Connecting the Puzzle Pieces for People with SCI
A world in which individuals with SCI in Canada, and eventually all persons with SCI worldwide, have access to Spinal Cord Stimulation (SCS) and ongoing specialized support within their communities to promote neuro-recovery and optimize health outcomes.
This landscape represents how Praxis is working to connect the puzzle pieces so that we can achieve our goal. As more initiatives are started and information is discovered the landscape will evolve. We would like anyone interested in this landscape to send us a summary of your work so that we can add more content from community projects involved in spinal cord stimulation to fill in the gaps.
Note: This innovation is currently in the exploratory phase to ensure and assess the safety and efficacy of this potential neuro-restorative innovation. Praxis is committed to evaluating this innovation to see how it can inform care and this landscape represents some of the actions we are taking to accelerate this process.
PLEX
Focus includes creating a network of SCI consumers interested in research, care, and treatments, developing partnerships between consumers and researchers related to priority setting and other efforts, and improving capacity for consumer-oriented research and care.
Learn more about current initiatives.
Clinical Trials
Focus includes making clinical study data available, developing best practices for clinical design, selection of outcome measures, regulatory submissions, recruitment, health economic evaluation and translation, and accessing existing data from SCI registries to answer clinical outcome questions.
Innovation
Focus includes planning to successfully commercialize products and services. This includes integration of economics and implementation science to assess value and developing, communicating and operationalizing a regulatory reform agenda.
Learn more about current initiatives.
Pre-Clinical Studies
Focus includes making pre-clinical study data available, identifying how it works, developing best practices for pre-clinical studies to determine readiness for clinical studies and exploring questions that arise in the clinical setting.
Learn more about current initiatives.
Best Practices for Clinical Delivery
Focus includes developing Clinical Practice Guidelines (CPG) and evidence-based protocols, developing knowledge, ways to standardize implementation efforts, coordinating national implementation of standardized best practices, integrating evidence informed practices into SCI standards, and ensuring peer support.
Learn more about current initiatives.
Collaborative Platforms
Focus includes expanding promising pilot studies to collaborative international multi-centre clinical trials, increasing recruitment for SCI clinical trials, and increasing information exchange between researchers and clinicians to enable further collaboration.
Learn more about current initiatives.
Spinal Cord Stimulation (SCS)
The targeted delivery of a stimulus (such as electrical or magnetic) to the nerve cells along the spinal cord. This stimulus acts on the central nervous system.
Neuromodulation
The alteration of nerve activity through targeted delivery of a stimulus, such as electrical stimulation or chemical agents, to specific neurological sites in the body.
Learn More
Pre-clinical studies
A study to test a drug, a procedure or another medical treatment in animals. The aim of a preclinical study is to collect data in support of the safety of the new treatment.
Person with lived experience (PLEX)
For Praxis, persons with lived experience include individuals with spinal cord injury, their families and caregivers.
Translational continuum
The progression of knowledge along key phases of development: idea/discovery, develop, validate, and market.
John Chernesky, PLEX Engagement Program Manager at Praxis, participated in the Up-LIFT Study of non-invasive ARC therapy for spinal cord injury. The purpose of this study is to evaluate the safety and effectiveness of non-invasive electrical spinal stimulation to maximize upper-extremity function.
“The positive effects were substantial; with an increase in strength and endurance, particularly in gross motor function, over a much longer time period with reduced fatigue and enhanced recovery.”
– John Chernesky, PLEX Engagement Program Manager
“Over the course of 16 weeks (8 weeks pre-training; 8 weeks training with spinal cord stimulation intervention), I was able to experience non-invasive transcutaneous spinal cord stimulation personally. The protocol was intensive, with up to three training sessions per week, each lasting around two hours.
I entered the study with no real expectations, although I was well aware of the possible benefits. It took a few sessions of stimulation, playing around with different stimulation parameters, before finding the optimal settings. When optimized, the stimulation felt like it created a global excitation of my entire nervous system, extending down to my lower limbs. I felt no negative neurological effects from the stimulation, other than a slight short-term increase in spastic muscle tone and some minimal discomfort at the electrode sites. The positive effects were substantial; with an increase in strength and endurance, particularly in gross motor function, over a much longer time period with reduced fatigue and enhanced recovery. In fact, my overall energy levels and quality of sleep were considerably improved throughout the duration of the intervention phase of the study. Autonomically, the areas that showed significant change were bowel function and cardiovascular control. Looking at the effect on upper extremities, the greatest improvement was in grip strength with some small changes in fine motor skills. Although the study was focused on upper-extremity function, I noticed the greatest changes in function in my torso and lower limbs.
