The primary objective of this study is to characterize functional brain networks in patients considered for (i) epilepsy surgery and (ii) tumour surgery with epilepsy surgery techniques. Characterization will be done preoperatively (MEG), during…
ID
Source
Brief title
Lesional epilepsy and neural networks
Condition
- Seizures (incl subtypes)
- Psychiatric disorders
- Nervous system, skull and spine therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are ECoG and MEG measures assessing functional
connectivity and neuronal brain networks (clustering coefficient and path
length), as well as the clinical measures of seizure frequency, epilepsy burden
and cognition.
Secondary outcome
This includes the MRI scans.
Background summary
Epilepsy is common in patients with circumscribed brain abnormalities, such as
primary brain tumours and focal cortical dysplasias. In a substantial number of
these patients, anti-epileptic drug treatment is ineffective. Patients with
lesional epilepsy in whom no brain tumour is present will be referred to
epilepsy surgery programs. The aim of these programs is to (1) identify and,
subsequently, (2) remove the ictal zone. This leads to long-term seizure
freedom in only 30-60% of patients.
Although in patients with brain tumours the primary aim of surgery is the
removal of the tumour, it is increasingly acknowledged that resective surgery
may also result in a decrease of seizure frequency. For both patient groups,
improvement of outcome of epilepsy surgery will therefore be extremely
relevant.
Electrocorticography (ECoG) and magnetoencephalography (MEG) are imaging
techniques that are used for detection of seizure activity and epileptic source
localization as well as assessment of functional connectivity and neural
network features throughout the brain. Recent research advances concerning
functional connectivity and network properties of the brain have indicated that
these techniques may be used for epileptic source localization and to
investigate factors that determine the frequency of epileptic seizures.
Application of these methods in candidates for epilepsy surgery may lead to
more effective treatment and improvement of surgical outcome.
Study objective
The primary objective of this study is to characterize functional brain
networks in patients considered for (i) epilepsy surgery and (ii) tumour
surgery with epilepsy surgery techniques. Characterization will be done
preoperatively (MEG), during surgery (ECoG) and post surgery (MEG). At each
stage, networks will be characterized using graph theoretical measures that are
expected to be related to seizure proneness.
The secondary objectives of this study are: (1) To relate network properties at
different stages to (i) seizure frequency, (ii) seizure burden, and (iii)
cognition; (2) To develop a model to predict the effect of surgery on network
changes and reduction of seizure burden.
Study design
This is a longitudinal observational study.
Study burden and risks
For patients, the burden associated with participation consists of a number of
visits to the outpatients* clinic for three MEG and MRI measurements, an ECoG
and two neuropsychological screenings. It should be stressed that the ECoG,
first MEG measurement as well as the first two MRI measurements are already
part of routine practice in epilepsy patients. Furthermore, patients will be
asked to keep a diary regarding the frequency and severity of epileptic
seizures during the course of their disease. No health-related risks are
involved in this study. In our view, the burden associated with participation
is proportionate to the potential value of the research for patients suffering
from epilepsy.
De Boelelaan 1117
1081 HV Amsterdam
NL
De Boelelaan 1117
1081 HV Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Inclusion criteria for pharmacoresistant epilepsy patients are (1) adult (>18 years) patients who (2) undergo resective surgical treatment at the VUmc regarding the Dutch Collaborative Epilepsy Surgery Program and (3) have given written informed consent. ;For brain tumour patients with epilepsy, inclusion criteria are (1) adult (* 18 years) patients who (2) undergo resective surgical treatment of the tumour with epilepsy surgery techniques at the VUmc, (3) are suffering from epilepsy which was not pre-existent to the lesion and (4) have given written informed consent.
Exclusion criteria
Exclusion criteria are (1) psychiatric disease or symptoms, (2) insufficient mastery of the Dutch language, (3) inability to communicate adequately.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL28447.029.09 |