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

Sponsor
Maastricht University Medical Center (Other)
Overall Status
Completed
CT.gov ID
NCT01335425
Collaborator
Epilepsiecentrum Kempenhaeghe (Industry)
47
1
38
1.2

Study Details

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.

Study Design

Study Type:
Observational
Actual Enrollment :
47 participants
Observational Model:
Case-Control
Time Perspective:
Cross-Sectional
Study Start Date :
Oct 1, 2010
Actual Primary Completion Date :
Dec 1, 2013
Actual Study Completion Date :
Dec 1, 2013

Outcome Measures

Primary Outcome Measures

  1. Mechanism that causes language problems in childhood epilepsy [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

Criteria

Ages Eligible for Study:
6 Years to 18 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Epilepsiecentrum Kempenhaeghe Heeze Noord-Brabant Netherlands 5591VE

Sponsors and Collaborators

  • Maastricht University Medical Center
  • Epilepsiecentrum Kempenhaeghe

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
René Besseling, M Sc, Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01335425
Other Study ID Numbers:
  • 10-3-044
  • NCT01248559
First Posted:
Apr 14, 2011
Last Update Posted:
Sep 23, 2015
Last Verified:
Sep 1, 2015

Study Results

No Results Posted as of Sep 23, 2015