1) To study cognition in children with absence epilepsy and the development of functional brain organization.2) To find prognostic factors in terms of clinical, 24h-video-EEG or/and MRI characteristics for cognitive deterioration and/or poor seizure…
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are:
1. Functional MRI parameters.
2. Neuropsychological parameters for neurocognitive development and behaviour,
i.e. cognitive capacities, language, memory, visual (spatial) & motoric
skills, attention/concentration, academic skills and behaviour.
3. Clinical characteristics (a priori defined characteristics are listed in
form C1, page 25):
i. Seizure semiology
ii. Seizure control.
iii. 24h-video-EEG (including standard hyperventilation and photic stimulation
test) characteristics (frequency, type and localisation of diurnal and
nocturnal epileptiform EEG discharges).
4. Educational development, educational delay (discrepancy score), results of
the *Leerling Volgsysteem* (i.e. CITO score).
5. General behavioural (by proxy) assessment using a set of questionnaires.
Secondary outcome
Secondary study parameters are:
1. Multimodal MRI parameters (structural, DTI and IVIM).
2. Demographic characteristics: age, gender, ethnicity, handedness, height,
weight, regular teaching.
3. Other epilepsy related factors and other clinical parameters: age at onset,
seizure semiology, seizure types, time between seizure onset and start AED
treatment, seizure frequency before start AED, response to first AED, response
to second AED etc., duration in years of seizures corrected for years in which
seizures were controlled, type and dose of medication per kg, medical history.
Background summary
The most prevalent pediatric epilepsy is absence epilepsy, which is an
idiopathic generalized epilepsy in otherwise healthy children characterized by
daily occurring episodes of brief loss of consciousness (staring spells). In
contrast to previous beliefs of the benign nature of absences, recent research
has identified deficits across a wide range of cognitive abilities and poor
seizure control in about 30% of patients with absence epilepsy. So far, little
information is available about the possible underlying changes of brain
maturation, brain reorganization and change of structure. Understanding the
cognitive development of these children and being able to identify children
prone to cognitive deterioration or poor seizure control is vital.
Most of our knowledge on absence 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 absence epilepsy longitudinally.
Firstly, it is unclear whether cognitive deficits are present at onset and how
cognitive abilities develop over time in patients with absence epilepsy.
Secondly, brain development may follow an altered course. Prior cohort studies
from our group on frontal lobe epilepsy (FLE) in children, suggest early
changes of functional brain organization, followed by changes of structural
connectivity.
Thirdly, certain features may be able to predict if a patient will have poor
response to treatment or will experience cognitive decline. Brain
characteristics on MRI may correlate with future cognitive deterioration or
poor seizure control. In addition, other clinical factors (i.e. semiology, EEG
charcteristicscharacteristics, seizure control) may as well have a prognostic
value.
In this study we aim to study the altered cognitive and brain development of
children with childhood absence epilepsy. In addition, we aim to identify
prognostic factors for cognitive deterioration and/or poor seizure control.
Study objective
1) To study cognition in children with absence epilepsy and the development of
functional brain organization.
2) To find prognostic factors in terms of clinical, 24h-video-EEG or/and MRI
characteristics for cognitive deterioration and/or poor seizure control in
patients with absence epilepsy.
Study design
2 year prospective longitudinal, controlled, comparative, clinical, follow up.
Study burden and risks
This study adheres to the *not unless* principle based on WHO guidelines for
research involving minors. There are no risks involved with EEG recordings or
cognitive assessments and the total burden will be kept to a minimum. The risks
of an MRI-scan are negligible because it is a magnetic field, does not involve
ionizing radiation and does not require contrast agents or anaesthetics. The
subjects are screened beforehand and excluded when they have claustrophobia or
any other contraindications for MRI investigations. Participants will be
prepared using a thorough preparation protocol, and if necessary with use of a
mock scanner, before scanning takes place.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Age
Inclusion criteria
1. Primarily presented with daily occurring episodes of brief loss of
consciousness (absences) in an otherwise normal child in the previous 2 years.
2. An EEG showing 3 Hz (2.5-4.5 Hz) generalized rythmic spike-and-wave
complexes with a discharge duration of at least 3 seconds on a present or
former EEG.
3. Early absence epilepsy , defined as a confirmed diagnosis or seizures within
2 years.
4. Aged 6-12 years at inclusion
5. Permitted accompanying factors:
- A few generalized tonic-clonic seizures (assessed individually according to
ILAE statements);
- Mild myoclonic eye(lid) movements
- Co-morbidities: Attention deficiency/concentration disorders, autism,
dyslexia and anxiety. These do not form exclusion criteria as this is
frequently seen in children with absence seizures and it might be uncertain if
the co-morbidity is a manifestation of the absence epilepsy., Age-gender
matched controls
- Overall healthy (do not have any of the exclusion criteria) and following a
regular school without major problems, which makes a normal intelligence
likely.
- Aged 6-12 years on inclusion
Exclusion criteria
* A diagnosis according to ILAE criteria of the following epilepsy syndromes:
Juvenile Absence Epilepsy; Eylide myoclonia with absences; Dravet syndrome;
Epilepsy with myoclonic-atonic seizures; Epilepsy with Myoclonic Absences;
Lennox-Gastaut syndrome; Frontal Lobe Epilepsy or other focal epilepsy.
* A confirmed diagnosis of epilepsy/seizures for more than 2 years (58).
* Recent hospitalizations in the last months or a history which might limit
participation in or completion of the study protocol.
* Behavioural characteristics which might hamper the gathering of useful MRI
data.
* Intellectual disability or other diseases/causes that may underlie cognitive
impairment (i.e. neurodegenerative diseases).
* History of major head trauma or head/brain surgery.
* MRI lesions on (previous) structural brain MRI- or CT-scans or symptomatic
epilepsies (e.g. epilepsy related to tumours, vascular abnormalities,
congenital dysgenesia).
* MRI contra-indications: claustrophobia, anxiety for an MRI scan, or presence
of metallic objects (e.g. prostheses, pacemakers, metal clips on blood vessels,
metal parts in the eye). Dental braces are no exclusion criterion for absence
patients.
* Regularly using drugs of abuse (asked during screening session).
* Parents or participants (aged*12 years) not willing to provide informed
consent.
* Parents or participants (aged*12 years) who do not want to get informed
whenever structural abnormalities are found during imaging.
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 | NL55455.068.15 |