locked-in syndrome paralysis speech impairment severe paralysis which causes problems with speaking
Conditions
Interventions
The participant will be implanted with a fully implantable device with 4 HD-ECoG electrode grids over the sensorimotor cortex. The device will transmit neural signals optically through the skin to an
train with and use the system at home (i.e., without researcher involvement) for validation of performance and usability. 
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
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, or, in case of a progressive disease, a likelihood of soon progressing into LIS (within an estimated 2 years) Current or imminent complete or incomplete tetraplegia (quadriplegia) or tetraparesis (quadriparesis) Current or imminent 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 for 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 Meets the ABILITY SD assessment for light transmission through the skin
Exclusion criteria
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, or a catabolic state, or strong and frequent spasms) 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 Having implanted materials that make implantation of the ABILITY SD system impossible or that are incompatible with ABILITY SD, such as cochlear implants or deep brain stimulators Anticipated need for therapies relying on the administration of gamma rays (radiosurgery) and therapies relying on the administration of ionizing radiations (e.g., brachytherapy, external beam radiation therapy, systemic radioisotope therapy) that may incur more than negligible exposure of the Implant. Anticipated need for MRI, Transcranial Magnetic Stimulation (TMS), or of diagnostics or therapies relying on ultrasound applied to the head, after implantation of the ABILITY SD system Unvaccinated against Streptococcus pneumoniae and unable to receive such vaccination (e.g., due to allergy) Allergy to materials used in the implant or external components that are in direct contact with the body of the participant
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints are (1) Usability of the BCI system and (2) Stability of BCI performance. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary endpoint 1: Device specifications and experimental parameters Secondary endpoint 2: Adverse events | — |
Countries
Netherlands
Contacts
Public ContactS Blok
Universitair Medisch Centrum Utrecht
Outcome results
None listed