Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2025-12-26 @ 12:25 AM
Study NCT ID:
NCT01046760
Status:
UNKNOWN
Last Update Posted:
2010-10-20
First Post:
2010-01-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Scholar Performance and Praxis Assessment in Children With Rolandic Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019305', 'term': 'Epilepsy, Rolandic'}, {'id': 'D001072', 'term': 'Apraxias'}, {'id': 'D004827', 'term': 'Epilepsy'}, {'id': 'D007802', 'term': 'Language'}], 'ancestors': [{'id': 'D004828', 'term': 'Epilepsies, Partial'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000073376', 'term': 'Epileptic Syndromes'}, {'id': 'D011596', 'term': 'Psychomotor Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2009-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2011-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2010-10-19', 'studyFirstSubmitDate': '2010-01-11', 'studyFirstSubmitQcDate': '2010-01-11', 'lastUpdatePostDateStruct': {'date': '2010-10-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Our data will indicate the group performance in tests of writing, arithmetic and reading.', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Another important aspect was the absence of orofacial apraxia in children with epilepsy.', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['epilepsy', 'language', 'childhood', 'praxis'], 'conditions': ['Rolandic Epilepsy', 'Apraxia']}, 'referencesModule': {'references': [{'pmid': '21103707', 'type': 'BACKGROUND', 'citation': 'Oliveira EP, Neri ML, Medeiros LL, Guimaraes CA, Guerreiro MM. School performance and praxis assessment in children with Rolandic Epilepsy. Pro Fono. 2010 Jul-Sep;22(3):209-14. doi: 10.1590/s0104-56872010000300009. English, Portuguese.'}], 'seeAlsoLinks': [{'url': 'http://internet.aquila.fapesp.br/agilis/', 'label': 'CARACTERIZACAO DAS MANIFESTACOES NEUROPSICOLINGUISTICAS EM CRIANCAS COM EPILEPSIA ROLANDICA.'}]}, 'descriptionModule': {'briefSummary': 'Rolandic Epilepsy is the most common form of childhood epilepsy. It is classified as idiopathic, age-related epilepsy syndrome with benign evolution. The absence of neuropsychological impairment is part of the criteria of benignity of this epilepsy syndrome. However recently have been suggested several deficits related to attention and language. The purpose of this study was assess school performance and to investigate problems of praxis in patients with rolandic epilepsy as compared to a control group composed of normal children with age, gender and educational level equivalents.', 'detailedDescription': 'Method: Nineteen patients aged between 7 and 12 years underwent clinical neurological evaluation, psychological assessment, through Weschsler Scales of Intelligence and language evaluation, to assess the academic performance and research of the presence or absence of praxis difficulties.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '7 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Amongst patients with rolandic epilepsy assisted at the Clinic of Neurological-Psychological-Language in childhood of Hospital de Clínicas of Universidade Estadual de Campinas (Unicamp).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of rolandic epilepsy using clinical, EEG and neuroimaging findings\n* Patients had neurological, ophthalmic and auditory unchanged, and intelligence quotient (IQ) equal to or above 80.\n* All parents signed the consent form, authorizing the participation of their children (as) in the search.\n\nExclusion Criteria:\n\n* With oral language and writing of the following tables, whereas the DSM-IV: pervasive developmental disorders, cerebral palsy child acquired aphasia, hearing impairment (including mild conductive hearing loss), progressive disease\n* What not signed the consent form.'}, 'identificationModule': {'nctId': 'NCT01046760', 'briefTitle': 'Scholar Performance and Praxis Assessment in Children With Rolandic Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'University of Campinas, Brazil'}, 'officialTitle': 'Scholar Performance and Praxis Assessment in Children With Rolandic Epilepsy', 'orgStudyIdInfo': {'id': '21 CFR 50.3.'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Rolandic Epilepsy', 'description': 'Patients older than seven years old with clinical and electroencephalographic diagnosis of Rolandic Epilepsy', 'interventionNames': ['Behavioral: Language Assessment']}], 'interventions': [{'name': 'Language Assessment', 'type': 'BEHAVIORAL', 'otherNames': ['Children with epilepsy, language impairment and dyslexia'], 'description': 'Patients underwent an assessment performed with School Performance Test, Syntactic Awareness Test and a Peabody Picture Vocabulary Test.', 'armGroupLabels': ['Rolandic Epilepsy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13041317', 'city': 'Campinas', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Clinical Hospital', 'geoPoint': {'lat': -22.90556, 'lon': -47.06083}}], 'overallOfficials': [{'name': 'Marilisa Guerreiro, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Campinas, Brazil'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Campinas, Brazil', 'class': 'OTHER'}, 'collaborators': [{'name': 'Fundação de Amparo à Pesquisa do Estado de São Paulo', 'class': 'OTHER_GOV'}], 'responsibleParty': {'oldNameTitle': 'Ecila Paula dos Mesquita de Oliveira', 'oldOrganization': 'UNICAMP'}}}}