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Scholar Performance and Praxis Assessment in Children With Rolandic Epilepsy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01046760
Recruitment Status : Unknown
Verified October 2010 by University of Campinas, Brazil.
Recruitment status was:  Active, not recruiting
First Posted : January 12, 2010
Last Update Posted : October 20, 2010
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Campinas, Brazil

Tracking Information
First Submitted Date January 11, 2010
First Posted Date January 12, 2010
Last Update Posted Date October 20, 2010
Study Start Date September 2009
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 11, 2010)
Our data will indicate the group performance in tests of writing, arithmetic and reading. [ Time Frame: one year ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01046760 on Archive Site
Current Secondary Outcome Measures
 (submitted: January 11, 2010)
Another important aspect was the absence of orofacial apraxia in children with epilepsy. [ Time Frame: one year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title Scholar Performance and Praxis Assessment in Children With Rolandic Epilepsy
Official Title Scholar Performance and Praxis Assessment in Children With Rolandic Epilepsy
Brief Summary 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.
Detailed Description 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 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).
  • Rolandic Epilepsy
  • Apraxia
Intervention Behavioral: Language Assessment
Patients underwent an assessment performed with School Performance Test, Syntactic Awareness Test and a Peabody Picture Vocabulary Test.
Other Name: Children with epilepsy, language impairment and dyslexia
Study Groups/Cohorts Rolandic Epilepsy
Patients older than seven years old with clinical and electroencephalographic diagnosis of Rolandic Epilepsy
Intervention: Behavioral: Language Assessment
Publications * Oliveira EP, Neri ML, Medeiros LL, Guimarães CA, Guerreiro MM. School performance and praxis assessment in children with Rolandic Epilepsy. Pro Fono. 2010 Jul-Sep;22(3):209-14. English, Portuguese.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: January 11, 2010)
Original Estimated Enrollment Same as current
Estimated Study Completion Date February 2011
Estimated Primary Completion Date February 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Diagnosis of rolandic epilepsy using clinical, EEG and neuroimaging findings
  • Patients had neurological, ophthalmic and auditory unchanged, and intelligence quotient (IQ) equal to or above 80.
  • All parents signed the consent form, authorizing the participation of their children (as) in the search.

Exclusion Criteria:

  • 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
  • What not signed the consent form.
Sexes Eligible for Study: All
Ages 7 Years to 12 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Brazil
Removed Location Countries  
Administrative Information
NCT Number NCT01046760
Other Study ID Numbers 21 CFR 50.3.
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ecila Paula dos Mesquita de Oliveira, UNICAMP
Study Sponsor University of Campinas, Brazil
Collaborators Fundação de Amparo à Pesquisa do Estado de São Paulo
Study Chair: Marilisa Guerreiro, doctor University of Campinas, Brazil
PRS Account University of Campinas, Brazil
Verification Date October 2010