The main objective of the study is to achieve knowlegde on change in seizure semiology with age in children with partial epilepsy and to improve the understanding in the cause and consequence of this change, in relation to changing functional…
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Evaluate the cause of change in seizures semiology
Analyses will be performed of associations between changes in seizure semiology
and changes in the development of neuronal networks and:
1 changes in underlying brain pathology
2 remote damage (e.g. dual pathology/ mesial temporal sclerosis)
3 the pattern of epileptiform activity during seizure onset, or speed of
seizure spreading
Assessment of differences in neuronal networks in children with and without
epilepsy
1 What are the baseline differences in neuronal networks in children with new
onset partial epilepsy and children without seizures.
2 What are the differences in neuronal networks in children with partial
epilepsy compared to the group of children without seizures three years after
the diagnosis of epilepsy or first assessment in the control group.
Secondary outcome
How often do we see a change in seizure semiology in children
1 How does seizure semiology change? (a definition of change in semiology is
described in the work plan).
2 What are the clinical characteristics of the children in whom seizure
semiology changes? (Characteristics that are examined are described in the work
plan)
3 What is the time course of changing semiology?
Background summary
Epilepsy is not a rare disorder in childhood. Recurrent seizures may have an
impact on cognitive and psychosocial development of the child.
It has been established that seizure semiology in young children with partial
epilepsy differs from semiology in adolecents and adults with partial epilepsy.
During brain maturation a change of localization of onset and spreading of
epileptiform activity may occur. Further, underlying structural brain
anormalities may change or new, remote structural damage emerges. How semiology
changes in the individual patient with age and its relation to developing
functional networks and changes in brain structure has not been investigated
until now.
Study objective
The main objective of the study is to achieve knowlegde on change in seizure
semiology with age in children with partial epilepsy and to improve the
understanding in the cause and consequence of this change, in relation to
changing functional networks. A better understanding of this relationship may
lead to an earlier prediction of medical intractability. In that case other
treatment options can be considered earlier and ideally further damage can be
prevented. The ultimate goal is not only to treat the epilepsy, but also to
guarantee optimal neuronal development.
Study design
Observational prospective follow-up study of children with partial epilepsy. In
retrospect, we will include patients who fullfill the inclusive criteria and
visit our specialized outpatient clinic from the first of July 2009 untill we
receive permission to start our study.
During a follow up period of 5 years clinical data and data from ancillary
investigations will be documented in detail. the following infromation will be
obtained from routine patient care: seizure semiology, repetitive EEGs will be
performed to assess possible changes in functional networks. Ictal EEG will be
performed in patients who experience more than one seizure a week at
presentation and in patients who develop a medical intractable epilepsy. To
assess changes in or the development of new structural brain abnormalities the
brain MRI (including two scientific MRI sequences - which will not influence
total MRI time - ) will be repeated in all patients with medical resistent
epilepsy and in all patients with an initial abnormal brain MRI.
No ancillary investigation is planned for the purpose of this study.
Relationships between age, semiology, functional networks and changes in
underlying structural abnormalities will be analyzed.
In children with paroxysmal events without epileptic origin we will conduct MRI
scans when it has an added clinical value (good clinical practice).
Furthermore, these children will undergo a second EEG 3 to 5 years at the
outpatient department to compare characteristics of neural networks with
children with partial epilepsy.
Study burden and risks
Part of general patient care, minimal burden, no risks
Lundlaan 6
Utrecht 3508 AB
NL
Lundlaan 6
Utrecht 3508 AB
NL
Listed location countries
Inclusion criteria
1. A total of 30 to 50 children, younger than 17 years of age, with new onset partial epilepsy -who may present with generalized seizures.
2. A total of 30 to 50 children, younger than 17 years of age who were judged, after taking the clinical history and recording of a standard EEG, not to have had seizures (also excluding children with febrile convulsions)
Exclusion criteria
Patients > 16 years of age.
Children with idiopathic generalized epilepsy.
Design
Recruitment
Medical products/devices used
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 | NL27747.041.09 |