The state of clinical trials of implantable brain–computer interfaces

Implanted brain–computer interfaces (iBCIs) translate brain activity recorded intracranially into commands for virtual or physical machines to restore or rehabilitate motor, sensory or speech functions. Currently, no iBCIs have been approved by regulatory agencies for the medical device market despite being in clinical trials since 1998, with little information available about their progress and outcomes. To address this gap, we conducted a review of all identified clinical trials of iBCIs for communication, motor control or restoration of tactile perception conducted between 1998 and 2023. We summarize findings from 21 research groups worldwide and their 67 participants who received implants to understand the challenges and opportunities in the iBCI field. This analysis highlights the importance of improving participant diversity, creating a participant registry to inform future research, regulatory and payer approvals, investor funding and new applications, adopting governed data sharing and standards, and boosting collaborative research.