#AAN2022 – Stentrode Enables Tasks With ‘Just a Thought’: Study
Synchron’s Stentrode, an innovative, implantable brain computer interface (BCI), was found safe in four amyotrophic lateral sclerosis (ALS) patients and let them communicate and perform daily online tasks by using “just their thought,” according to one-year data from a clinical trial.
The results were presented as part of an exclusive press briefing highlighting breakthrough science at the 2022 American Academy of Neurology (AAN) Annual Meeting, being held in Seattle April 2–7, and virtually April 24–26.
“People with ALS eventually lose their ability to move their limbs, making them unable to operate devices like a phone or computer,” Bruce Campbell, MD, the study’s author at the University of Melbourne, Australia, and a member of the AAN, said 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 much less invasive,” Campbell said, adding that Stentrode “receives electrical signals from 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 intent-to-move nerve impulses from the motor cortex — a region responsible for voluntary movement — into a digital signal.
While BCI devices to date typically require open brain surgery for implementation, Stentrode placement involves a much less invasive procedure.
The mesh-like device, the size of a matchstick and containing 16 electrodes, is inserted through a small “keyhole” incision in the neck, moved through the jugular vein, and placed precisely in a blood vessel that sits over the motor cortex.
Once in place, it expands, without blocking blood flow, to press the electrodes against the vessel wall, where it can record signals of brain activity linked to intended movement. These signals are then sent through a 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 movement-intended impulses, can be interpreted through 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 enables patients to use their thoughts and eye movements to control a cursor on the screen and keyboard commands, helping them regain the ability to perform daily tasks such as texting and online shopping.
In the current, Australia-based clinical study, called SWITCH (NCT03834857), Stentrode was implanted in a small number of adults with ALS, who were followed for one year.
Previous data from the two first participants showed that, within a few months of Stentrode implantation, patients were able to control a computer and complete daily tasks such as online banking, shopping, and texting.
Newly announced results, concerning all four ALS patients, demonstrated that the device was generally safe, with no serious adverse events leading to disability or death. Stentrode also stayed in place in all four patients and the blood vessel in which the device was implanted remained open.
Also, Stentrode allowed participants to use a computer to communicate by text and perform daily tasks such as online shopping and banking.
“These results are a huge advancement for the field of BCI,” said Thomas Oxley, MD, PhD, Synchron’s co-founder and CEO.
“Years of research and technological development culminated in this moment, and as we continue to develop our technology, it has the potential to change the lives of millions of patients globally who suffer from paralysis and other debilitating neurological and brain-related diseases,” Oxley added.
Synchron is planning to launch the first U.S.-based clinical trial of Stentrode. The study, dubbed COMMAND, is expected to enroll six patients at the University of Pittsburgh Medical Center and Mount Sinai Health System.
The trial will evaluate whether the device can help people with severe paralysis — including those with ALS — regain some functional independence and the ability to communicate digitally.
Stentrode received breakthrough device designation in the U.S., which is meant to accelerate the development and review of devices that might more effectively treat or diagnose life-threatening or irreversibly debilitating diseases.
Note: The ALS News Today team is providing coverage of the American Academy of Neurology (AAN) 2022 Annual Meeting. Go here to see the latest stories from the conference.
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