New York – (business wire) — Synchron, an embedded brain-computer interface (BCI) company, today published a medical journal. Department of Neurology, JAMA announced long-term, peer-reviewed safety results from a clinical study of four severely paralyzed patients implanted with Synchron’s first-generation Stentrode™ neuroprosthetic device. 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 Stentrode With Thought-Controlled Digital Switch (SWITCH) study, the first in humans, evaluated four patients implanted with Synchron’s Stentrode™. The patient participating in this study completed her 12-month follow-up without persistent neurological deficits. There was no agglomeration or migration of the device. Signal quality was stable and no significant degradation was observed. Each participant successfully controlled a personal computing device using the BCI. Participants could use implants to intentionally control everyday digital activities such as texting her messages, emailing, personal finance, online shopping, and communicating care needs to generate digital switches. I made it.
The study was led by investigators Professor Peter Mitchell, the leading neurointervention specialist who performed the procedure, and Professor Bruce Campbell, an angio-neurologist at Royal Melbourne Hospital and the University of Melbourne. The procedure was performed in a neural intervention angiography suite.
“We carefully conducted this first human study with safety as our number one priority. All patients tolerated the surgery well, and she was usually discharged within 48 hours,” said Professor Peter Mitchell, co-principal investigator of the study and his director of Neurointervention at Royal Melbourne Hospital. “The wide availability of an angiography suite for this procedure may facilitate rapid translation of BCI in people with paralysis. ”
Paralysis can result in a loss of control over the muscles of the body, but the brain remains intact. Motor intention is the brain signal that underlies the physical will to move. A brain-computer interface 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.
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 (Salt Lake City) and utilized Ripple’s neural sensing technology to provide core signal acquisition, data telemetry and signal processing capabilities.
“This technology has great potential for people with paralysis who want to maintain a level of independence.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 brain-computer interface. The decoder was simple and robust. That means patients didn’t have to train hard to perform the switch. “In our view, a motor neuroprosthesis should be safe and easy to use. Digital switches controlled by movement intentions bring back meaningful recovery of motor skills in paralyzed patients and things we take for granted, like texting a loved one her message or turning on a light. It may lead to ”
The publication of this study supports the ongoing COMMAND trial at Carnegie Mellon University, the University of Pittsburgh, and Mount Sinai Hospital to assess the safety of Stentrode and investigate a quantified efficacy measure. It follows Synchron’s announcement regarding registration. Three of her six participants were enrolled in her COMMAND exams, two of which were in New York City and one in Pittsburgh. Clinical trial sites are actively seeking the following participants: Patients with severe paralysis due to ALS, stroke, spinal cord injury, or multiple sclerosis may be suitable for study. If you are a provider, patient or caregiver interested in learning more about the ongoing US clinical trial, please email info@synchron.com.
Personal computing devices have changed the way people interact with the world. About 5.4 million people in the United States suffer from paralysis, which limits their ability to control computers and smartphones. BCI can restore motor skills by using cortical motor signals to bypass the impaired limb and directly control the computer. In high-income countries, it is estimated that by 2025, the number of people potentially eligible for BCI assistance will reach 50 million.
About Stentrode™
Synchron’s flagship technology, Stentrode, is an endovascular brain implant designed to allow patients to wirelessly control digital devices with a view to improving functional independence. Synchron’s base technology motor neuroprosthesis (motor BCI) is implanted via the jugular vein using neurointerventional techniques commonly used to treat stroke and does not require a craniotomy. The system is designed for patients suffering from paralysis as a result of various conditions and aims to be user-friendly and reliable for autonomous use by the patient.
About Syncron Co., Ltd.
Synchron is a clinical-stage endovascular brain-computer interface (BCI) company. Since 2012, the company has developed his BCI platform that uses minimally invasive surgery to avoid the need for craniotomy. The Synchron Switch™ BCI received FDA Breakthrough Device designation in 2020 and is currently undergoing clinical trials in the United States and Australia. Synchron has been published in multiple peer-reviewed journals, including JAMA Neurology, Nature Biotechnology, Nature Biomedical Engineering, and JNIS. Synchron is headquartered in Brooklyn, New York with an R&D facility in Melbourne, Australia. For more information, please visit www.synchron.com. follow me on twitter @sync.
