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CompletedNCT03878251EVALDIUpdated Jun 28, 2022

Outcomes Measures in Intellectual Disability

An interventional study of Quantitative attention evaluation criteria in intellectual disability in Attention Deficit in Intellectual Disability, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2022-06-28.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
6 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Attention Deficit in Intellectual Disability

Keywords

  • Intellectual disability
  • Attention evaluation criteria
  • Games on touchscreen
  • Eye tracking
03

In context

Intellectual Disability

363 studies on the registry are indexed under Intellectual Disability; 103 are open to participants now.

This study's enrollment of 40 is below the median of 53 across 236 interventional studies indexed under Intellectual Disability.

Browse Intellectual Disability studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
6 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. Behavioral disorders not compatible with interactive tool (major agitation, straight and self aggressiveness)
  2. Uncontrolled seizure disorder despite treatment
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Other
    X fragile syndrome patients

    Device: Quantitative attention evaluation criteria in intellectual disability

  • Other
    Angelman syndrome patients

    Device: Quantitative attention evaluation criteria in intellectual disability

  • Other
    Rett syndrome patients

    Device: Quantitative attention evaluation criteria in intellectual disability

  • Other
    Patients with other genetic rare syndromes with intellectual d

    Device: Quantitative attention evaluation criteria in intellectual disability

Interventions

  • DeviceQuantitative attention evaluation criteria in intellectual disability

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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: up to 3 months

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

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Study locations

1 site
  • Hôpital La Pitié-Salpêtrière
    Paris, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03878251
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Plateforme PRISME
Responsible party
Sponsor
First posted
Mar 18, 2019
Start date
Jul 7, 2021
Primary completion
Jun 7, 2022
Completion
Jun 7, 2022
Last update
Jun 28, 2022

Study contacts

CHARLES Perrine, MD PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

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