Primary objective of this study is to improve identification of epileptic HFOs in EEG and MEG, by comparing them to HFOs in corticography. Secondary objectives are to study the predictive value of non-invasively recorded HFOs for disease activity…
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- The number of patients with HFOs with each technique (corticography, scalp
EEG, MEG)
- The number of HFOs per minute with each technique
- The brain aeas showing HFOs with each technique
Secondary outcome
- The number of seizures before and after surgery
- The results of cognitive tests before and after surgery
Background summary
High frequency oscillations (HFOs) are proposed as biomarker for
epileptogenicity, but HFOs are currently used in intracranial
electroencephalography (iEEG). Very recent studies show that HFOs can also be
measured non-invasively using scalp EEG and magnetoencephalography (MEG). This
discovery needs more research before we can draw conclusions on HFOs.
Non-invasive HFO analysis will improve early identification of a focal epilepsy
generator, and might be used for monitoring of disease activity.
Hypothesis: HFOs recorded non-invasively with MEG and scalp EEG are biomarkers
of ictogenesis and disease activity like iEEG HFOs.
Study objective
Primary objective of this study is to improve identification of epileptic HFOs
in EEG and MEG, by comparing them to HFOs in corticography. Secondary
objectives are to study the predictive value of non-invasively recorded HFOs
for disease activity and cognitive functions.
Study design
Prospective observational cohort study
Study burden and risks
In this study, patient will undergo pre and post operative simultaneous EEG-MEG
recordings and pre- or intraoperative corticography. However, the corticography
is done in all patients regardless of our research. The only extra burden for
our patients would therefore be the simultaneous scalp EEG-MEG recording (two
times).
Risks
MEG and EEG are both safe recording techniques of brain signals, there is no
risk involved in undergoing an MEG-EEG.
Burden
-Patients would have to travel to the VU medical center in Amsterdam for the
MEG-EEG recording, because there is no MEG available in the UMCU.
-MEG-EEG recording can be uncomfortable because patients need to lie
practically motionless while the machine is recording brain signals. We expect
this to be too demanding for children under six. We will also exclude older
patients for whom this is expected or appears to be too much.
Benefit
A benefit of undergoing MEG-EEG is that patients get an extra test in their pre
and post surgical work-up.
Patients can not count on above mentioned benefit, but considering the very low
risk and small burden, we think it is ethically justified to perform this
study.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
-Patients have refractory focal epilepsy (not responding to treatment with anti-epileptic drugs) and are candidates for epilepsy surgery in the University Medical Center Utrecht with pre or intra operative corticography (measuring brains signals during surgery).
- Adults and children over six
- EEG and MEG compatible
Exclusion criteria
-Patients who undergo epilepsy surgery outside the UMCU, or without pre or intra operative corticography
-Patients with metal implants (not MEG compatible)
-Patients under six and other patients unable to lie down or sit motionless for at least 15 minutes (not MEG compatible)
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 | NL50715.041.14 |