Outcomes Measures in Intellectual Disability (EVALDI)

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

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.

Study Overview

• Status: Completed
• Conditions: Attention Deficit in Intellectual Disability
• Intervention / Treatment: Device: Quantitative attention evaluation criteria in intellectual disability

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 Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France
    • Hôpital La Pitié-Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: X fragile syndrome patients	Device: Quantitative attention evaluation criteria in intellectual disability; Quantitative interactive attention evaluation tests by using games on touchscreen and or eye tracking (oculometer)
OTHER: Angelman syndrome patients	Device: Quantitative attention evaluation criteria in intellectual disability; Quantitative interactive attention evaluation tests by using games on touchscreen and or eye tracking (oculometer)
OTHER: Rett syndrome patients	Device: Quantitative attention evaluation criteria in intellectual disability; Quantitative interactive attention evaluation tests by using games on touchscreen and or eye tracking (oculometer)
OTHER: Patients with other genetic rare syndromes with intellectual d	Device: Quantitative attention evaluation criteria in intellectual disability; Quantitative interactive attention evaluation tests by using games on touchscreen and or eye tracking (oculometer)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Plateforme PRISME
• Investigators: Principal Investigator: CHARLES Perrine, MD PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 7, 2021
• Primary Completion (ACTUAL): June 7, 2022
• Study Completion (ACTUAL): June 7, 2022

Study Registration Dates

• First Submitted: March 14, 2019
• First Submitted That Met QC Criteria: March 14, 2019
• First Posted (ACTUAL): March 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 27, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Intellectual disability; Eye tracking; Attention evaluation criteria; Games on touchscreen
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurodevelopmental Disorders; Intellectual Disability
• Other Study ID Numbers: K180106J; 2018-A00686-49 (REGISTRY: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No