An interventional study of ECoG (electrocorticography) sensing in Locked-in Syndrome, Neuromuscular Diseases and Brainstem Stroke, sponsored by UMC Utrecht. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-10-03.
Sponsored by UMC Utrecht · Not applicable, Interventional, and Supportive care
The goal of this clinical trial is to demonstrate communication through a brain implant in people in locked-in state, i.e. people with severe paralysis and communication problems.
The main questions it aims to answer are efficient and stable control of Brain-Computer interface (BCI) functions for communication with attempted hand movements and operation of a keyword-based speech BCI.
Participants will be implanted with four electrode grids, with in total 128 electrodes, on the surface of the brain and a connector on the skull. Participation includes visits of researchers for recording and training at home, 2-3 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.
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. In this study, the "CortiCom system" (which stands for Cortical Communication) wil be used. This system combines an implantable assembly, consisting of four small high-density (HD) ECoG grids on the hand and speech areas of the motor cortex, totalling 128-channels, and a transcutaneous pedestal connector, with an external data acquisition system. With the CortiCom system the overall hypothesis will be tested 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.
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.
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, participants 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.
20 studies on the registry are indexed under Locked-In Syndrome; 12 are open to participants now.
This study's planned enrollment of 2 is below the median of 7 across 17 interventional studies indexed under Locked-In Syndrome.
Browse Locked-In Syndrome studies →UMC Utrecht is the lead sponsor of 364 studies on the registry; 82 are open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Use implantable ECoG-based Brain Computer interface to control assistive technology
Device: ECoG (electrocorticography) sensing
Implant electrodes and pedestal connector and use, through amplifier and decoding, for control of BCI
Also known as: CortiCom-Utrecht assembly
Usability of the BCI system - Accuracy
Accuracy: \>80% sensitivity (true positive rate) for 1-command control, and 90% sensitivity and 80% classification accuracy (distinguishing between the six classes) for 6-command control
Time frame: 1 year
Usability of the BCI system - speed
Speed characters or keywords per minute
Time frame: 1 year
Usability of the BCI system - subjective workload Visual Analogue Scale (VAS)
Subjective Workload: Visual Analogue Scale Continuous scale: Little to no effort (0) - Much effort (5). Lower numbers are better.
Time frame: 1 year
Usability of the BCI system - subjective workload National Aeronautics and Space Administration-Task Load Index (NASA-TLX)
Subjective Workload: National Aeronautics and Space Administration-Task Load Index Scale: 21 point Likert-type scale. Lower numbers are better.
Time frame: 1 year
Usability of the BCI system - user satisfaction Psychosocial impact of assistive devices scale (PIADS)
User Satisfaction: Psychosocial impact of assistive devices scale. Likert-type scale -3, -2, -1, 0, 1, 2, 3. 3 is best result.
Time frame: 1 year
Usability of the BCI system - user satisfaction Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
User Satisfaction: Quebec User Evaluation of Satisfaction with assistive Technology version 2.0. Likert-type scale: Extremely dissatisfied - Dissatisfied - Slightly satisfied - Satisfied - Extremely satisfied. Extremely Satisfied is the best result.
Time frame: 1 year
Usability of the BCI system - validation
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 year
Degrees of Freedom of BCI Control.
the number of different commands that are successfully decoded, or the size of the decoded vocabulary
Time frame: 1 year
Stability of BCI performance (electrode-tissue interaction)
Longitudinal data of the 24-hour cycle after implantation of the impedance (in Ω). The data are fitted to determine trends and variance, over weeks, to determine improvement or deterioration of electrode-tissue interaction.
Time frame: 2 years
Stability of BCI performance (signal)
Longitudinal data of the 24-hour cycle after implantation of the raw power (after wavelet transform, in arbitrary units). The data are fitted to determine trends and variance, both within 24 hrs to detect a possible circadian pattern and over weeks, to determine improvement or deterioration of signal amplitude.
Time frame: 2 years
Stability of BCI performance (modulation)
Longitudinal data of the 24-hour cycle after implantation of the task-related modulation in power (correlation in r2). The data are fitted to determine trends and variance, over weeks, to determine improvement or deterioration of modulation.
Time frame: 2 years
Stability of BCI performance (performance)
Longitudinal data of the 24-hour cycle after implantation of the BCI performance (task accuracy). The data are fitted to determine trends and variance, both within 24 hrs to detect a possible circadian pattern and over weeks, to see improvement or deterioration of accuracy.
Time frame: 2 years
Independent use of BCI
Longitudinal data of independent use per day. The best result is 24h use. The data are fitted to determine trends and variance, both within 24 hrs to detect a possible circadian pattern and over weeks, to see increase or decrease of the hours of independent use.
Time frame: 2 years
Assess device specifications for future 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: 2 years
Plan to share: Yes — selected datasets will be available through a public repository after publication of results
Time frame: after first published results, no end date
Access criteria: Publicly available
Started Dec 2023 (actual). Primary completion is estimated for Sep 2028, 57 months after the start.
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