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A novel spinal cord stimulator treats paralysis without surgery. FDA will rule about it soon.
After his spinal cord injury in 2014, Sherown Campbell worked hard to regain as much bodily function as he could. Once a dedicated athlete, Campbell had to learn the new limits of his body. One of them, jarringly, was his body’s inability to sweat.
So when Campbell started sweating on his stationary bike for the first time in seven years, it felt surreal. It was late 2021, and Campbell was nearing the end of a clinical trial testing out a device to help paralyzed patients regain movement.
“I felt really refreshed and excited, because you get to this point where normally I’d have to back off or monitor if I’m overheating,” Campbell, 41, said. “To break through that, it just feels clear.”
Campbell is one of 60 participants with tetraplegia in a pivotal trial, published in Nature Medicine on Monday, testing startup Onward Medical’s non-invasive spinal cord stimulator. Researchers found that externally stimulating the spine and providing rehab therapy improved hand and arm function in 72% of participants. They reported no serious adverse events.
Experts cautioned that the therapy, while promising, is not likely to single-handedly restore movement for patients. Its potential is limited by researchers not understanding how or why the treatment works. Still, the positive results offer some hope. What’s more, the technology has a real shot of making it to the clinic — Onward submitted the trial to the Food and Drug Administration in April as a part of its application to market the breakthrough-designated device. It would be the first stimulator cleared by the agency to help spinal cord injury patients restore arm function.
“We’re just one step away from bringing these therapies to clinics and homes, where they can finally benefit people who have for too long had their needs unmet,” Onward CEO Dave Marver told STAT.
Onward Medical was founded by two scientists at the forefront of neurostimulation research, Grégoire Courtine and Jocelyn Bloch. Launched in the Netherlands in 2015, the company went public in 2021 with $101 million in funding, according to marketing intelligence firm Alphasense. This device, if approved, would be its first commercial product.
Every year, about 18,000 people have a spinal cord injury, according to the National Spinal Cord Injury Statistical Center. These injuries can dramatically affect their quality of life, and rehabilitative therapy has historically been a patient’s only option. In recent years, researchers have examined whether spinal cord stimulators, which have long been used to treat chronic pain, can jolt paralyzed limbs into motion. Much of the most exciting research involves implantable stimulators, which are placed directly on the spinal cord and allow for more complex, precise movements.
Onward is developing an implantable device as well, but the device in the Nature paper is external, delivering stimulation through the skin. Non-invasive spinal stimulation has emerged in recent years as a cheaper and more accessible method than surgical intervention, which can scare some patients away. Using non-invasive stimulators could also alleviate some financial burden, as people can spend millions in health care and living expenses over the course of their lives due to spinal cord injuries.
“Being able to bring that function back without requiring a surgery is, I think, life-changing for the majority of people with spinal cord injury,” said Chet Moritz, a co-author of the study and the co-director of the University of Washington Center for Neurotechnology.
Investigators enrolled patients in 14 neurorehabilitation centers across North America and Europe, observing them over two months using several internationally-approved standards to determine if arm and hand function significantly improved in more than 50% of patients — the trial’s primary endpoint. Investigators were thrilled to see gains in measures such as fingertip pinch force and hand prehension and strength, as well. They forgoed a control group to test for placebo for several reasons, including the difficulty to blind patients given the obvious sensation of stimulation. They also questioned whether it was ethical to ask patients with tetraplegia to travel to a clinic multiple times a week to then not receive treatment.
Moritz said a placebo effect was unlikely, given the appearance of physiological responses like Campbell’s experience of sweating after stimulation therapy.
Neurosurgeon Dimitry Sayenko was not involved in the study and thinks the FDA should approve the device, and the study’s robust sample size and multicenter approach impressed him. However, Sayenko worries that, without knowing how the device aids movement, the clinical value would be less. He is also skeptical that this device represents a breakthrough or that non-invasive spinal stimulation is a “magic bullet” that can help restore function in people with tetraplegia.
“Non-invasive spinal stimulation is very appealing. Is it a good competitor to invasive stimulation? I’m not sure,” said Sayenko, an assistant professor of neurosurgery at Houston Methodist. “I think that non-invasive spinal stimulation, by itself, or even in combination with activity based therapy, is unlikely going to change the current status quo. It may be a step forward, but it’s definitely not the answer.”
But for Melanie Reid, another study participant, small improvements in functioning and her independence are crucial.
“Everyone thinks that with a spinal cord injury, you just want to be able to walk again,” said Reid, a journalist with The Times of London. “But if you’re a tetraplegic or quadriplegic, what matters most is working hands. There’s no miracles in spinal injury, but tiny gains can be life changing.”
Campbell, too, felt the small advances made a big difference. He could more easily put on deodorant and wash his body with his left hand, and improve his typing speed. He started opening jars with his hands rather than his teeth. And he was able to better grip a steering wheel; critical to his role as a “child Uber driver” chauffeuring his 11 and 13 year-olds around, he joked.
Slowly, with more rehab therapy and advancements in the neurostimulation field, Campbell’s fear of never moving again has started to slip away. He participated in the study, which he heard about from his rehabilitation center in Colorado, because he wants those nightmares to cease for other patients.
“When I was injured, I was always looking for someone who had been through it or someone who had done well, so trying to pay it forward and do that now that I have 10 years with the injury,” Campbell said.
Marver, Onward’s CEO, said he expects a decision from the FDA within the next five months. Since spinal cord stimulators are already approved for pain and have standard insurance codes, he’s hopeful the treatment will be financially accessible to patients.