ongitudinal Early Epilepsy Study - LEES

Medisch Universitair Ziekenhuis Maastricht0 sites75 target enrollmentStarted: TBDLast updated: February 28, 2024

Conditions

Trial Snapshot

No summary available.

•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
•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
•- Aged 6-12 years on inclusion

•* 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
•* 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
•* Regularly using drugs of abuse (asked during screening session).
•* Parents or participants (aged*12 years) not willing to provide informed
•* Parents or participants (aged*12 years) who do not want to get informed
•whenever structural abnormalities are found during imaging.

Sponsor

Medisch Universitair Ziekenhuis Maastricht