Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-26 @ 5:06 PM
Study NCT ID:
NCT04608032
Status:
RECRUITING
Last Update Posted:
2024-02-09
First Post:
2020-10-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neuropsychological Assessment of Remediation for Cognitive Impairments in Schizophrenia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012559', 'term': 'Schizophrenia'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C410006', 'term': 'Thor protein, Drosophila'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The first group is about cognitive remediation therapy (ECo-Sz). The second group is about recovery oriented therapy (ThOR).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-02-07', 'studyFirstSubmitDate': '2020-10-23', 'studyFirstSubmitQcDate': '2020-10-23', 'lastUpdatePostDateStruct': {'date': '2024-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'FAUX-PAS Test', 'timeFrame': 'First week', 'description': 'A test assessing first and second degree theory of mind through short stories and pictures involved two or three characters - minimum value = 0 - maximum value = 60'}, {'measure': 'FAUX-PAS Test', 'timeFrame': 'Ten week week', 'description': 'A test assessing first and second degree theory of mind through short stories and pictures involved two or three characters - minimum value = 0 - maximum value = 60'}, {'measure': 'FAUX-PAS Test', 'timeFrame': 'Eighteen week week', 'description': 'A test assessing first and second degree theory of mind through short stories and pictures involved two or three characters - minimum value = 0 - maximum value = 60'}, {'measure': 'FAUX-PAS Test', 'timeFrame': 'Twenty six week', 'description': 'A test assessing first and second degree theory of mind through short stories and pictures involved two or three characters - minimum value = 0 - maximum value = 60'}, {'measure': 'The Rey/Taylor complex figure test', 'timeFrame': 'First week', 'description': 'The test is a neuropsychological assessment in which examinees are asked to reproduce a complicated line drawing, first by ping it freehand and then drawing from memory. This test permits the evaluation of visuospatial abilities, memory, attention, planning and working memory - minimum value = 0 - maximum value = 36'}, {'measure': 'The Rey/Taylor complex figure test', 'timeFrame': 'Ten week', 'description': 'The test is a neuropsychological assessment in which examinees are asked to reproduce a complicated line drawing, first by ping it freehand and then drawing from memory. This test permits the evaluation of visuospatial abilities, memory, attention, planning and working memory - minimum value = 0 - maximum value = 36'}, {'measure': 'The Rey/Taylor complex figure test', 'timeFrame': 'Eighteen week', 'description': 'The test is a neuropsychological assessment in which examinees are asked to reproduce a complicated line drawing, first by ping it freehand and then drawing from memory. This test permits the evaluation of visuospatial abilities, memory, attention, planning and working memory - minimum value = 0 - maximum value = 36'}, {'measure': 'The Rey/Taylor complex figure test', 'timeFrame': 'Twenty six week', 'description': 'The test is a neuropsychological assessment in which examinees are asked to reproduce a complicated line drawing, first by ping it freehand and then drawing from memory. This test permits the evaluation of visuospatial abilities, memory, attention, planning and working memory - minimum value = 0 - maximum value = 36'}, {'measure': 'MEM IV Logical Memory', 'timeFrame': 'First week', 'description': 'Composite score of the Weschler Memory Scale - fourth edition'}, {'measure': 'MEM IV Logical Memory', 'timeFrame': 'Ten week', 'description': 'Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'MEM IV Logical Memory', 'timeFrame': 'Eighteen week', 'description': 'Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'MEM IV Logical Memory', 'timeFrame': 'Twenty six week', 'description': 'Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'MEM IV Symbol Memory', 'timeFrame': 'First week', 'description': 'Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'MEM IV Symbol Memory', 'timeFrame': 'Ten