Stable and Independent Communication Brain-computer Interfaces (NCT03213561) | Clinical Trial Compass
TerminatedNot Applicable
Stable and Independent Communication Brain-computer Interfaces
Stopped: We have not succeeded in developing an approach that uses hdEEG to control a communication interface at an accuracy needed to complete the protocol.
Switzerland10 participantsStarted 2017-07-11
Plain-language summary
People with locked-in syndrome cannot move their limbs or talk because of a motor impairment, but remain conscious and intellectually awake. Restoring the ability to communicate to people with locked-in syndrome will have a positive effect on their quality of life, will enable them to reintegrate into society and increase their capacity to lead productive and fulfilling lives. This study sims to develop a new assisted communication device based on a brain-computer interface, a system that allows the user to control a computer with his brain activity. The investigators will develop this brain-computer system for long-term stability and independent use by using adaptive decoders. The investigators will test the long-term stability and independence of this system with healthy volunteers, people with tetraplegia and people with locked-in syndrome over time periods of several months.
Who can participate
Age range
18 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 for healthy persons:
* Older than 18
* Fluent in French, English, German or Italian
* Good visual acuity
Inclusion criteria for people with tetraplegia:
* Older than 18
* Fluent in French, English, German or Italian
* Good visual acuity
* Diagnosed with spinal cord injury, brainstem stroke, spinal stroke, muscular dystrophy or other non-degenerative motor neuron disorders
* Limited or no ability to use both hands - less than grade 4 muscle strength in elbow extension and wrist extension and less than grade 2 strength in finger flexor and abduction on both sides
Inclusion criteria for people with locked-in syndrome:
* Were fluent in French, English, German or Italian before losing the ability to speak
* Enough visual capability to see large letters from a distance of around 50cm according to caretaker's or guardian's opinion
Exclusion criteria for healthy persons:
* Smokers
* Substance or alcohol abuse
* Neurological or psychiatric illness
* History of cranio-facial surgery
* Metallic implants that would prohibit the subject from having a MRI scan
* Medications that may retard motor coordination and cognitive ability (such as sedatives)
* Seizure disorders
* Treated with anti-epileptic medications
Exclusion criteria for people with tetraplegia and locked-in syndrome:
* Disabling neurological illness other than tetraplegia or locked-in syndrome
* Disabling psychiatric illness
* History of cranio-facial surgery
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.