Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT03878251
Status:
COMPLETED
Last Update Posted:
2022-06-28
First Post:
2019-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Outcomes Measures in Intellectual Disability
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008607', 'term': 'Intellectual Disability'}], 'ancestors': [{'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-27', 'studyFirstSubmitDate': '2019-03-14', 'studyFirstSubmitQcDate': '2019-03-14', 'lastUpdatePostDateStruct': {'date': '2022-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation between number of successful attempts and intellectual disability evaluated by Intelligence quotient (IQ) or age of development', 'timeFrame': 'up to 3 months', 'description': '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'}], 'secondaryOutcomes': [{'measure': 'Maximal reached level for each test', 'timeFrame': 'up to 3 months'}, {'measure': 'Number of errors during the test', 'timeFrame': 'up to 3 months'}, {'measure': 'Time to reach each level of the test', 'timeFrame': 'up to 3 months'}, {'measure': 'Time to reach maximum level of the test', 'timeFrame': 'up to 3 months'}, {'measure': 'Total test duration', 'timeFrame': 'up to 3 months'}, {'measure': 'Fixing time for eye tracking', 'timeFrame': 'up to 3 months'}, {'measure': 'Successful test numbers in each level', 'timeFrame': 'up to 3 months'}, {'measure': 'Correlation with Intelligence quotient (IQ) or age of development according to intellectual disability severity', 'timeFrame': 'up to 3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Intellectual disability', 'Attention evaluation criteria', 'Games on touchscreen', 'Eye tracking'], 'conditions': ['Attention Deficit in Intellectual Disability']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients of both sex, with intellectual disability\n2. Minor patients 6 years old or more (age corresponding to the end of regression period observed in Rett patients) or major protected patients\n3. 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\n4. Affiliation to a social security system own or affiliated (excluding AME)\n5. Presence of parents or legal representative\n6. Informed consent signed by parents or legal representative\n\nExclusion Criteria:\n\n1. Behavioral disorders not compatible with interactive tool (major agitation, straight and self aggressiveness)\n2. Uncontrolled seizure disorder despite treatment'}, 'identificationModule': {'nctId': 'NCT03878251', 'acronym': 'EVALDI', 'briefTitle': 'Outcomes Measures in Intellectual Disability', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': 'Development and Validation of Quantitative Attention Evaluation Criteria in Patients With Intellectual Disability', 'orgStudyIdInfo': {'id': 'K180106J'}, 'secondaryIdInfos': [{'id': '2018-A00686-49', 'type': 'REGISTRY', 'domain': 'IDRCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'X fragile syndrome patients', 'interventionNames': ['Device: Quantitative attention evaluation criteria in intellectual disability']}, {'type': 'OTHER', 'label': 'Angelman syndrome patients', 'interventionNames': ['Device: Quantitative attention evaluation criteria in intellectual disability']}, {'type': 'OTHER', 'label': 'Rett syndrome patients', 'interventionNames': ['Device: Quantitative attention evaluation criteria in intellectual disability']}, {'type': 'OTHER', 'label': 'Patients with other genetic rare syndromes with intellectual d', 'interventionNames': ['Device: Quantitative attention evaluation criteria in intellectual disability']}], 'interventions': [{'name': 'Quantitative attention evaluation criteria in intellectual disability', 'type': 'DEVICE', 'description': 'Quantitative interactive attention evaluation tests by using games on touchscreen and or eye tracking (oculometer)', 'armGroupLabels': ['Angelman syndrome patients', 'Patients with other genetic rare syndromes with intellectual d', 'Rett syndrome patients', 'X fragile syndrome patients']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Paris', 'country': 'France', 'facility': 'Hôpital La Pitié-Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'CHARLES Perrine, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': 'Plateforme PRISME', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}