In the current study we expand on the knowledge previously learned in the pilot study and address a wider range of neuroscientific questions related to brain electrophysiological and hemodynamic responses. Because of the rarity and richness of this…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
NA, this is basic brain function research
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The end-points per primary objective are as follows:
1) Achieving offline high-dimensional BCI control using high-density ECoG grids.
2) Establishing and modeling of the relationship between hemodynamic signals
measured with fMRI or optical imaging and the underlying neuronal activation
patterns measured with high-density ECoG.
Secondary outcome
NA
Background summary
Evidence from electrophysiological studies suggests that brain functions are a
result of the connectivity between collections of neurons performing specific
tasks, so-called neural ensembles or functional units. In the last decades, an
increasing number of papers have been published on the neurophysiological
underpinnings of human cognition and behavior at this level of detail, in
particular using electrode grids (silicon sheets with embedded platinum discs)
positioned under the dura in surgery patients. This technique, named
electrocorticography or ECoG, has empowered the study of neurophysiological
mechanisms and consequently improved the treatment of neurological and
psychiatric brain disorders. At the UMC Utrecht, a combination of favorable
factors such as 1) the excellent reputation in research on brain function
involving implanted ECoG grids in the epilepsy surgery program, 2) the
increasing number of surgeons at the UMC who are skilled in awake surgery (now
4), and 3) the increasing number of performed awake surgeries in the last years
(50+ per year), has reinforced the fact that intraoperative recordings (awake
and sleep) are a unique opportunity for research on brain function. In the last
four years, we have conducted a pilot study with high-density ECoG grid
recordings in epilepsy and tumor patients during awake surgeries (approved MREC
14-622). We introduced small high-density ECoG grids as a tool to study the
detail of functional units. These grids promise to extract more detailed
information from a smaller patch of the human cortex, potentially providing an
advance in the field of human cognition and behaviour. In the pilot study we
have determined whether awake surgery on patients with a brain tumor or other
lesions allows for ECoG data collection of adequate quality to address research
questions, which yielded exceptionally encouraging results. Optimal
investigation of human brain functions at that level of detail is only feasible
with highly resolved ECoG grids and is essential to increase the understanding
about the human brain and can contribute to future improvement of
neurotechnology devices, such as Brain Computer Interfaces (BCIs) and possibly
in the long-run close-loop deep-brain stimulation systems.
Study objective
In the current study we expand on the knowledge previously learned in the pilot
study and address a wider range of neuroscientific questions related to brain
electrophysiological and hemodynamic responses. Because of the rarity and
richness of this type of data we will combine multiple objectives in one study,
such that we can efficiently address multiple research questions using one
single setup. The main goal of this study is, therefore, to use high-density
ECoG grids to address two main objectives:
1. Investigate the possibilities for high-dimensional brain decoding for
ECoG-based Brain Computer Interfaces (BCIs);
2. Assess the precise relationship between hemodynamics and neuronal activity;
Study design
Subjects are included in an observational study, which includes intraoperative
ECoG recordings with a high-density grid, intraoperative optical imaging and
pre- or post-surgery structural and functional Magnetic Resonance Imaging (MRI,
fMRI) scans.
Study burden and risks
During the surgery we will ask the neurosurgeon to temporarily position a
high-density electrode grid on exposed or closely accessible brain surface, at
a time that is convenient. ECoG grids are frequently used during epilepsy
surgery and there are no known risks associated with their intraoperative use.
All hardware used for the ECoG recordings is CE or MTKF certified and is safe.
The ECoG measurements are not required for the surgery. There is no immediate
benefit to the participants. There are no known risks associated with
intraoperative optical imaging and pre- or post-surgical MRI/fMRI acquisition.
Intraoperative ECoG and/or optical recordings may slightly increase the
duration of surgery (several minutes). Including all procedures, the burden can
be considered minimal.*
Heidelberglaan 100
Utrecht 3584CX
NL
Heidelberglaan 100
Utrecht 3584CX
NL
Listed location countries
Age
Inclusion criteria
- age 18 years and higher and mentally competent;
- a clinical indication for resection of a tumor or other lesion (e.g. focus of
epileptic seizures);
- a clinical indication for awake surgery (or if applicable, for a full asleep
procedure);
Exclusion criteria
- indication for longer than average (225 min) duration of the procedure
(estimation by the neurosurgeon);
- the neurosurgeon decides that a certain patient is not eligible to
participate in the study (e.g. for medical or surgical reasons);
- planned trepanation too far away for grid placement on a target location
(evaluation by the neurosurgeon and researcher combined);
- reported function loss that prohibits the accurate performance of the
required tasks;
Other exclusion criteria refer to specific parts of the study and do not affect
the overall exclusion of the study. These are for example exclusion criteria
for fMRI research, which include pregnancy, claustrophobia and presence of
metals in the body
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 | NL70197.041.19 |