Volunteers needed to participate in trial of experimental treatment
Researchers at NeuRA are seeking volunteer research participants to study the effects of 12 weeks of electrical spinal cord stimulation applied over the skin combined with walking training in paraplegics with incomplete spinal cord injury.
If you meet the criteria, you can register your interest at any time.
NOTE: While this trial is for incomplete spinal cord injury, with further funding, we aim to widen this research to trial a range of injuries, including complete injuries, and a range of bodily functions.
The eWalk trial
Transcutaneous spinal cord stimulation to improve walking in people with incomplete spinal cord injury
Directed by Prof Simon Gandevia FAA at NeuRA in Sydney, the eWalk trial (ACTRN12620001241921) is testing the efficacy of transcutaneous spinal stimulation to restore or improve the ability to stand and walk in people with paraplegia. This is a multi-centred, double-blind randomised sham-controlled clinical trial—an important missing element in the global scientific evidence supporting neurostimulation for SCI.
The trial was instigated by SpinalCure and is funded in partnership with CatWalk NZ, with further support from Spinal Cord Injuries Australia.
20 participants are being recruited in Sydney. Three international research groups—in Toledo (Spain), Chicago (USA), and Glasgow (UK)—will each treat a further 10 volunteers bringing the total cohort to 50 participants.
The primary outcome will be walking ability, measured using the ‘Walking Index for SCI II’ scale (WISCI II). All participants will receive intensive locomotor training comprising three one-hour sessions per week, over 12 weeks, in combination with either stimulation or sham stimulation. Secondary outcome measures will capture different aspects of recovery, strength, spasticity, and bowel function.
This trial has begun. Read our 2 June 2021 media release 'Landmark trial aims to help people with spinal cord injury walk again'.
Project Spark aims to expand this research around Australia
Success in studies overseas
In 2011, one of the world’s most prestigious medical journals, The Lancet, did something unusual. It published a paper with an “n = 1”, meaning the results were from just one person, highlighting the extraordinary nature of the reported breakthrough. The study detailed the case of C7/T1 paraplegic Rob Summers, who was the first person in the world to receive an epidural electrical stimulator to treat spinal cord injury.
For the first time ever, a peer-reviewed scientific paper showed it was possible to restore meaningful movement and function to a person years after they were paralysed.
Fast-forward to 2018, and an incredible milestone in SCI research was reached — six volunteers recovered the ability to stand and walk with only the aid of a walking frame for balance (watch research participants talk about their progress) (Published papers from Louisville KN and the Mayo Clinic). Many more have recovered life changing movement and function in other experiments.
SpinalCure first became interested in neurostimulation as a direct result of the Lancet paper and after a great deal of work and much investigation and fundraising, in 2019 SpinalCure and Neuroscience Research Australia (NeuRA) announced a collaboration to further develop neurostimulation treatments in Australia.
What is spinal cord neurostimulation?
Most spinal cord injuries in Australia are ‘contusion’ injuries where the spinal cord is crushed on one side but not completely severed. This leaves some nerve pathways between the brain and body intact. However, these pathways seem to go dormant. One approach, epidural stimulation, was originally developed to treat chronic pain. A tiny array of electrodes is implanted in the epidural space on the ‘dura’ (the protective layer that surrounds the spinal cord) and used to deliver electrical impulses to precise parts of the cord. In addition to returning significant control of muscles, epidural spinal cord stimulation has been shown to safely restore important autonomic functions — such as bladder control and blood pressure control and sexual function for paralysed patients.
Epidural stimulation requires an expensive operation and is not without risks. The alternative is to place the electrodes on the skin (transcutaneous) at certain locations over the spinal cord. This method has also been shown to improve blood pressure control, bladder function, control of legs and hand function.
Assuming larger scale clinical trials confirm benefits and safety, this treatment could be made more widely available in a matter of years.
Nine months later, NeuRA’s new Spinal Cord Injury Research Centre (SCIRC) was completed and the first test stimulation experiments commenced — an incredibly cathartic moment for those of us who have been working so long to bring the promise of this line of research to paralysed Australians.
The SCIRC contains an extensive exercise facility complete with gravity assisted walking track and treadmills along with other state-of-the art research equipment. This is surrounded by research labs, offices and wheelchair accessible loos big enough to host a party in.
The research is being led by Professor Simon Gandevia FAA FAHMS FRACP and by Professor Jane Butler PhD, with Dr Bonne Lee MBBS, FAFRAM, Dr Claire Boswell-Ruys PhD and Dr Euan McCaughey MEng, PhD, CEng, making up the all-star core team.
Most of the headline results have used implanted epidural stimulators (see panel, “What is neurostimulation”). However, the work at NeuRA is focussing on the ability of “transcutaneous” neurostimulation, which uses electrodes placed on the skin, to restore movement and autonomic function, such as bladder/bowel control, sexual function and cardiovascular stability. This method of applying the stimulation eliminates the high cost and risks of an operation and the long post-operative recovery. Thus, any successful treatment developed could be distributed much more quickly and more widely.
Despite these positive results, a lack of highly controlled clinical trials has prevented this technology from being converted into clinical practice. SpinalCure and NeuRA have partnered to address this need, leading to the SCIRC's flagship clinical trial, the eWalk trial, which commenced treating volunteers in March 2022. (See box) The trial will primarily look at restoring the ability to stand and take steps.
Funding permitting, other neurostimulation experiments are planned in addition to this formal clinical trial, focusing on the restoration of other functions that would greatly improve people's quality of life and independence.
Of course, all this work is expensive. In addition to NeuRA’s own significant investment in building the SCIRC, SpinalCure and our NZ partner, CatWalk have contributed $1.75m each to fund the eWalk trial. Our friends at Spinal Cord Injuries Australia have also recognised the promise of this research and invested $100,000 in the project.
The more funds we can raise, the faster these treatments can be developed and eventually made available across Australia. While being some way from a complete cure, which will likely require a combination of interventions, neurostimulation is profoundly improving volunteers’ health, abilities and quality of life. SpinalCure’s goal for the coming years is to see these benefits made available to all Australian’s affected by spinal cord injury.
The mobile research lab
The trial requires volunteers to commit to an hours laboratory training three times a week for 12 weeks. Requiring these disabled research participants to travel to NeuRA in Sydney’s eastern suburbs, would not only be an enormous burden to the volunteers but would be very expensive in terms of wheelchair taxi fees.
The beauty of this intervention is that it can be delivered to the participant – minimising the personal and cost burdens. NeuRA has designed a Mobile Therapy Gym to outfit a Mercedes-Benz VS30 Sprinter van. This van will be able to house all the equipment required to deliver a session of the transcutaneous spinal stimulation in conjunction with the locomotor training.
There is an exciting opportunity for a progressive company to sponsor this vehicle.
Please download this information document for more detail.
To find out more contact us on 02 9356 8321 or [email protected]