NCT01335425

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 14, 2011

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

3.2 years

First QC Date

April 13, 2011

Last Update Submit

September 22, 2015

Conditions

Keywords

Language problemschildhood epilepsybening (rolandic) epilepsy (of childhood) with centro temporal spikesbrain maturationstructral connectivityfunctional connectivity

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • aged between 6-18
  • diagnosis of Rolandic epilepsy (or other childhood epilepsies as listed in study population description)

You may not qualify if:

  • structural brain lesions which might influence cognition

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Epilepsiecentrum Kempenhaeghe

Heeze, North Brabant, 5591VE, Netherlands

Location

MeSH Terms

Conditions

Epilepsy, RolandicLandau-Kleffner SyndromeEpilepsy

Condition Hierarchy (Ancestors)

Epilepsies, PartialBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic Syndromes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M Sc

Study Record Dates

First Submitted

April 13, 2011

First Posted

April 14, 2011

Study Start

October 1, 2010

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations