Synchron, a brain data transfer company, today announced that the National Institutes of Health (NIH) has awarded a $10M grant for the initiation of the COMMAND U.S. clinical trial of the Synchron motor neuroprosthesis to Carnegie Mellon University, University of Pittsburgh Medical Center (UPMC), Mount Sinai Health System and Synchron collectively. The FDA granted approval in July to begin this breakthrough trial, paving the way for Synchron’s StentrodeTM to become first commercially available implantable brain computer interface. The Stentrode is the only brain computer interface (BCI) implanted without the need for open brain surgery.
“This significant investment by NIH reflects the mature stage of Synchron’s technology. We are excited to be collaborating with three world-leading U.S. institutions to deliver on the long promise of brain computer interface technology.” said Synchron CEO Thomas Oxley, MD, PhD. “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. UPMC and Mount Sinai Health System will collectively recruit eligible patients, perform the minimally-invasive neurointervention procedures and monitor the subjects’ clinical status.
This new study, the COMMAND trial, will evaluate the safety and efficacy of the Stentrode in six severely paralyzed patients in the U.S. for regaining digital communication and functional independence. Synchron is also continuing to evaluate this device in the SWITCH human clinical trial in Australia, where four patients have been implanted with Synchron’s Stentrode to control digital devices through thought.
“This technology has the potential to revolutionize 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, PT, PhD, director of Rehabilitation Innovation for the Mount Sinai Health System, and associate professor of Rehabilitation Medicine at Icahn School of Medicine at Mount Sinai.
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 Stentrode converts the thoughts associated with attempted movement into cursor and keyboard commands, a function typically performed by part of the body known as ‘motor neurons’. The Stentrode device is small and flexible enough to safely pass through curving blood vessels, and is implanted using neurointerventional techniques commonly used to treat strokes.
A publication in the Journal of NeuroInterventional Surgery (JNIS) in October 2020 demonstrated that the first two patients implanted with the Stentrode were each able to learn to control texting and typing 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.
Future applications may include the potential to diagnose and treat conditions of the nervous system, including Parkinson’s disease, epilepsy, depression, and hypertension, as well as non-medical solutions.
The project is funded by the NIH BRAIN Initiative (NS120191-01).
About the StentrodeTM
Synchron’s flagship technology, the Stentrode is a minimally invasive brain implant designed to enable patients to wirelessly control digital devices through thought and improve functional independence. This motor neuroprosthesis (MNP), Synchron’s foundational technology, is implanted via the jugular vein using neurointerventional techniques commonly used to treat stroke. It does not require drilling into the skull or open brain surgery. The system is designed to be user friendly and dependable for, as well as operated autonomously by, patients suffering from paralysis as a result of a broad range of conditions. The Stentrode has been granted Breakthrough Device Designation from the U.S. FDA.
Synchron, a brain interface platform company, is a leader in the field of implantable neural interface technology. The company is already in the clinical stage with a commercially-viable neuroprosthesis for the treatment of paralysis and is developing the first endovascular implantable neuromodulation therapy. Future applications may include the potential to diagnose and treat conditions of the nervous system, including Parkinson’s disease, epilepsy, depression, and hypertension, as well as non-medical solutions. Headquartered in New York City, Synchron has offices in Silicon Valley, California and R&D facilities in Melbourne, Australia.