Longitudinal Early Epilepsy Study

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Maastricht University Medical Center
Updated on 8 November 2020
Investigator
Mariette HJ Debeij-van Hall, MD, PHD
Primary Contact
Kempenhaeghe (1.2 mi away) Contact
+1 other location

Summary

This longitudinal study will focus on the cognitive and brain development of children with absence epilepsy. In addition, the investigators aim to identify prognostic factors for cognitive deterioration and/or poor seizure control in these children.

Description

The aim is to study the cognitive and brain development of children with absence epilepsy. In addition, this study aims to identify prognostic factors for cognitive deterioration and/or poor seizure control.

Objective
  1. To study the development of cognition in children with absence epilepsy and the functional brain organization over time.
  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 population:

60 children with recently diagnosed (<2 years) absence epilepsy, aged 6 to 12 years. In addition, this study includes a control group of 15 age and gender matched healthy volunteers.

Main study parameters/endpoints:

Endpoints are the development of clinical parameters (semiology, 24h-video-EEG and seizure control), neuropsychological/behavioural outcomes, structural/functional MRI parameters, and educational performance.

Details
Treatment MRI, 24h-EEG + video, Neuropsychological tests, Neuropsychological tests
Clinical Study IdentifierNCT02954107
SponsorMaastricht University Medical Center
Last Modified on8 November 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age between 6 yrs and 12 yrs?
Gender: Male or Female
Do you have Absence seizure?
Primarily presented with daily occurring episodes of brief loss of consciousness (absences) in an otherwise normal child in the previous 2 years
An EEG showing 3 Hz (2.5-4.5 Hz) generalized rhythmic spike-and-wave complexes with a discharge duration of at least 3 seconds on a present or former EEG(58)
Early absence epilepsy , defined as a confirmed diagnosis or seizures within 2 years
Aged 6-12 years
Permitted accompanying factors
A few generalized tonic-clonic seizures (assessed individually according to International League Against Epilepsy [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

Exclusion Criteria

A potential subject (both for the control and patient group) who meets any of the following criteria will be excluded from participation in this study
A diagnosis according to ILAE criteria of the following epilepsy syndromes: Juvenile Absence Epilepsy; Eyelid 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 (59)
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 (aged12 years) not willing to provide informed consent
Parents or participants (aged12 years) who do not want to get informed whenever structural abnormalities are found during imaging
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