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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 3, 2016
Sponsor:
Collaborator:
Epilepsiecentrum Kempenhaeghe
Information provided by (Responsible Party):
Maastricht University Medical Center

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.

Condition or disease Intervention/treatment
Absence Epilepsy Epilepsy, Absence Other: MRI Other: 24h-EEG + video Other: Neuropsychological tests

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.


Study Type : Observational [Patient Registry]
Estimated Enrollment : 60 participants
Observational Model: Case Control
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Longitudinal Early Epilepsy Study
Study Start Date : September 2016
Estimated Primary Completion Date : September 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Group/Cohort Intervention/treatment
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.
Other: MRI
Other: 24h-EEG + video
Other: Neuropsychological tests
Controls
Overall healthy children aged 6-12 years of age following a regular school without major problems.
Other: MRI
Other: Neuropsychological tests



Primary Outcome Measures :
  1. Change of multimodal MRI parameters on brain connectivity [ Time Frame: Baseline; first year; second year ]
  2. Change of cognition measured by a battery of neuropsychological tests [ Time Frame: Baseline; first year; second year ]
  3. 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 ]

Secondary Outcome Measures :
  1. Age in months at which seizures began (age of onset) assessed by interview at the baseline measurment [ Time Frame: Baseline ]
  2. 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

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  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.
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 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.

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 (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.

Information from the National Library of Medicine

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


Contacts
Contact: Eric LA Fonseca Wald, MD +31 (0)43 387 65 84 LEES.studie.kinderneurologie@mumc.nl
Contact: Sylvia Klinkenberg, MD, PHD +31 (0)43 387 70 54 s.klinkenberg@mumc.nl

Locations
Netherlands
Kempenhaeghe Recruiting
Heeze, Limburg, Netherlands, 5591 VE
Contact: Mariette HJ Debeij-van Hall, MD, PHD    +31 (0)40 227 97 77    debeij-vanhallm@kempenhaeghe.nl   
Maastricht University Medical Center Recruiting
Maastricht, Limburg, Netherlands, 6202 AZ
Contact: Eric LA Fonseca Wald, MD    +31 (0)43 387 65 84    eric.fonsecawald@mumc.nl   
Contact: Sylvia Klinkenberg, MD, PHD    +31 (0)43 387 70 54    s.klinkenberg@mumc.nl   
Principal Investigator: Johan SH Vles, MD, PHD         
Sponsors and Collaborators
Maastricht University Medical Center
Epilepsiecentrum Kempenhaeghe
Investigators
Study Director: Johan SH Vles, MD, PHD Maastricht University Medical Center

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT02954107     History of Changes
Other Study ID Numbers: NL55455.068.15
152055 ( Other Identifier: Maastricht University Medical Centre+ )
First Posted: November 3, 2016    Key Record Dates
Last Update Posted: November 3, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Absence
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsy, Generalized