Synchron’s Brain-Computer Interface Implants Could Allow Paraplegics to Interact with the World Again

During a recent video call with ReturnByte, Dr. Tom Oxley, CEO of medical device startup Synchron, expressed his clear disapproval of utilizing brain-computer interface technology to enhance the capabilities of physically fit individuals. He emphasized that their focus is not on developing a BCI for controlling entertainment platforms like Spotify or Netflix.

“The BCI has all this hype and excitement about where it could go,” Oxley continued. “But the reality is, what does it do for patients? We’re describing this problem for patients who don’t want to enhance their brains or their bodies, but want to restore the basic agency and autonomy that [able-bodied people] take for granted.”

About 31,000 Americans currently suffer from amyotrophic lateral sclerosis (ALS), and 5,000 are diagnosed each year. Nearly 300,000 Americans suffer from spinal cord paralysis, and about 18,000 more join those ranks each year. Thousands more are paralyzed by stroke and accident and lose the ability to see, hear or feel the world around them. And with no motor control in their limbs, these Americans may also lose access to a critical part of modern life: the smartphone.

“[The smartphone] creates our independence and our autonomy,” Oxley said. “It’s communicating with each other, sending text messages, sending emails. It controls the lights in your house, does your banking, does your shopping and everything else.”

“If you can control your phone again,” he said. “You can restore elements of your lifestyle.”

So while Elon Musk promises a fantastical cyberpunk future where everyone knows Kung Fu and can upload their consciousness to the cloud if they want, startups like Synchron, along with Medtronic, Blackrock Neurotech, BrainGate and Precision Neuroscience, and countless academic research groups are at work. incorporate this changing medical technology into clinical practice reliably and ethically.

The best way to a man’s mind is through his jugular vein

Brooklyn-based Synchron made history in 2022 when it became the first company to successfully implant a BCI in a human patient as part of the groundbreaking SWITCH trial in collaboration with Mount Sinai Hospital. Until now, the medical community has generally had only two options for capturing the myriad electrical signals produced by our brains: low-precision but non-invasive EEG wave shields or high-quality Utah Array nerve sensors that require open brain surgery to install. .

Synchron’s Stentrode device offers a third: it’s surgically guided up through a patient’s jugular vein to rest in a large blood vessel near their motor cortex, where its integrated array of sensors produces a better signal than an EEG shield without the messy implantation or potential performance. drop out of probe groups.

“We’re not inserting invasive electronics into the brain, so the surgical procedure itself is minimally invasive,” Dr. David Putrino, director of rehabilitation innovation at Mount Sinai Health System, explained to ReturnByte. “The other part of it is that you’re not asking a neurologist to learn anything new… They know how to place stents, and you’re really asking to put a stent in a large vessel — it’s not a difficult task.”

“These types of vascular surgeries in the brain are commonly performed,” said Dr. Zoran Nenadić, William J. Link Chair and Professor of Biomedical Engineering at the University of California, Irvine. “I think they’re smart about using this route to deliver these implants into the human brain, which is otherwise an invasive surgery.”

While the Stentrode’s signal quality isn’t quite the same as a sensor array, it doesn’t suffer from the signal degradation that arrays do. In fact, quite the opposite. “When you use permeable electrodes and put them in the brain,” Putrino said, “gliosis forms around the electrodes and the impedances change, the signal quality decreases, you lose certain electrodes. In this case, when the electrode vascularizes into the blood vessels, it actually stabilizes and improves the recording over time.”

A device for quiet moments of terror

“We’re finally paying attention to a segment of people with disabilities who haven’t previously had access to technology that provides digital autonomy,” Putrino said. He notes that for many severely paralyzed people who can wiggle a finger or a toe or who can use eye-tracking technology, the communication devices available to them are situational at best. Warning buttons can move out of reach, eye tracking systems are largely fixed tools and unusable in cars.

“We talk to these people on a regular basis and the fears that are raised that this technology can help,” Putrino recalls. “It’s in these quiet moments that it’s like the eye tracking has been left off for the night and then it starts to suffocate, how do you invite someone in? Your call button or communication device is pushed aside and you see the nurse start to prepare the wrong medicine for you. How do you warn them? These moments often happen in the life of a disabled person, and we don’t have an answer to these things.”

He went on to say that BCI-locked patients are no longer isolated. They can simply wake their digital device from sleep mode and use it to alert caregivers. “This works outdoors, it works in different lighting settings, it works whether you’re lying on your back or sitting in your chair,” Putrino said. “The goal is versatile, continuous digital control.”

There is still at least half a decade to reach the goal. “Our goal in the next five years is to get market acceptance and then we’re ready to expand that point,” Oxley said. The speed of scaling depends on the company’s access to cath labs. These facilities are found in both primary and secondary hospitals, so there are thousands around the country, Oxley said. Far more than the handful of entry-level hospitals equipped to handle open-brain BCI implantation surgeries.

A show of hands and another hole in your head

In 2021, Synchron conducted the SWITCH safety study on the Stentrode device itself, implanted it in four ALS patients and monitored their health over the next year. According to a 2022 press release, the study concluded that the device is “safe, with no serious adverse events that resulted in injury or death.” The stentrode “remained in place in all four patients and the vessel in which the device was implanted remained open.”

Encouraged by this success, Synchon launched its headline-grabbing COMMAND study last year, which uses the company’s entire brain.io system in six patients to help them communicate digitally. “We’re really trying to show that this thing improves quality of life and improves individual agency,” Putrino said. The team had originally expected that the recruitment process, through which candidate patients are screened, would take five full years.

