Longitudinal Early Epilepsy Study (LEES)
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|ClinicalTrials.gov Identifier: NCT02954107|
Recruitment Status : Recruiting
First Posted : November 3, 2016
Last Update Posted : November 19, 2018
|Condition or disease||Intervention/treatment|
|Absence Epilepsy Epilepsy, Absence||Other: MRI Other: 24h-EEG + video Other: Neuropsychological tests|
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.
- To study the development of cognition in children with absence epilepsy and the functional brain organization over time.
- 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.
2 year prospective longitudinal, controlled, comparative, clinical, follow up.
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.
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||60 participants|
|Target Follow-Up Duration:||2 Years|
|Official Title:||Longitudinal Early Epilepsy Study|
|Actual Study Start Date :||September 2016|
|Estimated Primary Completion Date :||September 2019|
|Estimated Study Completion Date :||January 2020|
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.
Other: 24h-EEG + video
Other: Neuropsychological tests
Overall healthy children aged 6-12 years of age following a regular school without major problems.
Other: Neuropsychological tests
- Change of multimodal MRI parameters on brain connectivity [ Time Frame: Baseline; first year; second year ]
- Change of cognition measured by a battery of neuropsychological tests [ Time Frame: 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. [ Time Frame: Within 2 years ]
- Age in months at which seizures began (age of onset) assessed by interview at the baseline measurment [ Time Frame: Baseline ]
- Seizure semiology assessed by anamnesis and video-EEG [ Time Frame: Baseline; first year; second year ]Seizure semiology will be re-assessed at the different time points
- Epileptiform activity assessed by a 24h-EEG [ Time Frame: Baseline; first year; second year ]Epileptiform acitivty will be re-assessed at the different time points
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02954107
|Contact: Eric LA Fonseca Wald, MD||+31 (0)43 387 65 84||LEES.email@example.com|
|Contact: Sylvia Klinkenberg, MD, PHD||+31 (0)43 387 70 firstname.lastname@example.org|
|Heeze, Limburg, Netherlands, 5591 VE|
|Contact: Mariette HJ Debeij-van Hall, MD, PHD +31 (0)40 227 97 77 email@example.com|
|Maastricht University Medical Center||Recruiting|
|Maastricht, Limburg, Netherlands, 6202 AZ|
|Contact: Eric LA Fonseca Wald, MD +31 (0)43 387 65 84 firstname.lastname@example.org|
|Contact: Sylvia Klinkenberg, MD, PHD +31 (0)43 387 70 54 email@example.com|
|Principal Investigator: Johan SH Vles, MD, PHD|
|Study Director:||Johan SH Vles, MD, PHD||Maastricht University Medical Center|