Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-02-25 @ 4:59 PM
Study NCT ID:
NCT04179435
Status:
UNKNOWN
Last Update Posted:
2019-11-27
First Post:
2019-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive and Brain Development in Adolescents With Gilles de la Tourette Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Between group comparison'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 132}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2019-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-11-25', 'studyFirstSubmitDate': '2019-11-20', 'studyFirstSubmitQcDate': '2019-11-25', 'lastUpdatePostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Behavioral test main outcome measures [1]', 'timeFrame': 'from 16 to 20 months', 'description': 'reaction times'}, {'measure': 'Behavioral test main outcome measures [2]', 'timeFrame': 'from 16 to 20 months', 'description': 'discounting factor'}, {'measure': 'Behavioral test main outcome measures [3]', 'timeFrame': 'from 16 to 20 months', 'description': 'number of premature responses'}, {'measure': 'Behavioral test main outcome measures [4]', 'timeFrame': 'from 16 to 20 months', 'description': 'agency composite scores'}, {'measure': 'Brain MRI scan measures', 'timeFrame': 'from 16 to 20 months', 'description': 'whole brain structural connectivity, whole brain functional connectivity, brain cortical and subcortical structures volumes and morphology'}, {'measure': 'Transcranial magnetic stimulation', 'timeFrame': 'from 16 to 20 months', 'description': 'intracortical inhibition (SICI) scores'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tourette Syndrome in Adolescence']}, 'referencesModule': {'references': [{'pmid': '36460852', 'type': 'DERIVED', 'citation': "Atkinson-Clement C, Duflot M, Lastennet E, Patsalides L, Wasserman E, Sartoris TM, Tarrano C, Rosso C, Burbaud P, Deniau E, Czernecki V, Roze E, Hartmann A, Worbe Y. How does Tourette syndrome impact adolescents' daily living? A text mining study. Eur Child Adolesc Psychiatry. 2023 Dec;32(12):2623-2635. doi: 10.1007/s00787-022-02116-1. Epub 2022 Dec 2."}]}, 'descriptionModule': {'briefSummary': 'In children with neurodevelopmental disorders, adolescence is usually associated with a reshaping of the clinical picture and symptomatology. Tourette syndrome (TS) is a paradigmal neurodevelopmental syndrome characterised by involuntary paroxysmal movements (motor tics) and vocalisation (vocal tics) often associated with various psychiatric disorders. The neuronal and cognitive mechanisms associated with TS symptoms improvement during adolescence, or the persistence in adulthood remains unknown, and this is what we aim to address in this study.', 'detailedDescription': 'Thus, the aims of the present project is threefold:\n\nAim 1: To evaluate the maturation of cognitive functions in adolescents with TS compared to typically developing adolescents.\n\nTo achieve this aim, three distinct cognitive dimensions will be assessed in all subjects (patients and controls): (i) reward sensitivity and habit formation; (ii) cognitive impulsivity and action control and (iii) self-agency.\n\nAim 2: To identify neuronal correlates of cognitive function and brain development in health and disease. To achieve this aim, we will use a combined behavioural (as described in Aim 1), (i) neuroimaging and (ii) TMS approaches.\n\nAim 3: To predict clinical outcome . In this part of the project we aim to identify behavioural, imaging or neurophysiological markers of clinical outcome in patients with TS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Tourette syndrome\n* Ages 13 - 18\n* Acceptance to perform the Brain MRI\n* Acceptance to perform the cognitive testing\n* Acceptance to perform the TMS measures\n\nExclusion Criteria:\n\n* Learning disability\n* Incompatibility with MRI procedure (metal body implants, pregnancy)'}, 'identificationModule': {'nctId': 'NCT04179435', 'acronym': 'CADETS', 'briefTitle': 'Cognitive and Brain Development in Adolescents With Gilles de la Tourette Syndrome', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Institut National de la Santé Et de la Recherche Médicale, France'}, 'officialTitle': "Développement Cognitif et cérébral Chez Les Adolescents Souffrants d'un Syndrome de Gilles de la Tourette", 'orgStudyIdInfo': {'id': 'C19-11'}, 'secondaryIdInfos': [{'id': '2019-A00992-55', 'type': 'REGISTRY', 'domain': 'CADETS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Tourette syndrome', 'description': 'Patients with Tourette syndrome aged 13 - 18 y.o. Interventions : Brain scans, cognitive testing, TMS measures', 'interventionNames': ['Behavioral: Behavioral testing on cognitive computerized tasks', 'Other: brain MRI', 'Other: TMS']}, {'type': 'OTHER', 'label': 'Controls', 'description': 'Controls matched to Tourette syndrome group nterventions : Brain scans, cognitive testing, TMS measures', 'interventionNames': ['Behavioral: Behavioral testing on cognitive computerized tasks', 'Other: brain MRI', 'Other: TMS']}], 'interventions': [{'name': 'Behavioral testing on cognitive computerized tasks', 'type': 'BEHAVIORAL', 'description': 'Testing on cognitive computerized tasks', 'armGroupLabels': ['Controls', 'Tourette syndrome']}, {'name': 'brain MRI', 'type': 'OTHER', 'description': 'Brain MRI scans', 'armGroupLabels': ['Controls', 'Tourette syndrome']}, {'name': 'TMS', 'type': 'OTHER', 'description': 'Measure of the cortical inhibitory capacity using TMS measures', 'armGroupLabels': ['Controls', 'Tourette syndrome']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Worbe Yulia, MD, PhD', 'role': 'CONTACT', 'email': 'Yulia.worbe@aphp.fr', 'phone': '+ 33 1 57 43 55'}], 'overallOfficials': [{'name': 'Worbe Yulia, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institut National de la Santé Et de la Recherche Médicale, France'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}