Synchron’s Stentrode, an innovative implantable brain-computer interface (BCI), was found to be safe in four patients with amyotrophic lateral sclerosis (ALS) and enabled them to communicate and perform daily tasks online using “only their thought,” according to data from a year of a clinical trial.
The findings were presented as part of an exclusive press briefing highlighting scientific breakthroughs at the 2022 American Academy of Neurology (AAN) Annual Meeting, taking place in Seattle April 2-7 and virtually. April 24-26.
“People with ALS eventually lose the ability to move their limbs, making them unable to use devices like a phone or computer,” said Bruce Campbell, MD, study author at the University. of Melbourne, Australia, and a member of the AAN. in a press release.
“Our research is exciting because while other devices require surgery that involves opening the skull, this brain-computer interface device is far less invasive,” Campbell said, adding that Stentrode “receives electrical signals of the brain, allowing people to control a computer by thought.”
Brain-computer interfaces aim to restore voluntary motor control of digital devices in paralyzed people by converting movement intention nerve impulses from the motor cortex – a region responsible for voluntary movement – into a digital signal.
While BCI devices to date generally require open brain surgery for implementation, Stentrode placement involves a much less invasive procedure.
The mesh-like device, the size of a match and containing 16 electrodes, is inserted through a small “keyhole” incision in the neck, moved through the jugular vein and placed precisely into a blood vessel that lies above the motor cortex.
Once in place, it expands, without blocking blood flow, to press the electrodes against the vessel wall, where it can register signals of brain activity related to the intended movement. These signals are then sent via wire to a small sensor implanted under the skin on the user’s chest, which then wirelessly transmits the data to a computer or smartphone.
The data, associated with certain impulses intended for movement, can be interpreted by algorithms and transformed into specific digital actions. This is achieved through a training period involving the patient and a neuroscientist using Synchron’s custom training software.
This allows patients to use their thoughts and eye movements to control an on-screen cursor and keyboard commands, helping them regain the ability to perform everyday tasks such as texting and online shopping. line.
In the current Australian-based clinical study, called SWITCH (NCT03834857), Stentrode was implanted in a small number of adults with ALS, who were followed for one year.
Earlier data from the first two participants showed that within months of Stentrode implantation, patients were able to control a computer and perform daily tasks such as online banking, shopping, and sending SMS.
The recently announced results, for the four ALS patients, demonstrated that the device was generally safe, with no serious adverse events leading to disability or death. Stentrode also remained in place in all four patients, and the blood vessel into which the device was implanted remained open.
Additionally, Stentrode enabled participants to use a computer to communicate by text and perform daily tasks such as online shopping and banking.
“These results are a significant step forward for the field of BCI,” said Thomas Oxley, MD, PhD, co-founder and CEO of Synchron.
“Years of research and technology development have culminated in this moment, and as we continue to develop our technology, it has the potential to change the lives of millions of patients around the world who suffer from paralysis and other neurological diseases. and debilitating brain,” Oxley said. added.
Synchron plans to launch the first clinical trial of Stentrode in the United States. The study, called COMMAND, is expected to enroll six patients at the University of Pittsburgh Medical Center and Mount Sinai Health System.
The trial will assess whether the device can help people with severe paralysis – including those with ALS – regain some functional independence and the ability to communicate digitally.
Stentrode has been awarded Breakthrough Device designation in the United States, which aims to accelerate the development and examination of devices that can more effectively treat or diagnose life-threatening or irreversibly debilitating diseases.
Editor’s note: The ALS News Today team provides coverage of the 2022 Annual Meeting of the American Academy of Neurology (AAN). Go here to see the latest stories from the conference.