Synchron to test brain-computer interface in human clinical trials

Synchron, a company competing with Elon Musk’s Neuralink and others to bring brain-computer interfaces (BCIs) to market, has become the first in its industry to enroll a patient in a Food and Drug Administration-approved clinical trial. .

the first feasibility study will assess the safety and effectiveness of permanently implanted BCIs, which aim to restore functionality to paralyzed people by allowing them to control digital devices using only their thoughts.

A milestone for the BCI industry: Since the 1990s, a small but growing body of research has shown that BCIs can allow paralyzed people to use their thoughts to type words, control a computer cursor, and moving robotic hands and arms. In recent years, BCIs have even helped paralyzed people find limb movement and the to touch.

But the industry is still young. Before BCIs can begin to restore functionality to the more than 5 million people in the United States who suffer from paralysis, companies like Synchron and Neuralink must demonstrate that the technology is safe, effective in non-research settings, and capable to be produced at affordable prices. .

Sychron’s clinical trial represents a major step towards removing regulatory and practical barriers for the BCI industry.

How BCIs translate thoughts into action

All BCIs work in the same general way: a device monitors brain activity, decodes that activity into data representing the desired action, and then sends a command to a body part or external device to perform the desired action. In other words, BCIs repair the broken communication links between the brain and the body.

Translating brain activity into commands takes some training. Using machine learning-based software, the BCI system ultimately learns to link specific expressions of brain activity to a target action.

One area where BCIs differ is in invasiveness. The most invasive devices must be implanted under the skull, requiring open-brain surgery. Synchron’s interface, called a stentrode, is still invasive, but it takes an arguably more appealing approach by implanting the device in the chest, similar to a pacemaker procedure. This method is not only safer, but also greatly increases the number of physicians who would be able to implant the interfaces into patients.

The Strangler

But how does a thorax implant with the brain? Beginning in the chest, a tiny stent containing sensors is routed through the jugular vein and up into the blood vessels of the brain, where it remains permanently and eventually fuses with the blood vessel.

Illustration of the stentrode system. (Credit: Synchronized)

Stents have been used since the 1980s to treat heart disease by keeping arteries open, and more recently to treat idiopathic intracranial hypertension. But the strentrode is the first to use stents as part of a BCI.

“What we’re doing differently is using blood vessels as a natural highway to the brain and linking the inside of blood vessels with electrodes or sensors that can record brain activity,” said Synchron’s CEO. , Thomas Oxley, in a statement. video.

The signals recorded by the sensors inside the blood vessels then travel down to the implant in the chest, which wirelessly transmits the data to external digital devices. In short, it’s a Bluetooth connection for the brain.

For Graham Felstead, a 75-year-old man paralyzed from amyotrophic lateral sclerosis (ALS), strentrode helped regain the ability to email, shop and bank online. As part of a 2019 Synchron clinical trial in Australia, Felstead was implanted with the stentrode, becoming the first person to be implanted with a BCI implanted into blood vessels in the brain.

Synchron’s recently approved preliminary feasibility study follows that successful Australian clinical study, in which the stentrode enabled four paralyzed patients to perform basic tasks on a computer: controlling cursor clicks with more 90% accuracy and enter at least 14 characters per minute.

It’s still not enough the futuristic vision promised by others in the BCI industry. For some companies, the long-term goal is to create devices that transform the way we communicate, for example by enabling telepathy or the ability “to share full sensory and emotional experiences, not just photos”, as Mark Zuckerberg mentioned in 2015.

Thomas Oxley, CEO of Synchron mentioned “the enterprise’s north star is to achieve whole-brain data transfer”. But for now, the focus is on the motor cortex, where simpler, more affordable BCIs could soon help improve the quality of life of paralyzed people.

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