week', 'description': 'Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'MEM IV Symbol Memory', 'timeFrame': 'Eighteen week', 'description': 'Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'MEM IV Symbol Memory', 'timeFrame': 'Twenty six week', 'description': 'Composite score of the Weschler Memory Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'The Balloon Analogue Risk Task', 'timeFrame': 'First week', 'description': 'The Balloon Analogue Risk Task is a computerized measure of risk taking behavior - no minimum or maximum value'}, {'measure': 'The Balloon Analogue Risk Task', 'timeFrame': 'Ten week', 'description': 'The Balloon Analogue Risk Task is a computerized measure of risk taking behavior - no minimum or maximum value'}, {'measure': 'The Balloon Analogue Risk Task', 'timeFrame': 'Eighteen week', 'description': 'The Balloon Analogue Risk Task is a computerized measure of risk taking behavior - no minimum or maximum value'}, {'measure': 'The Balloon Analogue Risk Task', 'timeFrame': 'Twenty six week', 'description': 'The Balloon Analogue Risk Task is a computerized measure of risk taking behavior - no minimum or maximum value'}, {'measure': 'D2 Test', 'timeFrame': 'First week', 'description': 'The test is neuropsychological measure of selective and sustained attention and visual scanning speed - no minimum or maximum value'}, {'measure': 'D2 Test', 'timeFrame': 'Ten week', 'description': 'The test is neuropsychological measure of selective and sustained attention and visual scanning speed - no minimum or maximum value'}, {'measure': 'D2 Test', 'timeFrame': 'Eighteen week', 'description': 'The test is neuropsychological measure of selective and sustained attention and visual scanning speed - no minimum or maximum value'}, {'measure': 'D2 Test', 'timeFrame': 'Twenty six week', 'description': 'The test is neuropsychological measure of selective and sustained attention and visual scanning speed - no minimum or maximum value'}, {'measure': 'ToM-15', 'timeFrame': 'First week', 'description': 'The test is a task assessing theory of mind abilities you cannot move more than one disk at a time; a disk can only be placed on another disk larger than it or on an empty location - no minimum or maximum value'}, {'measure': 'ToM-15', 'timeFrame': 'Ten week', 'description': 'The test is a task assessing theory of mind abilities you cannot move more than one disk at a time; a disk can only be placed on another disk larger than it or on an empty location - no minimum or maximum value'}, {'measure': 'ToM-15', 'timeFrame': 'Eighteen week', 'description': 'The test is a task assessing theory of mind abilities you cannot move more than one disk at a time; a disk can only be placed on another disk larger than it or on an empty location - no minimum or maximum value'}, {'measure': 'ToM-15', 'timeFrame': 'Twenty six week', 'description': 'The test is a task assessing theory of mind abilities you cannot move more than one disk at a time; a disk can only be placed on another disk larger than it or on an empty location - no minimum or maximum value'}, {'measure': 'Cubes Subtest', 'timeFrame': 'First week', 'description': 'Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'Cubes Subtest', 'timeFrame': 'Ten week', 'description': 'Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'Cubes Subtest', 'timeFrame': 'Eighteen week', 'description': 'Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'Cubes Subtest', 'timeFrame': 'Twenty six week', 'description': 'Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'Visual Puzzle Subtest', 'timeFrame': 'First week', 'description': 'Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'Visual Puzzle Subtest', 'timeFrame': 'Ten week', 'description': 'Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'Visual Puzzle Subtest', 'timeFrame': 'Eighteen week', 'description': 'Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'Visual Puzzle Subtest', 'timeFrame': 'Twenty six week', 'description': 'Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'Similiraties Subtest', 'timeFrame': 'First week', 'description': 'Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'Similiraties Subtest', 'timeFrame': 