In 2002, Maria Sutter was living in New York City, working for a SoHo architecture firm, and starting to bicycle around the city as part of her active lifestyle. “It was pretty commonplace for me to bike from April to October,” she says. “I’d bike between 40 and 80 miles.”

Then in October 2004, Sutter’s life changed forever. While on a 40-mile ride through the Bronx, she was stopped at a light waiting to make a left-hand turn when she was rear-ended by a car.

The accident caused a cervical level spinal cord injury, leaving Sutter, then 28, a quadriplegic. “I’m in a power wheelchair, and I [only] have feeling and movement from the middle of my chest up,” she says.

Thanks to the Cleveland FES Center, Maria Sutter has use of her left arm and hand after an accident caused a cervical level spinal cord injury.But thanks to the work being done at Cleveland FES Center, Sutter, now 43 and living in her hometown of Medina, has some use of her left arm and hand.

The FES Center is featured in the documentary “I Am Human,” which makes its Cleveland premiere Thursday, Jan. 30, 2020, at 5 p.m. at the Hanna Theatre.

The documentary, by filmmakers Taryn Southern and Elena Gaby, debuted last year at the Tribeca Film Festival. It explores what it means to be human by following three people with implantable brain interfaces.

One of the three featured is Bill Kochevar, a Cleveland veteran who, after becoming paralyzed from the shoulders down after a bicycling accident in 2006, participated in an FES Center study in 2014 that used brain implants and sensors to give him the use of his hand and arm. Kochevar (who died in 2017 for causes unrelated to the study) was believed to be the first person with quadriplegia to regain arm and hand movement.

The research and work that led to the breakthrough technology that helped Sutter and Kochevar was all done through an FES team in Cleveland. This year, they are about to take their technology to a whole new level with a $3 million feasibility study called “Reconnecting the Hand and Arm with Brain (ReHAB).” The study will take what was learned in cases like Sutter and Kochevar and apply their knowledge to a more sophisticated approach.

Stimulating research

FES, which stands for Functional Electrical Stimulation, is a collaboration between Louis Stokes Cleveland VA Medical Center, MetroHealth Medical Center, Case Western Reserve University, University Hospitals of Cleveland, and the Cleveland Clinic Neurological Institute.

Founded in 1991, the FES Center, housed in the Stokes VA Medical Center, develops innovative solutions that improve the quality of life of individuals with neurological or other musculoskeletal impairments. The organization uses its technology to help quadriplegics regain hand and arm function, manage pain through electrical stimulation, and help those with nervous system disorders like Parkinson’s Disease through deep brain stimulation.

The five organizations came together to implement electrical stimulation on paralyzed nerves and muscles to improve function in people with neurological disabilities. The group has been leading the charge ever since. “The FES Center and the rest of the neurological community in Cleveland is big,” says Robert Kirsch, FES executive director and chairman of CWRU’s department of biomedical engineering. “I’m not sure we’re as well-known locally as we’re known nationally.”

A team of 200 people makes up the consortium, with 85 clinicians and scientists as well as technical staff, engineers, therapists, and technicians.

“It’s a pretty big group,” says Kirsch. “We’re really a national leader in this area. We do a lot of science and engineering and a lot of neurological applications in this area. But we do a lot of different kinds of things.”

The researchers all have one goal in mind: to help those affected by spinal cord injuries like Sutter.

“We try to either replace what was lost or reconnect different parts of the nervous system,” Kirsch says. “We do quite a bit of basic science, but what I think we’re known for most is applications in people. We do this not just to understand the disease, we do this to treat people.”

The Functional Electrical Stimulation (FES) hardwareIndependence for Sutter and Kochevar

Sutter first learned of the FES Center through her sister, who told Sutter about their studies while she was undergoing occupational therapy at Metro. In 2006, Michael Keith, an orthopaedic surgeon at Metro and an investigator at FES, performed a “tendon transfer,” in which Sutter says an active tendon is manipulated so it can imitate a compromised tendon.

A rear deltoid tendon was detached from Sutton’s shoulder and reattached in her left bicep (she’s left-handed). “The tendon transfer can stimulate the triceps function to extend the arm to reach for things,” she says.

The next step came in 2007, when 12 electrodes were implanted into muscles in Sutter’s forearm and hand. A control stimulator was implanted in her abdomen, and an external control box allows her to set up different hand functions, like holding a pen and writing, holding and swinging a tennis racket, grabbing a can of soda, or holding a hair dryer.

Sutter says she no longer relies on special cutlery when eating, and she can swat tennis balls to her semi-retired service dog, Bronson, among other tasks.

“It definitely equalized the playing field, being able to do more things by myself, for myself,” she says. “I’m really lucky because this technology is here, and it’s more advanced and more abundant than anywhere else.”

Then, Cleveland FES Center took their research to a new level with Kochevar’s 2014 procedure at UH, in which two 96-electrode arrays were implanted into the motor cortex of his brain and 36 electrodes throughout his arm muscles.

“It turns out, whenever the nerves are injured, the muscles are still [functional],” says neurosurgeon Jonathan Miller, professor of neurology at CWRU’s school of medicine and director of functional and restorative neurosurgery at UH. “The problem is the command signal and how do you tell it what to do—even for simple things like turning a doorknob or buttering a piece of toast.”

Using an external computer interface, Kochevar was able to move his arm and fingers. “He was great at feeding himself, which is what we were looking for,” says Miller. “It provided straight arm stability. But there were limitations—he needed arm-assistance, and there was no sensory feedback. Still, it made a big difference for him.”

Stepping it up

The brain implants made a remarkable step forward from the technology used in Sutter’s procedure. “We’ve come a long way,” Miller says, adding that FES has improved the technology once again.

The FES team is about to embark on the next leg of its feasibility study, the ReHAB project. The FDA-approved study, funded by a $3 million U.S. Department of Defense grant, is an enhanced version of the previous technology. Miller says it will hopefully fix the limitations Kochevar experienced.

Miller and Kirsch are joined in the ReHAB study by co-principal investigator Bolu Ajiboye, associate professor of biomedical engineering at the Case School of Engineering, as well as Jennifer Sweet, UH neurosurgeon, and Anand Kumar, UH chief of plastic and reconstructive surgery.

“The long-term goal is to ultimately provide a new mechanism for independence for those who have lost some function,” says Miller, adding that the sensory ability is a major leap forward, although he says the team is still early in the research of this technology.

The team plans on having up to 12 participants in the study, and Miller says he hopes to have the first participant scheduled for surgery in the next few months.

The study is slated to end in March 2024. Miller says he is optimistic and excited by the possibilities this new study may show.

“If we can use computers to do this, it would change everything,” Miller says. “If it works, it could be transformative.”

“I Am Human premieres Thursday, Jan. 30, 2020, at the Hanna Theatre, 2067 East 14^th St. in Playhouse Square. The event begins at 5 p.m., with a 6 p.m. screening of the move. A panel discussion with Cleveland FES Center researchers Ajiboye, Miller, Kirsch, and Dustin Tyler, and filmmakers Taryn Southern and Elena Gaby will follow at 7:30 p.m. Tickets are $25, $60 for VIP, $15 for students.