This electric brain implant could help stroke victims recover. The first patient: A Seattle-area mechanic

Neurosurgeons and engineers at the University of Washington School of Medicine reached a milestone this summer, implanting a device inside the skull of a stroke victim that they believe can help him recover movement in his arm and hand.

The surgery caps years of work and decades of research based on the idea that stimulating parts of the brain can increase “neuroplasticity,” rewiring the brain to regain lost function after a stroke or debilitating accident.

Jeffrey Ojemann, vice chair for discovery and professor of neurological surgery at UW Medicine, called it a “watershed moment.”

“And not just for me, but for many, many researchers who’ve moved in this direction, people who’ve tried to start companies and have not been successful,” Ojemann said. “It’s the culmination of several generations of science and investment in science.”

Almost 800,000 people experience a stroke every year in the U.S., according to the Centers for Disease Control and Prevention (CDC). More than 4 million Americans are living with the effects of a stroke. Only 10% of those people will recover fully. Close to half either have moderate to severe impairments or require long-term care.

“People often get some function back after a stroke, but not all,” Ojemann said. “We want to see whether by stimulating the brain during rehabilitation sessions we can help them regain more function.”

New device holds promise

In July, a device made by CorTec GmbH, a German company, was implanted in a human patient for the first time by neurosurgeons at Harborview Medical Center.

The patient, a 52-year-old mechanic from the Seattle area, has suffered multiple strokes, including an event four years ago that limited his ability to use one side of his body.

When he starts a six-week rehabilitation next week, researchers will use electrical impulses from the implanted device to stimulate his brain. More specifically, they will induce neurons to wire together when he tries to perform certain movements.

While previous studies have stimulated the brain to increase neuroplasticity, the CorTec device uniquely connects to different areas of the brain and responds to neural activity with targeted stimulus in a matter of milliseconds.

“It's an idea that people have had for a while, but this is really the first time that we've been able to do it with a device that'll let you train two areas together and let you have that kind of timing that's necessary to help the brain rewire,” Ojemann said.

Letting the brain do the work

The CorTec device is an implant consisting of two soft, thin silicon sheets embedded with tiny electrodes. The sheets are placed on the surface of the brain over the area affected by the stroke.

The electrodes connect to a small controller implanted in the skull that relays information through the skin to a computer that can analyze changes in brain waves and adjust electrical impulses in response to that neural activity.

But the CorTec implant is not permanent. After nine months, the patients will undergo a second surgery to remove it.

The device is not MRI compatible, which means that, as long as it is implanted on the surface of the brain, a patient would not be able to undergo a traditional brain scan.

“So, clearly that’s not acceptable,” said Dr. Jeffrey Herron, an associate professor of neurological surgery at UW Medicine, who works on the engineering, technical, and regulatory side of the five-year study.

Both Herron and Ojemann said they view training the brain to help it find a workaround after a stroke and then removing the device as a positive.

“There’s something nice about a device that only has to be in as long as it’s needed,” Herron said. “The brain didn’t evolve to have devices implanted into it.”

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Ojemann said previous studies have pointed to the importance of letting the patient control how their brain is reacting to the stimulus as opposed to having the device act like a crutch on which the brain depends.

“At the end of the day, you're really tapping into the brain's own ability to recover,” he said. “The goal is not to be dependent on the device so much as to help the brain’s own mechanisms move forward.”

Communicating with the brain

The ability of researchers to understand and influence the way the brain works is at a transformative moment thanks to increased understanding of brain functionality and the rapid advancement of technology.

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To this point, the use of devices in connection with the human brain has been divided into two areas: neuromodulation, which involves stimulating the brain to improve clinical outcomes, and brain-computer interfaces (or BCI), which sense how the brain works to decode neural activity.

Herron, who has a Ph.D. in electrical engineering, sees an opportunity in the stroke study to combine those two areas.

By programming a device that reads brain activity and responds with targeted stimulation based on those messages, he believes researchers can create “co-processors” that could act upon a brain message to help complete its intended outcome. An example of bridging this gap could include using a fork to pick up food, or in the case of the first patient in the study, using the tools that have been a central part of his work as a mechanic.

