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Longitudinal Early Epilepsy Study

Longitudinal Early Epilepsy Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02954107
Acronym
LEES
Enrollment
60
Registered
2016-11-03
Start date
2016-09-30
Completion date
2020-01-31
Last updated
2018-11-19

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

Conditions

Absence Epilepsy, Epilepsy, Absence

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.

Detailed 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.

Interventions

OTHERMRI
OTHER24h-EEG + video
OTHERNeuropsychological tests

Sponsors

Epilepsiecentrum Kempenhaeghe
CollaboratorINDUSTRY
Maastricht University Medical Center
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes

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 rhythmic spike-and-wave complexes with a discharge duration of at least 3 seconds on a present or former EEG(58). 3. Early absence epilepsy , defined as a confirmed diagnosis or seizures within 2 years. 4. Aged 6-12 years 5. 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.

Design outcomes

Primary

MeasureTime frame
Change of multimodal MRI parameters on brain connectivityBaseline; first year; second year
Change of cognition measured by a battery of neuropsychological testsBaseline; 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

MeasureTime frameDescription
Age in months at which seizures began (age of onset) assessed by interview at the baseline measurmentBaseline
Seizure semiology assessed by anamnesis and video-EEGBaseline; first year; second yearSeizure semiology will be re-assessed at the different time points
Epileptiform activity assessed by a 24h-EEGBaseline; first year; second yearEpileptiform acitivty will be re-assessed at the different time points

Countries

Netherlands

Contacts

Primary ContactEric LA Fonseca Wald, MD
LEES.studie.kinderneurologie@mumc.nl+31 (0)43 387 65 84
Backup ContactSylvia Klinkenberg, MD, PHD
s.klinkenberg@mumc.nl+31 (0)43 387 70 54

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026