Outcomes Measures in Intellectual Disability

Overview

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.

Full Title of Study: “Development and Validation of Quantitative Attention Evaluation Criteria in Patients With Intellectual Disability”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 7, 2022

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.

Interventions

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

Arms, Groups and Cohorts

  • Other: X fragile syndrome patients
  • Other: Angelman syndrome patients
  • Other: Rett syndrome patients
  • Other: Patients with other genetic rare syndromes with intellectual d

Clinical Trial Outcome Measures

Primary Measures

  • Correlation between number of successful attempts and intellectual disability evaluated by Intelligence quotient (IQ) or age of development
    • Time Frame: 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 Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 6 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Assistance Publique – Hôpitaux de Paris
  • Collaborator
    • Plateforme PRISME
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • CHARLES Perrine, MD PhD, Principal Investigator, Assistance Publique – Hôpitaux de Paris

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