CompletedNot Applicable

First Study With a Brain Implant to Help Locked-in Patients Communicate at Home

Netherlands6 participantsStarted 2015-09-09

Plain-language summary

In this study a new means of communication for people with locked-in syndrome will be tested. The investigators will record brain signals directly from the surface of the brain by means of a completely implantable system. These brain signals are fed wirelessly into an assistive technology device and will control this device for communication and environmental control at the users home.

Who can participate

Age range

18 Years – 75 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: * Age 18 - 75 * Locked-in status (i.e. severely paralyzed with communication problems) * in case of trauma or stroke: at least 1 year after the event * in case of a neuromuscular disease: slow progression allowed * Rudimentary form of communication possible (e.g. through assistive technology, eye blinks or eye movements, severely impaired speech) * Mentally and physically capable of giving informed consent * Lives in or close to the Netherlands * MR compatible * able to lie flat in the scanner * no metal objects in or attached to the body * no claustrophobia * Visus (largely) intact * Cognition intact (IQ\>80) * Compatible with implantation procedure * good respiratory function or stable respiratory situation using ventilation assistance Exclusion Criteria: * Strong and frequent spasms * Vital indication for blood thinners * Current brain tumor or history of tumor resection * Quick medical or neurological deterioration * Patients who are considered legally incapable (and who therefore will not be able to give informed consent) * Current or recent psychiatric disorder * Catabolic state * Allergy to the materials of the implant

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

Number of Participants Reaching Proficiency Level 2: Unsupervised BCI Performance

Timeframe: up to 1 year

Trial details

NCT IDNCT02224469

SponsorUMC Utrecht

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-02-14

Results submitted2025-07-17

View on ClinicalTrials.gov More Locked-In Syndrome trials