|- candidate number||21169|
|- NTR Number||NTR5038|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||17-dec-2014|
|- Secondary IDs|| 15-038 METC|
|- Public Title||Ultra snelle hersengolven bij mensen met epilepsie|
|- Scientific Title||Non-invasively recorded high frequency oscillations as biomarker in focal epilepsy|
|- hypothesis||We hypothesize that HFOs recorded non-invasively with MEG and scalp EEG are biomarkers of disease activity like iEEG HFOs|
|- Healt Condition(s) or Problem(s) studied||Epilepsy, Seizures, Focal epilepsy|
|- Inclusion criteria||Patients with refractory epilepsy|
six years and older
|- Exclusion criteria||metal implants|
no MEG compatibility
having had depth electrodes (sEEG)
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-mrt-2015|
|- planned closingdate||1-mrt-2018|
|- Target number of participants||30|
|- Interventions||EEG, MEG and ECoG before and after resection.|
EEG and ECoG are part of the standard clinical work-up.
Pre-operative MEG is part of standard clinical work-up for some patients.
Patients will undergo extra post-operative MEG and sometimes pre-operative MEG together with simultaneous EEG.
|- Primary outcome||The occurrence of HFOs in EEG, MEG and ECoG.|
The main study endpoints are the number of patients showing HFOs with each technique, the number of HFOs per channel and the brain areas that show HFOs.
|- Secondary outcome||Number of seizures before and after surgery and cognitive outcome|
|- Timepoints||EEG and MEG will take place before surgery, right after inclusion. Surgery will follow within 2 week- 3 months and followed by MEG and EEG in 6 weeks to 6 months.|
Surgical outcome and cognitive outcome are determined 1 year after surgery.
|- Trial web site||-|
|- CONTACT FOR PUBLIC QUERIES|| Nicole van Klink|
|- CONTACT for SCIENTIFIC QUERIES|| Nicole van Klink|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|Dutch Epilepsy Foundation (NEF), ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Rationale: |
Background: A new biomarker is needed to establish prognosis in focal epilepsy. High frequency oscillations (HFOs) seem a good candidate biomarker, but HFOs are currently used in intracranial electroencephalography (iEEG). When measured with subdural grids, this is called corticography. HFOs can also be measured non-invasively using scalp EEG and magnetoencephalography (MEG). This is a very recent discovery which needs more research before we can draw conclusions on HFOs. Non-invasive HFO analysis will improve early identification of a focal epilepsy generator, and will be available in all patients.
Hypothesis: HFOs recorded non-invasively with MEG and scalp EEG are biomarkers of ictogenesis and disease activity like iEEG HFOs.
Primary objective of this study is to improve identification of epileptic HFOs in EEG and MEG, by using combined MEG-EEG recordings and to compare these with HFOs in corticography. Secondary objective is to study the relation of non-invasively recorded HFOs with the number of seizures and cognitive test results before and after surgery.
Prospective observational study
Patients with drug-resistant focal epilepsy who will undergo epilepsy surgery with intraoperative corticography in the UMCU and will get a clinical MEG registration, and patients with drug-resistant focal epilepsy who will undergo epilepsy surgery with pre-operative corticography in the UMCU, regardless whether they get a clinical MEG registration or not. All patients are six years of age or older. In total we will include 30 patients.
Intervention (if applicable):
Main study parameters/endpoints:
The parameter we study is HFOs. We will compare the number and distribution of HFOs recorded with different techniques (corticography and simultaneous MEG and scalp EEG), look at how the extent of brain tissue generating HFOs correlates to seizure frequency, and investigate if there is a correlation between the number of HFOs remaining after surgery and the number of postoperative seizures and cognitive functioning, and compare these measures between the different techniques.
|- Main changes (audit trail)|
|- RECORD||17-dec-2014 - 15-apr-2015|