Ignite Creation Date:
2025-12-25 @ 1:25 AM
Ignite Modification Date:
2025-12-28 @ 1:36 AM
Study NCT ID:
NCT05742893
Status:
COMPLETED
Last Update Posted:
2024-04-11
First Post:
2023-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of a Speech-Language Assessment Tool for Pragmatic and Discourse Skills in Schizophrenia Spectrum Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-02-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-10', 'studyFirstSubmitDate': '2023-02-02', 'studyFirstSubmitQcDate': '2023-02-14', 'lastUpdatePostDateStruct': {'date': '2024-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assess of pragmatic skills', 'timeFrame': 'day 0', 'description': 'The patients is evaluated by means of a semi-directed interview'}, {'measure': 'assess discourse skills', 'timeFrame': 'day 0', 'description': 'he patient is evaluated through two image description tasks'}, {'measure': 'assess narrative skills', 'timeFrame': 'day 0', 'description': 'the patients is evaluated through the oral restitution of two heard texts.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psychotic Disorders']}, 'descriptionModule': {'briefSummary': 'The scientific literature has largely objectified language disorders in schizophrenia. And more precisely, the impairment of pragmatic and discursive language skills. Currently, there is no standardized language assessment tool specific to these patients. The aim of this study is to compare the effectiveness of a newly developed speech-language assessment tool for pragmatic and discourse skills for patients suffering from schizophrenia .', 'detailedDescription': "The scientific literature has largely objectified language disorders in schizophrenia. And more precisely, the impairment of pragmatic and discursive language skills. Currently, there is no standardized language assessment tool specific to these patients. The aim of this study is to compare the effectiveness of a newly developed speech-language assessment tool for pragmatic and discourse skills for patients suffering from schizophrenia.\n\nTo do so, patients will have to pass six tests: three tests of the new tool and three corresponding gold standard tests. The first two tests will assess pragmatic skills by means of a semi-directed interview. The next two tests will assess discourse skills through two image description tasks. Finally, the last two tests will evaluate narrative skills through the oral restitution of two heard texts.\n\nThe main objective is to compare the performance of schizophrenic patients detected in the pathological zone with the scales of the new tool versus the gold standard scales.\n\nThe secondary objective is to determine which skills are most affected by comparing patients' scores in pragmatic skills versus those in discourse skills.\n\nThis tool would allow to precisely objectify language disorders and to optimize the multidisciplinary diagnosis and care of patients suffering from schizophrenia."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female between the ages of 18 and 60\n* Patient with a diagnosis of schizophrenic spectrum disorder and other psychotic disorders meeting DSM V criteria\n* Patient who has been clinically and treatment stable for at least three months\n* Patient who can read and write French\n* Patient who is a beneficiary of a social security plan or similar\n* Patient with ability to sign free and informed consent\n\nExclusion Criteria:\n\n* \\- Patient hospitalized under restraint\n* Patient under guardianship\n* Patient who has stopped taking his or her treatment\n* Patient who had a change in treatment in the period of less than three months prior to the pass\n* Patient with a worsening of the disease in the three months prior to the inclusion visit'}, 'identificationModule': {'nctId': 'NCT05742893', 'acronym': 'VEOS', 'briefTitle': 'Comparison of a Speech-Language Assessment Tool for Pragmatic and Discourse Skills in Schizophrenia Spectrum Disorders', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Comparison of a Speech-Language Pathology Assessment Tool for Pragmatic and Discourse Skills for Patients With Schizophrenic Spectrum Disorders and Other Psychotic Disorders', 'orgStudyIdInfo': {'id': '22-AOI-04'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'diagnostic', 'description': 'all patients have the study test', 'interventionNames': ['Diagnostic Test: Measurement of pragmatic and discourse test scores in the two scales.']}], 'interventions': [{'name': 'Measurement of pragmatic and discourse test scores in the two scales.', 'type': 'DIAGNOSTIC_TEST', 'description': 'The aim of this study is to compare the effectiveness of a newly developed speech-language assessment tool for pragmatic and discourse skills for patients suffering from schizophrenia .', 'armGroupLabels': ['diagnostic']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06003', 'city': 'Nice', 'country': 'France', 'facility': 'Chu de Nice', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Benoit Michel', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Hospitalier Universitaire de Nice'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}