A Sensorimotor Microelectrode Brain-Machine Interface for Individuals With Significant Upper Limb Impairment

What this Trial Is About

This research focuses on individuals with severe paralysis who have intact brain function but cannot move due to injuries or diseases affecting the spinal cord, nerves, or muscles. The study aims to demonstrate the safety and effectiveness of using two CRS Arrays (microelectrodes) implanted in the brain to record motor cortex activity and provide sensory cortex microstimulation. This technology is known as a brain-machine interface (BMI), which interprets neural signals to control external devices and mimics sensory input through microstimulation. Participants will receive implantation of two Blackrock Microsystems CRS Arrays, one in the motor cortex and one in the sensory cortex. There is no control group; all participants will be implanted with these microelectrodes. The study involves long-term recording of neural activity and training participants to use the BMI technology for controlling devices. The intervention period includes implantation and follow-up monitoring. During the study, participants will undergo assessments including functional magnetic resonance imaging (fMRI) to evaluate cortical activation, neuropsychological and psychosocial evaluations, and safety monitoring for one year following array implantation. Researchers will measure both safety and the efficacy of the arrays in recording neural activity and enabling control of external devices. Participants are expected to stay near the research site for training and follow-up visits over the study period, which lasts at least 18 months.

Cortical Recording and Stimulating Array Brain-Machine Interface