Attention Deficit in Intellectual Disability Clinical Trial
— EVALDIOfficial title:
Development and Validation of Quantitative Attention Evaluation Criteria in Patients With Intellectual Disability
Verified date | June 2022 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 40 |
Est. completion date | June 7, 2022 |
Est. primary completion date | June 7, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital La Pitié-Salpêtrière | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris | Plateforme PRISME |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Maximal reached level for each test | up to 3 months | ||
Secondary | Number of errors during the test | up to 3 months | ||
Secondary | Time to reach each level of the test | up to 3 months | ||
Secondary | Time to reach maximum level of the test | up to 3 months | ||
Secondary | Total test duration | up to 3 months | ||
Secondary | Fixing time for eye tracking | up to 3 months | ||
Secondary | Successful test numbers in each level | up to 3 months | ||
Secondary | Correlation with Intelligence quotient (IQ) or age of development according to intellectual disability severity | up to 3 months |