Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

Single Neuron Population Dynamics in Human Speech Motor Cortex for a Speech Prosthesis

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.

The goal of the BrainGate2 research and development project is to identify the core methods and features for a medical device that could allow people with paralysis, including severe speech impairment, to recover a host of abilities that normally rely on the hands or on speech.

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)