Clinical trial NCT03878251: Outcomes Measures in Intellectual Disability
Official title: Development and Validation of Quantitative Attention Evaluation Criteria in Patients With Intellectual Disability
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Attention Deficit in Intellectual Disability
Keywords: Intellectual disability
Attention evaluation criteria
Games on touchscreen
Eye tracking
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Plateforme PRISME
First posted: 2019-03-18
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation between number of successful attempts and intellectual disability evaluated by Intelligence quotient (IQ) or age of development
timeFrame: up to 3 months
Secondary outcomes:
measure: Maximal reached level for each test
timeFrame: up to 3 months
measure: Number of errors during the test
timeFrame: up to 3 months
measure: Time to reach each level of the test
timeFrame: up to 3 months
measure: Time to reach maximum level of the test
timeFrame: up to 3 months
measure: Total test duration
timeFrame: up to 3 months
measure: Fixing time for eye tracking
timeFrame: up to 3 months
measure: Successful test numbers in each level
timeFrame: up to 3 months
measure: Correlation with Intelligence quotient (IQ) or age of development according to intellectual disability severity
timeFrame: up to 3 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital La Pitié-Salpêtrière
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: CHARLES Perrine, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: