Outcomes Measures in Intellectual Disability (EVALDI)
Primary Purpose
Attention Deficit in Intellectual Disability
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Quantitative attention evaluation criteria in intellectual disability
Sponsored by
About this trial
This is an interventional other trial for Attention Deficit in Intellectual Disability focused on measuring Intellectual disability, Attention evaluation criteria, Games on touchscreen, Eye tracking
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- Behavioral disorders not compatible with interactive tool (major agitation, straight and self aggressiveness)
- Uncontrolled seizure disorder despite treatment
Sites / Locations
- Hôpital La Pitié-Salpêtrière
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
X fragile syndrome patients
Angelman syndrome patients
Rett syndrome patients
Patients with other genetic rare syndromes with intellectual d
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Maximal reached level for each test
Number of errors during the test
Time to reach each level of the test
Time to reach maximum level of the test
Total test duration
Fixing time for eye tracking
Successful test numbers in each level
Correlation with Intelligence quotient (IQ) or age of development according to intellectual disability severity
Full Information
NCT ID
NCT03878251
First Posted
March 14, 2019
Last Updated
June 27, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Plateforme PRISME
1. Study Identification
Unique Protocol Identification Number
NCT03878251
Brief Title
Outcomes Measures in Intellectual Disability
Acronym
EVALDI
Official Title
Development and Validation of Quantitative Attention Evaluation Criteria in Patients With Intellectual Disability
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 7, 2021 (Actual)
Primary Completion Date
June 7, 2022 (Actual)
Study Completion Date
June 7, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Plateforme PRISME
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit in Intellectual Disability
Keywords
Intellectual disability, Attention evaluation criteria, Games on touchscreen, Eye tracking
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
X fragile syndrome patients
Arm Type
Other
Arm Title
Angelman syndrome patients
Arm Type
Other
Arm Title
Rett syndrome patients
Arm Type
Other
Arm Title
Patients with other genetic rare syndromes with intellectual d
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
Quantitative attention evaluation criteria in intellectual disability
Intervention Description
Quantitative interactive attention evaluation tests by using games on touchscreen and or eye tracking (oculometer)
Primary Outcome Measure Information:
Title
Correlation between number of successful attempts and intellectual disability evaluated by Intelligence quotient (IQ) or age of development
Description
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
Time Frame
up to 3 months
Secondary Outcome Measure Information:
Title
Maximal reached level for each test
Time Frame
up to 3 months
Title
Number of errors during the test
Time Frame
up to 3 months
Title
Time to reach each level of the test
Time Frame
up to 3 months
Title
Time to reach maximum level of the test
Time Frame
up to 3 months
Title
Total test duration
Time Frame
up to 3 months
Title
Fixing time for eye tracking
Time Frame
up to 3 months
Title
Successful test numbers in each level
Time Frame
up to 3 months
Title
Correlation with Intelligence quotient (IQ) or age of development according to intellectual disability severity
Time Frame
up to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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 Criteria:
Behavioral disorders not compatible with interactive tool (major agitation, straight and self aggressiveness)
Uncontrolled seizure disorder despite treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CHARLES Perrine, MD PhD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital La Pitié-Salpêtrière
City
Paris
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Outcomes Measures in Intellectual Disability
We'll reach out to this number within 24 hrs