Objective: Primary Objective 1: Demonstrate efficient and stable control of essential BCI functions (initiate BCI, call caregiver, and menu selections). Primary Objective 2: Demonstrate efficient and stable operation of a keyword-based speech BCI.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
ernstige verlamming en communicatieproblemen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Main study parameters/endpoints: Primary endpoints are Usability of the BCI
system and Degrees of Freedom of BCI Control.
Secondary outcome
Primary endpoints are Usability of the BCI system and Degrees of Freedom of BCI
Control. The secondary endpoint is Stability and Independent use of BCI
performance.
Background summary
Rationale: Locked-In Syndrome (LIS) is a neurological condition in which
communication is impossible, or profoundly impaired, due to loss of speech and
other motor functions, while cognition is intact. The most distressing aspect
of LIS is the inability to initiate and sustain communication. Existing
assistive technologies (ATs) fall short of a remedy. An effective
brain-computer interface (BCI) for communication would dramatically improve
quality of life for people with LIS. Electrocorticography (ECoG) with
non-penetrating subdural electrodes is a promising implantable approach for
BCI. Within our earlier Utrecht Neural Prosthesis (UNP project, METC 12-370),
we have demonstrated the feasibility of achieving stable and reliable
ECoG-BCI-based communication in people with LIS. We used the Medtronic Activa
PC+S device to record 4 channels of ECoG from functional magnetic resonance
imaging (fMRI)-localized targets in the sensorimotor cortex. In this new study,
we will use the *CortiCom system*. This system combines an implantable
assembly, consisting of four small high-density (HD) ECoG grids, totalling
128-channels, and a transcutaneous pedestal connector, with an external data
acquisition system. With the CortiCom system we can test our overall hypothesis
that broader and more densely spaced ECoG electrodes can better tap into the
spatial detail of the organization of the sensorimotor cortex in order to
expand BCI function and restore meaningful communication in LIS. Specifically,
the CortiCom system will substantially increase the number and density of
electrodes recording from the brain to determine whether more sophisticated
control and communication can be achieved with more comprehensive and detailed
spatial sampling of representations for movements of the hand/arm and of speech
articulators. Clinically meaningful outcomes for people with LIS include rapid
reestablishment, and stable maintenance of communication, at minimum consisting
of a caregiver call-button and menu selections.
Study objective
Objective: Primary Objective 1: Demonstrate efficient and stable control of
essential BCI functions (initiate BCI, call caregiver, and menu selections).
Primary Objective 2: Demonstrate efficient and stable operation of a
keyword-based speech BCI.
Study design
Study design: This study is an interventional pilot study.
Intervention
Intervention: Participants will be implanted with an assembly consisting of
HD-ECoG electrode grids over the sensorimotor cortex and a transcutaneous
pedestal connector. The assembly will be connected with an external data
acquisition system during recordings. During recordings, feedback about the
neural signals is given via a visual display and participants are trained to
employ the neural signals for fast brain-based communication. Upon adequate
performance, they can independently (i.e., without researcher involvement)
train with and use the system at home for validation of performance and
usability. After implantation, participation has a duration of 1 year, with a
possibility of extension.
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefit and group relatedness: The research is fully directed at the patient
population participating in the study. The benefit will be an increase in
knowledge on neural signals and on the usability of an ECoG-based BCI as a
means of communication for patients in a locked-in state. There is a chance
that participants experience benefit from participation in terms of acquiring a
new means of communication. The burden of participation is mostly related to
hospital visits, a hospital admission including surgery, and frequent visits of
the research team to the resident of the participant (for testing and
training). The most important risks are those associated with the surgical
implantation of the HD-ECoG electrode grids and placement of the transcutaneous
pedestal connector, which are similar to those of any brain surgery (e.g.
hemorrhage, infection, brain oedema). Other risks include those of CT scans, an
MRI scan (participants are likely to require respiratory support, which
requires specific attention during the scan), and disappointment if the system
fails to provide a reliable and fast communication channel.
Universiteitsweg 100
Utrecht 3584CG
NL
Universiteitsweg 100
Utrecht 3584CG
NL
Listed location countries
Age
Inclusion criteria
• 18-70 years
• Clinical diagnosis of locked-in state caused by traumatic brain injury,
brainstem stroke,
neurodegenerative disease, neuromuscular disease or another cause
• Complete or incomplete tetraplegia (quadriplegia) or tetraparesis
(quadriparesis)
• Motor-related speech impairment (dysarthria or anarthria)
• Either receiving tracheostomy invasive ventilation, or having a stable and
adequate
respiratory situation without respiratory support, allowing for safe
intubation, mechanical ventilation and detubation during surgery according to
the involved clinicians, and, if relevant (e.g., in case of a progressive
condition), in combination with a confirmed desire to receive tracheostomy
invasive ventilation when that becomes necessary
• Meeting surgical safety criteria, including surgical clearance by the study
physicians
• Meeting (neuro)psychological evaluation criteria
• Ability to communicate reliably, such as through eye movement
• Willingness and ability to provide informed consent
• Lives within reasonable distance from UMC Utrecht
• Participant consents to the study and still wishes to participate at the time
of the study
• Vision and hearing largely intact
Exclusion criteria
• Performance on formal neuropsychological testing that indicates a significant
current or
recent psychiatric disorder, cognitive or behavioral impairment, that would
interfere with obtaining informed consent or fully participating in study
activities
• Medical conditions contraindicating surgery of a chronically implanted device
or that could
interfere with study participation (for example active infections, unexplained
fever, existing scalp lesions or skin breakdown, osteomyelitis, hepatitis, any
autoimmune disease/disorder, epilepsy, skin disorders causing excessive skin
sloughing or poor wound healing, cranioplasty, significant cardiovascular,
metabolic, or renal impairments, chronic oral or intravenous use of steroids or
immunosuppressive therapy, active cancer within the past year or requires
chemotherapy, uncontrolled autonomic dysreflexia within the past 3 months,
hydrocephalus with or without an implanted ventricular shunt or a medical
contraindication to stop anti-coagulant medications during surgery)
• Presence of pre-surgical findings in anatomical, functional, and/or vascular
neuroimaging that makes achieving implant locations too challenging or
incompatible with desired risk levels
• Inability to undergo MRI for pre-implantation evaluation, for example due to
the presence
of implanted devices that are incompatible with MRI, which may include
pacemakers,
cardiac defibrillators, spinal cord or vagal nerve stimulators, deep brain
stimulators, and
cochlear implants
• Anticipated need for MRI after implantation of the CortiCom assembly
Design
Recruitment
Medical products/devices used
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 | NL81205.041.23 |