MORGANTOWN – Researchers at WVU’s Rockefeller Neuroscience Institute are part of a team exploring cutting-edge technology to help people with neurological injuries and disabilities function and communicate.
Dr. Peter Konrad, chair of neurosurgery at RNI, and Radhey Sharma, professor in WVU’s Wadsworth Department of Civil and Environmental Engineering, led RNI’s first in-human trials of Precision Neuroscience’s Layer 7 Cortical Interface.
Layer 7 is an orange, paper-thin printed film, about 5 inches long, as wide as your pinkie finger. The square end, thumbnail-sized, contains 1,024 microelectrodes. It’s called a brain-computer interface, or BCI.
Konrad performed the surgery on six patients, implanting the BCI on the surface of their brains to record and map their brain activity.
Precision Neuroscience says: “The first application for our system will be a goal that BCI researchers have long sought: restoring functions such as speech and movement to millions of severely paralyzed people.”
Konrad explained that neuroscientists understand the map of the system – what part of the brain works with what part of the body. The idea of interfacing the brain with an external device or system in order to help a patient move or communicate has been around for a long time but the original technology was relatively crude.
The brain, he said, contains trillion cells and networks and there has to be a significant magnitude of interface – data channels – in order to work with the nervous system at a level you can do something.
Twenty years ago, an interface had only about 100 channels – electrodes – and had to be inserted into the brain. With that interface, a patient could think and move a cursor on a screen. The Layer 7 has 1,024 electrodes, enabling many times more interaction.
Even now, some research is still pursuing technology to weave interfaces into the brain. Precision Neuroscience is unique in developing a BCI that can sit on the surface and be implanted through a tiny slit. “We set out to develop something that had never been built before: a high-bandwidth digital connection to the brain that did not rely on penetrating electrodes, which damage brain tissue,” Precision said.
Sharma agrees. “What is beautiful about it is it does not need any drilling in the brain – it can be just on the surface.”
RNI’s human trials began in April 2023. Konrad implanted the Layer 7 on six patients who were undergoing tumor removal surgery in the area responsible for speech production. Some were unconscious, some were awake and could speak; they had the Layer 7 implanted for 15 minutes and the RNI team was able to capture the brain activity for patients in both states, in real time and in detail never before achieved.
Precision and the National Science Foundation jointly funded the trials, Konrad and Sharma said; it cost just under $100,000.
The brain business
But moving forward will be a challenge, they said.
Precision thinks it can bring the first commercial version of the Layer 7 to market by the end of 2025.
But for the industry in general, things likely won’t move that fast.
“The technology definitely is there,” Konrad said, “in which patients can drive a robot by thought, they can create text and words on a screen by thought, and they also can receive input from an artificial limb in some crude way to actually feel when things are working through that limb.”
The RNI trials were proof of concept, Konrad said. But scaling up for Layer 7 or any BCI will take time and piles of money: Taking a device to market takes about 10 years and $300 million. Startups have created devices to help people, gone out of business and left patients with orphaned implants.
Part of the problem is the need for FDA approval, Konrad and Sharma said. The FDA’s rightful mission is to ensure devices are safe and effective, but the law is badly written and makes the approval mountain nearly unclimbable. Congress would need to rewrite the law to simplify the process and still keep it safe.
“Businesses are carving pathways in which they can’t enter the market without raising $300 million, and if it doesn’t sell, its gone,” Konrad said. “There’s a crying need in this country to understand a different pathway for helping patients with this.”
Another factor is that a device is specific to a particular electric problem. The vast difference in neural needs makes it impassible to have a single one-size-fits-all device.
RNI and Precision aren’t alone in this endeavor though. Konrad and Sharma said. WVU, Georgia Tech, the University of Houston and two other institutions are members of the National Science Foundation-funded Industry-University Cooperative Research Center for Building Reliable Advances and Innovations in Neurotechnology, housed at the University of Houston.
“It is home base for scientists developing and testing the efficacy, safety and long-term reliability of patient-centered neurotechnology,” an article on the IUCRC said.
This summer, WVU will host the IUCRC annual conference in Morgantown, Konrad and Sharma said. It will bring together industry, academia and federal agencies – FDA, NIH, NSF – to explore the technologies being developed, the obstacles and possible solutions to the obstacles.
And while the technologies are still in their very early stages, Konrad and Sharma have their eyes on the horizon, too: a patch for spinal cord injuries to restore movement, BCIs for wounder warriors who’ve lost limbs or suffered traumatic brain injury in combat, BCIs for athletes injured on the field and suffering TBIs.
The military is a big investor in this field, Sharma noted.
And Konrad pointed out the importance of this research taking place in West Virginia. We have here in Morgantown a community of scientists, engineers and physicians driving the latest advances to promote and lead neural device development for West Virginia, the nation and the world, and to make West Virginia a key site for future-tech.
Email: dbeard@dominionpost.com
