Innovative Brain-Computer Interface for People With Spinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorUMC Utrecht
About this trial
The goal of this clinical trial is to demonstrate control of digital devices through a brain implant in people with spinal cord injury. The main question it aims to answer is efficient, independent, BCI-based control over digital devices in settings of daily living of an individual with SCI. In this project an advanced generation fully implantable BCI system will be used, the Brain InterChange (BIC) from CorTec.
Participants will be implanted with an electrode grid on the surface of the brain and an amplifier/transmitter on the skull, under the skin. Participation includes visits of researchers for recording and training at home, 1-3 times per week for one year. Extension of participation after one year is possible. If successful, the participant will be able to use the BCI at home independently, without the presence of a researcher.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of SCI at the cervical level C4 or higher (C1-C4)
Complete or incomplete tetraplegia (quadriplegia) or tetraparesis (quadriparesis), i.e., level A or B at the American Spinal Injury Association (ASIA) Impairment Scale
Meeting surgical safety criteria, including surgical clearance by the study physicians
Meeting (neuro)psychological evaluation criteria
Disqualifiers
Having a spinal cord injury with a degenerative or progressive etiology.
Having evident swallowing problems.
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)
Trial design
Design model
Single group
Treatments tested in this trial
ECoG (electrocorticography) sensing
DeviceImplant electrodes and amplifier/transmitter and use, through amplifier and decoding, for control of BCI
Treatment groups
1 Participants
are divided into 1 treatment groupGroup A: ECoG (electrocorticography) sensingExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Effectiveness of BCI Control: Accuracy
Accuracy: \>80% sensitivity (true positive rate) for 1-command control; 80% classification accuracy (distinguishing between multiple classes) for multi-command control; and 80% classification accuracy and the correlation between the intended and actual response for multi-command continuous control
Time frame
1 year2
Efficiency of BCI control: Speed
number of accurate selections made per minute
Time frame
1 year3
Efficiency of BCI control: Subjective Workload - Visual Analogue Scale
Subjective Workload: Visual Analogue Scale Continuous scale: Little to no effort (0) - Much effort (5). Lower numbers are better.
Time frame
1 year4
Efficiency of BCI control: Subjective Workload - National Aeronautics and Space Administration-Task Load Index
Subjective Workload: National Aeronautics and Space Administration-Task Load Index Scale: 21 point Likert-type scale. Lower numbers are better.
Time frame
1 yearSecondary outcomes
1
Assess device specifications for future, larger-scale, application of HD ECoG-BCIs
qualitative description on device specifications and experimental parameters, such as the specific decoder settings, for future, larger scale, application of HD ECoG-BCIs
Time frame
1 year2
Validation of software for independent home-use of advanced BCIs
Validation: Questionnaire to evaluate user satisfaction and ease of use of the home use software. Likert-type scale: fully disagree - disagree - neither agree or disagree - agree - fully agree - not applicable. Fully agree is the best result.
Time frame
1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov