Synchron was announced by the medical journal as follows: jam neurology announced peer-reviewed long-term safety results from a clinical study of four severely paralyzed patients implanted with the company’s first-generation Stentrode neural prosthesis. In this study, we found that neural prosthesis devices could be used to transmit neural signals from within the blood vessels of the brain for long periods of time without serious device-related adverse events.
The SWITCH (Stentrode with think-controlled digital switch) trial, the first in humans, evaluated four patients implanted with Synchron’s Stentrode. The patient participating in this study completed his 12-month follow-up without persistent neurological deficits. There was no coagulation or migration of the device, reports a Synchron press release, and signal quality remained stable with no evidence of significant degradation.
Additionally, each participant successfully controlled a personal computing device with a brain-computer interface (BCI). They were able to use implants to generate intentionally controlled digital switches for everyday digital activities such as texting, emailing, personal finance, online shopping, and communication of care needs.
The study was led by neurointerventionist Peter Mitchell and vascular neurologist Bruce Campbell, both from the University of Melbourne, Melbourne, Australia, who performed the procedure. The procedure was performed in a neural intervention angiography suite.
“We conducted this first-person study carefully, with a primary focus on safety. All patients tolerated the surgery well and were typically discharged within 48 hours.” The wide availability of an angiography suite for MRI may facilitate rapid translation of BCI in people with paralysis.”
As described in a Synchron press release, paralysis can lead to loss of control over the body’s muscles, but the brain remains intact. Motor intention is the brain signal underlying the physical will to move, and the BCI is designed to restore lost motor intention signaling associated with paralysis. The device is implanted in the brain’s motor cortex via the jugular vein in a minimally invasive endovascular procedure. Once implanted, it detects and wirelessly transmits motor intent to control personal digital devices.
In the SWITCH trial, motor intention was detected using a robust decoder that searches for power changes in specific frequency bands. A digital switch was performed under the voluntary control of the frequency band shift by the user.
Synchron’s first generation system was developed in partnership with Ripple LLC and will utilize Ripple’s neural sensing technology to provide core signal acquisition, data telemetry and signal processing capabilities, according to the release.
“This technology has great potential for people with paralysis who want to maintain a certain level of independence,” added Co-Principal Investigator Campbell. “Stentrode enables a form of motor recovery by allowing individuals to use switches to communicate and engage with the digital world.”
“The SWITCH study is an early demonstration of safety in a small number of participants using a commercial-grade BCI. No,” said Synchron CEO and founder Tom Oxley. “In our view, a motor neuroprosthesis should be safe and easy to use. A digital switch controlled by motor intention could be used to meaningfully restore motor skills in paralyzed patients, or to send text messages to loved ones.” It can lead to us taking back things we take for granted, such as transmitting and turning on lights.”
The study announcement follows the COMMAND trial, which is being conducted at Carnegie Mellon University, University of Pittsburgh, and Mount Sinai Hospital in the United States, to assess the safety and quantify efficacy of Stentrode by enrolling patients in it. It follows Synchron’s announcement that it will. Three of his six participants have been enrolled in his COMMAND trial, and clinical trial sites continue to actively seek additional participants.
