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Research

Cleveland FES Center's Restorative Technology

By Sam Maddox

Functional electrical stimulation (FES) is the use of low-power electric signals on muscle. It has been part of the spinal cord paralysis world for more than 30 years; back in the early 1980s people living with paralysis began to use FES to "ambulate," while using walkers and braces -- not practical or everyday functional, but quite mediagenic. FES is most commonly used today as a means of exercise. FES ergometry "bikes" using surface stimulation are common in rehabs and even some fitness centers.

Ohio, and in particular Cleveland, has always been the epicenter of the FES field. I recently toured the Cleveland FES Center.

It was indeed a speed-visit, with 21 sit-downs in a single day. This included ten Ph.D. scientists and three medical doctors, all top hands in what they call neuroprosthetics. I was also introduced to a handful of people using FES in their daily lives, whether for grasping, standing, or coughing. As you might expect, these FES grads like their restored function very much.


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It doesn't take long to figure out that people here are FES geeks, and I mean that in a good, obsessive way. Turnover is low; apparently, they don't ever let you leave. Smart young techs come here to break into medical engineering; they know a frontier opportunity when they see it. And because of the depth and breadth of the programs, this place is the center of the universe for people seeking non-biological nerve recovery.

The FES Center is a consortium of three institutional partners: Cleveland VA Medical Center, Case Western Reserve University, and MetroHealth Medical Center. The center is funded with a grant portfolio of about $45 million, which supports basic research, clinical research and clinical trials. About half of that comes from the Department of Veterans Affairs.

Hunter Peckman, Ph.D.
Hunter Peckham, Ph.D., the executive director for the FES Center.

Hunter Peckham, Ph.D., the executive director for the FES Center, was my host for the day. He's been around rehabilitation engineering since the slide rule days; he's considered a titan in functional restoration and it was his competence and charisma that got the multidisciplinary FES Center going 22 years ago.

Some might say FES has already seen its golden days, back in the early 1990s. Dozens of experiments using electrical stimulation of paralyzed muscle -- work done in large part at Case Western by Peckham and colleagues -- led to its FDA-approved commercialization by a Cleveland company called NeuroControl. The system of implanted FES for hand grasp (the Freehand) and another for bladder control (Vocare) proved reliable (at least 250 Freehand systems were implanted) and many users continue, years later, to get meaningful function (e.g. a quadriplegic with no hand function able to grasp a sandwich by shrugging a shoulder; a person with no voluntary bladder control flipping a switch to void at will).

"The FES systems were well-tested and fully approved," said Peckham. "But the original FES business model was unsustainable." The marketplace, as it relates to reimbursement from government and insurance companies, never met expectations of the technologists. NeuroControl shut down in 2001.

The sun did not set on the electrical stim concept, however. Today there is much better technology, although it is fundamentally based on the same implanted wires and stimulators from the earlier days. There are 24 channels instead of eight, the electrodes are smaller and more sensitive, the surgical techniques much less invasive, and the hardware less prone to breakage. The system, now modular, is called the Networked Neuroprosthesis System. It is fully implanted, scalable, upgradeable, and tailored to an individual's needs, from simple to complex applications. For example, one might start with a module to assist standing; then perhaps add components for bladder or pain control.

The market for neuroprosthetics is fairly sizable, especially if you include stroke and pain. But is it large enough for standard business? Not yet. Peckham urges the industry to think differently: "Of course we cannot lose $10,000 to $15,000 every time we deploy a neuroprosthetic device," he said. "Reimbursement is difficult and private industry is unwilling to accept the risk. So we have devised a new commercialization model, based on a non-profit vehicle." The idea is that a foundation affiliated with Case Western would cover FES surgery and hardware not covered by insurance reimbursement. In a few years, it is hoped, the cost of a procedure will converge with that of reimbursement. The FES Center's idea to rely on philanthropy is still evolving but it may be the only way to fund these life-changing, but expensive, applications.

The commercial use of FES is almost certain to rebound; hand function, again, will lead the way. The physiology of arm and hand is very well understood; the clinical experience from Freehand is still relevant and compelling. Plus, there is a large waiting list of people who want the function that this sort of device can restore.

