- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01046760
Scholar Performance and Praxis Assessment in Children With Rolandic Epilepsy
October 19, 2010 updated by: University of Campinas, Brazil
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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São Paulo
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Campinas, São Paulo, Brazil, 13041317
- Clinical Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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).
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Rolandic Epilepsy
Patients older than seven years old with clinical and electroencephalographic diagnosis of Rolandic Epilepsy
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Patients underwent an assessment performed with School Performance Test, Syntactic Awareness Test and a Peabody Picture Vocabulary Test.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Our data will indicate the group performance in tests of writing, arithmetic and reading.
Time Frame: one year
|
one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Another important aspect was the absence of orofacial apraxia in children with epilepsy.
Time Frame: one year
|
one year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Chair: Marilisa Guerreiro, doctor, University of Campinas, Brazil
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Anticipated)
February 1, 2011
Study Completion (Anticipated)
February 1, 2011
Study Registration Dates
First Submitted
January 11, 2010
First Submitted That Met QC Criteria
January 11, 2010
First Posted (Estimate)
January 12, 2010
Study Record Updates
Last Update Posted (Estimate)
October 20, 2010
Last Update Submitted That Met QC Criteria
October 19, 2010
Last Verified
October 1, 2010
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 21 CFR 50.3.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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