Feasibility of the BrainGate2 Neural Interface System in Persons With Tetraplegia

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.

Inclusion Criteria: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.Exclusion Criteria:Between 18 and 75 years of age.The patient must be able to speak understandably or if unable to speak understandably must have one reliable means of communication.Complete or incomplete tetraplegia (quadriplegia)A minimum of twelve months elapsed post-injury and recovery must have plateaued at least 3 months prior to baseline screening.Per clinical opinion, a life expectancy of greater than 6 months.Must be within a three-hour drive of the Study site and geographically stable for at least 15 months after enrollment.(There are additional exclusion criteria)