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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01046760
Other study ID # 21 CFR 50.3.
Secondary ID
Status Active, not recruiting
Phase N/A
First received January 11, 2010
Last updated October 19, 2010
Start date September 2009
Est. completion date February 2011

Study information

Verified date October 2010
Source University of Campinas, Brazil
Contact n/a
Is FDA regulated No
Health authority Brazil: Ethics Committee
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 20
Est. completion date February 2011
Est. primary completion date February 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 7 Years to 12 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective


Related Conditions & MeSH terms


Intervention

Behavioral:
Language Assessment
Patients underwent an assessment performed with School Performance Test, Syntactic Awareness Test and a Peabody Picture Vocabulary Test.

Locations

Country Name City State
Brazil Clinical Hospital Campinas São Paulo

Sponsors (2)

Lead Sponsor Collaborator
University of Campinas, Brazil Fundação de Amparo à Pesquisa do Estado de São Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Our data will indicate the group performance in tests of writing, arithmetic and reading. one year No
Secondary Another important aspect was the absence of orofacial apraxia in children with epilepsy. one year No
See also
  Status Clinical Trial Phase
Completed NCT01335425 - The Rolandic Epilepsy/ESES/Landau-Kleffner Syndrome and Correlation With Language Impairment Study N/A
Completed NCT03547050 - Rolandic Epilepsy Genomewide Association International Study
Recruiting NCT04569708 - Sleep Spindles and Memory in Rolandic Epilepsy N/A
Completed NCT01515436 - The Effect of Music Periodicity on Interictal Epileptiform Discharges N/A
Terminated NCT04610879 - Changing Agendas on Sleep, Treatment and Learning in Epilepsy Phase 4