Testing an ECoG-based Brain Device for Helping Adults with Severe Neurological Disabilities Control Communication and Movement

What this Trial Is About

Researchers are exploring the use of electrocorticography ECoG signals to control complex devices for motor and speech functions in adults who have severe neurological disorders such as ALS, spinal cord injury, stroke, multiple sclerosis, and muscular dystrophies. This study aims to determine if brain signals recorded directly from the brains surface can be used to operate robotic systems and generate speech, providing new communication and neuroprosthetic options for affected individuals. Participants will use a high-performance ECoG-based neural interface involving subdural cortical electrodes combined with the Blackrock NeuroPort Array device. The study involves training and assessing participants ability to control a robotic system and produce speech via brain signals. The intervention is device-based, and follow-up includes a long-term monitoring period of up to 6 years after implantation to track safety and functional outcomes. During the study, participants will undergo neurological assessments and training with the ECoG device. Researchers will monitor safety by tracking treatment-emergent adverse events and evaluate the primary and secondary objectives related to motor and speech control capabilities. The study includes regular follow-up visits over several years to assess device performance, participant function, and tolerability of the implant. Total participation may last up to 6 years post-implantation for ongoing safety and efficacy evaluation.

ECoG BMI for Motor and Speech Control