Paralyzed patients effectively control computer in a historic trial
Medical technology company Synchron published in a press release on Monday the results of a clinical study that saw paralyzed patients effectively send out neural signals via an implantable brain-computer interface.
The study highlighted the long-term safety results from a clinical study in which four patients with severe paralysis implanted with Synchron’s first-generation Stentrode, a neuroprosthesis device, were able to control a computer.
The results indicated that it is possible and safe to use the neuroprosthesis device to transmit neural signals from inside a blood vessel in the brain over a long-term period without any serious side effects.
The SWITCH study
Called the Stentrode With Thought-Controlled Digital Switch (SWITCH) study, the research marks the first-in-human study of its kind that followed the evolution of four patients implanted with Synchron’s Stentrode through a period of 12 months.
Throughout that time, no clots surfaced, and the device did not migrate from its original positioning. In addition, the signal quality remained stable with no evidence of deterioration.
Perhaps more impressively, all four participants were able to control a personal computing device with the brain-computer interface to perform such activities as texting, emailing, personal finance, online shopping, and communication of care needs.
Paper published in @JAMANeuro today, reporting on long term (12 month) data in the first four stentrode BCI participants in @UniMelb @TheRMH. These participants were inspiring to us. We are learning and improving everyday. ❤️❤️ @synchroninc https://t.co/LdZ9hLBx5C pic.twitter.com/zySp8khtwr
— Thomas Oxley (@tomoxl) January 10, 2023
The procedures were performed in a neurointerventional angiography suite.
“We carefully conducted this first-in-human study with a primary focus on safety. The patients all tolerated the procedure well and were typically discharged home within 48 hours,” said in the statement Professor Peter Mitchell, Director of Neurointervention at Royal Melbourne Hospital.
“The wide-spread availability of the angiography suite for this procedure could promote a rapid translation of brain-computer interface for people with paralysis.”
Restoring lost motor intent signal
Paralysis notoriously leads to a loss of control of muscles in the body. However, motor intent is often still active in the brain of paralyzed patients and can signal the physical will to move.
Synchron’s brain-computer interface is engineered to restore the lost motor intent signal transmission associated with paralysis. The device is placed via surgery into the motor cortex of the brain via the jugular vein.
This process is a minimally-invasive endovascular procedure. Once implanted, the device detects and proceeds to wirelessly transmit motor intent.
This form of communication allows the device’s wearer to control personal digital devices.
“This technology holds great promise for people with paralysis who want to maintain a level of independence,” said Professor Bruce Campbell, 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.”
The researchers now hope to provide paralyzed patients with the meaningful restoration of motor capability.
“The SWITCH study is an early demonstration of safety in a low number of participants using a commercial grade brain-computer interface. The decoder was simple and robust, meaning that patients didn’t have to train hard-to-execute switches,” concluded Tom Oxley, Synchron CEO and Founder.
“Our view is that a motor neuroprosthesis should be safe and easy to use.”