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Innovative Brain-Computer Interface for People With Spinal Cord Injury

Study acronym: INTENSE-BCI
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
The goal of this clinical trial is to demonstrate control of digital devices through a brain implant in people with spinal cord injury. The main question it aims to answer is efficient, independent, BCI-based control over digital devices in settings of daily living of an individual with SCI. In this project an advanced generation fully implantable BCI system will be used, the Brain InterChange (BIC) from CorTec. Participants will be implanted with an electrode grid on the surface of the brain and an amplifier/transmitter on the skull, under the skin. Participation includes visits of researchers for recording and training at home, 1-3 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.
Trial Details
NCT Number NCT07640711
Lead Sponsor UMC Utrecht
Conditions
(from sponsor)		 Spinal Cord Injury, Tetraplegia C1-C4, Quadriplegia
Related terms Quadriplegia, Spinal Cord Injuries
Enrollment 1 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov