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OpenTrials
Completed

NCT Number: NCT03878251

Outcomes Measures in 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.

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Key information

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital La Pitié-Salpêtrière

Paris, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Quantitative attention evaluation criteria in intellectual disability

Device

Quantitative interactive attention evaluation tests by using games on touchscreen and or eye tracking (oculometer)

Primary outcomes

  1. 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 outcomes

  1. Maximal reached level for each test

    Time frame: up to 3 months

  2. Number of errors during the test

    Time frame: up to 3 months

  3. Time to reach each level of the test

    Time frame: up to 3 months

  4. Time to reach maximum level of the test

    Time frame: up to 3 months

  5. Total test duration

    Time frame: up to 3 months

  6. Fixing time for eye tracking

    Time frame: up to 3 months

  7. Successful test numbers in each level

    Time frame: up to 3 months

  8. Correlation with Intelligence quotient (IQ) or age of development according to intellectual disability severity

    Time frame: up to 3 months

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Plateforme PRISME

Registry information

Official study title

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

Acronym: EVALDI

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 18, 2019
Registry last updated
Jun 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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