In the current proposal, two primary objectives will be addressed. The first is to establish the spatial correspondence between fMRI, ECoG/stereo-EEG and ECS for different brain functions in children. The second is to investigate the feasibility of…
ID
Source
Brief title
Condition
- Seizures (incl subtypes)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The end-points are described per primary objective: 1) Spatial match between
fMRI/ECoG/stereo-EEG activation patterns and ECS results for different brain
functions. 2) Mapping of target regions for BCI control and the ability of
patients to achieve accurate BCI control.
Secondary outcome
Not applicable
Background summary
Each year, a number of patients with refractory epilepsy are implanted with
subdural strips and grids of electrodes (ECoG) or with 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. In
the last years, a great portion of the scheduled patients are children, because
they have a lot to gain by early resection of the epileptic focus (Spencer and
Huh, 2008; Maehara et al., 2002). At the UMC, more than 70% of children treated
are seizure free after 1 year. 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,
such as the mapping of brain functions and the development of assistive
technology known as Brain-Computer Interfaces (BCIs). In the current proposal,
we address these two topics in this population of patients, yielding two
primary objectives.
Study objective
In the current proposal, two primary objectives will be addressed. The first is
to establish the spatial correspondence between fMRI, ECoG/stereo-EEG and ECS
for different brain functions in children. The second is to investigate the
feasibility of an ECoG/stereo-EEG-BCI for children.
Study design
Subjects will be included in an observational study.
Study burden and risks
There are no known risks associated with fMRI acquisition. The technique does
not require administration of any contrast agent or ionizing radiation. The
fMRI procedure is painless. Slight discomfort may occur due to lying still with
the head and part of the body confined in a tunnel-like device. There are no
known risks associated with performing tasks during ECoG/stereo-EEG recordings.
Implantation of electrodes does carry a risk which is taken into account in the
clinical decision to operate. The present study does not add to that risk, as
the grids are implanted purely for diagnostic purposes. The tasks are much like
simple computer tasks or watching videos for children, and as such pose a
minimal additional burden. No direct benefits are expected for the subjects of
the current study. If results are positive, they are expected to form the basis
for alternative, fast, and patient-friendly methods of functional mapping (as a
manner to guide or eventually replace ECS), suitable for children of the same
population (refractory epilepsy).
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- Epilepsy patient (m/f) scheduled for implantation with either ECoG grids or
stereo-EEG electrode strips
- Mental age 5-18 years
Exclusion criteria
For fMRI:
- metal objects in the body that are not MRI compatible
- inability to lie still
-anxiety in scanner (evaluated by parent or after practise in mock scanner),
For ECoG and stereo-EEG: none
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 | NL48022.041.14 |