JAMA Neurology today published peer-reviewed, long-term safety results involving four people with severe bilateral upper-limb paralysis. Twelve months after having Synchron’s Stentrode implanted inside a blood vessel in the brain, there were no adverse events. In addition, there was no vessel occlusion or device migration.
On top of the positive safety results, the Stentrode demonstrated it could work. All four patients’ BCI implants had stable signal strength throughout, with a mean (SD) signal bandwidth of 233 (16) Hz. There was offline decoding of at least five attempted movement types. Plus, each patient learned to successfully control a computer with the BCI.
“The SWITCH study is an early demonstration of safety in a low number of participants using a commercial grade brain-computer interface,” Synchron CEO Dr. Tom Oxley said in a news release.
“The decoder was simple and robust, meaning that patients didn’t have to train hard to execute switches,” Oxley said. “Our view is that a motor neuroprosthesis should be safe and easy to use.”
Brain-computer interfaces are a hot space
On top of Synchron, other attention-grabbing BCI companies include Elon Musk’s Neuralink and longtime pioneer Blackrock Neurotech.
Millions of Americans live with paralysis that could inhibit their ability to use smartphones and other personal computing devices, according to Synchron. The company estimates that 50 million people in high-income countries could benefit from a BCI by 2025.
“This technology holds great promise for people with paralysis who want to maintain a level of independence,” said Dr. Bruce Campbell, the SWITCH study’s co-principal investigator. Campbell is a vascular neurologist from the Royal Melbourne Hospital and the University of Melbourne.
“The Stentrode enables a form of motor restoration, with individuals able to use the switches to communicate and engage with their digital world,” Campbell said.
Another co-principal investigator in the study was Professor Peter Mitchell, director of neurointervention at Royal Melbourne Hospital. He noted that angiography suites are widely available. So he thinks the Stentrode implant procedure could promote a rapid translation of BCI for people with paralysis.
Synchron says enrollment is ongoing for its COMMAND trial. The study is taking place at Carnegie Mellon, the University of Pittsburgh and Mount Sinai Hospital, It will assess the Stentrode’s safety and explore quantified efficacy measures. Researchers have signed up three out of six participants.
