Outcomes Measures in Intellectual Disability

NCT ID: NCT03878251

Last Updated: 2022-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-07

Study Completion Date

2022-06-07

Brief Summary

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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

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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.

Conditions

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Attention Deficit in Intellectual Disability

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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X fragile syndrome patients

Group Type OTHER

Quantitative attention evaluation criteria in intellectual disability

Intervention Type DEVICE

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

Angelman syndrome patients

Group Type OTHER

Quantitative attention evaluation criteria in intellectual disability

Intervention Type DEVICE

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

Rett syndrome patients

Group Type OTHER

Quantitative attention evaluation criteria in intellectual disability

Intervention Type DEVICE

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

Patients with other genetic rare syndromes with intellectual d

Group Type OTHER

Quantitative attention evaluation criteria in intellectual disability

Intervention Type DEVICE

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

Interventions

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Quantitative attention evaluation criteria in intellectual disability

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Plateforme PRISME

UNKNOWN

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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CHARLES Perrine, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Hôpital La Pitié-Salpêtrière

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2018-A00686-49

Identifier Type: REGISTRY

Identifier Source: secondary_id

K180106J

Identifier Type: -

Identifier Source: org_study_id

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