The National Institutes of Health (NIH) has collectively awarded Carnegie Mellon University, University of Pittsburgh Medical Center (UPMC), Mount Sinai Health System and Synchron with a US$10 million grant for the initiation of the US COMMAND clinical trial to assess the Stentrode motor neuroprosthesis. The US Food and Drug Administration (FDA) granted approval to begin this breakthrough trial in July, paving the way for Synchron’s Stentrode device to become the first commercially available, implantable brain-computer interface (BCI).
This investment brings 2021 funding for the Synchron BCI programme to US$50 million. The Stentrode is the only BCI that can be implanted without the need for open brain surgery, a company press release states.
“This significant investment by NIH reflects the mature stage of Synchron’s technology,” said Synchron CEO Thomas Oxley. “We are excited to be collaborating with three world-leading US institutions to deliver on the long promise of BCI technology. We have overcome technical problems that have previously restricted clinical translation of BCI: it is wireless, mobile, fully implantable, and does not require open brain surgery or robots.”
Carnegie Mellon University will take the lead in management of the grant, while UPMC and Mount Sinai Health System will recruit eligible patients, perform the minimally invasive neurointervention procedures and monitor the participants’ clinical status, the release adds.
The COMMAND trial will evaluate the safety and efficacy of the Stentrode in helping six severely paralysed patients in the USA regain digital communication and functional independence, with the first patient set to be enrolled later this year. Synchron is also continuing to evaluate its device in the SWITCH human clinical trial in Australia, where four patients have been implanted with the Stentrode to control digital devices through thought.
“This technology has the potential to revolutionise our ability to care for patients by solving health challenges that have previously been insurmountable—including communication with patients with certain types of paralysis,” said David Putrino, director of Rehabilitation Innovation for the Mount Sinai Health System, and associate professor of Rehabilitation Medicine at Mount Sinai’s Icahn School of Medicine (New York, USA).
Synchron’s technology is designed to facilitate better communication between the patient, and their caregivers and medical professionals, ultimately improving patient care. It has allowed patients implanted with the device to perform daily tasks, including texting, emailing, online shopping and banking, enabling functional independence, the release also details. The Stentrode converts the thoughts associated with attempted movement into cursor and keyboard commands—a function typically performed by motor neurons. It is small and flexible enough to safely pass through curving blood vessels, and is implanted via neurointervention techniques commonly used to treat strokes.
Future applications of the device may include the potential to diagnose and treat conditions of the nervous system, such as Parkinson’s disease, epilepsy, depression and hypertension, as well as non-medical solutions, Synchron’s press release concludes.
