Testing the BrainGate2 Neural Interface System to Help People with Tetraplegia Control Tablet Communication Apps

What this Trial Is About

This research aims to improve communication for people with tetraplegia caused by brainstem stroke, advanced amyotrophic lateral sclerosis ALS, spinal cord injuries, or other motor neuron disorders. The study focuses on developing an intracortical brain-computer interface iBCI that helps participants intuitively and reliably control communication apps on standard tablet computers. This device feasibility study is led by Dr. Leigh R. Hochberg and explores new methods to translate brain signals related to movement into tablet control. Participants receive the BrainGate Neural Interface System, which involves placement of sensors into the motor cortex area related to arm and hand movement. This device is evaluated for its ability to provide rapid and intuitive communication control. The study follows a single group design where all participants use the BrainGate system to determine its feasibility and safety over time. During the trial, participants are monitored for at least one year to track sensor implant duration without serious device-related adverse events or the need for device removal. The study involves ongoing assessments of device performance and participant interaction with communication apps on tablets. Participants must live within three hours of the study site and have prior enrollment in a related BrainGate trial. The total study duration extends until July 2027, including follow-up for safety and device use.

Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia (BG-Tablet-01)