Mocco J, et al. Long-term safety of an endovascular brain-computer interface for severe paralysis: results from a first-in-man clinical trial. Presented at the American Association of Neurological Surgeons Annual Meeting; April 29-May 2; Philadelphia Cream.
Disclosures: 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 has enabled paralyzed people to perform computational activities, according to a presenter at the annual meeting of the American Association of Neurological Surgeons.
“[The trial] was designed to solve a problem, and that is paralysis. There are 5 million people in the United States living with paralysis,” J MoccoMD, 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 outside 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 through thought, Mocco and colleagues evaluated five people with severe upper extremity paralysis, including four were suitable for implantation. The BCI (Stentrode, Synchron) device was implanted in the superior sagittal sinus of recipients and connected to a subcutaneous electronic unit that transmits signals through the skin to an external device to allow laptop control.
Study outcomes included serious adverse events resulting in death or increased permanent disability within 12 months of implantation, as well as target vessel occlusion and device migration, which were assessed at 3 and 12 month. The researchers also recorded the device’s signal fidelity and stability for 12 months, and recorded the use of the device to perform routine computing tasks.
According to the 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 communication of care needs. In addition, all implanted participants remained free of target vessel occlusion and device migration, as evidenced by postoperative imaging.
The last patient was followed until December 2021 and no serious adverse events were reported.
“How will we respond to requests for cosmetic intermodulation? Will we be able to solve some of the problems that go to the very heart of our humanity? » samir ShethMD, 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.”