The potential of a pioneering spinal cord stimulation technology to restore functions in paralysed people has been demonstrated in a new UK study.
All participants in the Pathfinder2 trial, funded by Spinal Research, made significant improvements in their upper body strength, trunk control and balance while some saw major 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 peer-reviewed study – published recently in Neuromodulation: Technology at Neural Interface -combined external spinal cord stimulation – where electrical pulses are delivered through the skin – with activity-based rehabilitation.
Ten participants with chronic spinal cord injuries completed 120 sessions at a Neurokinex rehabilitation centre combining the use of ONWARD Medical’s ARC-EX Therapy with activity-based rehabilitation.
The year-long trial was funded by Spinal Research, the UK’s leading charity funding groundbreaking research to achieve a future where paralysis can be cured.
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.”
Spinal Research is also funding three other UK studies involving use of implantable and external spinal cord stimulation systems and Tara added: “With proper investment in the spinal research field we could see significant progress towards a cure for paralysis in the next five to seven years.
“Without that investment, nothing can go further. With it, neurological repair is possible and that will also have great benefits for other conditions such as Parkinson’s, Stroke and MS.”
Every two hours someone in the UK is paralysed after suffering a spinal cord injury. It can happen to anyone of any age, at any time, with devastating consequences.
Dan Woodall from Rainham, Kent, was paralysed from the waist down in 2016 after falling from a bypass after a night out. “I walked out of my house that night but didn’t walk back through the door.
Dan’s bowel and bladder function, commonly impacted by a spinal cord injury, were improved as well as leg strength and movement. “Using ONWARD 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.”
The technology used in the study, developed by ONWARD Medical, is known as ARC-EX Therapy, and uses targeted electrical stimulation to excite the spinal cord so that signals weakened or interrupted by a spinal cord injury can drive movement. That movement enables rehabilitation that results in improvement in hand strength and sensation.
In December 2024, the ONWARD ARC-EX System was approved by the US FDA for use in clinical settings for hand strength and sensation. Home use authorization in the US for this first-of-its-kind therapy is anticipated later this year. The Company plans to seek CE Mark certification to commercialize the ARC-EX System in Europe in 2025.
“The Pathfinder2 study 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,” said ONWARD Medical CEO Dave Marver. “These data suggest those with chronic spinal cord injuries benefit from extended and continuous access to ARC-EX Therapy.”
The potential of combining this pioneering technology with personalised activity-based rehabilitation to promote meaningful recovery offers real hope for paralysed people living with new and chronic spinal cord injuries.
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 ARCEX 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.”
Source: Released on behalf of Spinal Research by d’Arcy PR.
Image: Credit Neurokinex
