BrainGate2 Study Testing a Neural Interface Device to Help People with Tetraplegia Control Computers and Assistive Technology with Their Thoughts

What this Trial Is About

Researchers are evaluating the BrainGate2 Neural Interface System to understand its safety and feasibility for people with tetraplegia, including those with severe speech impairments. The study aims to develop a medical device that could help individuals with paralysis regain abilities that normally depend on hand movement or speech. The project focuses on people with conditions such as spinal cord injury, brainstem stroke, muscular dystrophy, amyotrophic lateral sclerosis, and other motor neuron disorders. The intervention involves placing up to six small BrainGate2 sensors into the motor-related cortex of the brain, including areas related to speech. These sensors connect to percutaneous pedestals to record neural signals, which are monitored weekly for a year or longer. The study is designed to collect preliminary safety data and demonstrate the ability of participants to control computer cursors and other assistive devices using their thoughts. Participants will be involved in regular neural recordings and evaluations to track the devices safety and functionality over a one-year post-implant period. Researchers will assess the feasibility of the system and gather data to inform larger future studies, including neural decoding methods and success measures. The total participation duration may extend beyond one year, with ongoing monitoring of device performance and participant ability to control assistive technologies.

BrainGate2: Feasibility Study of an Intracortical Neural Interface System for Persons With Tetraplegia