Dr. Putrino wasn’t prepared for the disinterest, especially given the permanent nature of these tests and the quality of life patients can expect once they’re admitted. “Many of our patients have end-stage ALS, so being involved in a trial is a non-trivial decision,” Putrino said. “It’s like, do you want to spend the last years of your life with researchers, not with family members?”

“Do you want to make this choice for people who are considering litigation and have a spinal cord injury?” asked Putrino, because these people are also eligible for implantation. “We’re having a very frank conversation with them, look, this is a one-generation device,” he warns. “Do you want to wait for generation five because you don’t have a short life expectancy, you can live another 30 years. This is a permanent implant.”

Still, public interest in Synchron’s BCI work has led to such an influx of interested patients that the team was able to perform its implant surgery on the study’s sixth and final patient in early August—nearly 18 months ahead of schedule. The team must continue the study for at least another year (to meet minimum safety standards, as in the previous SWITCH trial), but has already received permission from the NIH to extend its observational portion to the original five years. This gives Synchron significantly more data to use in the future, Putrino explained.

How can we avoid another Argus II SNAFU

Our Geordi LaForge visor future seemed a real lock in 2013 when Second Sight Medical Products received FDA Humanitarian Use Device Designation for its Argus II Retinal Prosthesis, two years after it received commercial approval in Europe. A medical device designed to restore at least rudimentary functional vision to people suffering from profound vision loss from retinitis pigmentosa was implanted in the patient’s retina and converted digital video signals from an external, glass-mounted camera into analog electrical impulses that the brain can understand — effectively bypassing the diseased parts of the patient’s eye system.

With the FDA’s technical blessing in hand (humanitarian use cases are not subject to nearly the same scrutiny as full FDA approval), Second Sight applied for an IPO in 2013 and listed on NASDAQ the following year. Seven years after that, the company went belly up in 2020, declaring it out of business and wishing luck to the vacuum cleaners who spent $150,000 to get its hardware into their skulls.

“Once you’re in that [humanitarian use] category, it’s hard to go back and do all the research necessary to move forward with traditional FDA approvals,” Dr. An Do, an assistant professor in the Department of Neurology at the University of California, Irvine, told ReturnByte. “I think the other thing is that these are rare diseases. There’s a very small group of people that they’re serving.”

As IEEE Spectrum rightly points out, one loose wire, one degraded connection, or faulty wire, and these patients can lose what little vision they have regained. It’s also possible that an implant without regular maintenance will eventually cause an infection or interfere with other medical procedures, requiring expensive, invasive surgery to remove it.

“I’m constantly worried about this,” Putrino admitted. “This is the question that keeps me awake at night. I think we obviously need to make sure that companies can move forward in good faith to the next phase of their work before starting clinical trials.”

He also urges the FDA to expand its review of BCI companies to potentially include the applicant’s continued financial stability. “I think that’s definitely something that we need to think about because we don’t want to implant patients and then just have them lose this technology.”

“We always talk to our patients when recruiting that this is a permanent implant,” Putrino continued. “We commit to them that they can always come to us with questions about the devices, even outside of the clinical trial.”

But Putrino admits that even with the best intentions, companies simply cannot guarantee their customers continued commercial success. “I really don’t know how we can protect against a complete failure of the company,” he said. “This is just one of the risks that people take when they come in. It’s a complicated thing, and I’m concerned because we’re on the bleeding edge here, and it’s unclear if we’ll have good answers for this after the technology goes beyond clinical trials.”

Fortunately, the FDA does. As an agency official explained to ReturnByte, “FDA’s decisions are intended to be patient-centered, and the health and safety of device users is our top priority.” If a company goes bankrupt or is otherwise unable to provide the services it previously sold, in addition to potentially being ordered by a court to continue treating existing patients, “the FDA may also take steps to protect patients under these circumstances. For example, the FDA may issue recommendations to the public about actions that healthcare providers and patients should undertake.

The FDA official also points out that the evaluation process itself includes determining whether the applicant demonstrates sufficient confidence in the device’s safety and effectiveness when used as intended in its environment for its expected lifetime… FDA requirements apply to devices regardless of the company’s decision. stop selling and distributing the device.”

The Synchron Switch BCI, on the other hand, is made of biologically inert materials that will eventually be absorbed back into the body, “so even if Synchron were to disappear tomorrow, the Switch BCI is designed to stay safely in the patient’s body indefinitely,” Oxley said. “The BCI runs on a software platform designed for stable and independent use, so patients can use the platform without our direct involvement.”

However, this approach “is not sufficient and that, given the potential impact of BCI on individuals and society, the nature of what is safe and effective and the balance between risk and benefit require special attention,” argued a paper published in the AMA in 2021. Journal of Ethics. “The line between therapy and BCI improvement is hard to draw precisely. Therapeutic devices work to correct or compensate for some disease state, returning them to ‘normal’ or species-typical standard form. But what and more importantly, who gets to define normality? How much below average IQ can you before a mandatory increase in your score with a BCI implant is deemed worthy of society?

Oped’s authors acknowledge that “While BCIs raise several ethical concerns, such as how to define personhood, respect for autonomy, and the adequacy of informed consent, not all ethical questions rightfully form the basis of government regulation.” The FDA’s job is to test devices for safety and effectiveness, not equality. As such, the authors argue instead that “a new committee or regulatory body with humanistic goals, including both individual and societal concerns, should be provided for at the federal level to help regulate the nature, scope, and use of these devices.”