Longitudinal Early Epilepsy Study

Absence Epilepsy Clinical Trial

— LEES  

Official title:

Longitudinal Early Epilepsy Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02954107
• Other study ID #: NL55455.068.15
• Secondary ID: 152055
• Status: Recruiting
• Start date: September 2016
• Est. completion date: January 2020

Study information

• Verified date: November 2018
• Source: Maastricht University Medical Center
• Contact: Eric LA Fonseca Wald, MD
• Phone: +31 (0)43 387 65 84
• Email: LEES.studie.kinderneurologie[@]mumc.nl
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Absence Epilepsy
• Epilepsy
• Epilepsy, Absence

Intervention

Other:
• MRI

• 24h-EEG + video

• Neuropsychological tests

Locations

Country	Name	City	State
Netherlands	Kempenhaeghe	Heeze	Limburg
Netherlands	Maastricht University Medical Center	Maastricht	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Epilepsiecentrum Kempenhaeghe

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of multimodal MRI parameters on brain connectivity		Baseline; first year; second year
Primary	Change of cognition measured by a battery of neuropsychological tests		Baseline; first year; second year
Primary	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	Age in months at which seizures began (age of onset) assessed by interview at the baseline measurment		Baseline
Secondary	Seizure semiology assessed by anamnesis and video-EEG	Seizure semiology will be re-assessed at the different time points	Baseline; first year; second year
Secondary	Epileptiform activity assessed by a 24h-EEG	Epileptiform acitivty will be re-assessed at the different time points	Baseline; first year; second year