Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2025-12-29 @ 12:10 AM
Study NCT ID:
NCT05285059
Status:
RECRUITING
Last Update Posted:
2023-03-27
First Post:
2022-03-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implicit Learning in Epileptic Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2026-03-21', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-23', 'studyFirstSubmitDate': '2022-03-07', 'studyFirstSubmitQcDate': '2022-03-16', 'lastUpdatePostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Response time', 'timeFrame': 'The day of the inclusion', 'description': 'Response time (in milliseconds) recorded during the ASRT task'}, {'measure': 'Response accuracy recorded during the ASRT task', 'timeFrame': 'The day of the inclusion', 'description': 'Response accuracy (percentage of correct answers)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epilepsy,', 'children,', 'implicit learning'], 'conditions': ['Epilepsy']}, 'descriptionModule': {'briefSummary': 'Epileptic children suffer from impairments in various learning and memory tasks. Yet, no study investigated implicit learning in epileptic children. Implicit learning is not only underlying motor skills acquisition, but also social and cognitive ones. Because acquisition of new skills is optimal during childhood, the study of implicit learning mechanism in children is of major importance. The present study will be the first to explore implicit learning mechanisms in children with epilepsy. Implicit learning mechanisms can be preserved or altered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '8 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study focuses on children with epilepsy.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* For Patient group only: Children with epilepsy\n* For Control group only: Children without neurological, psychiatric or developmental impairments\n* For both groups: Parent or tutors agreement\n* For both groups: Affiliated to French social security\n\nExclusion Criteria:\n\n* Neurological impairments unrelated to epilepsy\n* Psychiatric impairments unrelated to epilepsy\n* Developmental impairments unrelated to epilepsy'}, 'identificationModule': {'nctId': 'NCT05285059', 'acronym': 'IMPLICIT', 'briefTitle': 'Implicit Learning in Epileptic Children', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Implicit Learning in Epileptic Children', 'orgStudyIdInfo': {'id': '69HCL21_1190'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients', 'description': '8- to 14-years-old children with epilepsy', 'interventionNames': ['Behavioral: ASRT task']}, {'label': 'Control', 'description': '8- to 14-years-old children without neurological, psychiatric, or developmental impairments', 'interventionNames': ['Behavioral: ASRT task']}], 'interventions': [{'name': 'ASRT task', 'type': 'BEHAVIORAL', 'description': 'The ASRT (Alternating Serial Reaction Time) task is a computerized behavioral task measuring implicit learning. This task consists of 20 series of trials lasting 2 minutes each.\n\nIn each trial, a stimulus is displayed on the screen in one of the four possible predefined locations. The participant must press a button to indicate the position of the stimulus on the screen. Response content and response time are recorded.\n\nAt the end of every trial, the participant can take a break and resume the task whenever ready. The task lasts about 45 to 50 minutes.', 'armGroupLabels': ['Control', 'Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69675', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marcastel Agathe, PhD', 'role': 'CONTACT', 'email': 'Agathe.marcastel@chu-lyon.fr', 'phone': '+33 4 27 85 60 40'}], 'facility': 'Agathe Marcastel, PhD', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '69675', 'city': 'Bron', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Nemeth Dezso, Pr', 'role': 'CONTACT', 'email': 'dezso.nemeth@univ-lyon1.fr', 'phone': '+33 4 81 10 66 04'}], 'facility': 'Dezso Nemeth', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'MARCASTEL Agathe', 'role': 'CONTACT'}], 'facility': "Service d'Epileptologie Clinique, des Troubles du sommeil et de Neurologie fonctionnelle de l'enfant, à Hôpital Femme Mère et Enfant,", 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'centralContacts': [{'name': 'Marcastel Agathe, PhD', 'role': 'CONTACT', 'email': 'Agathe.marcastel@chu-lyon.fr', 'phone': '+33 4 27 85 60 40'}, {'name': 'Nemeth Dezso, Pr', 'role': 'CONTACT', 'email': 'dezso.nemeth@univ-lyon1.fr', 'phone': '+33 4 81 10 66 04'}], 'overallOfficials': [{'name': 'Marcastel Agathe, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Service d'Epileptologie Clinique, des Troubles du sommeil et de Neurologie fonctionnelle de l'enfant - Hôpital Femme Mère Enfant"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}