ongitudinal Early Epilepsy Study

Recruiting

Conditions: Childhood Absence Epilepsy
Primary generalized seizures
10039911

Registration Number: NL-OMON53316

Lead Sponsor: Medisch Universitair Ziekenhuis Maastricht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 75

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.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters are:<br /><br>1. Functional MRI parameters.<br /><br>2. Neuropsychological parameters for neurocognitive development and behaviour,<br /><br>i.e. cognitive capacities, language, memory, visual (spatial) & motoric<br /><br>skills, attention/concentration, academic skills and behaviour.<br /><br>3. Clinical characteristics (a priori defined characteristics are listed in<br /><br>form C1, page 25):<br /><br>i. Seizure semiology<br /><br>ii. Seizure control.<br /><br>iii. 24h-video-EEG (including standard hyperventilation and photic stimulation<br /><br>test) characteristics (frequency, type and localisation of diurnal and<br /><br>nocturnal epileptiform EEG discharges).<br /><br>4. Educational development, educational delay (discrepancy score), results of<br /><br>the Leerling Volgsysteem (i.e. CITO score).<br /><br>5. General behavioural (by proxy) assessment using a set of questionnaires.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary study parameters are:<br /><br>1. Multimodal MRI parameters (structural, DTI and IVIM).<br /><br>2. Demographic characteristics: age, gender, ethnicity, handedness, height,<br /><br>weight, regular teaching.<br /><br>3. Other epilepsy related factors and other clinical parameters: age at onset,<br /><br>seizure semiology, seizure types, time between seizure onset and start AED<br /><br>treatment, seizure frequency before start AED, response to first AED, response<br /><br>to second AED etc., duration in years of seizures corrected for years in which<br /><br>seizures were controlled, type and dose of medication per kg, medical history. </p><br>