The effects persisted throughout the stimulation phase of the study, but mostly subsided within a couple weeks of the study ending. There is still increased activation in my torso and lower limbs, although not as significant as during the study. Spasticity levels also appear lower, and energy levels remain high. Of note, I have ceased use of spasticity medications (Botox and Dantrolene) since the study’s completion.”
“When optimized, the stimulation felt like it created a global excitation of my entire nervous system, extending down to my lower limbs. I felt no negative neurological effects from the stimulation, other than a slight short-term increase in spastic muscle tone and some minimal discomfort at the electrode sites.” John Chernesky.
Spinal Cord Stimulation
A life-changing therapy that brings more than just the ability to walk again.
“Epidural stimulation has been life-changing for me as a person living with SCI.”
Sandra Mulder – Praxis Annual Report 2021
Praxis Spinal Cord Institute support and outreach for spinal cord stimulation (SCS) research across Canada is helping to raise awareness for this exciting new treatment in SCI. Grant funding, engagement with persons with lived experience (PLEX), an SCS research hub, commercialization mentoring and literature reviews all help to push opportunities for SCS through research and into the hands of users.
What is SCS?
During SCS studies for managing intractable pain, researchers noted that electrical stimulation through implanted electrode arrays could also help people with SCI walk again. Further research showed that not only was locomotion made possible, but SCS through either implanted or non-invasive devices made a huge difference in bladder and bowel function, management of autonomic dysreflexia and other clinical issues associated with SCI. In short, a lot of the secondary complications that arise post-SCI that impact quality of life could be managed or abolished with SCS of specific spinal regions.
Why SCS?
Spinal cord injury results in more than just loss of walking function or quadriplegia; there’s a disruption to many other body systems, leading to issues with bowel and bladder emptying, temperature regulation, blood pressure maintenance and respiratory function among others. These seriously impact quality of life and can precipitate conditions such as autonomic dysreflexia, which can be fatal.
“The positive effects were substantial; with an increase in strength and endurance, particularly in gross motor function, over a much longer time period with reduced fatigue and enhanced recovery” John Chernesky.
Praxis is highly involved in exploring this exciting new potential in SCI therapy. Support ranges from funding and literature reviews for researchers to engagement with PLEX for their experiences of SCS and priorities for treatment. Praxis SCI Commercialization programs mentor and guide companies with medtech innovation, bringing SCS devices from bench to bedside and into the hands of users.
Grants and funding
Team Planning Grant support for Dr. Andre Krassioukov on non-invasive transcutaneous SCS for bowel, bladder and sexual health management led to initial pilot data gathering. From this, the team won major funding from the US Department of Defense Office of the Congressionally Directed Medical Research Programs (CDMRP) to conduct a translational study on SCS. His application was recommended for funding for the F21 Spinal Cord Injury Research Program Translational Research Award.
Literature review
The SCS Scoping Review, designed to describe the status of SCS research in the restoration and/or improvement of motor, sensory and autonomic function for individuals living with SCI, reviewed 103 original research articles and highlighted priority areas where more research is needed to improve the evidence for efficacy and safety.
PLEX user experience outreach
By acting as a hub for user feedback, Praxis supported a virtual session, which brought three PLEX together to share their experiences of SCS. There’s also been raised awareness from interviews and feature articles.
In April 2020, Praxis collaborated with NASCIC in the SCIPOP-SCS Research Survey, soliciting feedback from PLEX to identify priorities, share expectations and assess demand for SCS.
SCS research hub support
Establishing a digital presence in SCS for Canada, Praxis hosts web resource pages to connect researchers and PLEX for information, clinical trials and news. The institute also initiated an e-newsletter to share initiatives and updates among the SCS research and commercialization communities.
Innovation Program Mentoring
Companies, SpineX and Neural Drive benefitted from PLEX guidance from Praxis SCI commercialization programs that help refine innovation along PLEX priorities. One-on-one mentoring from skilled commercialization and business leaders helps companies bring their medtech innovations successfully to the marketplace. SCI Accelerate program alum, SpineX has reached clinical trial status for its SCONE™ transcutaneous spinal cord stimulator, which has been recognized by the FDA as a Breakthrough Device. SpineX SCS technology is not confined solely to SCI treatment but is applicable for a much broader range of medical conditions.
SCS has the potential to be a game-changer in the lives of many people living with SCI, but only where there is access to and support for clinical trials and commercialization of technology. Praxis aims to accelerate SCS technology into clinical use for SCI community benefit.