Status:
COMPLETED
Outcomes Measures in Intellectual Disability
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Plateforme PRISME
Conditions:
Attention Deficit in Intellectual Disability
Eligibility:
All Genders
6+ years
Phase:
NA
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 intell...
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...
Eligibility Criteria
Inclusion
- 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
- Behavioral disorders not compatible with interactive tool (major agitation, straight and self aggressiveness)
- Uncontrolled seizure disorder despite treatment
Key Trial Info
Start Date :
July 7 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 7 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03878251
Start Date
July 7 2021
End Date
June 7 2022
Last Update
June 28 2022
Active Locations (1)
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1
Hôpital La Pitié-Salpêtrière
Paris, France