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Longitudinal Early Epilepsy Study

Longitudinal Early Epilepsy Study - LEES

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON53316
Enrollment
75
Registered
2019-12-11
Start date
2016-11-30
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Absence Epilepsy

Interventions

Absence
Children
Cognitive
Epilepsy

Sponsors

Medisch Universitair Ziekenhuis Maastricht
Lead Sponsor

Eligibility

Age
2 Years to 17 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)