In a first-of-its-kind clinical trial, bioelectronic medicine researchers, engineers, and surgeons at Northwell Health’s Feinstein Institutes for Medical Research have successfully implanted microchips into the brain of a man living with paralysis and have developed artificial intelligence (AI) algorithms to re-link his brain to his body and spinal cord. And this double neural bypass forms an electronic bridge that allows information to flow again between the man’s paralyzed body and brain to restore movement and sensations in his hand and lasting gains in his arm and wrist outside of the laboratory.
The research team has unveiled the trial participant’s groundbreaking progress four months after a 15-hour open-brain surgery that took place on March 9 at North Shore University Hospital (NSUH).
Paralyzed from the chest down, Keith Thomas, 45, of Massapequa, NY, was the first human to use the technology. And during the height of the pandemic, on July 18, 2020, a diving accident caused Thomas to suffer an injury at the C4 and C5 level of the vertebrae in his spine, leaving him unable to move and feel from the chest down. Alone and isolated in the hospital for more than six months, Thomas found new hope by participating in Prof. Bouton’s clinical trial and is grateful to be a part of something so historic and more significant than himself.
More than a hundred million people worldwide live with movement impairment or paralysis. And this clinical trial aims to restore lasting physical movement outside the research lab and re-establish the sense of touch.
Feinstein Institutes’ researchers and clinicians, including Santosh Chandrasekaran, Ph.D. and Adam Stein, MD, chair of physical medicine and rehabilitation at Northwell Health, spent months mapping Thomas’ brain using functional MRIs to help pinpoint the areas responsible for both arm movement and the sensation of touch in his hand. Armed with that information, surgeons led by Ashesh Mehta, MD, PhD, and Netanel Ben-Shalom, MD, a neurosurgeon at Northwell Lenox Hill Hospital, performed a grueling 15-hour surgery at NSUH, during parts of which the study participant was awake and giving surgeons real-time feedback. As they probed portions of the surface of his brain, Thomas would tell them what sensations he was feeling in his hands.
Back in the lab, through two ports protruding from Thomas’ head, he connects to a computer that uses AI to read, interpret and translate his thoughts into action, known as thought-driven therapy and the foundation of the double neural bypass approach. And the bypass starts with Thomas’ intentions (e.g. he thinks about squeezing his hand), which sends electrical signals from his brain implant to a computer. The computer then sends signals to highly-flexible, non-invasive electrode patches placed over his spine and hand muscles in his forearm to stimulate and promote function and recovery. And tiny sensors at his fingertips and palm send touch and pressure information back to the sensory area of his brain to restore sensation. This two-arm electronic bridge forms the novel double neural bypass to restore movement and the sense of touch. In the lab, Thomas can now move his arms at will and feel his sister’s touch as she holds his hand in support. This is the first time he has felt anything in the three years since his accident.
Researchers say Thomas is already starting to see some natural recovery from his injuries thanks to this new approach, which could reverse some of the damage for good. His arm strength has more than doubled since enrolling in the study, and he is beginning to experience new sensations in his forearm and wrist, even when the system is off.
Previous research by Prof. Bouton, and later, by other groups, used a single neural bypass to help people move paralyzed limbs with their thoughts. And in those cases, doctors implanted one or more microchips in the brain that bypassed the spinal cord injury and used stimulators to activate target muscles. But that approach only worked while participants were hooked up to computers, often only available in laboratories, and did not restore movement and feeling in the actual limb while promoting plasticity for long-lasting natural recovery.
The hope is that the brain, body, and spinal cord will relearn how to communicate. New pathways will be forged at the injury site thanks to the double neural bypass, similar to how a kidney can regenerate to overcome trauma or disease.
The Feinstein Institutes for Medical Research is the global scientific home of bioelectronic medicine, which combines molecular medicine, neuroscience, and biomedical engineering. And at the Feinstein Institutes, medical researchers use modern technology to develop new device-based therapies to treat disease and injury.
Building on years of research in molecular disease mechanisms and the link between the nervous and immune systems, our researchers discover neural targets that can be activated or inhibited with neuromodulation devices, like vagus nerve implants, to control the body’s immune response and inflammation. And if inflammation is successfully controlled, diseases – such as arthritis, pulmonary hypertension, Crohn’s disease, inflammatory bowel diseases, diabetes, cancer and autoimmune diseases – can be treated more effectively.
Beyond inflammation, using novel brain-computer interfaces, our researchers developed techniques to bypass injuries of the nervous system so that people living with paralysis can regain sensation and use their limbs. And by producing bioelectronic medicine knowledge, disease, and injury could one day be treated with our nerves without costly and potentially harmful pharmaceuticals.
You can learn more in the video below:
KEY QUOTES:
“This is the first time the brain, body and spinal cord have been linked together electronically in a paralyzed human to restore lasting movement and sensation. When the study participant thinks about moving his arm or hand, we ‘supercharge’ his spinal cord and stimulate his brain and muscles to help rebuild connections, provide sensory feedback, and promote recovery. This type of thought-driven therapy is a game-changer. Our goal is to use this technology one day to give people living with paralysis the ability to live fuller, more independent lives.”
— Chad Bouton, professor in the Institute of Bioelectronic Medicine at the Feinstein Institutes, vice president of advanced engineering at Northwell Health, developer of the technology and principal investigator of the clinical trial
“There was a time that I didn’t know if I was even going to live, or if I wanted to, frankly. And now, I can feel the touch of someone holding my hand. It’s overwhelming,” said Mr. Thomas. “The only thing I want to do is to help others. That’s always been the thing I’m best at. If this can help someone even more than it’s helped me somewhere down the line, it’s all worth it.”
— Keith Thomas
“Because we had Keith’s images and he was talking to us during parts of his surgery, we knew exactly where to place the brain implants. We inserted two chips in the area responsible for movement and three more in the part of the brain responsible for touch and feeling in the fingers.”
— Dr. Mehta, professor at the Feinstein Institutes’ Institute of Bioelectronic Medicine, director of Northwell’s Laboratory for Human Brain Mapping and the surgeon who performed the brain implant
“Millions of people live with paralysis and loss of feeling, with limited options available to improve their condition. Prof. Bouton and his team are committed to advancing new bioelectronic technologies and open new clinical paths to restore movement and sensation.”
— Kevin J. Tracey, MD, president and CEO of the Feinstein Institutes and Karches Family Distinguished Chair in Medical Research
