MedTrace Logo

Investigation on the Cortical Communication System

NCT06207591 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2025-10-03

No results posted yet for this study

Summary

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

Interventions

DEVICE

ECoG (electrocorticography) sensing

Implant electrodes and pedestal connector and use, through amplifier and decoding, for control of BCI

Sponsors & Collaborators

Principal Investigators

  • Nick F Ramsey, PhD · UMC Utrecht

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-15
Primary Completion
2028-09-30
Completion
2029-09-30

Countries

  • Netherlands

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06207591 on ClinicalTrials.gov