Outcomes Measures in Intellectual Disability

Study Overview
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Brief Summary
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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
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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.

Official Title
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Development and Validation of Quantitative Attention Evaluation Criteria in Patients With Intellectual Disability

Conditions
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Attention Deficit in Intellectual Disability

Intervention / Treatment
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* Device: Quantitative attention evaluation criteria in intellectual disability


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients of both sex, with intellectual disability Minor patients 6 years old or more (age corresponding to the end of regression period observed in Rett patients) or major protected patients 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 Affiliation to a social security system own or affiliated (excluding AME) Presence of parents or legal representative Informed consent signed by parents or legal representative Exclusion Criteria: Behavioral disorders not compatible with interactive tool (major agitation, straight and self aggressiveness) Uncontrolled seizure disorder despite treatment

Ages Eligible for Study
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Minimum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: X fragile syndrome patients<br> | Device: Quantitative attention evaluation criteria in intellectual disability<br>* Quantitative interactive attention evaluation tests by using games on touchscreen and or eye tracking (oculometer)<br>|
| Other: Angelman syndrome patients<br> | Device: Quantitative attention evaluation criteria in intellectual disability<br>* Quantitative interactive attention evaluation tests by using games on touchscreen and or eye tracking (oculometer)<br>|
| Other: Rett syndrome patients<br> | Device: Quantitative attention evaluation criteria in intellectual disability<br>* Quantitative interactive attention evaluation tests by using games on touchscreen and or eye tracking (oculometer)<br>|
| Other: Patients with other genetic rare syndromes with intellectual d<br> | Device: Quantitative attention evaluation criteria in intellectual disability<br>* Quantitative interactive attention evaluation tests by using games on touchscreen and or eye tracking (oculometer)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between number of successful attempts and intellectual disability evaluated by Intelligence quotient (IQ) or age of development | 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 | up to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal reached level for each test |  | up to 3 months | 
| 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 | 
| Total test duration |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eye tracking, Intellectual disability, Attention evaluation criteria, Games on touchscreen