Using the BrainGate2 Neural Interface to Help People With Tetraplegia Speak Again

What this Trial Is About

Researchers are exploring how to improve communication for people who have lost the ability to speak fluently due to neurological conditions like ALS, stroke, or spinal cord injuries. This study focuses on developing and testing a medical device called an intracortical brain-computer interface iBCI that measures brain activity related to speech production. The aim is to understand how brain cells work together to generate speech and to translate this understanding into technology that allows users to communicate through a computer by trying to speak. The study involves implanting the BrainGate2 Neural Interface System, a sensor placed in the speech-related area of the brain. This device records brain signals as participants attempt to speak, helping researchers decode intended speech. Participants will have the sensor implanted and monitored over time to evaluate the devices function and safety, including a primary focus on keeping the implant for at least one year without serious device-related adverse events. During the study, participants will be closely followed to assess the accuracy of the decoded speech from the brain signals, with evaluations continuing up to five years or until the participant exits the study. Researchers will monitor device safety, participant health, and functional outcomes through regular assessments. The total duration of participation varies, with long-term follow-up to understand both device performance and participant experience.

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Speech-02)