Locked-in SyndromeCortiComNCT06207591
Investigation on the Cortical Communication System
A study testing ECoG (electrocorticography) sensing in people with Locked-in Syndrome and Neuromuscular Diseases, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Locked-in Syndrome, Neuromuscular Diseases, Brainstem Stroke
- What is being tested?
- ECoG (electrocorticography) sensing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteNetherlands
- Study dates
- 15 Dec 2023to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-70 years
- Clinical diagnosis of locked-in state state or likelihood of soon progressing into LIS (within an estimated 2 years), caused by traumatic brain injury, brainstem stroke, neurodegenerative disease, neuromuscular disease or another cause
- • 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 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
Show all 12Show fewer
- 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 University Medical Center Utrecht
- Participant consents to the study and still wishes to participate at the time of the study
- Vision and hearing largely intact
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands1 site, 1 recruiting
- Recruiting
University Medical Center
Utrecht, 3584CX
Mariska J Vansteensel, PhD, +31887555121, neuroprothese@umcutrecht.nl
Erik J Aarnoutse, PhD, +31887555123, e.j.aarnoutse@umcutrecht.nl
About this study
Official title: Investigation on the Cortical Communication (CortiCom) System
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.
Read more
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.
Read the detailed description
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.
- Being tested
- ECoG (electrocorticography) sensing
- Keywords
- Locked-in, Amyotrophic lateral sclerosis, Neurodegenerative disease
- Medical subject headings
- Locked-In Syndrome, Neuromuscular Diseases, Brain Stem Infarctions, Brain Injuries, Traumatic, Amyotrophic Lateral Sclerosis, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECoG (electrocorticography) sensingDevice
Also called CortiCom-Utrecht assembly
Implant electrodes and pedestal connector and use, through amplifier and decoding, for control of BCI
| Study group | Role | What they receive |
|---|---|---|
| ECoG (electrocorticography) sensing | Experimental | Use implantable ECoG-based Brain Computer interface to control assistive technology Receives: Device: ECoG (electrocorticography) sensing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Usability of the BCI system - speed
Speed characters or keywords per minute
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Degrees of Freedom of BCI Control.
the number of different commands that are successfully decoded, or the size of the decoded vocabulary
Measured: 1 year
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start15 Dec 2023
- Primary completionSep 2028 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Locked-in SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Principal investigator, Erik Aarnoutse, PhD, UMC Utrecht
- Investigators
- Nick F Ramsey, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207591
- Sponsor's protocol ID
- UMCU 23-171
- Other IDs
- NL81205.041.23
- Acronym
- CortiCom
- Status last verified
- Sep 2025
- First submitted
- 1 Dec 2023
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: selected datasets will be available through a public repository after publication of results
Publications
Vansteensel MJ, Leinders S, Branco MP, Crone NE, Denison T, Freudenburg ZV, Geukes SH, Gosselaar PH, Raemaekers M, Schippers A, Verberne M, Aarnoutse EJ, Ramsey NF. Longevity of a Brain-Computer Interface for Amyotrophic Lateral Sclerosis. N Engl J Med. 2024 Aug 15;391(7):619-626. doi: 10.1056/NEJMoa2314598.
PubMed 39141854Vansteensel MJ, Pels EGM, Bleichner MG, Branco MP, Denison T, Freudenburg ZV, Gosselaar P, Leinders S, Ottens TH, Van Den Boom MA, Van Rijen PC, Aarnoutse EJ, Ramsey NF. Fully Implanted Brain-Computer Interface in a Locked-In Patient with ALS. N Engl J Med. 2016 Nov 24;375(21):2060-2066. doi: 10.1056/NEJMoa1608085. Epub 2016 Nov 12.
