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Delivering electrical stimulation to the spinal cord using a new device can significantly improve hand and arm function in people with severe paralysis, a breakthrough clinical trial has shown.
The study is the first convincing demonstration of a non-invasive device providing lasting benefits for tetraplegic patients, researchers said.
The École Polytechnique Fédérale de Lausanne (EPFL) in Switzerland developed the Arc-EX device, which sends electric currents to the area of the spinal cord injury via electrodes placed on the skin.
Arc-EX was tested in an international trial with 65 participants in Europe and North America in a study led by Chet Moritz, professor of rehabilitation medicine at the University of Washington.
Seventy-two per cent of trial participants experienced significant improvement in both strength and function of their upper limbs after two months of using the therapy and 90 per cent improved in at least one measure, according to results published in Nature Medicine on Monday.
The outcome “far exceeded our hypothesis of a 50 per cent response rate, giving new hope to people with SCI [spinal cord injury]”, said Moritz. “After only two months, more than half of participants achieved average improvements . . . in grasp force greater than that required to lift filled cups and in pinch force equivalent to that required to pick up an item with a fork or insert a key.”
Melanie Reid, a tetraplegic journalist in Scotland whose movement improved after taking part in the Arc-EX trial, said: “I wish this technology had been around 14 years ago when I had my riding accident.”
The Arc-EX trial was the first non-invasive SCI therapy to show strong effects persisting after the course of electrical stimulus had finished, said Moritz.
Researchers believe the electrical pulses bring about long-lasting improvement by stimulating the regrowth of residual and damaged nerves around the injury site.
Harvey Sihota, an executive at UK medical charity Spinal Research, said the successful trial was a “stride towards restoring hope, function and independence for people living with spinal cord injury, even for those injured many years ago. There are no approved therapies for chronic SCI, so it is very exciting for a clinical trial to get to this stage.”
Several companies and universities, including EPFL, are developing implanted devices that may give paralysed patients a more spectacular improvement in movement when inserted beside the spine. But implants are much more complex, expensive and risky than non-invasive devices such as Arc-EX.
“Everyone seems to think that people with spinal injuries want to walk again but what matters most is improving our hand function,” said Reid.
Edelle Field-Fote, a member of the research team and professor of rehabilitation medicine at Atlanta’s Emory University, said: “Many people who are classified as having a ‘complete’ spinal cord injury will have some remaining nerve connections and might benefit from the therapy.”
But others whose spinal cord is completely severed might need an implant to bridge the gap, she added.
Onward Medical, a company set up to commercialise EPFL’s neurotechnology, applied last month to the US Food and Drug Administration for regulatory approval of Arc-EX.
“We are now in discussions with the FDA and expect to be able to commercialise Arc-EX in the US before the end of this year. Then we will ask for approval in Europe immediately afterwards,” said Grégoire Courtine, EPFL project leader and co-founder of Onward.
EPFL and Onward aim to extend the technology beyond spinal injury to other conditions such as stroke, while continuing to develop brain and spinal cord implants, Courtine said.
Data released by the NHS and medical charities last Friday showed that there are 4,400 new spinal injuries a year in the UK, almost twice as many as the previous estimate. The comparable figure in the US is 18,000 per year, according to Field-Fote.
Illustration by Ian Bott