Spinal Cord InjuryINTENSE-BCINCT07640711
Innovative Brain-Computer Interface for People With Spinal Cord Injury
A study testing ECoG (electrocorticography) sensing in people with Spinal Cord Injury and Tetraplegia C1-C4, run by UMC Utrecht at 1 site in Netherlands.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spinal Cord Injury, Tetraplegia C1-C4, Quadriplegia
- 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
- 1 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2026to Aug 2028
- 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
- 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
- Ability to communicate reliably, via speech or other means
- Willingness and ability to provide informed consent.
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- 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.
- For candidates who are not currently receiving invasive ventilation, and who have current respiratory problems (e.g., at night), there should be a clear and confirmed desire to proceed with tracheostomy ventilation whenever that would become necessary.
Who cannot join
- 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)
- 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 or devices that deliver diaphragm pacing.
- Anticipated need for MRI after implantation of the Brain InterChange system.
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
Utrecht, 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: Innovative Neurotechnology For Society - Brain-Computer Interface
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.
Read the detailed description
Spinal Cord Injury (SCI) results in motor impairments in body parts innervated by the spinal cord below the site of the lesion. In addition to loss of leg movements, individuals with high cervical SCI experience significant impairments in arm and hand function (tetraplegia), impacting their access to digital devices, with obvious consequences for their ability to communicate, participate in society and the workforce, autonomously manage their life, and benefit from the entertainment options digital devices offer these days. Current assistive technologies (AT) for control over digital devices, such as voice control, eye-tracking, and head- or mouth-controlled devices, are often unintuitive, slow, limited in functionality, aesthetically unattractive, and they often interfere with regular movement or speech. An effective Brain-Computer Interface (BCI) would enable individuals with SCI to use movement-related neural signals to directly control digital devices, taking away the disadvantages of current AT. This would dramatically improve their quality of life.
The Brain InterChange from CorTec is an active implantable medical device for measurement of neuronal activity and electrical stimulation of the human nervous system, comprising an internal and an external unit. The internal unit consists of a small high-density ECoG grid with 32 contacts placed subdurally and a connected implantable amplifier/transmitter device that is placed subcutaneously. The external unit comprises a headpiece, for power transmission to the internal unit, a communication unit, that receives the data transmitted from the internal unit and controls the power transmission, and a USB cable, that connects the communication unit to the computer that has software to process and translate the brain data to a means of digital device control for SCI patients with custom in-house software developed during this study.
The BCI system also allows to 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, the aim is to generate a more natural relation between intent (movement attempt of a body part) and effect (sensation in the same body part), which is expected to lead to fast training and accurate BCI performance.
- Conditions
- Spinal Cord Injury, Tetraplegia C1-C4, Quadriplegia
- Being tested
- ECoG (electrocorticography) sensing
- Medical subject headings
- Spinal Cord Injuries, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECoG (electrocorticography) sensingDevice
Also called Brain Interchange
Implant electrodes and amplifier/transmitter 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 digital devices Receives: Device: ECoG (electrocorticography) sensing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Efficiency of BCI control: Speed
number of accurate selections made per minute
Measured: 1 year
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.
Measured: 1 year
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.
Measured: 1 year
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
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
Stability of BCI performance: impedance
Longitudinally follow the electrode impedance (in Ω), to assess their stability throughout the day and across the weeks and months after implantation.
Measured: 1 year
Stability of BCI performance: signal dynamics
Longitudinally follow the raw signal dynamics (in µV) of neural signals, to assess their stability throughout the day and across the weeks and months after implantation.
Measured: 1 year
Stability of BCI performance: task-related modulation
Longitudinally follow the task-related modulation in power (in µV), to assess their stability throughout the day and across the weeks and months after implantation.
Measured: 1 year
Effects of somatosensory feedback on BCI Training and Performance: accuracy
Compare BCI control accuracy (in %), including variability and improvement therein before and after applying somatosensory feedback through electrocortical stimulation of the somatosensory cortex
Measured: 1 year
Effects of somatosensory feedback on BCI Training and Performance: neural signals
Compare neural signal changes (in µV) in the sensorimotor areas before and after applying somatosensory feedback through electrocortical stimulation of the somatosensory cortex
Measured: 1 year
Secondary outcomes (2)
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
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies 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
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UMC Utrecht
- Sponsor type
- University, hospital or other
- 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
- NCT07640711
- Sponsor's protocol ID
- NL-009756
- Other IDs
- METC nummer 25-211
- Acronym
- INTENSE-BCI
- Status last verified
- Jun 2026
- First submitted
- 29 May 2026
- Last updated
- 11 Jun 2026
- 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Neurotechnology For Society - Brain-Computer Interface
- ClinicalTrials.gov ID
- NCT07640711
- Acronym / sponsor ID
- INTENSE-BCI / NL-009756
- Conditions
- Spinal Cord Injury, Tetraplegia C1-C4, Quadriplegia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- UMC UtrechtUniversity, hospital or other
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 11 Jun 2026 (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 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.
