N/A
Completed N=6
First Study With a Brain Implant to Help Locked-in Patients Communicate at Home
Locked-In Syndrome
Source: ClinicalTrials.gov NCT02224469 ↗
Enrolled (actual)
6
Serious AEs
83.3%
Results posted
Dec 2025
Primary outcomePrimary: Number of Participants Reaching Proficiency Level 2: Unsupervised BCI Performance — 1 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Reaching Proficiency Level 2: Unsupervised BCI Performance |
1 | — |
| SECONDARY Patient Device Satisfaction |
3.5 | — |
| SECONDARY Effects Device on Quality of Life |
2.43 | — |
| SECONDARY Quality of Life by Scoring Subjective Well-being in ACSA Score |
2 | — |
| SECONDARY Hours of Use of BCI Device Per Day |
21.26 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02224469). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.