Actively Recruiting
Investigation on the Cortical Communication System
Led by UMC Utrecht · Updated on 2025-10-03
2
Participants Needed
1
Research Sites
298 weeks
Total Duration
On this page
Sponsors
U
UMC Utrecht
Lead Sponsor
J
Johns Hopkins University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this clinical trial is to demonstrate communication through a brain implant in people in locked-in state, i.e. people with severe paralysis and communication problems. The main questions it aims to answer are efficient and stable control of Brain-Computer interface (BCI) functions for communication with attempted hand movements and operation of a keyword-based speech BCI. Participants will be implanted with four electrode grids, with in total 128 electrodes, on the surface of the brain and a connector on the skull. Participation includes visits of researchers for recording and training at home, 2-3 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.
CONDITIONS
Official Title
Investigation on the Cortical Communication System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 18 to 70 years
- Clinical diagnosis of locked-in state or likely to develop it within 2 years caused by brain injury, stroke, neuromuscular or neurodegenerative disease, or similar
- Current or expected complete or partial paralysis of all four limbs
- Current or expected speech impairment related to motor function
- Receiving invasive ventilation via tracheostomy or stable respiratory status allowing safe surgery
- Cleared for surgery by study physicians
- Meets neuropsychological criteria
- Able to communicate reliably, such as through eye movement
- Willing and able to give informed consent
- Lives within reasonable distance from University Medical Center Utrecht
- Vision and hearing largely intact
- Consents to participate at study time
You will not qualify if you...
- Significant psychiatric, cognitive, or behavioral disorders interfering with consent or participation
- Medical conditions that contraindicate surgery or interfere with participation, including infections, skin or bone problems, autoimmune diseases, epilepsy, cancer, or severe cardiovascular, metabolic, or kidney issues
- Pre-surgical imaging findings making implantation too risky or impossible
- Inability to undergo MRI due to incompatible implanted devices
- Expected need for MRI after implantation
AI-Screening
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Trial Site Locations
Total: 1 location
1
University Medical Center
Utrecht, Netherlands, 3584CX
Actively Recruiting
Research Team
M
Mariska J Vansteensel, PhD
CONTACT
E
Erik J Aarnoutse, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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