A common implant designed to stimulate the spinal cord is enabling paralyzed patients to move again, a first-of-its-kind discovery in a clinical study at HCMC in Minneapolis.
While findings have varied among the roughly 20 study participants, the upshot so far is that people can regain function after spinal cord injury and not simply maintain the limited mobility they have, said Dr. David Darrow, the principal investigator.
The trial could be the first to force the US Food and Drug Administration to approve a device that restores function after spinal cord injury, he said. “So this, using neuromodulation, is exciting, because if we get positive change, hopefully we can turn that into bigger and bigger changes.”
Crystal LaBo was tested Thursday at her third follow-up appointment at HCMC after implanting the stimulator in March. When the device is active at certain settings, it can lift legs and bend ankle limbs that had been immobile for 23 years after LaBo was injured in a car accident.
While family and friends are amazed by her new moves, LaBo said they’re largely for show because she can’t put enough pressure on her legs yet to stand or walk. Far more significant are the hidden benefits. Stimulating her stabilized her blood pressure, eliminated extreme temperature swings and allowed her to urinate without using a catheter.
“It was more important to me than moving my legs,” she said. “I know that might sound strange.”
LaBo, 41, who lives in northern Ohio, had been looking for options for regaining mobility for years, but most of the studies required patients with recent spinal cord injuries. She was about to undertake a trial in Indonesia before finding the HCMC study, called E-STAND. The acronym stands for Epidural Stimulation After Neurologic Damage.
LaBo maintains an active, independent lifestyle as a mother of four and co-owner with her husband of two gourmet grilled cheese restaurants. She often cooks and serves food from her wheelchair when staff are short. But she always hoped for more.
“I always had the mentality that I would walk again one day,” she said. “I don’t know if I thought it would be like this, but I’m happy about it. I knew that eventually one day someone would come up with something.”
Darrow said FDA approval could be swift if the HCMC study is successful, because the stimulator is widely used for pain management.
Most people with severe spinal cord injuries have only a fraction of their nerve fibers still able to send signals from the brain to their lower extremities, Darrow said.
“Clinically we don’t see any movement, we don’t see any function,” he said. “When we turn on stimulation at the bottom of the spinal cord, it actually changes its receptivity to those remaining fibers. We’re just spinning the spinal cord so it’s more able to receive.”
Stimulation tends to improve motor function but not sensation, so patients like LaBo learn to move with their eyes again rather than their feelings and instincts.
“I’m really moving my feet, but I can’t feel it,” LaBo said during Thursday’s exam. “So, am I really moving? It’s a mind game with myself.”
Patients enroll in the study for 13 months and participate in monthly visits. Each time they are sent home with a new range of stimulation settings so researchers can find out which ones are most effective.
Patients can turn the stimulator on and off, which LaBo says is helpful because the device can sometimes cause sudden involuntary movements. She hasn’t dared to place a tray of food on her lap with the stimulator on not since a twitch in her leg catapulted one into her face.
LaBo said progress has been steady but slow. His family and friends have created a chalkboard of future goals if he can continue to regain mobility. Her husband and all four of her children want her to play on her feet again.
“She may not realize it, but she looks like a little girl at Christmas” every time she reaches a new level of movement, said her husband, Dustin LaBo.
The study is debunking myths that patients with older lesions can’t make progress, Darrow said. What’s not clear is whether patients will need stimulation permanently.
Darrow said that about half of the patients in the study report some gains when their pacemakers are off, but not in range of motion with the pacemakers. The research team’s most recent study found increased muscle activation and coordination in study participants.
“We see a building effect over time with more and more stimuli,” he said. “So, I think it will still require stimulation, but that’s a tough question at this point.”
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