'Ten week', 'description': 'Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'Similiraties Subtest', 'timeFrame': 'Eighteen week', 'description': 'Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'Similiraties Subtest', 'timeFrame': 'Twenty six week', 'description': 'Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'Working Memory Subtest', 'timeFrame': 'First week', 'description': 'Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'Working Memory Subtest', 'timeFrame': 'Ten week', 'description': 'Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'Working Memory Subtest', 'timeFrame': 'Eighteen week', 'description': 'Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20'}, {'measure': 'Working Memory Subtest', 'timeFrame': 'Twenty six week', 'description': 'Composite score of Weschler Adult Intelligence Scale - fourth edition - minimum value = 0 - maximum value = 20'}], 'primaryOutcomes': [{'measure': 'STROOP', 'timeFrame': 'pre-inclusion', 'description': 'Interference score'}, {'measure': 'TMTB', 'timeFrame': 'pre-inclusion', 'description': 'Trail Making Test'}, {'measure': 'Litteral score of Verbal fluences', 'timeFrame': 'pre-inclusion', 'description': 'Litteral score of Verbal fluences'}, {'measure': 'GO/NOGO', 'timeFrame': 'pre-inclusion', 'description': 'cognitive control score'}, {'measure': 'tower of Hanoi', 'timeFrame': 'pre-inclusion', 'description': 'Tower planning total score from tower of Hanoi'}, {'measure': 'Matrix test (WAIS-IV)', 'timeFrame': 'pre-inclusion', 'description': 'The perceptual reasoning score of the Matrix test.'}], 'secondaryOutcomes': [{'measure': 'Mini-500', 'timeFrame': 'pre-inclusion', 'description': '(Entretien structuré Neuropsychiatrique International'}, {'measure': 'CTQ', 'timeFrame': 'pre-inclusion', 'description': 'Childhood Trauma Questionnaire - minimum value = 28 - maximum value = 112'}, {'measure': 'PANSS', 'timeFrame': 'pre-inclusion', 'description': 'Positive and Negative Syndrome Scale - minimum value = 30 - maximum value = 210'}, {'measure': 'EESEP', 'timeFrame': 'Eighteen week', 'description': 'Self-Efficacity Rating Scale - minimum value = 21 - maximum value = 105'}, {'measure': 'EESEP', 'timeFrame': 'Twenty six week', 'description': 'Self-Efficacity Rating Scale - minimum value = 21 - maximum value = 105'}, {'measure': 'ERF', 'timeFrame': 'First week', 'description': 'Functional Impact Scale - minimum value = 5 - maximum value = 35'}, {'measure': 'ERF', 'timeFrame': 'Ten week', 'description': 'Functional Impact Scale - minimum value = 5 - maximum value = 35'}, {'measure': 'ERF', 'timeFrame': 'Eighteen week', 'description': 'Functional Impact Scale - minimum value = 5 - maximum value = 35'}, {'measure': 'ERF', 'timeFrame': 'Twenty six week', 'description': 'Functional Impact Scale - minimum value = 5 - maximum value = 35'}, {'measure': 'ERF-CS', 'timeFrame': 'First week', 'description': 'Functional Impact Scale for Social Cognition disorders- minimum value = 4 - maximum value = 20'}, {'measure': 'ERF-CS', 'timeFrame': 'Ten week', 'description': 'Functional Impact Scale for Social Cognition disorders- minimum value = 4 - maximum value = 20'}, {'measure': 'ERF-CS', 'timeFrame': 'Eighteen week', 'description': 'Functional Impact Scale for Social Cognition disorders- minimum value = 4 - maximum value = 20'}, {'measure': 'ERF-CS', 'timeFrame': 'Twenty six week', 'description': 'Functional Impact Scale for Social Cognition disorders- minimum value = 4 - maximum value = 20'}, {'measure': 'MCQ-30', 'timeFrame': 'First week', 'description': 'Short French Meta-Cognitions Questionnaire - minimum value = 30 - maximum value = 120'}, {'measure': 'MCQ-30', 'timeFrame': 'Ten week', 'description': 'Short French Meta-Cognitions Questionnaire - minimum value = 30 - maximum value = 120'}, {'measure': 'MCQ-30', 'timeFrame': 'Eighteen week', 'description': 'Short French Meta-Cognitions Questionnaire - minimum value = 30 - maximum value = 120'}, {'measure': 'MCQ-30', 'timeFrame': 'Twenty six week', 'description': 'Short French Meta-Cognitions Questionnaire - minimum value = 30 - maximum value = 120'}, {'measure': 'QFS', 'timeFrame': 'First week', 'description': 'Social Functioning