Longitudinal Early Epilepsy Study
LEES
2 other identifiers
observational
60
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Sep 2016
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2016
CompletedFirst Submitted
Initial submission to the registry
September 26, 2016
CompletedFirst Posted
Study publicly available on registry
November 3, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2020
CompletedNovember 19, 2018
November 1, 2018
3 years
September 26, 2016
November 16, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Change of multimodal MRI parameters on brain connectivity
Baseline; first year; second year
Change of cognition measured by a battery of neuropsychological tests
Baseline; first year; second year
Time in months since start of medication till seizure control is attained, as assessed by anamnesis and a confirmatory routine-EEG.
Within 2 years
Secondary Outcomes (3)
Age in months at which seizures began (age of onset) assessed by interview at the baseline measurment
Baseline
Seizure semiology assessed by anamnesis and video-EEG
Baseline; first year; second year
Epileptiform activity assessed by a 24h-EEG
Baseline; first year; second year
Study Arms (2)
Absence epilepsy
Children aged 6-12 years of age primarily presenting with episodes of brief loss of consciousness (absences) in an otherwise normal child in the previous 2 years. With 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.
Controls
Overall healthy children aged 6-12 years of age following a regular school without major problems.
Interventions
Eligibility Criteria
1. Children aged 6-12 years of age primarily presenting with episodes of brief loss of consciousness (absences) in an otherwise normal child in the previous 2 years. With 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. 2. Overall healthy children aged 6-12 years of age following a regular school without major problems.
You may qualify if:
- 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
You may not qualify if:
- 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).
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Kempenhaeghe
Heeze, Limburg, 5591 VE, Netherlands
Maastricht University Medical Center
Maastricht, Limburg, 6202 AZ, Netherlands
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Johan SH Vles, MD, PHD
Maastricht University Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 26, 2016
First Posted
November 3, 2016
Study Start
September 1, 2016
Primary Completion
September 1, 2019
Study Completion
January 1, 2020
Last Updated
November 19, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share