The overall aim of this study is to identify developmental deficits in children with Rolandic epilepsy. If developmental deficits are observed, we hope to determine timing, persistence, and prognostic factors for developmental deficits and improveā¦
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
- Developmental disorders NEC
- Age related factors
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Identification of prognostic variables regarding seizure frequency, EEG and
neuropsychological investigations.
Secondary outcome
n.a.
Background summary
Rolandic epilepsy, or benign childhood epilepsy with centrotemporal spikes
(BCECTS), is the most prevalent type of paediatric epilepsy. Recent studies
suggest that prognosis of Rolandic epilepsy might not be as benign as its name
suggests. Overall cognition scores are generally within reference ranges, but
several aspects of cognition seem to be negatively affected by Rolandic
epilepsy: language, visuomotor coordination, memory, and attention span.
Most of our knowledge on Rolandic epilepsy and interrelated factors are derived
from cross-sectional cohort studies and post-hoc analyses of age effects,
whereas only a few studies investigate the Rolandic epilepsy longitudinally
(Lindgren, 2004, Ay 2004). Understanding development of these children and
being able to identify children prone to developmental deterioration is crucial
in order to offer proper guidance in a clinical setting. This longitudinal
study aims to analyse developmental deficits in children suffering from
Rolandic epilepsy by investigating clinical, cognitive, behavioural, and
academic functioning.
Study objective
The overall aim of this study is to identify developmental deficits in children
with Rolandic epilepsy. If developmental deficits are observed, we hope to
determine timing, persistence, and prognostic factors for developmental
deficits and improve early identification and counseling of children at risk.
Study design
This is an observational study in children with proven Rolandic epilepsy who
visit the outpatient clinic of Kempenhaeghe within the program "Child, school
and epilepsy". This program includes standard visits with 24-hours-EEG
recordings, neuropsychological evaluation and questionaires for both teachers
and parents.
Children will be investigated at baseline and after 1 and 2 years. A small
amount of children will be asked at age 15 (after puberty and when Rolandic
epilepsy will no longer be present) for follow-up investigation, including
24-hours-EEG recordings and neuropsychological investigation.
Study burden and risks
While children in this study will have litlle benefit of enrollment. they do
however benefit from the extensive diagnostic investigations. For example,
results of neuropsychological tests can be used for changing the mentoring
system at school. For parents there is counseling and it may help in the
reduction of prescribing anti-epileptic drugs.
Scientific results derived from this study may be of influence in future
treatment and follow-up.
Taking part in this study is a time-effort. The 24-hour EEG-system is carried
by the child for 24 hours (electrodes and battery in a small backpack). During
this time the child is not able to bathe or shower. Most children are familiar
with this type of investigation during the diagnostic procedure regarding the
epilepsy.
In the neuropsychological investigations the child sits together with the
investigator in a testing room. This can be both intensive and fun because most
tests are computer based and many children are used to do that in their spare
time.
Sterkselseweg 65
Heeze 5591 VE
NL
Sterkselseweg 65
Heeze 5591 VE
NL
Listed location countries
Age
Inclusion criteria
Rolandic epilepsy (clinical and electrophysiological criteria)
children aged between 4-16
Exclusion criteria
Seizures that are not classified as Rolandic seizures (clinical and electrophysiological grounds)
Parents or participants (aged 12 or older) that are not willing to provide informed consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL60546.015.17 |