Until now, neuromodulation devices have been mostly created in what Herron calls an “always on” format.

“My specialty has been taking devices that are always on and making them responsive by making a real-time system that can trigger or close the loop around sensed activity from the brain,” Herron said.

He compared the old way of stimulating the brain to heating up a room using a space heater. Herron wants to use devices to metaphorically add a thermostat to create conditions that encourage recovery.

“Nothing in the brain works in an ‘always on’ sort of manner,” Herron explained. “So, we're trying to make our systems more in tune with the underlying rhythms and behavior that we see in the brain, which is constantly trying to take in information and adjusting on a moment-to-moment basis.”

Designing a new paradigm

Hanbin Cho is one of the key researchers working on a program to help the CorTec implant respond effectively to brain impulses. Cho is a Ph.D. student with the UW’s Medicine’s GRIDlab, which is run by Ojemann and Herron through the Department of Neurosurgery.

She has spent much of the last four years creating and testing programs to most effectively strengthen neural connections using implanted CorTec devices.

Her work is aimed at helping patients in the UW stroke study, but her open design also allows for future researchers to program the CorTec implant to achieve different goals for different types of patients.

In preparation for the stroke study, Cho tested her “adaptive stimulation paradigm” on patients at the Epilepsy Monitoring Unit at UW Medicine. Those patients have electrodes implanted on their brains to monitor for seizure activity.

“It was just establishing how does it look, how does the algorithm perform, and how does the system perform,” Cho said. “And we got really promising results from those experiments.”

Now, for the first time, the system she programmed and the design she created is inside an actual patient and has the potential to monitor and improve his recovery.

“When we were at the surgery, I was talking to Dr. Herron and he was like, ‘How does it feel?’ and I was like, ‘It doesn’t feel real,’” Cho said. “Being a part of it for so many years and actually seeing this very huge milestone be achieved while I'm still a part of this group is super amazing.”

Step by step

The UW Medicine stroke study has two phases.

In the first phase, known as the “safety trial,” the CorTec device will be implanted in the skulls of four patients and used during physical therapy to test how well it works and measure how patients respond to general stimulation.

After that safety trial, a second phase involving eight patients will work toward a more direct testing of Cho’s adaptive stimulation paradigm, where electrode stimulation is more closely controlled and coordinated with the brain’s impulses.

UW Medicine is still recruiting patients for the study, but there are restrictions on who can take part. Participants have to be between the ages of 22 and 75 and have difficulty moving their arms or hands. Their most recent stroke has to have been more than six months ago, and they can’t be on blood thinners or have an irregular heartbeat.

The study is funded by the National Institutes of Health. Its progress has been impacted by uncertainty about the continuation of that funding under the Trump administration, according to Ojemann.

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“We’ve had all sorts of bureaucratic delays,” he said. “I can manage budgets, and I can move a budget up or down to maximize it. I’ve learned that over 20-plus years. But if I don’t know the rules of the game, it’s virtually impossible to move forward.”

He said the study was scaled down due to questions about whether its NIH funding would continue, but he and his team were able to keep moving forward thanks to private support for UW Medicine.

Because the study involves a new device being implanted for the first time in a human patient, getting it approved and funded required jumping through a number of regulatory hoops, Herron said.

“It takes a big team to pull this sort of stuff together,” he said. “It takes not just clinicians, but it also takes engineers, neuroscientists, ethicists. It takes a wide variety of people to make this sort of thing work, and it's such a pleasure to see it get to this point.”

As for Cho, she was able to incorporate tests she performed after the device was implanted into the first patient as part of her doctoral thesis, which she’s defending before her committee this week.

After her defense, she plans to transfer to a postdoc research position and continue working with that patient when he begins his six weeks of implant-assisted physical therapy next week.

“It's been a huge accomplishment,” Cho said. “It's going to be a very, very unique opportunity to explore some really interesting research questions, and hopefully have a really important impact on improving the recovery potential for people with strokes.”

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