Interim Safety Profile From the Feasibility Study of the BrainGate Neural Interface System

Brain-computer interfaces (BCIs) are being developed to help people with paralysis regain mobility, communication, and independence. The BrainGate system is a chronically implanted microelectrode array BCI whose safety in humans was previously unknown. This study reports on the safety of the BrainGate system through a prospective, open-label, nonrandomized feasibility study. The study enrolled adults with quadriparesis from spinal cord injury, brainstem stroke, or motor neuron disease across seven clinical sites in the United States. The study tracked device-related serious adverse events (SAEs) requiring device explantation or resulting in death or permanently increased disability during the one-year post-implant evaluation period, as well as the type and frequency of other adverse events.

• 1
  The BrainGate trial, involving 14 adults, showed an average device implantation duration of 872 days, totaling 12,203 days of safety experience. The most common device-related adverse event was skin irritation around the percutaneous pedestal.
• 2
  No safety events required device explantation, and there were no unanticipated adverse device events, intracranial infections, participant deaths, or adverse events resulting in permanently increased disability related to the investigational device.
• 3
  The BrainGate Neural Interface system has a safety record comparable with other chronically implanted medical devices. These data suggest a favorable risk/benefit ratio in appropriately selected individuals to support ongoing research and development.