Rolandic EpilepsyRELNCT01335425
The Rolandic Epilepsy/ESES/Landau-Kleffner Syndrome and Correlation With Language Impairment Study
An observational study of Rolandic Epilepsy and Nocturnal Frontal Lobe Epilepsy, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Rolandic Epilepsy, Nocturnal Frontal Lobe Epilepsy, Landau-Kleffner Syndrome
- How many people
- 47 participants
- Where
- 1 siteNetherlands
- Study dates
- Oct 2010to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- aged between 6-18
- diagnosis of Rolandic epilepsy (or other childhood epilepsies as listed in study population description)
Who cannot join
- structural brain lesions which might influence cognition
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Epilepsiecentrum Kempenhaeghe
Heeze, North Brabant, 5591VE
About this study
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.
- Conditions
- Rolandic Epilepsy, Nocturnal Frontal Lobe Epilepsy, Landau-Kleffner Syndrome, Electrical Status Epilepticus During Slow Wave Sleep
- Keywords
- Language problems, childhood epilepsy, bening (rolandic) epilepsy (of childhood) with centro temporal spikes, brain maturation, structral connectivity, functional connectivity
- Medical subject headings
- Epilepsy, Rolandic, Landau-Kleffner Syndrome, Epilepsy
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: course of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startOct 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rolandic EpilepsyStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Epilepsiecentrum Kempenhaeghe
- Responsible party
- Principal investigator, René Besseling, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335425
- Sponsor's protocol ID
- 10-3-044
- Acronym
- REL
- Status last verified
- Sep 2015
- First submitted
- 13 Apr 2011
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rolandic Epilepsy/ESES/Landau-Kleffner Syndrome and Correlation With Language Impairment Study
- ClinicalTrials.gov ID
- NCT01335425
- Acronym / sponsor ID
- REL / 10-3-044
- Conditions
- Rolandic Epilepsy, Nocturnal Frontal Lobe Epilepsy, Landau-Kleffner Syndrome, Electrical Status Epilepticus During Slow Wave Sleep
- Keywords
- Language problems, childhood epilepsy, bening (rolandic) epilepsy (of childhood) with centro temporal spikes, brain maturation, structral connectivity, functional connectivity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Epilepsiecentrum Kempenhaeghe
- Study start
- Oct 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- aged between 6-18
- diagnosis of Rolandic epilepsy (or other childhood epilepsies as listed in study population description)
Key exclusion criteria (1 listed)
- structural brain lesions which might influence cognition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rolandic Epilepsy and Nocturnal Frontal Lobe Epilepsy, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mechanism that causes language problems in childhood epilepsy (time frame: course of study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.