Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:10 AM
Study NCT ID:
NCT07285720
Status:
RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-11-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Phonological Constraints on Language Development in Individuals With Williams Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018980', 'term': 'Williams Syndrome'}, {'id': 'D007802', 'term': 'Language'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D021921', 'term': 'Aortic Stenosis, Supravalvular'}, {'id': 'D001024', 'term': 'Aortic Valve Stenosis'}, {'id': 'D000082862', 'term': 'Aortic Valve Disease'}, {'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-11-17', 'studyFirstSubmitQcDate': '2025-12-02', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'questionnaire score of patients with WS caracterisation', 'timeFrame': '2 years', 'description': 'questionnaire score for cognitive profile of patients with WS caracterisation'}], 'secondaryOutcomes': [{'measure': 'Impact of hyperacusis on questionnaire score', 'timeFrame': '2 years', 'description': 'Impact of hyperacusis on questionnaire score'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Williams syndrome', 'Language', 'Phonological Short-Term Memory', 'EEG-NIRS'], 'conditions': ['Williams Syndrome', 'Language', 'Phonological Short-Term Memory', 'EEG-NIRS']}, 'descriptionModule': {'briefSummary': 'Williams syndrome (WS) is a neurodevelopmental disease characterized by mild to moderate intellectual disability and an extremely heterogeneous cognitive profile. Research has outlined two main features of WS: an atypical social behavior associated with surprising language abilities, and a hyperacusis. The purpose of this project is to investigate the relationships between both these abilities, and particularly the role of the hyperacusis on language abilities. The hyperacusis would be crucial in developing language skills: the apparent strength in the verbal domain could rely on Phonological Short Term Memory (PSTM) more in individuals with WS than in typically developing individuals. In addition, the investigators will compare individuals with WS to individuals with Down syndrome (DS): DS is often associated to strong limitations in the PSTM with poor language abilities. To this end, the investigators will use a highly innovative approach including physiological assessments (EEG-NIRS protocol) and questionnaires. The performance of people with WS will be compared to those of participants with DS and TD participants of same DA and cognitive assessments.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For SW and SD: genetic diagnosis and aged between 6- and 17 years old.\n* For typical participants: any child, adolescent or young adult of the same developmental or chronological age (between 6 and 17 years of age)\n* adult group (between 20 and 60 years).\n\nExclusion Criteria:\n\n* Autistic Associated Disorders,\n* West syndrome'}, 'identificationModule': {'nctId': 'NCT07285720', 'acronym': 'SOUNDS', 'briefTitle': 'Phonological Constraints on Language Development in Individuals With Williams Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Phonological Constraints on Language Development in Individuals With Williams Syndrome', 'orgStudyIdInfo': {'id': 'PI2022_843_0021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with Williams syndrome', 'interventionNames': ['Other: EEG-NIRS protocol', 'Other: Questionnaire']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Patients with Down syndrome', 'interventionNames': ['Other: EEG-NIRS protocol', 'Other: Questionnaire']}, {'type': 'SHAM_COMPARATOR', 'label': 'Healthy children', 'interventionNames': ['Other: EEG-NIRS protocol', 'Other: Questionnaire']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy adults', 'interventionNames': ['Other: EEG-NIRS protocol', 'Other: Questionnaire']}], 'interventions': [{'name': 'EEG-NIRS protocol', 'type': 'OTHER', 'description': "Each participant will be tested individually in a quiet room at the GRAMFC (Groupe de Recherches sur l'Analyse Multimodale de la Fonction Cérébrale, INSERM-UMR1105, Université Picardie Jules Verne and CHU Amiens-Picardie). Duration of subject's participation in the study is 120 minutes", 'armGroupLabels': ['Healthy adults', 'Healthy children', 'Patients with Down syndrome', 'Patients with Williams syndrome']}, {'name': 'Questionnaire', 'type': 'OTHER', 'description': "Each participant will be tested individually in a quiet room at the GRAMFC (Groupe de Recherches sur l'Analyse Multimodale de la Fonction Cérébrale, INSERM-UMR1105, Université Picardie Jules Verne and CHU Amiens-Picardie). Duration of subject's participation in the study is 120 minutes", 'armGroupLabels': ['Healthy adults', 'Healthy children', 'Patients with Down syndrome', 'Patients with Williams syndrome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabrice WALLOIS, MD, PhD', 'role': 'CONTACT', 'email': 'wallois.fabrice@chu-amiens.fr', 'phone': '03 22 08 77 77'}], 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Fabrice Wallois, Pr', 'role': 'CONTACT', 'email': 'fabrice.wallois@u-picardie.fr', 'phone': '33+3 22 08 77 75'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}