Michael Barbella, Managing Editor12.15.22
The first patients have been enrolled in Synchron's COMMAND trial.
The University of Pittsburgh (Pennsylvania) study site will assess the safety quantified efficacy of Synchron’s Stentrode in severely paralyzed patients. The product is designed to enable patients to control digital devices, hands-free.
“Today marks an important milestone in our mission to advance technology access for the millions of people who have lost the ability to use digital devices,” Synchron Founder and CEO Tom Oxley, M.D., Ph.D. “We are excited to expand the COMMAND trial with enrollment at the University as we look to advance a scalable BCI solution to market.”
The early feasibility COMMAND trial, funded by the National Institutes of Health, is being conducted under the first investigational device exemption (IDE) awarded by the U.S. Food and Drug Administration (FDA) to a company assessing a permanently implanted BCI. This new site at the University marks the second approved COMMAND trial location, joining Mount Sinai in New York City.
Synchron's Stentrode is implanted within the motor cortex of the brain through the jugular vein in a minimally-invasive endovascular procedure. Once implanted, it detects and wirelessly transmits motor intent, restoring a capability for severely paralyzed patients to control personal devices with hands-free point-and-click. The trial will assess the impact of tasks such as texting, emailing, online shopping, and telehealth services. The FDA granted Breakthrough Device designation to Synchron in August 2020 and an IDE in July 2021.
“Synchron’s Stentrode has the potential to restore functionality to the millions of people worldwide suffering from paralysis,” said Raul Nogueira, M.D., Endowed Professor and Division chief of Cerebrovascular Medicine, director, UPMC Stroke Institute, professor of Neurology and Neurosurgery at the University of Pittsburgh. “Giving patients the option to receive this device without the need for open brain surgery, may open endless possibilities into the application and scalability of this promising technology.”
Synchron’s flagship technology, the Stentrode, is an endovascular brain implant designed to enable patients to wirelessly control digital devices through thought and improve functional independence. Synchron’s foundational technology, a motor neuroprosthesis (MNP), or motor BCI, is implanted via the jugular vein using neurointerventional techniques commonly used to treat stroke, and does not require drilling into the skull or open brain surgery. The system is designed for patients suffering from paralysis as a result of a broad range of conditions, and aims to be user friendly and dependable for patients to use autonomously.
“This technology may open up the possibility for patients with paralysis to use digital devices to communicate with loved ones again, and restore independence back into their lives,” said David Lacomis, M.D., principal investigator and chief of Neuromuscular Division at the University of Pittsburgh. “Something as simple as surfing the web or doing online grocery shopping can seem mundane to some, but it can change the world for someone who previously had those fundamental abilities taken away.”
COMMAND trial sites in New York, NY and Pittsburgh, PA are recruiting patients.
Synchron, an endovascular brain interface company, is developing a neuroprosthesis for treating paralysis and the first endovascular implantable neuromodulation therapy. Future applications include the potential to diagnose and treat nervous system conditions, including Parkinson’s disease, epilepsy, depression, and hypertension. Synchron is headquartered in New York City with R&D facilities in Melbourne, Australia.
The University of Pittsburgh (Pennsylvania) study site will assess the safety quantified efficacy of Synchron’s Stentrode in severely paralyzed patients. The product is designed to enable patients to control digital devices, hands-free.
“Today marks an important milestone in our mission to advance technology access for the millions of people who have lost the ability to use digital devices,” Synchron Founder and CEO Tom Oxley, M.D., Ph.D. “We are excited to expand the COMMAND trial with enrollment at the University as we look to advance a scalable BCI solution to market.”
The early feasibility COMMAND trial, funded by the National Institutes of Health, is being conducted under the first investigational device exemption (IDE) awarded by the U.S. Food and Drug Administration (FDA) to a company assessing a permanently implanted BCI. This new site at the University marks the second approved COMMAND trial location, joining Mount Sinai in New York City.
Synchron's Stentrode is implanted within the motor cortex of the brain through the jugular vein in a minimally-invasive endovascular procedure. Once implanted, it detects and wirelessly transmits motor intent, restoring a capability for severely paralyzed patients to control personal devices with hands-free point-and-click. The trial will assess the impact of tasks such as texting, emailing, online shopping, and telehealth services. The FDA granted Breakthrough Device designation to Synchron in August 2020 and an IDE in July 2021.
“Synchron’s Stentrode has the potential to restore functionality to the millions of people worldwide suffering from paralysis,” said Raul Nogueira, M.D., Endowed Professor and Division chief of Cerebrovascular Medicine, director, UPMC Stroke Institute, professor of Neurology and Neurosurgery at the University of Pittsburgh. “Giving patients the option to receive this device without the need for open brain surgery, may open endless possibilities into the application and scalability of this promising technology.”
Synchron’s flagship technology, the Stentrode, is an endovascular brain implant designed to enable patients to wirelessly control digital devices through thought and improve functional independence. Synchron’s foundational technology, a motor neuroprosthesis (MNP), or motor BCI, is implanted via the jugular vein using neurointerventional techniques commonly used to treat stroke, and does not require drilling into the skull or open brain surgery. The system is designed for patients suffering from paralysis as a result of a broad range of conditions, and aims to be user friendly and dependable for patients to use autonomously.
“This technology may open up the possibility for patients with paralysis to use digital devices to communicate with loved ones again, and restore independence back into their lives,” said David Lacomis, M.D., principal investigator and chief of Neuromuscular Division at the University of Pittsburgh. “Something as simple as surfing the web or doing online grocery shopping can seem mundane to some, but it can change the world for someone who previously had those fundamental abilities taken away.”
COMMAND trial sites in New York, NY and Pittsburgh, PA are recruiting patients.
Synchron, an endovascular brain interface company, is developing a neuroprosthesis for treating paralysis and the first endovascular implantable neuromodulation therapy. Future applications include the potential to diagnose and treat nervous system conditions, including Parkinson’s disease, epilepsy, depression, and hypertension. Synchron is headquartered in New York City with R&D facilities in Melbourne, Australia.