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.