BrainGate2 Neural Interface System to Help People With Tetraplegia Control Devices Using Thought Study of Device Safety and Feasibility in ALS and Related Conditions

What this Trial Is About

Researchers are studying the BrainGate2 Neural Interface System to evaluate its safety and feasibility in helping people with tetraplegia control computer cursors and other assistive devices using their thoughts. This study aims to explore a medical device that could restore abilities normally relying on hands or speech, especially for those with paralysis and severe speech impairment. The research is led by Leigh R. Hochberg, MD, PhD, focusing on the dynamics of neuron populations in the speech motor cortex. The study involves placing the BrainGate2 sensor into the speech-related cortex of participants. This device is being tested to see how well it can interpret neural signals for communication and control purposes. The intervention period includes device implantation and monitoring to gather data on device safety and functional feasibility over time. Participants will be involved for up to five years, during which safety will be monitored for at least one year and feasibility assessed at study exit or earlier. The study includes assessments of device function, participant ability to control devices via neural signals, and ongoing health evaluations. This long-term involvement helps researchers understand how the device performs and its potential in real-world use for people with severe paralysis.

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia