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

ABSTRACT:

Background and objectives

Brain-computer interfaces (BCIs) are being developed to restore mobility, communication, and functional independence to people with paralysis. Though supported by decades of preclinical data, the safety of chronically implanted microelectrode array BCIs in humans is unknown. We report safety results from the prospective, open-label, nonrandomized BrainGate feasibility study (NCT00912041), the largest and longest-running clinical trial of an implanted BCI.

Methods

Adults aged 18-75 years with quadriparesis from spinal cord injury, brainstem stroke, or motor neuron disease were enrolled through 7 clinical sites in the United States. Participants underwent surgical implantation of 1 or 2 microelectrode arrays in the motor cortex of the dominant cerebra

SUBMITTER: Rubin DB 

PROVIDER: S-EPMC10074470 | biostudies-literature | 2023 Mar

REPOSITORIES: biostudies-literature