Outcomes Measures in Intellectual Disability

Not Applicable

Completed

• Conditions: Attention Deficit in Intellectual Disability
• Interventions: Device: Quantitative attention evaluation criteria in intellectual disability

• Registration Number: NCT03878251
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study First Submitted: 2019-03-14
• Study First Submitted QC: 2019-03-14
• Study First Posted: 2019-03-18
• Study Start: 2021-07-07
• Status Verified: 2022-06
• Primary Completion: 2022-06-07
• Study Completion: 2022-06-07
• Last Update Submitted: 2022-06-27
• Last Update Posted: 2022-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with other genetic rare syndromes with intellectual d	Quantitative attention evaluation criteria in intellectual disability	-
Rett syndrome patients	Quantitative attention evaluation criteria in intellectual disability	-
X fragile syndrome patients	Quantitative attention evaluation criteria in intellectual disability	-
Angelman syndrome patients	Quantitative attention evaluation criteria in intellectual disability	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Number of errors during 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
Correlation with Intelligence quotient (IQ) or age of development according to intellectual disability severity	up to 3 months
Maximal reached level for each test	up to 3 months
Time to reach each level of the test	up to 3 months
Successful test numbers in each level	up to 3 months
Fixing time for eye tracking	up to 3 months

Trial Locations

Locations (1)

Hôpital La Pitié-Salpêtrière; 🇫🇷 Paris, France