Forty-three people quadriplegic due to spinal cord injuries have partially regained control of their hands with a device that applies electrical stimuli to injured neurons, according to the results of a clinical trial presented today in the journal Nature Medicine. The company Onward Medical, which has developed the device, expects it to be approved at the end of this year in the United States and in 2025 in the European Union.
“Many people believe that you want to walk again, but your hands are what matters most,” Melanie Reid, one of the participants in the clinical trial, who suffered a spinal cord injury after falling from a horse ago, declared at a press conference on Thursday. fourteen years old, when he was 52. Reid highlighted the importance of “putting your hand to your mouth to feed yourself” or “scrolling on a tablet or mobile phone.” According to Reid, “small improvements [in hand control] make a big difference.”
The ARC-EX device applies electrical stimuli with electrodes placed on the skin in the cervical region, where the spinal cord injury occurred. It works in cases where the spinal cord is not completely severed and there are neurons connected between the brain and the hands. The objective of neurostimulation, designed to be applied as a physiotherapy treatment and so that patients can continue applying it later at home, is to reactivate these neurons.
In the clinical trial, 60 patients from the United States, Canada and the United Kingdom have received the treatment. All of them had suffered the spinal cord injury at least a year before and had undergone rehabilitation therapies during the first months to recover the functionality of their hands as much as possible.
They received an average of 25 one-hour neurostimulation sessions. “Like any other type of therapy, it is tedious; But when you start to see changes, it is motivating,” Sherown Campbell, another of the study participants, who suffered a spinal cord injury in 2014 while practicing a wrestling sport with a friend, declared at the press conference.
At the end of the sessions planned in the clinical trial, 43 participants (72%) had experienced increases in strength and improvements in function in their hands and arms. Another eleven had improved in one of the two, strength or function (but the treatment did not achieve the effectiveness objectives that had been defined before starting the study, which required improvement in both aspects). The remaining six patients did not improve in either of the two.
This video shows the improvement experienced by one of the study participants, comparing what he can do without neurostimulation, two days after starting electrode therapy and three months later:
Functional improvements included hand-gripping and pincer actions and finger precision. For example, lifting full glasses of water, pressing buttons on a remote control, using a fork, or putting a key in a lock.
Fifty-two of the study participants (87%) reported experiencing a significant improvement in quality of life. In addition to feeling less dependent on other people, they improved in sleep quality, pain reduction, and upper trunk sensations, including touch sensations.
“It’s been important to me to be able to help cook at home and prepare balloons for my children’s birthday parties,” Sherown Campbell explained.
Unlike other rehabilitation therapies for people with spinal cord injuries, which achieve improvements during the first months and then stagnate, with the ARC-EX device the improvement has been increasing until the end of the study. If the study had continued, it is likely that the improvement would have been greater, the researchers point out.
According to Grégoire Courtine, a neuroscientist at the University Hospital of Lausanne (Switzerland) and co-founder of Onward Medical, “with [ARC-EX] stimulation we observe the growth of new neuronal connections,” so the more the treatment is applied, the more Connections are formed and the greater the improvement patients experience. The device, Courtine explained, is designed to be used by people with manual disabilities, thinking that users “can use it at home to maintain and improve recovery.”
With the results of the clinical trial, Onward Medical has requested the US Food and Drug Administration (FDA) for authorization to market ARC-EX as an innovative therapy (breakthrough therapy), a formula that accelerates the approval of therapies for serious disorders when preliminary clinical results indicate substantial improvement. “We hope to be able to market before the end of the year in the US,” Courtine stated at the press conference. Onward Medical will subsequently apply for approval in the European Union.
The price has not yet been set, Courtine reported, “but the idea is to make it affordable.”
Courtine’s team at the Lausanne University Hospital and Onward Technical is also developing neurostimulation technology based on a spinal implant that receives information from the brain and transmits it to the legs. This technology has been successfully tested in people with paraplegia and Parkinson’s, who have recovered the ability to walk.
Looking ahead, implantable technology will be more precise and can deliver neurostimulation throughout the day, so “it can improve activities of daily living more” than physical therapy, Courtine said. But ARC-EX, she noted, has the advantage of being a non-invasive technology, which can be applied on a large scale in physical therapy consultations and which can now reach a larger number of patients more quickly.
For Melanie Reid, “after fourteen years [since the spinal cord injury], I thought nothing was going to change. Suddenly realizing that she had more strength in her fingers and thumb was extraordinary. It is something that makes you hold your head higher and see life a little differently.”
