: Device: Quantitative attention evaluation criteria in intellectual disability

Study type: Interventional

Funder types: Other

Identifiers

NCT03878251

K180106J

2018-A00686-49 (Registry Identifier)

Details and patient eligibility

About

Objective quantitative primary endpoints are lacking in Clinical trials in intellectual disability. We propose to develop quantitative interactive attention evaluation criteria in patients with intellectual disability by using games on touchscreen and or eye tracking.

Full description

The aim of the study is to develop and validate quantitative interactive attention evaluation criteria by using games on touchscreen and or eye tracking in patients with intellectual disability. Tests will have to be suitable whatever severity and etiology of intellectual disability. Tests have to evaluate attention and concentration troubles in intellectual disability.Once validated, tests could be used as outcome measures in clinical trials and as cognitive reeducation tools in intellectual disability.

Enrollment: 40 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients of both sex, with intellectual disability
2. Minor patients 6 years old or more (age corresponding to the end of regression period observed in Rett patients) or major protected patients
3. Patients with more or less severe intellectual disability from various causes including Fragile X syndrome, Rett syndrome, Angelman syndrome and other etiologies of intellectual disabilities and intellectual disabilities without identified etiology
4. Affiliation to a social security system own or affiliated (excluding AME)
5. Presence of parents or legal representative
6. Informed consent signed by parents or legal representative

Exclusion criteria

1. Behavioral disorders not compatible with interactive tool (major agitation, straight and self aggressiveness)
2. Uncontrolled seizure disorder despite treatment

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 4 patient groups

X fragile syndrome patients

Other group

Treatment:

Device: Quantitative attention evaluation criteria in intellectual disability

Angelman syndrome patients

Other group

Treatment:

Device: Quantitative attention evaluation criteria in intellectual disability

Rett syndrome patients

Other group

Treatment:

Device: Quantitative attention evaluation criteria in intellectual disability

Patients with other genetic rare syndromes with intellectual d

Other group

Treatment:

Device: Quantitative attention evaluation criteria in intellectual disability