Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia
This study tests whether people with severe paralysis (tetraplegia) can use an experimental brain interface system to control a computer cursor and other devices just by thinking about moving them. The BrainGate2 system uses tiny sensors placed on the brain's surface to detect thought signals and translate them into device commands. The main goal is to show that this approach is safe and that it works as intended.
Key Objective: This trial tests whether people with paralysis can regain the ability to control computers and assistive devices through thought alone using a brain-computer interface.
Who to Consider: People with tetraplegia (severe paralysis of all four limbs) who have difficulty communicating or controlling devices may want to consider this study.
Trial Parameters
Brief Summary
The purpose of this study is to obtain preliminary device safety information and demonstrate proof of principle (feasibility) of the ability of people with tetraplegia to control a computer cursor and other assistive devices with their thoughts.
Eligibility Criteria
Inclusion Criteria: * Between 18 and 80 years of age. * Participants must have a diagnosis of amyotrophic lateral sclerosis (ALS) as verified by a clinical expert in neurologic diseases. * Participants with a diagnosis of ALS with anarthria, or severe dysarthria with decline in the preceding four months. * Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment. Exclusion Criteria: * Visual impairment such that extended viewing of a computer monitor would be difficult even with ordinary corrective lenses * Chronic oral or intravenous steroids or immunosuppressive therapy * Other serious disease or disorder that could seriously affect ability to participate in the study (There are additional exclusion criteria)