A clinical trial carried out with spinal cord injuries from several countries has managed to restore the ability to pick up a marble or play with a Rubik’s cube. The patients had had some of their cervical vertebrae damaged for more than 12 months and had little hope of recovering or improving the movement of their hands or the dexterity in their fingers. In this first phase, neuroscientists sought to validate the safety and effectiveness of the device. Although the research has some limitations that must be refined, they hope to market it this year in the United States and in Europe next year.
During the last months of the coronavirus pandemic, doctors, neurologists and nurses from 14 neurorehabilitation centers in four countries (the United Kingdom, Canada, the United States and the Netherlands) recruited 65 people who had a spinal cord injury at the level of the vertebrae. cervical (the first starting from the neck). This region is responsible for providing sensitivity and movement, among others, to arms, hands and fingers. All of those recruited had had the injury at least a year ago and a third of them had had the injury more than five years ago. This is relevant, since over time, the effects of rehabilitation are very limited once the chronic phase of tetraplegia is reached. The results of the clinical trial have just been published in the journal Nature Medicine and they are very hopeful.
The initial group was reduced to 60 people due to the withdrawal of the other five, all for personal reasons. After two months of training, they were given an electrical stimulation system similar in appearance to those used to treat or relax muscle injuries. But this device, which they call ARC-EX, condenses almost two decades of research inside. It is one of the fruits of the work that the neuroscientist from the Federal Polytechnic School of Lausanne (Switzerland), Grégoire Courtine, and his team have been carrying out for years and which is based on the use of electrostimulation to restore communication between the brain and the body. rest of the body. In Courtine’s laboratory they began by restoring mobility to rodents, and then applied the accumulated knowledge to improve the motor skills of people who had been in a wheelchair for years. A derived line of research achieved a few months ago that a person disabled by Parkinson’s could walk again.
Now, with electrodes attached to the skin, and placed above and below the injured area, ARC-EX greatly improved the sensitivity of 43 of the participants (72% of the sample) in their dominant hand. In addition to improving mobility, they managed to recover a good part of their dexterity in their fingers, even being able to tie shoelaces, type on a computer or put table tennis balls in a small bucket. Compared to other approaches, the application is non-invasive (they did not have to open the body and place devices in the spine itself). Additionally, the improvements were maintained once the ARC-EX training was over.
“Stimulation leads to reorganization of the spinal cord, which promotes improvements that persist when stimulation is turned off,” says Courtine. In fact, all evaluations of improvements were done without any encouragement. 90% of the participants declared that they had improved their sensitivity and skills. Additionally, there was a reduction in muscle spasms and uncontrolled movements. In the other major objective of the clinical trial, that of safety, they did not record any adverse effects that could be related to the device.
“The stimulation may be generating neuroplasticity or, in a certain sense, healing part of the spinal cord injury”
Chet Moritz, professor of electrical and computer engineering at the University of Washington and director of the clinical trial
Professor of electrical and computer engineering and rehabilitation medicine at the University of Washington (United States) Chet Moritz, is the first author of this study and responsible for the clinical trial. “After just two months, more than half of the participants achieved improvements in grip strength greater than that needed to lift a full glass and equivalent to that required to stab something with a fork or insert a key,” he says. Moritz. In an online press conference to present the study he argued that “the stimulation may be generating neuroplasticity or, in a certain sense, healing part of the spinal cord injury.”
Two of the participants in the clinical trial also participated in the press conference. One is the fighter Sherown Campbell, from Broomfield (Colorado, United States), who broke his neck in 2014 fighting with a friend. After several months of working at Craig Hospital in Colorado, “I can now help in the kitchen and I have been able to do things with my son, like blow up balloons for his birthday party.” Scottish Melanie Reed, 52, fell from a horse years ago, damaging her spinal cord at the level of the C6-C7 vertebrae, losing most of the mobility of her hands. “Now I have been able to do scroll on the tablet or taking off the seat belt with my left hand,” he says.
Until now, most of the progress that Courtine and her collaborators had made had to do with lower back injuries, which condemn them to a wheelchair. ARC-EX is designed for the upper extremities. ONWARD Medical, the company that developed the device and for which Courtine is scientifically responsible, has submitted a request to the United States Food and Drug Administration (FDA) for authorization. “ONWARD Medical expects to obtain marketing approval this year in the United States and in 2025 for Europe,” she says.
The head of Neurology at the National Paraplegic Hospital of Toledo and head of Research and Innovation at the Los Madroños Hospital in Madrid, Antonio Oliviero, highlights that “this is an excellent quality study on a relevant technological advance: transcutaneous cervical spinal electrical stimulation. (non-invasive) associated with rehabilitation is safe and could be effective.” In statements to SMC Spain, the director of the Bioengineering Institute of the Miguel Hernández University of Elche, Eduardo Fernández, recalls that spinal cord injury at the cervical level “usually results in a permanent alteration of the functions of the arms and hands. , and this has a great impact on the quality of life of the affected people” and adds “one of the main obstacles to developing effective therapies in this field is the limited repair and regeneration capacity of the central nervous system.” In fact, rehabilitation becomes very difficult as time passes since the injury.
The Spanish scientists consulted highlight, however, a serious limitation of this research: unlike most clinical trials, this one did not have a control group with which to compare nor were the participants selected randomly. In fact, it is the final message that Fernández leaves: “The future is hopeful and we must be prepared to be able to include these new therapies in the usual clinical treatments of patients with spinal cord injuries. However, it is necessary to move forward little by little and not create false expectations.”
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