Rolandic EpilepsyNCT01046760
Scholar Performance and Praxis Assessment in Children With Rolandic Epilepsy
An observational study of Rolandic Epilepsy and Apraxia, run by University of Campinas, Brazil at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 7 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Rolandic Epilepsy, Apraxia
- What is being tested?
- Language Assessment
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 20 participants
- Where
- 1 siteBrazil
- Study dates
- Sep 2009to Feb 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
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).
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Rolandic Epilepsy, Apraxia
- Being tested
- Language Assessment
- Keywords
- epilepsy, language, childhood, praxis
- Medical subject headings
- Epilepsy, Rolandic, Apraxias, Epilepsy, Language
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Language AssessmentBehavioural
Also called Children with epilepsy, language impairment and dyslexia
Patients underwent an assessment performed with School Performance Test, Syntactic Awareness Test and a Peabody Picture Vocabulary Test.
| Study group | Role | What they receive |
|---|---|---|
| Rolandic Epilepsy | Patients older than seven years old with clinical and electroencephalographic diagnosis of Rolandic Epilepsy Receives: Behavioral: Language Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Our data will indicate the group performance in tests of writing, arithmetic and reading.
Measured: one year
Secondary outcomes (1)
Another important aspect was the absence of orofacial apraxia in children with epilepsy.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startSep 2009
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rolandic EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Campinas, Brazil
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Investigators
- Marilisa Guerreiro, doctor, Study chair, University of Campinas, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046760
- Sponsor's protocol ID
- 21 CFR 50.3.
- Status last verified
- Oct 2010
- First submitted
- 11 Jan 2010
- Last updated
- 20 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21103707
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scholar Performance and Praxis Assessment in Children With Rolandic Epilepsy
- ClinicalTrials.gov ID
- NCT01046760
- Acronym / sponsor ID
- 21 CFR 50.3.
- Conditions
- Rolandic Epilepsy, Apraxia
- Keywords
- epilepsy, language, childhood, praxis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of Campinas, BrazilUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Sep 2009
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rolandic Epilepsy | – | Behavioral: Language AssessmentPatients older than seven years old with clinical and electroencephalographic diagnosis of Rolandic Epilepsy |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- 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).
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Language AssessmentAlso: Children with epilepsy, language impairment and dyslexiaPatients underwent an assessment performed with School Performance Test, Syntactic Awareness Test and a Peabody Picture Vocabulary Test. | Behavioural | Rolandic Epilepsy |
Primary outcome
Our data will indicate the group performance in tests of writing, arithmetic and reading.
Time frame: one year
1 secondary outcome
Another important aspect was the absence of orofacial apraxia in children with epilepsy.
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2010.
- Background: PubMed 21103707Oliveira 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.
- CARACTERIZACAO DAS MANIFESTACOES NEUROPSICOLINGUISTICAS EM CRIANCAS COM EPILEPSIA ROLANDICA.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marilisa Guerreiro, doctor study chair
University of Campinas, Brazil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rolandic Epilepsy and Apraxia, run by University of Campinas, Brazil at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Our data will indicate the group performance in tests of writing, arithmetic and reading. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01046760, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2010.