Longitudinal Early Epilepsy Study

Longitudinal Early Epilepsy Study

Sponsors

Lead Sponsor: Maastricht University Medical Center

Collaborator: Epilepsiecentrum Kempenhaeghe

Source 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.

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.

Overall Status Unknown status
Start Date 2016-09-01
Completion Date 2020-01-01
Primary Completion Date 2019-09-01
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
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 Outcome
Measure Time Frame
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
Enrollment 60
Condition
Intervention

Intervention Type: Other

Intervention Name: MRI

Intervention Type: Other

Intervention Name: 24h-EEG + video

Arm Group Label: Absence epilepsy

Intervention Type: Other

Intervention Name: Neuropsychological tests

Eligibility

Sampling Method:

Non-Probability Sample

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.

Gender:

All

Minimum Age:

6 Years

Maximum Age:

12 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Johan SH Vles, MD, PHD Study Director Maastricht University Medical Center
Overall Contact

Last Name: Eric LA Fonseca Wald, MD

Phone: +31 (0)43 387 65 84

Email: [email protected]

Location
Facility: Status: Contact:
Kempenhaeghe | Heeze, Limburg, 5591 VE, Netherlands Recruiting Mariette HJ Debeij-van Hall, MD, PHD +31 (0)40 227 97 77 [email protected]
Maastricht University Medical Center | Maastricht, Limburg, 6202 AZ, Netherlands Recruiting Eric LA Fonseca Wald, MD +31 (0)43 387 65 84 [email protected] Johan SH Vles, MD, PHD Principal Investigator
Location Countries

Netherlands

Verification Date

2018-11-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Absence epilepsy

Description: 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.

Label: Controls

Description: Overall healthy children aged 6-12 years of age following a regular school without major problems.

Acronym LEES
Patient Data No
Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

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