Questionnaire - no minimum or maximum value'}, {'measure': 'QFS', 'timeFrame': 'Ten week', 'description': 'Social Functioning Questionnaire - no minimum or maximum value'}, {'measure': 'QFS', 'timeFrame': 'Eighteen week', 'description': 'Social Functioning Questionnaire - no minimum or maximum value'}, {'measure': 'QFS', 'timeFrame': 'Twenty six week', 'description': 'Social Functioning Questionnaire - no minimum or maximum value'}, {'measure': 'SAIQ', 'timeFrame': 'First week', 'description': 'Self-Appraisal of Illness Questionnaire - minimum value = 17- maximum value = 68'}, {'measure': 'SAIQ', 'timeFrame': 'Ten week', 'description': 'Self-Appraisal of Illness Questionnaire - minimum value = 17- maximum value = 68'}, {'measure': 'SAIQ', 'timeFrame': 'Eighteen week', 'description': 'Self-Appraisal of Illness Questionnaire - minimum value = 17- maximum value = 68'}, {'measure': 'SAIQ', 'timeFrame': 'Twenty six week', 'description': 'Self-Appraisal of Illness Questionnaire - minimum value = 17- maximum value = 68'}, {'measure': 'SCS', 'timeFrame': 'First week', 'description': 'Revised Self-Consciousness Scale - minimum value = 0 - maximum value = 66'}, {'measure': 'SCS', 'timeFrame': 'Ten week', 'description': 'Revised Self-Consciousness Scale- minimum value = 0 - maximum value = 66'}, {'measure': 'SCS', 'timeFrame': 'Eighteen week', 'description': 'Revised Self-Consciousness Scale - minimum value = 0 - maximum value = 66'}, {'measure': 'SCS', 'timeFrame': 'Twenty six week', 'description': 'Revised Self-Consciousness Scale - minimum value = 0 - maximum value = 66'}, {'measure': 'SDS', 'timeFrame': 'First week', 'description': 'Social Desirability Scale - minimum value = 0 - maximum value = 33'}, {'measure': 'SDS', 'timeFrame': 'Ten week', 'description': 'Social Desirability Scale - minimum value = 0 - maximum value = 33'}, {'measure': 'SDS', 'timeFrame': 'Eighteen week', 'description': 'Social Desirability Scale - minimum value = 0 - maximum value = 33'}, {'measure': 'SDS', 'timeFrame': 'Twenty six week', 'description': 'Social Desirability Scale - minimum value = 0 - maximum value = 33'}, {'measure': 'STORI', 'timeFrame': 'First week', 'description': 'Stage of Recovery Instrument - minimum value = 0 - maximum value = 50'}, {'measure': 'STORI', 'timeFrame': 'Ten week', 'description': 'Stage of Recovery Instrument - minimum value = 0 - maximum value = 50'}, {'measure': 'STORI', 'timeFrame': 'Eighteen week', 'description': 'Stage of Recovery Instrument - minimum value = 0 - maximum value = 50'}, {'measure': 'STORI', 'timeFrame': 'Twenty six week', 'description': 'Stage of Recovery Instrument - minimum value = 0 - maximum value = 50'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Schizophrenia', 'Neurocognition', 'Social cognition', 'Metacognition', 'Cognitive remediation'], 'conditions': ['Schizophrenic Disorders']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effect of a cognitive remediation program on neurocognitive, social cognitive and metacognitive functions designed for patients living with a schizophrenia spectrum disorder.', 'detailedDescription': 'Evaluation of the specific therapeutic efficacy of the ecological cognitive remediation program for schizophrenia spectrum disorder \\[ECo-Sz\\] on neurocognitive deficits, social cognition deficits and metacognition deficits of patients with a schizophrenia spectrum disorder.\n\nIn this double-blind (patients, outcomes assessors) controlled randomized trial the investigators compare patients receiving Ecological Cognitive training program for schizophrenia spectrum disorder \\[ECo-Sz\\] to patients benefiting from recovery-oriented therapy \\[ThOR\\]. Patients are treated for two months and monitored for four months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Schizophrenia Disorder diagnosis, according to Diagnostic and Statistical Manual of mental disorders - Fifth edition (DSM-V) - Patient stabilized in terms of positive and negative symptomatology (absence or presence of weak positive and negative symptoms)\n* Positive and Negative stable symptoms (no or few positive and negative symptoms)\n* Stable and effective minimum dose of medication (antipsychotic) for the