PubMed 27959736The neural representation of fine hand movements in an individual approaching locked-in syndrome (2025) S.H. Geukes, A. Bekius, M.P. Branco, M.S.W. Verberne, A. Schippers, Z.V. Freudenburg, E.J. Aarnoutse, M.J. Vansteensel, N.E. Crone, N.F. Ramsey. 11th International BCI Meeting, Banff, Canada, DOI: 10.3217/978-3-99161-050-2-085
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation on the Cortical Communication (CortiCom) System
- ClinicalTrials.gov ID
- NCT06207591
- Acronym / sponsor ID
- CortiCom / UMCU 23-171
- Keywords
- Locked-in, Amyotrophic lateral sclerosis, Neurodegenerative disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 17 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECoG (electrocorticography) sensing | Experimental | Device: ECoG (electrocorticography) sensingUse implantable ECoG-based Brain Computer interface to control assistive technology |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 18-70 years
- Clinical diagnosis of locked-in state state or likelihood of soon progressing into LIS (within an estimated 2 years), caused by traumatic brain injury, brainstem stroke, neurodegenerative disease, neuromuscular disease or another cause
- • 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 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECoG (electrocorticography) sensingAlso: CortiCom-Utrecht assemblyImplant electrodes and pedestal connector and use, through amplifier and decoding, for control of BCI | Device | ECoG (electrocorticography) sensing |
Primary outcome
Usability of the BCI system - Accuracy
Time frame: 1 year
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
Usability of the BCI system - speed
Time frame: 1 year
Speed characters or keywords per minute
Usability of the BCI system - subjective workload Visual Analogue Scale (VAS)
Time frame: 1 year
Subjective Workload: Visual Analogue Scale Continuous scale: Little to no effort (0) - Much effort (5). Lower numbers are better.
Usability of the BCI system - subjective workload National Aeronautics and Space Administration-Task Load Index (NASA-TLX)
Time frame: 1 year
Subjective Workload: National Aeronautics and Space Administration-Task Load Index Scale: 21 point Likert-type scale. Lower numbers are better.
Usability of the BCI system - user satisfaction Psychosocial impact of assistive devices scale (PIADS)
Time frame: 1 year
User Satisfaction: Psychosocial impact of assistive devices scale. Likert-type scale -3, -2, -1, 0, 1, 2, 3. 3 is best result.
Usability of the BCI system - user satisfaction Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
Time frame: 1 year
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.
Usability of the BCI system - validation
Time frame: 1 year
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.
Degrees of Freedom of BCI Control.
Time frame: 1 year
the number of different commands that are successfully decoded, or the size of the decoded vocabulary
5 secondary outcomes
Stability of BCI performance (electrode-tissue interaction)
Time frame: 2 years
Stability of BCI performance (signal)
Time frame: 2 years
Stability of BCI performance (modulation)
Time frame: 2 years
Stability of BCI performance (performance)
Time frame: 2 years
Independent use of BCI
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Background: PubMed 39141854Vansteensel MJ, Leinders S, Branco MP, Crone NE, Denison T, Freudenburg ZV, Geukes SH, Gosselaar PH, Raemaekers M, Schippers A, Verberne M, Aarnoutse EJ, Ramsey NF. Longevity of a Brain-Computer Interface for Amyotrophic Lateral Sclerosis. N Engl J Med. 2024 Aug 15;391(7):619-626. doi: 10.1056/NEJMoa2314598.
- Background: PubMed 27959736Vansteensel MJ, Pels EGM, Bleichner MG, Branco MP, Denison T, Freudenburg ZV, Gosselaar P, Leinders S, Ottens TH, Van Den Boom MA, Van Rijen PC, Aarnoutse EJ, Ramsey NF. Fully Implanted Brain-Computer Interface in a Locked-In Patient with ALS. N Engl J Med. 2016 Nov 24;375(21):2060-2066. doi: 10.1056/NEJMoa1608085. Epub 2016 Nov 12.
- Results publicationThe neural representation of fine hand movements in an individual approaching locked-in syndrome (2025) S.H. Geukes, A. Bekius, M.P. Branco, M.S.W. Verberne, A. Schippers, Z.V. Freudenburg, E.J. Aarnoutse, M.J. Vansteensel, N.E. Crone, N.F. Ramsey. 11th International BCI Meeting, Banff, Canada, DOI: 10.3217/978-3-99161-050-2-085
- Individual participant dataSharing planned: Yes. selected datasets will be available through a public repository after publication of results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nick F Ramsey, PhD principal investigator
UMC Utrecht
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECoG (electrocorticography) sensing in people with Locked-in Syndrome and Neuromuscular Diseases, run by UMC Utrecht at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mariska J Vansteensel, PhD (+31887555121, neuroprothese@umcutrecht.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability of the BCI system - Accuracy (time frame: 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06207591, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.