Initial clinical trials of a “neurotechnology” system conceived at Brown University and being developed by a spinoff company in Foxboro have shown it enabled two quadriplegics to control movements with their thoughts alone, simply by reading their brain signals.
The pilot clinical trial findings are featured on the cover of the latest issue of the journal Nature, released Wednesday, as a major advance in neuroscience.
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The device, called “BrainGate,” was created by Cyberkinetics Neurotechnology Systems Inc. based on research in the laboratory of neuroscientist John P. Donoghue, director of Brown’s Brain Science Program and chief scientific officer at Cyberkinetics.
The company, which got its initial funding from venture capital and has been public for two years, has a licensing agreement with the Brown University Research Foundation.
Cyberkinetics President and CEO Timothy R. Surgenor said he doesn’t expect BrainGate to be ready for commercialization for another two or three years, but when it is, it could make a big difference for the patients it’s designed to help.
“The intended population is people with spinal-cord injuries … people who’ve had strokes, or with ALS [Lou Gehrig’s disease] or muscular dystrophy,” he said. “The idea is that their brain is still intact, but for some reason they can’t connect to the rest of their bodies.”
Nationwide, about 200,000 to 400,000 people fit that category, Surgenor said, and about 10,000 to 20,000 new cases occur every year. “It’s not a huge market,” he said, “but it’s a compelling market, because these people have such a serious disability.”
BrainGate consists of a surgically implanted sensor that records brain cells’ activity and decodes those signals in real time to control an external device – a prosthetic hand or limb, a computer, a remote control, a wheelchair.
One of the long-term goals of the research is to pair BrainGate with a muscle stimulator system and allow people with paralysis to move their limbs again.
Cyberkinetics is also developing a related technology, the “NeuroPort” system, which would use the same type of sensor to diagnose irregular brain activity, such as that from epilepsy.
It also has a third product in the works, “Andara,” based on research at Purdue University, which stimulates the neurons of people who’ve recently suffered a spinal-cord injury to partially regenerate their neural fibers, restoring some function, sensation and movement.
Andara is the farthest along, Surgenor said, having completed a 10-person clinical trial, and it could be a candidate for U.S. Food & Drug Administration approval by next year.
With all three technologies, Surgenor said, Cyberkinetics’ priority is the “operating system,” the fundamental concept, and the company might allow others to develop the applications.
“This is going to be an important technology in the future,” he said, and “we want to be the Microsoft of that type of development.”
The pilot clinical trial described in Nature is important, Surgenor said, because it involved intensive testing of the technology, especially with the first participant, Matthew Nagle, a 25-year-old with a spinal-cord injury.
The article also looks at the initial performance with a second trial patient, a 55-year-old man with spinal-cord injury. A person with ALS and another who’d suffered a brain-stem stroke also are involved in the pilot trials, Surgenor said.
Dr. Leigh R. Hochberg, a neurologist with Boston-area hospitals and a neuroscience investigator at Brown, who coauthored the Nature article, said the tests found that the brain’s ability to produce movement-related signals remains, even after a spinal-cord injury makes it impossible for those signals to reach the rest of the body.
Donoghue said the brain’s immediate response was also encouraging.
“When asked to ‘think right’ or ‘think left,’ patients were able to change their neural activity immediately,” he said. “And their use of the device is seemingly easy.”
