high spinal cord injury, cervical spinal cord injury high spinal cord injury, cervical spinal cord injury
Conditions
Interventions
In this project, we will use an advanced generation fully implantable BCI system, the Brain InterChange (BIC) from CorTec, to accomplish efficient, independent, BCI-based control over digital devices
provide users with somatosensory feedback about their motor attempts (in addition to the visual feedback), by delivering 
electrocortical stimulation (ECS) to the somatosensory regions of the brain. As such, we aim to generate a more natural relation between intent (movement attempt of a body part) and effect (sensation
accurate BCI performance.
Sponsors
Universitair Medisch Centrum Utrecht
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 18-70 years? oldClinical diagnosis of SCI at the cervical level C5 or higher (C1-C5) Complete or incomplete tetraplegia (quadriplegia) or tetraparesis (quadriparesis), i.e., level A or B at the American Spinal Injury Association (ASIA) Impairment ScaleMeeting surgical safety criteria, including surgical clearance by the study physiciansMeeting (neuro)psychological evaluation criteriaAbility to communicate reliably, via speech or other meansWillingness and ability to provide informed consent?.Lives within reasonable distance from UMC UtrechtParticipant consents to the study and still wishes to participate at the time of the study?.Vision and hearing largely intact.For candidates who are not currently receiving invasive ventilation, there should be a clear and confirmed desire to proceed with tracheostomy ventilation when it becomes necessary.
Exclusion criteria
Exclusion criteria: Having a significant current or recent anxiety disorder or depression or cognitive 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 implantsAnticipated need for MRI after implantation of the CorTec Brain InterChange system.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoints are (1) Usability of the BCI system, (2) Stability of BCI performance and (3) Effects of somatosensory feedback on BCI training and performance. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary study parameters to address the secondary objective are device specifications and experimental parameters, such as the specific decoder settings, for future, larger scale, application of HD ECoG-BCIs. | — |
Countries
Netherlands
Contacts
Public ContactS Blok
Universitair Medisch Centrum Utrecht
Outcome results
None listed