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

Rolandic Epilepsy Clinical Trial

— REL  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01335425
• Other study ID #: 10-3-044
• Status: Completed
• Phase: N/A
• First received: April 13, 2011
• Last updated: September 22, 2015
• Start date: October 2010
• Est. completion date: December 2013

Study information

• Verified date: September 2015
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

Other known NCT identifiers

• NCT01248559

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
Netherlands	Epilepsiecentrum Kempenhaeghe	Heeze	Noord-Brabant

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	Mechanism that causes language problems in childhood epilepsy	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.	course of study	No