The National Institutes of Health (NIH) in the US has awarded a $10m grant for a study that will assess the effectiveness of the Stentrode brain computer interface (BCI) developed by Synchron.
Stentrode is a minimally invasive brain implant developed to enable paralysed patients to control digital devices with their thoughts.
The technology aims to improve communication between the patient and their caregivers in a bid to enhance patient care and treatment.
The study of Stentrode, referred to as the COMMAND trial, will include six severely paralysed patients. Outcomes will include triggering digital communication and achieving improvements in functional independence.
The US Food and Drug Administration (FDA) approved the trial last month.
University of Pittsburgh Medical Center (UPMC) and Mount Sinai Health System will jointly recruit the eligible patients and conduct the minimally-invasive neuro intervention procedures. They will also be monitoring the clinical status of the subjects.
Carnegie Mellon University is also associated with the initiative and will take the lead in the management of the NIH grant.
Synchron CEO Thomas Oxley said: “This significant investment by NIH reflects the mature stage of Synchron’s technology. 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.”
Mount Sinai Health System’s rehabilitation innovation director David Putrino said: “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.”
Last year, Stentrode received breakthrough device designation from FDA.