Detailed description
Spinal Cord Injury (SCI) results in motor impairments in body parts innervated by the spinal cord below the site of the lesion. In addition to loss of leg movements, individuals with high cervical SCI experience significant impairments in arm and hand function (tetraplegia), impacting their access to digital devices, with obvious consequences for their ability to communicate, participate in society and the workforce, autonomously manage their life, and benefit from the entertainment options digital devices offer these days. Current assistive technologies (AT) for control over digital devices, such as voice control, eye-tracking, and head- or mouth-controlled devices, are often unintuitive, slow, limited in functionality, aesthetically unattractive, and they often interfere with regular movement or speech. An effective Brain-Computer Interface (BCI) would enable individuals with SCI to use movement-related neural signals to directly control digital devices, taking away the disadvantages of current AT. This would dramatically improve their quality of life.
The Brain InterChange from CorTec is an active implantable medical device for measurement of neuronal activity and electrical stimulation of the human nervous system, comprising an internal and an external unit. The internal unit consists of a small high-density ECoG grid with 32 contacts placed subdurally and a connected implantable amplifier/transmitter device that is placed subcutaneously. The external unit comprises a headpiece, for power transmission to the internal unit, a communication unit, that receives the data transmitted from the internal unit and controls the power transmission, and a USB cable, that connects the communication unit to the computer that has software to process and translate the brain data to a means of digital device control for SCI patients with custom in-house software developed during this study.
The BCI system also allows to 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, the aim is to generate a more natural relation between intent (movement attempt of a body part) and effect (sensation in the same body part), which is expected to lead to fast training and accurate BCI performance.
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 digital devices |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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
- Ability to communicate reliably, via speech or other means
Key exclusion criteria (7 listed)
- 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)
- 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.
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: Brain InterchangeImplant electrodes and amplifier/transmitter and use, through amplifier and decoding, for control of BCI | Device | ECoG (electrocorticography) sensing |
Primary outcome
Effectiveness of BCI Control: Accuracy
Time frame: 1 year
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
Efficiency of BCI control: Speed
Time frame: 1 year
number of accurate selections made per minute
Efficiency of BCI control: Subjective Workload - Visual Analogue Scale
Time frame: 1 year
Subjective Workload: Visual Analogue Scale Continuous scale: Little to no effort (0) - Much effort (5). Lower numbers are better.
Efficiency of BCI control: Subjective Workload - National Aeronautics and Space Administration-Task Load Index
Time frame: 1 year
Subjective Workload: National Aeronautics and Space Administration-Task Load Index Scale: 21 point Likert-type scale. Lower numbers are better.
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.
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.
Stability of BCI performance: impedance
Time frame: 1 year
Longitudinally follow the electrode impedance (in Ω), to assess their stability throughout the day and across the weeks and months after implantation.
Stability of BCI performance: signal dynamics
Time frame: 1 year
Longitudinally follow the raw signal dynamics (in µV) of neural signals, to assess their stability throughout the day and across the weeks and months after implantation.
Stability of BCI performance: task-related modulation
Time frame: 1 year
Longitudinally follow the task-related modulation in power (in µV), to assess their stability throughout the day and across the weeks and months after implantation.
Effects of somatosensory feedback on BCI Training and Performance: accuracy
Time frame: 1 year
Compare BCI control accuracy (in %), including variability and improvement therein before and after applying somatosensory feedback through electrocortical stimulation of the somatosensory cortex
Effects of somatosensory feedback on BCI Training and Performance: neural signals
Time frame: 1 year
Compare neural signal changes (in µV) in the sensorimotor areas before and after applying somatosensory feedback through electrocortical stimulation of the somatosensory cortex
2 secondary outcomes
Assess device specifications for future, larger-scale, application of HD ECoG-BCIs
Time frame: 1 year
Validation of software for independent home-use of advanced BCIs
Time frame: 1 year
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 11 Jun 2026.
- 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 Spinal Cord Injury and Tetraplegia C1-C4, 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 10 inclusion and 7 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 11 Jun 2026. 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?
Effectiveness of BCI Control: Accuracy (time frame: 1 year). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Jun 2026.