In the current proposal, we address four primary objectives:- Assess the precise relationship between hemodynamics and neuronal activity- Investigate the possibilities for high-dimensional brain decoding for ECoG(stereo-EEG)-BCI - Establish whether…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
primary objective 2: locked-in syndroom, primary objective 3: epilepsie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The end-points are described per primary objective:
- Establishment and modeling (quantification) of the relationship between
hemodynamic signals measured with fMRI and underlying neuronal activation
patterns
- The ability of patients to achieve high-dimensional BCI control
- The correspondence between fMRI and ECS and between ECoG/stereo-EEG and ECS
- Function-selective measures of network dynamics, i.e. connectivity, causality
and spatiotemporal patterns
Secondary outcome
NA
Background summary
In the UMC Utrecht, each year about 10 epilepsy patients are implanted with
subdural electrode grids (ECoG) or depth electrodes (stereo-EEG) in order
identify the epileptogenic focus and to determine whether this region can be
surgically resected without loss of essential function, such as motor and
language. The neuronal signals measured using intracranial electrodes are of
very high quality because of the direct contact between the neural tissue and
the measuring electrodes, and are therefore highly suitable to answer a wide
range of fundamental and applied neuroscientific questions. In the current
proposal, we address four primary objectives, all centred around two
populations of patients: ECoG patients and stereo-EEG patients.
Study objective
In the current proposal, we address four primary objectives:
- Assess the precise relationship between hemodynamics and neuronal activity
- Investigate the possibilities for high-dimensional brain decoding for
ECoG(stereo-EEG)-BCI
- Establish whether fMRI or ECoG/stereo-EEG frequency mapping can be a guide or
an alternative to
ECS
- Elucidate the nature and functional correlate of interactions within and
between regions involved in language and cognitive control
Study design
Subjects will be included in an observational study, with interventional
components for some participants
Study burden and risks
There are no known risks associated with fMRI acquisition and the burden can be
considered minimal (performing the fMRI localizer tasks may be slightly
tiring). For patients from the ECoG population, during the clinical
grid-implantation procedure, we will ask the neurosurgeon to implant an extra,
high-density ECoG grid on a location that is clinically irrelevant, without
changing the size or the location of the craniotomy. The added risk on
post-implantation complications for participants due to this extra grid is
estimated to be minimal (0.1% or 0.26%). High-density grids will not be offered
to patients from the stereo-EEG population. There are no known risks associated
with performing localizer or BCI experiments during ECoG/stereo-EEG recordings
and the burden can be considered minimal. Electrocortical stimulation using
(high-density) ECoG grids has proven to be safe and effective, and the risk of
stimulation-induced seizures was found to be minimal.
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- Epilepsy patient (m/f) scheduled for implantation with ECoG grids (for ECoG
population) or stereo-EEG electrodes (for stereo-EEG population)
- 18 years or older
Exclusion criteria
There are no exclusion criteria for the current study. If a patient fulfils the
inclusion criteria and gives informed consent, he/she can be included in the
study. If a subject does not qualify for 3T and/or 7T fMRI (because of e.g.
unremovable metals in the body), or is not willing to perform one or both of
these scans, he / she will be asked to contribute to the ECoG or stereo-EEG
part of the study. If a patient has already performed a clinical fMRI scan, or
when clinical fMRI tasks are combined with research fMRI tasks in the same
session, we will evaluate whether it is possible to use the data of the
clinical scan/tasks for this research, to avoid having to perform a new fMRI
scan, or a repetition of the same tasks, to minimize burden. Whether or not
this is possible will depend on, among others, the task battery performed
clinically.
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 | NL50036.041.14 |