An Endovascular Motor Neuroprosthesis Enables Patients with Paralysis to Control Digital Devices by Thinking: Experience of Field Clinical Engineers


Clinical Trials

Poster Number: 64


Elliott Hough, MNurs, Synchron Inc

Patients with paralysis caused by MD retain a functional motor cortex with measurable signals in response to attempted movement. Using brain-computer interfaces (BCI) that function as motor neuroprostheses (MNPs), these signals can be translated for the control of external devices to improve patient access to digital world. Previously, BCI implantation required removal of a portion of the skull and placement of electrodes on brain surface or in parenchyma. A minimally invasive BCI (Stentrode, Synchron, Brooklyn, NY) reaches the brain by vascular access, removing the need for craniotomy. Unlike non-vascular, penetrating BCIs, no components extrude from head and external components are lightweight, compact, and unobtrusive. The MNP was implanted in four patients with paralysis in an Australian first-in-human trial. The patients had no unanticipated adverse device effects (UADEs) at the 12-month follow-up. Two patients who remain in active sessions with Field Clinical Engineers (FCEs), with current average length of implant of 27.5 (SD 3.5) months, have had no UADEs. Approximately six weeks following implant, patients began weekly, home-based training with an FCE to learn how to operate a standard laptop computer by thinking. The subjects’ confidence grew weekly as their training scores improved. All patients learned to use the MNP to independently operate computer for shopping, banking, communicating (e.g., texting, email, WhatsApp, Twitter), playing games, enjoying music and videos, browsing internet, and using smart home apps. Patients reported feeling empowered by regaining more independence and sense of meaning in their lives, and caregivers reported they could deliver care more effectively. Minimal calibration of system is needed, facilitating its home use without the presence of FCEs after training period ends. An FDA-approved, multisite, early feasibility study in the US is currently enrolling patients with severe quadriparesis to assess safety and impact of renewed digital activities on patients’ quality of life.