Mocco J, et al. Long-term safety of an endovascular brain-computer interface for severe paralysis: results of a first-in-human clinical trial. Presented at: American Association of Neurological Surgeons annual meeting; Apr. 29-May 2; Philadelphia.
Mocco reports financial relationships with BlinkTBI, Cardinal Consulting, Cerebrotech, CVAid, Endostream, Imperative Care, Myra Medical, Neurolutions, NTI, Penumbra, Radical, RIST, Serenity, Songbird, Stryker Neurovascular, Synchron, Truvic, Tulavi, Vastrax, Viseon and Viz.ai. Sheth reports consulting fees from Boston Scientific, NeuroPace and Zimmer Biomet ROSA.
PHILADELPHIA — An endovascular brain-computer interface allowed those who are paralyzed to perform computer-based activities, according to a presenter at the American Association of Neurological Surgeons annual meeting.
“[The trial] was designed to address a problem, and that is paralysis. There are 5 million people in the United States living with paralysis,” J Mocco, MD, MS, professor of neurosurgery at Mount Sinai Health System, said during the presentation. “With the use of our prosthesis, we can essentially transmit … a signal from the brain to the external world and engage with technology.”
Seeking to examine the safety of an endovascular brain-computer interface (BCI) and whether the implant could help patients control a computer by thought, Mocco and colleagues evaluated five people with severe upper-limb paralysis, four of whom were suitable for implantation. The BCI device (Stentrode, Synchron) was implanted in recipients’ superior sagittal sinus and connected to a subcutaneous electronics unit that transmits signals through the skin to an external device to allow laptop computer control.
Study outcomes included serious adverse events resulting in death or permanent increased disability within 12 months after implantation, as well as target vessel occlusion and device migration, which were evaluated at 3 and 12 months. Researchers also recorded the device’s signal fidelity and stability for 12 months, and logged use of the device to perform routine computer tasks.
According to study results, all participants were able to use a computer with the recorded signals and perform daily activities such as texting, emailing and personal finance, online shopping and communicating care needs. Further, all implanted participants remained free of target vessel occlusion and device migration, as evidenced by post-operative imaging.
The last patient was monitored through December 2021, and no serious adverse events were reported.
“How will we respond to requests for cosmetic intermodulation? Will we be able to address some of the issues that get to the very core of our humanness?” Sameer Sheth, MD, PhD, associate professor of neurosurgery at Baylor College of Medicine, asked during the presentation. “Regardless of the answers to these questions, we must continue to drive and guide our future efforts because the direct interface of the nervous system is our wheelhouse.”