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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT01335425

Recruitment Status : Completed

First Posted : April 14, 2011

Last Update Posted : September 23, 2015

Sponsor:

Collaborator:

Epilepsiecentrum Kempenhaeghe

Information provided by (Responsible Party):

René Besseling, Maastricht University Medical Center

Study Description

Brief Summary:

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

Study Design


Study Type :	Observational
Actual Enrollment :	47 participants
Observational Model:	Case Control
Time Perspective:	Cross-Sectional
Study Start Date :	October 2010
Actual Primary Completion Date :	December 2013
Actual Study Completion Date :	December 2013

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Autosomal dominant nocturnal frontal lobe epilepsy Epilepsy-aphasia spectrum Pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

Genetic and Rare Diseases Information Center resources: Status Epilepticus Landau-Kleffner Syndrome

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

Mechanism that causes language problems in childhood epilepsy [ Time Frame: course of study ]
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.

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:	6 Years to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
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

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): NCT01335425

Locations


Netherlands
Epilepsiecentrum Kempenhaeghe
Heeze, Noord-Brabant, Netherlands, 5591VE

Sponsors and Collaborators

Maastricht University Medical Center

Epilepsiecentrum Kempenhaeghe

More Information


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
First Posted:	April 14, 2011 Key Record Dates
Last Update Posted:	September 23, 2015
Last Verified:	September 2015

Keywords provided by René Besseling, 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:


Syndrome Epilepsy Status Epilepticus Epilepsy, Rolandic Epilepsy, Frontal Lobe Landau-Kleffner Syndrome	Disease Pathologic Processes Brain Diseases Central Nervous System Diseases Nervous System Diseases Epilepsies, Partial

To Top