Innovative Brain-Computer Interface for People With Spinal Cord Injury (NCT07640711) | Clinical Trial Compass
RecruitingNot Applicable
Innovative Brain-Computer Interface for People With Spinal Cord Injury
Netherlands1 participantsStarted 2026-08
Plain-language 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. 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
* 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.
Exclusion Criteria:
* 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 break…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Effectiveness of BCI Control: Accuracy
Timeframe: 1 year
2
Efficiency of BCI control: Speed
Timeframe: 1 year
3
Efficiency of BCI control: Subjective Workload - Visual Analogue Scale
Timeframe: 1 year
4
Efficiency of BCI control: Subjective Workload - National Aeronautics and Space Administration-Task Load Index
Timeframe: 1 year
5
User satisfaction Quebec User Evaluation of Satisfaction with assistive Technology (QUEST)
Timeframe: 1 year
6
user satisfaction Psychosocial impact of assistive devices scale (PIADS)