The Rolandic Epilepsy/ESES/Landau-Kleffner Syndrome and Correlation With Language Impairment Study (REL)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Epilepsiecentrum Kempenhaeghe
Information provided by (Responsible Party):
René Besseling, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01335425
First received: April 13, 2011
Last updated: June 24, 2013
Last verified: June 2013
  Purpose

In clinical practice language impairment is frequently reported in association with nocturnal epileptiform activity. There is a spectrum of epileptic conditions that are characterized by nocturnal epileptiform activity. From mild to severe this spectrum involves: Rolandic epilepsy (RE), nocturnal frontal lobe epilepsy (NFLE), Landau-Kleffner syndrome (LKS) and electrical status epilepticus during slow wave sleep (ESES). The exact characteristic of the relationship between nocturnal epileptiform activity and language impairment is yet to be explored. The investigators suggest that nocturnal epileptiform EEG discharges and nocturnal epileptic seizures during development will cause diseased neuronal networks that involve language. The diseased neuronal networks are less efficient compared with normal neuronal networks.

Objective: Identification of a diseased neuronal network characteristic in children with nocturnal epileptiform activity, which can explain language impairment in these children. For this the investigators will use functional magnetic resonance imaging (MRI) to analyse brain activity and diffusion weighted MRI to investigate white matter connectivity.


Condition
Rolandic Epilepsy
Nocturnal Frontal Lobe Epilepsy
Landau-Kleffner Syndrome
Electrical Status Epilepticus During Slow Wave Sleep

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Mechanism that causes language problems in childhood epilepsy [ Time Frame: course of study ] [ Designated as safety issue: No ]
    Morphological, anatomical or functional correlate that can explain the comorbidity of language problems in childhood epilepsy. In Rolandic epilepsy, e.g., the epileptic focus is in the brain motor strip, and from classical anatomy no connection is known from the motor strip to the language areas. Think of deviations in the brain such as cortical thinning in both regions or aberrant functional or anatomical networks linking both regions.


Estimated Enrollment: 40
Study Start Date: October 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children aged 6 to 18 years seen in tertiary referral center for epilepsy Kempenhaeghe with a proven diagnosis of Rolandic epilepsy and without intracerebral lesions (e.g. tumour) on structural MRI or other pathology, which may influence cognition.

In addition, children with electrical status epilepticus of sleep (ESES), ESES-like, or Landau-Klefner syndrome might be included.

Criteria

Inclusion Criteria:

  • aged between 6-18
  • diagnosis of Rolandic epilepsy (or other childhood epilepsies as listed in study population description)

Exclusion Criteria:

  • structural brain lesions which might influence cognition
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335425

Locations
Netherlands
Epilepsiecentrum Kempenhaeghe
Heeze, Noord-Brabant, Netherlands, 5591VE
Sponsors and Collaborators
Maastricht University Medical Center
Epilepsiecentrum Kempenhaeghe
  More Information

No publications provided

Responsible Party: René Besseling, M Sc, Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01335425     History of Changes
Obsolete Identifiers: NCT01248559
Other Study ID Numbers: 10-3-044
Study First Received: April 13, 2011
Last Updated: June 24, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
Language problems
childhood epilepsy
bening (rolandic) epilepsy (of childhood) with centro temporal spikes
brain maturation
structral connectivity
functional connectivity

Additional relevant MeSH terms:
Epilepsy
Status Epilepticus
Epilepsy, Frontal Lobe
Landau-Kleffner Syndrome
Epilepsy, Rolandic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Epilepsies, Partial

ClinicalTrials.gov processed this record on April 17, 2014