Rodney Gorham has successfully used a Synchron brain-computer interface implant for five years, a milestone for the company. The implant, called the Stentrode, allows him to control digital devices with his thoughts, providing critical assistance as he lives with ALS.
Synchron is preparing for a larger pivotal trial needed for regulatory approval, working with the FDA to define clinical endpoints. The technology relies on decoding algorithms to translate neural signals into actions, with Gorham's long-term feedback being instrumental in its development.
The main topics covered are: the milestone of long-term BCI use, the technical function of Synchron's Stentrode implant, the path to regulatory approval, and the role of user feedback in evolving the technology's capabilities.
Rodney Gorham recently passed a milestone that few people have reached. He’s had a brain-computer interface implanted for five years.
Made by startup Synchron, the experimental implant allows him to control a computer and other digital devices around his home using just his thoughts. It’s been a lifeline for 65-year-old Gorham, who has amyotrophic lateral sclerosis, or ALS, and can no longer walk, talk, or move his hands.
Synchron is among several companies, including Elon Musk’s Neuralink, aiming to commercialize brain-computer interfaces to help individuals with paralysis. Over the past five years, Synchron’s software and hardware have gone through many iterations, with Gorham helping to shape the evolution of the technology. Out of the 10 volunteers to get Synchron’s implant so far, Gorham has been living with it the longest. He received it in December 2020 as part of a trial in Australia. (The longest-ever user of an implanted brain-computer interface is Nathan Copeland, who’s had one for more than 10 years. He has four research-grade arrays in his brain made by Blackrock Neurotech.)
“We've done a lot of trial and error with Rodney trying out different things to figure out what we think the first use case we should build the first product and clinical trial around,” says Tom Oxley, Synchron’s founding CEO. “He's played a pivotal role in helping us test out new decoders, new interaction methods, and application integrations,”
Synchron’s first product is dubbed the Stentrode, a tiny mesh tube that sits in a blood vessel against the brain and collects neural signals. It’s inserted into the jugular vein at the base of the neck and threaded through the vessel until it reaches the motor cortex, the part of the brain responsible for voluntary movement. A surgically placed unit in the chest receives the brain signals then transmits them out of the body to an external receiver.
The company is gearing up to test the Stentrode in a larger, so-called pivotal trial needed for regulatory approval. It’s been in talks with the US Food and Drug Administration to decide on the trial’s clinical endpoint—a measurable outcome used to assess the safety and effectiveness of a device. Determining the effectiveness of a brain-computer interface is a bit trickier than a traditional drug or device that directly treats a disease, and it’s a question that the field is currently grappling with.
Brain-computer interfaces rely on decoding algorithms to translate brain activity into the user’s intended actions. For instance, a person might think about making a fist or tapping their foot to carry out a mouse click on a computer screen. Someone who is paralyzed may not be able to physically make a fist or tap their foot, but the neurons in their brain still fire in a unique pattern when they attempt to do so. A decoder has to be able to consistently recognize that raw neural signal in order for a brain-computer interface to be useful.
Initially, Gorham used his brain-computer interface for single clicks, Oxley says. Then he moved on to multi-clicks and eventually sliding control, which is akin to turning up a volume knob. Now he can move a computer cursor, an example of 2D control—horizontal and vertical movements within a two-dimensional plane.
Over the years, Gorham has gotten to try out different devices using his implant. Zafar Faraz, a field clinical engineer for Synchron, says Gorham directly contributed to the development of Switch Control, a new accessibility feature Apple announced last year that allows brain-computer interface users the ability to control iPhones, iPads, and the Vision Pro with their thoughts.
In a video demonstration shown at an Nvidia conference last year in San Jose, California, Gorham demonstrates using his implant to play music from a smart speaker, turn on a fan, adjust his lights, activate an automatic pet feeder, and run a robotic vacuum in his home in Melbourne, Australia.
“Rodney has been pushing the boundaries of what is possible,” Faraz says.
As a field clinical engineer, Faraz visits Gorham in his home twice a week to lead sessions on his brain-computer interface. It’s Faraz’s job to monitor the performance of the device, troubleshoot problems, and also learn the range of things that Gorham can and can’t do with it. Synchron relies on this data to improve the reliability and user-friendliness of its system.
In the years he’s been working with Gorham, the two have done a lot of experimenting to see what’s possible with the implant. Once, Faraz says, he had Gorham using two iPads side by side, switching between playing a game on one and listening to music on the other. Another time, Gorham played a computer game in which he had to grab blocks on a shelf. The game was tied to an actual robotic arm at the University of Melbourne, about six miles from Gorham’s home, that remotely moved real blocks in a lab.
Gorham, who was an IBM software salesman before he was diagnosed with ALS in 2016, has relished being such a key part of the development of the technology, his wife Caroline says.
“It fits Rodney's set of life skills,” she says. “He spent 30 years in IT, talking to customers, finding out what they needed from their software, and then going back to the techos to actually develop what the customer needed. Now it’s sort of flipped around the other way.” After a session with Faraz, Gorham will often be smiling ear to ear.
Through field visits, the Synchron team realized it needed to change the setup of its system. Currently, a wire cable with a paddle on one end needs to sit on top of the user’s chest. The paddle collects the brain signals that are beamed through the chest and transmits them via the wire to an external unit that translates those signals into commands. In its second generation system, Synchron is removing that wire.
“If you have a wearable component where there's a delicate communication layer, we learned that that's a problem,” Oxley says. “With a paralyzed population, you have to depend on someone to come and modify the wearable components and make sure the link is working. That was a huge learning piece for us.”
Brain-computer interfaces will need to be easy for caregivers to set up in the home if patients are going to use them regularly.
During the years he’s been in the Synchron trial, Gorham’s condition has slowly progressed. Using his implant requires a lot of concentration, and he tires easily now. He used to do interviews with reporters via WhatsApp, but now it’s hard for him to text for long stretches. (This story relied on interviews with his wife Caroline, field specialist Faraz, and Oxley.)
It raises big questions for Synchron and other companies around the usefulness of these devices for patients with neurodegenerative diseases. Will patients be able to keep using them as their disease worsens? Will insurance cover an expensive device that requires surgery and has a potentially limited lifespan? Life expectancy after an ALS diagnosis is three to five years, but many people live longer. (Since Synchron’s first surgery in 2019, some participants have passed away due to the natural progression of their ALS.)
People with more stable forms of paralysis—for instance due to spinal cord injury—may be able to use a brain-computer interface for the rest of their lives. They may still experience mental fatigue from operating a device for hours a day, though.
“From my point of view,” says Caroline, “I think the companies have to take into consideration the human component more, because every human is different.”
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