The Stentrode motor neuroprosthesis, developed by Synchron, has taken another step towards becoming the world’s first commercially available, endovascular brain-computer interface (BCI) technology after the company’s investigational device exemption (IDE) application received US Food and Drug Administration (FDA) approval. The COMMAND trial, an early feasibility study (EFS) of Stentrode, is now set to begin later this year at Mount Sinai Hospital in New York, USA.
This study will assess the safety and efficacy of the device in patients with severe paralysis. Outcomes will include the use of brain data to control digital devices and achieve improvements in functional independence, according to a Synchron press release.
“The approval of this IDE reflects years of safety testing performed in conjunction with FDA,” said Synchron CEO Thomas Oxley. “We have worked together to pave a pathway forward towards the first commercial approval for a permanently implanted BCI for the treatment of paralysis. We are thrilled to finally be launching a US clinical trial this year.”
Synchron claims that its technology solves multiple challenges that have restricted the commercial translation of BCIs out of the experimental laboratory to date. Where other implantable BCI approaches involve drilling into the skull and placing needle electrodes directly into the brain tissue—potentially resulting in long-term brain inflammation—the Stentrode device is delivered into the brain via the jugular vein in a minimally invasive, two-hour procedure. No robotic assistance is required for the procedure, which can be performed in widely available angiography suites. The implant is also “fully internalised”, with no wires coming out of the head or body.
Patients can begin using the device at home soon after implantation and may wirelessly control external devices simply by thinking about moving their limbs. The system is designed to facilitate better communication and functional independence for patients by enabling daily tasks like texting, emailing, online commerce and accessing telemedicine, the release adds.
“Synchron’s north star is to achieve whole-brain data transfer,” Oxley added. “The blood vessels provide surgery-free access to all regions of the brain, and at scale. Our first target is the motor cortex for treatment of paralysis, which represents a large unmet need for millions of people across the world and a market opportunity of US$20 billion.”
Synchron is collaborating with Carnegie Mellon University and the University of Pittsburgh Medical Center, both based in Pittsburgh, USA, and Mount Sinai Health System, to conduct the COMMAND trial of its Stentrode device. A total of six patients are planned for the study, with enrolment beginning later this year.
The company also continues to evaluate the device in the SWITCH clinical trial, which began enrolling patients in 2019 at the Royal Melbourne Hospital in Australia and is currently ongoing. Four patients have received the Stentrode implant in the trial and are utilising the neuroprosthesis for data transfer from the motor cortex to control digital devices. Data from the first two patients in this study, which were published in the Journal of NeuroInterventional Surgery (JNIS) in October 2020, demonstrated each patient was able to control their devices to text and type through direct thought. Following implantation and a short period of machine learning-assisted training, they were able to use the system unsupervised in their homes to send text messages, do online shopping and manage their finances.