last three months\n* Cognitive complaint expressed by the patient\n* Informed consent form read, initialed and signed\n* Understanding of spoken and read French\n* Patient registered on the social welfare system\n\nExclusion Criteria:\n\n* Other diagnosis at the forefront than Schizophrenia of the DSM-V\n* Medical history neurological disorder resulting in hospitalization\n* Acute episode in the last three month\n* Somatic disorders resulting in cognitive impairment\n* Engagement in a research protocol either currently or over the last month\n* Neuropsychological assessment evaluation during the last six month\n* Patients under the protection of a conservator (simple or reinforced)\n* Individuals in vulnerable circumstances'}, 'identificationModule': {'nctId': 'NCT04608032', 'acronym': 'NARCIS', 'briefTitle': 'Neuropsychological Assessment of Remediation for Cognitive Impairments in Schizophrenia', 'organization': {'class': 'OTHER', 'fullName': 'Centre hospitalier de Ville-Evrard, France'}, 'officialTitle': 'Neuropsychological Assessment of Remediation for Cognitive Impairments in Schizophrenia', 'orgStudyIdInfo': {'id': '10477M-NARCIS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ecological Cognitive training program for schizophrenia spectrum disorder [ECo-Sz]', 'description': 'To inform the patient about cognitive impairments and their repercussions ; to train the patient in problem-solving skills through exercices ; to implement strategies in daily life. Duration : two month. Frequency : Two one hour individual sessions and one hour of at-home training per week. Modalities : pen and papers exercices (tools, token, cards, maps and chessboard). Modules : Psychoeducation, Attention, Memory, Executive functions, Social cognition and metacognition, Functional impairments', 'interventionNames': ['Other: [Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder']}, {'type': 'ACTIVE_COMPARATOR', 'label': '[THoR] Recovery-Oriented Therapy', 'description': "Individual psychotherapy sessions focussing on autonomy in daily life, management of mood disorders' and functional impact, social skills, motivation and the regulation of sleep and daily activities", 'interventionNames': ['Other: Recovery-Oriented Therapy']}], 'interventions': [{'name': '[Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder', 'type': 'OTHER', 'otherNames': ['[Eco-Sz]'], 'description': 'The first group will have \\[Eco-Sz\\] Ecological Cognitive training program for schizophrenia spectrum disorder', 'armGroupLabels': ['Ecological Cognitive training program for schizophrenia spectrum disorder [ECo-Sz]']}, {'name': 'Recovery-Oriented Therapy', 'type': 'OTHER', 'otherNames': ['[THoR]'], 'description': 'The second group will have \\[THoR\\] Recovery-Oriented Therapy', 'armGroupLabels': ['[THoR] Recovery-Oriented Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93330', 'city': 'Neuilly-sur-Marne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Clémence Isaac, MSC', 'role': 'CONTACT', 'email': 'clm.isaac@gmail.com', 'phone': '0143093232'}, {'name': 'Clémence ISAAC, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ch Ville Evrard', 'geoPoint': {'lat': 48.85373, 'lon': 2.54903}}, {'zip': '93330', 'city': 'Neuilly-sur-Marne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Clémence ISAAC, PHD', 'role': 'CONTACT', 'email': 'clm.isaac@gmail.com', 'phone': '0143093232'}, {'name': 'Youcef BENCHERIF, CRA', 'role': 'CONTACT', 'email': 'y.bencherif@epsve.fr', 'phone': '0143093232'}, {'name': 'Clémence ISAAC, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alex MOTUT, MSC', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'URC Ville Evrard', 'geoPoint': {'lat': 48.85373, 'lon': 2.54903}}], 'centralContacts': [{'name': 'Dominique JANUEL, MBBS', 'role': 'CONTACT', 'email': 'd.januel@epsve.fr', 'phone': '0143093232'}], 'overallOfficials': [{'name': 'Clémence ISAAC, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'URC EPS Ville Evrard'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre hospitalier de Ville-Evrard, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Clémence ISAAC', 'investigatorAffiliation': 'Centre hospitalier de Ville-Evrard, France'}}}}