The research objective is to obtain a more targeted RFTC treatment strategy by gaining more insight into the organization of epilepsy networks. We will study how RFTC affects large-scale brain networks in focal epilepsy and whether these network…
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the post-treatment seizure outcome
(ILAE-classification)26 at 12 months post-RFTC.
Interim measurements include seizure outcome at 3 and 6 months post-RFTC.
Seizure outcome is determined by the treating physician at set interval at the
outpatient clinic.
Secondary outcome
Secondary endpoints will be (in order of secondary research questions):
1. Same as primary/main parameter/endpoint
2. SEEG findings comprising baseline recordings, seizure recordings,
stimulations at 1 Hz pre- and post-RFTC. Data is recorded during the inpatient
admission by the treating physician.
3. Neurological outcomes between 6 to 12 months post-RFTC determined by the
treating physician through neurological examination and neuropsychological
outcomes between 6 to 12 months by using standardized tests.
Background summary
Epilepsy, the fourth most common chronic brain disorder, is characterized by
recurrent seizures. In focal epilepsy, the seizures start at a specific place
in the brain: the epileptogenic zone. Brain surgery, in which the epileptogenic
zone is removed, can stop or reduce seizures in selected patients who have not
been helped with anti-epileptic drugs. Several non-invasive investigations are
required to determine the location of the epileptogenic zone. If these are
insufficiently certain to demonstrate the epileptogenic zone, an invasive brain
examination, such as stereo-electroencephalography (SEEG), may be the answer.
In this SEEG study, multiple depth electrodes are implanted in the brain,
followed by a seizure registration to determine the epileptogenic zone.
In addition to removing this epileptogenic zone through brain surgery,
minimally invasive treatment methods have recently become available. One of
these is SEEG-guided radiofrequency thermocoagulation (RFTC), which turns a
seizure diagnostic technique (SEEG) into a technique to treat these seizures
during the same study. The epileptogenic zone is locally heated and destroyed
by a short-term application of current via the implanted SEEG electrodes. RFTC
is a treatment method with a chance of cure in patients who are either not
eligible for brain surgery (neurosurgical inaccessible areas of the brain) or
as a precursor to later brain surgery if the epileptogenic zone is not yet
completely clear. With (temporary) seizure reduction after RFTC, a good outcome
can be expected after eventual epilepsy surgery. RFTC thus offers a cure for
patients who can only expect relief from seizures with non-curative treatments.
In recent years, it has been increasingly assumed that focal epilepsy is not
limited to a single epilepsy source, but rather a widespread epilepsy network:
a group of brain regions whose activity in one site will affect activity in all
others. This new way of thinking about focal epilepsy has implications for the
surgical approach. Interrupting a critical network node will affect the
seizures. The subject of modern research is to determine critical brain nodes
within the epilepsy network.
Study objective
The research objective is to obtain a more targeted RFTC treatment strategy by
gaining more insight into the organization of epilepsy networks. We will study
how RFTC affects large-scale brain networks in focal epilepsy and whether these
network changes relate to treatment effect and/or neuro(psycho)logical outcome.
We will also investigate whether electrophysiological and neuroimaging network
biomarkers can predict treatment outcome prior to RFTC. With this we want to be
able to better identify the optimal target for RFTC. The aim is to improve
treatment options with seizure freedom without neuro(psycho)logical deficits.
Study design
Study design: This study is a prospective, longitudinal, observational cohort
study.
Duration: Total duration of the study will be 4 years. Study duration
compromises 1) an inclusion phase with collection of data (duration 2,75 years)
with at least one year follow-up for each patient and 2) an analysis phase with
data analysis and reporting (duration 4 years), starting in parallel with the
inclusion phase. Research will be conducted according to all GCP standards.
Study burden and risks
- When participating in this study, additional brain MRI sequences will be
performed on the patient during the study. This is done during two outpatient
MRI examinations (without SEEG electrodes) that are scheduled as part of the
regular treatment. As a result, the patient will have to stay in the MRI
scanner twice for approximately 30 minutes longer (each MRI examination will
not take longer than 60 minutes).
- There is no additional (day) admission or administration of drugs
specifically for this study.
During the research period, admissions will be made - completely within the
framework of regular care - at the Academic Center for Epileptology
Kempenhaeghe and Maastricht UMC+ for 1/ surgical implantation of the SEEG
electrodes (admission MUMC+), 2/ SEEG seizure registration and radiofrequency
thermocoagulation ( admission Kempenhaeghe OR MUMC+) and 3/ surgical
explantation of the SEEG electrodes (admission MUMC+).
- The patient does not have to carry out any assignments specific to the study
at home.
- No drugs are administered specifically for this study.
P. Debyelaan 25
Maastricht 6229HX
NL
P. Debyelaan 25
Maastricht 6229HX
NL
Listed location countries
Age
Inclusion criteria
patients (age >=18 years) with DRE under presurgical evaluation for epilepsy
surgery through SEEG potentially eligible for RFTC treatment
patients able to give informed consent
Exclusion criteria
-Patients who cannot meet the mild physical or psychological criteria for
prolonged MRI recording
-Pacemaker, VNS, DBS, and other MRI incompatible metal implants
-Pregnancy
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 | NL80927.068.22 |