The researchers in Cleveland think their technology is also getting close to clinical application for trunk stability, standing, cough stimulation and, again, bowel and bladder control. They are working on a system to prevent pressure sores, using implanted stimulation on the glutes to improve tissue health.

Jen French
Jen French says new FES system allows her to stand longer without fatigue.

Jen French, who has a C 6/7 spinal cord injury, got an FES system back in 1999. She has what she calls "an addiction to function." She just got upgraded to a newer Cleveland modular system with more channels, which allows her to stand and take steps, and which offers her much better trunk support. She lives in Florida but came to Cleveland every few months as part of a research project with Ron Triolo, Ph.D., who runs the lower extremity program at the Center. "The system has been really good for me." said French. "Socially, I don't have to be the only one sitting -- I can stand up like everyone else during the seventh inning stretch. Health-wise, I don't get pressure sores, my bone density is that of a female my age without disability, and the FES controls my spasms."

French, who has just been named to the US Paralympic sailing team, testified that the new FES system allows her to stand longer without fatigue. She has better balance and trunk control. "Without FES I'm reminded of the way I was after the spinal cord injury, minus all these new bionic functions. It is a reminder to appreciate the technology."

Read more about Jen here.

Scott Fedor and Chris Wynn.
FES users: Scott Fedor and Chris Wynn

Two other FES users came to the Center to testify: Chris Wynn got a Freehand unit in 1996; Eric Schremp got his the following year. Both showed me their shrug-switched hand function and grip. "Very happy with it," said Chris. "Me too," said Eric.

People with upper level injuries usually can't move secretions without suctioning or manual assisted cough. They are therefore quite vulnerable to respiratory infection. Scott Fedor, a C3 quadriplegic, came in to the Center to show me his implanted gadget: unaided, he can barely blow out a candle. But with his FES system, which fires up muscles in his chest, he initiates a vigorous cough -- adjustable from mild to extra forceful. "I have to say, this is a real lifesaver for me," said Fedor. "The system allowed me to get my trach removed, which decreased secretions. I used to have to travel with a suction kit and health aide. Now I am able to travel with my friends without any worries and without an aide. It is tough to imagine not having it."

The FES Center cough program is directed by Anthony DiMarco, M.D. His research was also instrumental in bringing FES to breathing function. The NeuRx diaphragm pacing system gained notoriety for enrolling Christopher Reeve as the third patient in its clinical trial. Laszlo Nagy, the fourth to get the system, was on hand during my FES Center visit. He continues to live ventilator-free; he works for Synapse Biomedical, the company that took diaphragm pacing through clinical trials to the market. Nagy, who went from nursing home to full independence, wanted to be sure I knew the company had recently gotten FDA approval to treat people with amyotrophic lateral sclerosis (ALS).

Two other companies have recently formed from Cleveland's FES incubator. Drs. Kevin Kilgore and Niloy Bhadra of Case Western and MetroHealth, formed Neuros Medical to commercialize an electrical nerve block, targeting chronic pain.

Another start-up, Conservocare, uses FES to block spasms in the urinary sphincter. Ken Gustafson, Ph.D., part of the Center's neuro-urology program, says Conservocare's device sends electrical signals to the nerve responsible for causing the spasms; this quiets the spasms and allows the bladder to empty, thus reducing kidney issues. Preclinical animal research is ongoing.

Gustafson is part of another bladder project: push-button voiding, on demand. The Vocare system has long been available in Europe as the Finetech-Brindley system; NeuroControl licensed it in the U.S. in the late 1990s but it never gained broad appeal. Many patients, said Gustafson, didn't want it because it involved rhizotomy, cutting nerves in the sacral area, which can affect sexual function. Said Gustafson, "We sidestep the issue of nerve cutting with an electronic nerve block." Expect to see a new FES bladder product in coming months.

There are numerous clinical trials involving FES. Visit www.clinicaltrials.gov, search for FES. For more on the Cleveland Center, visit www.FEScenter.org.

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Continue Christopher Reeve's LegacyPhoto by Timothy Greenfield-Sanders