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

History of Changes

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:

Genetics Home Reference related topics: autosomal dominant nocturnal frontal lobe epilepsy autosomal dominant partial epilepsy with auditory features pyridoxal 5'-phosphate-dependent epilepsy

MedlinePlus related topics: Epilepsy

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

U.S. FDA Resources

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

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, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on February 27, 2015

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