The state of clinical trials of implantable brain–computer interfaces

We are thrilled to share a comprehensive review of implantable brain-computer interfaces (iBCIs) published in Nature Portfolio Reviews Bioengineering, authored by BCI pioneer Ian Burkhart and colleagues. This landmark paper highlights the incredible strides our field has made over the past 25 year. It’s journey we are proud to be a part of!

Key insights from the review:

1. Global Collaboration: 21 research groups worldwide have worked with 67 participants to restore or rehabilitate motor, sensory, or speech functions using iBCIs.
   
2. Advancement Priorities: Emphasizes the importance of improving participant diversity, fostering data sharing, and enhancing collaborative research to accelerate iBCI translation and commercialization.
   
3. Increasing Longevity: Participation durations average over three years, with some extending beyond nineÑshowcasing the technologyÕs long-term viability and potential as a lifetime solution.
   
4. Technological Advancements: Integration of machine learning and AI has dramatically improved decoding speed and accuracy, enabling more precise connections between the brain and external devices.

As for Blackrock Neurotech:

1. Our NeuroPort microelectrode array has been used by 13 research groups and implanted in 38 of the 67 participants as of December 2023 and growing today, demonstrating the trust placed in our technology.
   
2. Offering the highest spatial resolution among iBCI electrodes, the NeuroPort enables precise neuronal-level measurementsÑa critical factor in restoring motor control for those affected by spinal cord injuries, stroke, ALS, and other conditions.

Congratulations to Ian Burkhart, Michelle P., Jose L Contreras-Vidal, Ph.D.s, and all the researchers, participants, and collaborators who have contributed to this remarkable field. Together, weÕre unlocking human potential by bridging the gap between the brain and technology, poised to lead the future of neurotechnology.

Study Abstract

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.

Read the full paper here.