The Rolandic Epilepsy/ESES/Landau-Kleffner Syndrome and Correlation With Language Impairment Study (REL)
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ClinicalTrials.gov Identifier: NCT01335425 |
Recruitment Status
:
Completed
First Posted
: April 14, 2011
Last Update Posted
: September 23, 2015
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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 |
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Rolandic Epilepsy Nocturnal Frontal Lobe Epilepsy Landau-Kleffner Syndrome Electrical Status Epilepticus During Slow Wave Sleep |
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 |

- 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.

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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 |
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.
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

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