Attention Deficit in Intellectual Disability
Conditions
Keywords
Intellectual disability, Attention evaluation criteria, Games on touchscreen, Eye tracking
Brief summary
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.
Detailed 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.
Interventions
DEVICEQuantitative attention evaluation criteria in intellectual disability
Quantitative interactive attention evaluation tests by using games on touchscreen and or eye tracking (oculometer)
Sponsors
Plateforme PRISME
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation between number of successful attempts and intellectual disability evaluated by Intelligence quotient (IQ) or age of development | up to 3 months | Test performed 1 time during a visit (1 day) can be repeated (for a maximum of 15 patients) within 3 months if an adaptation of the interactive tool is necessary |
Secondary
| Measure | Time frame |
|---|---|
| Number of errors during the test | up to 3 months |
| Time to reach each level of the test | up to 3 months |
| Time to reach maximum level of the test | up to 3 months |
| Maximal reached level for each test | up to 3 months |
| Fixing time for eye tracking | up to 3 months |
| Successful test numbers in each level | up to 3 months |
| Correlation with Intelligence quotient (IQ) or age of development according to intellectual disability severity | up to 3 months |
| Total test duration | up to 3 months |
Countries
France
Outcome results
None listed