Classification of Evidence
death, disability, paralysis
LOCKED-IN SYNDROME
This study provides Class IV evidence that the neurosurgically placed BrainGate Neural Interface system is associated with a low rate of SAEs defined as those requiring device explantation, resulting in death, or resulting in permanently increased disability during the 1-year postimplant period.For many people with paralysis, the cortical substrates of motor activity, speech, and cognition are intact but functionally disconnected from the nerves and muscles that enable movement and communication. Among the most physically disabled are individuals with locked-in syndrome, who have limited or no volitional muscle control.There are several classes of BCIs under development that use different sensors and decoding algorithms.Two reviews have addressed the safety of implanted BCIs.In 2004, the first trial of the BrainGate Neural Interface System was launched.