Outcomes Measures in Intellectual Disability

Attention Deficit in Intellectual Disability Clinical Trial

— EVALDI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03878251
• Other study ID #: K180106J
• Secondary ID: 2018-A00686-49
• Status: Completed
• Phase: N/A
• Start date: July 7, 2021
• Est. completion date: June 7, 2022

Study information

• Verified date: June 2022
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Attention Deficit in Intellectual Disability
• Intellectual Disability

Intervention

Device:
• Quantitative attention evaluation criteria in intellectual disability
Quantitative interactive attention evaluation tests by using games on touchscreen and or eye tracking (oculometer)

Locations

Country	Name	City	State
France	Hôpital La Pitié-Salpêtrière	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Plateforme PRISME

Country where clinical trial is conducted

France, 

Outcome

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