The growing potential of spinal cord stimulation technology as a treatment for paralysis has been further demonstrated in a UK study.
All 10 participants, living with spinal cord injury (SCI), made significant improvements in upper body strength, trunk control and balance.
Some of the participants of the Pathfinder2 trial also made gains in hand grip and dexterity, and lower body functions.
Gains made did not plateau, even after a year, demonstrating the therapy offers long-term benefits.
The trial involved 10 adults with chronic SCI ranging from C4 to T12 levels. Participants had injuries for at least one year and were medically stable.
The study combined spinal cord stimulation tech developed by Onward Medical with activity-based rehab. It was funded by the charity, Spinal Research, and published in the journal, Neuromodulation: Technology at Neural Interface.
“My dream came true”
Claire Trivedi’s life changed in 2017 when a cluster of abnormal blood vessels in her spinal cord suddenly burst leaving the mother-of-two paralysed from the waist down.
Through the year-long trial, she completed 120 sessions at a Neurokinex rehab centre combining the use of the technology with activity-based rehab.
It enabled her to take her first unsupported steps in an emotional moment she never thought would happen.
Claire, (pictured above) 48, from London, said: “I was told my injury was complete and I just had to get used to my situation, but I refused to give up. I dreamed that one day I might take a few steps and my dream came true.
“About 10 weeks before I finished the trial, I took my first steps just using a walking frame, without any leg supports. Everyone cried.
“I was putting my all into the trial and was being rewarded. Even though it was really slow I could see improvements. My legs were getting stronger and I had hope.
“And although all the gains haven’t continued, I definitely think the stimulation had a massive impact on my rehab and I can’t wait for it to be licensed in the UK.”
Onward’s ARC-EX Therapy uses targeted electrical stimulation to excite the spinal cord so that signals weakened or interrupted by an SCI can drive movement. That movement enables rehabilitation that results in improvement in hand strength and sensation.
In December, the system was approved by the US FDA for use in clinical settings for hand strength and sensation. Home use authorisation in the US is anticipated later this year. The company plans to seek CE Mark certification to commercialise it in Europe in later this year. Onward CEO Dave Marver said the trial provides “critical insights to the spinal cord injury community, demonstrating that improvements resulting from ARC-EX Therapy extend for at least one year, with no observed
plateau”.
He added: “These data suggest those with chronic spinal cord injuries benefit from extended and continuous access to ARC-EX Therapy.”
Dan Woodall from Rainham, Kent, was paralysed from the waist down in 2016 after falling from a bypass after a night out. His bowel and bladder function, commonly impacted by an SCI, were improved as well as leg strength and movement.
“Using Onward’s ARC-EX Therapy gave me back control over muscle groups I never thought I’d move again, including my right hamstrings and hip flexors,” said the 33-year-old.
“I’ve also regained some bowel and bladder control—something I was told in hospital after my accident might never happen. Just knowing when you want to use the toilet is such a massive thing for your independence and mental health.
“The fact that the gains have continued after the trial is really encouraging and I can’t wait to see where this goes.”
Spinal Research chair Tara Stewart said: “This therapy is not a silver bullet. It works on spared spinal tissue so results will vary widely, and it does need to be paired with proper active rehabilitation over a consistent period of time.
“Even so, this is a game changing moment. It’s now time to stop talking about spinal cord injury as being incurable and to stop telling people with this injury that nothing can be done.”
Harvey Sihota, founder and CEO of Neurokinex, said: “I’m hugely encouraged by the positive outcomes of the Pathfinder2 study and believe ARC-EX Therapy will enable us to deliver even greater gains for people living with a spinal cord injury.
“There is no doubt that spinal stimulation technologies will take spinal cord injury rehab and outcomes to the next level bringing even more meaningful functional improvements that offer people greater independence.
“Particularly exciting is that, unlike a lot of the more invasive protocols being researched, access to the ARC-EX System is within touching distance for people. Within the year, we hope to be able to offer this option to our community alongside our activity-based rehab protocols.”
This story appeared on our sister publication Neuro Rehab Times.
