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Clinical Trials

Much of what we now know about spinal cord injury has been learned over the past twenty years. What lies ahead of us has been described by some as the “golden age” of SCI research and clinical care. The Ontario Neurotrauma Foundation (ONF) is strategically supporting research, clinical interventions and many other strategies that minimize further damage, improve care and accelerate functional improvements.

ONF has supports the Riluzole Trial. Riluzole as a drug has already been approved by the US FDA and Health Canada, the Australian authorities and other countries for use in Amyotrophic Lateral Sclerosis (ALS). Riluzole acts on the sodium channels in cells, helping to prevent the accumulation of excess sodium in cells that results as a part of the flow of post-injury pathophysiological events after spinal cord injury.

Its use in acute Spinal Cord Injury has shown some promising results. Therefore, the phase IIB/III trial of Riluzole in Spinal Cord Injury Study (RISCIS) is underway to evaluate the benefits of this drug in acute cervical spinal cord injury.  Its neuroprotective properties may result in functional recovery. Such positive results from this drug trial have potential for rapid translation to clinical practice with significant best practice implementation and improved quality of life for a person who has sustained SCI.

The ONF provided initial support for the three Toronto-based academic hospitals (Toronto Western Hospital, St. Michael’s Hospital and Sunnybrook Hospital) to participate in this ongoing trial. There were 27 study sites in Canada, the U.S., Australia by January 2017 with 143 participants as of January 2019. The study is scheduled for completion in 2020. Two studies have already been published on the use of riluzole in the treatment of SCI.

Riluzole for acute traumatic spinal cord injury: a promising neuroprotective treatment strategy (2014)

Riluzole as a neuroprotective drug for spinal cord injury: from bench to bedside (2016)

Ontario Neurotrauma Foundation Spinal Cord Injury Research

Ontario Neurotrauma Foundation Research Initiatives in Partnership with Rick Hansen Institute

In September 2015 Ontario Neurotrauma Foundation in partnership with Rick Hansen Institute launched a funding initiative for projects focused on secondary complications, neuro-recovery and long-term health, wellness and community participation for those with SCI. Grants were available for up to three years with maximum $50,000/year.

Individual Spinal Cord Injury Projects Funded Through the Ontario Neurotrauma Foundation and Rick Hansen Institute Partnership

Enhancing Primary Care for Spinal Cord Injury Consumers by Clinical Use of Videoconferencing

Principal Investigator: Dr. James Milligan, Center for Family Medicine, Kitchener

The purpose of this study, now completed, was to examine the feasibility of clinician utilization of personal computer video conferencing (PCVC) to increase primary care clinician capacity to improve through efficient use of limited resources complex chronic care and secondary complications such as pressure ulcers, bowel and bladder dysfunction for people with SCI. Secondary outcomes include investigating SCI consumer perception of clinician capacity to improve complex chronic care.

This study has been developed with input from people living with SCI and their families, clinicians, researchers, advocacy agencies and the CFFM eHealth Centre of Excellence. The Centre for Family Medicine (CFFM) in Kitchener-Waterloo is the principal location of this study.

Preventing Falls One Step at a Time: Reactive Balance Training for Spinal Cord Injury

Principal Investigator: Dr. Kristin Musselman, Toronto Rehabilitation Institute, University Health Network

This study examined the feasibility and effectiveness of reactive step training in people with iSCI. The main objective is to determine if reactive balance training leads to greater improvements in balance reactions, scores on clinical scales, and fall rates compared with conventional walking training. This unconventional training may change current rehabilitation for iSCI by placing greater emphasis on balance and fall prevention. By improving balance and reducing falls, people with iSCI will experience fewer complications (e.g., injuries), and greater recovery of function and community participation.

Development and Implementation of a Clinical Decision Support System to Improve Outcomes Associated with Activity-Based Therapies

Principal Investigator: Dr. Dalton Wolfe, Lawson Health Sciences Center

The Parkwood Program of Rehabilitation Innovation for Movement Enhancement (PRIME) initiative, now completed aimed to develop, test, implement and sustain an electronic clinical decision support and data management system that includes clinical protocols to guide clinical decision-making and reporting functions in the area of locomotor training for persons with spinal cord injury (SCI) and acquired brain injury (ABI).

An initial prototype incorporating features of existing protocols and locomotor training principles (e.g., optimizing sensor input, enhancing normal movement, minimizing compensation, task specificity) was developed as the basis for continued iterative, end-user directed development and feasibility testing. PRIME prototypes encompass manual and robotic over ground and treadmill-supported approaches, but further development and improvement cycles continue.

The clinical treatment and assessment procedures embedded in PRIME will enable systematic tracking of practices and related outcomes, thereby representing a practice-based research platform to serve both quality improvement and research purposes.

Enhancing Recovery in Non-Traumatic Spinal Cord Injury: Implementation of an Integrated Program for the Assessment of Rehabilitation Therapies

Principal Investigator: Dr. Neil Duggal, London Health Sciences Center

The goal of this study is to improve the quality of life for patients who undergo surgery for arthritis in the neck, which accounts for less than two percent of all hospital admissions and is the most common cause of spinal cord injury in patients older than 55 years. The study will review clinical care spanning preoperative evaluation, surgery and rehabilitation in conjunction with state-of-the-art imaging techniques to demonstrate how rehabilitative therapy has the ability to accelerate recovery of neurological function and improve quality of life in patients by triggering brain recruitment and plasticity. Using hand function as a proxy of neurological recovery, this study will carefully evaluate neurological function in two groups of patients, those receiving rehabilitation and those not receiving rehabilitation after spine surgery, and correlate patient outcomes through the application of advanced imaging.

EEG-Triggered Functional Electrical Stimulation Therapy for Upper Limb Rehabilitation

Principal Investigator: Dr. Marquez Cesar, Toronto Rehabilitation Institute, University Health Network

This brain-controlled electrical stimulation therapy will be delivered over several weeks in addition to daily occupational therapy. In each session, participants will be asked to perform repeatedly a series of functional tasks that require hand opening, grasping an object, and releasing it. Each one of these motions will be assisted by functional electrical stimulation which in turn will be activated by a brain-computer interface capable of identifying the intention to move through analysis of electroencephalographic (EEG) activity. We will measure differences in Functional Independence Measure (FIM), Spinal Cord Independence Measure (SCIM), and Toronto Rehabilitation Institute Hand Function Test (TRI-HFT) scores between the beginning and end of the intervention, and compare its effects against conventional and functional electrical stimulation therapies.

Nerve Transfers in Tetraplegia: A Multi-Centre, Multi-Disciplinary Pilot Study

Principal Investigator: Dr. Kirsty Boyd, Ottawa Hospital

The overall goal of this research is to determine how nerve transfer surgery can be optimized to improve upper extremity function in patients with cervical SCI. This study will lay the groundwork for future studies to compare the effectiveness of nerve transfers to traditional tendon transfer/tenodesis surgery in cervical SCI, investigate the role of combining these surgeries and assess best practices for timing of nerve transfer surgery after SCI particularly in cases of combined upper and lower motor neuron injury patterns.

SCI team grants funded through the Ontario Neurotrauma Foundation/Rick Hansen Institute partnership

A team grant initiative developed by the Ontario Spinal Cord Injury Network (OSCIRN) in 2017 focuses on team-based spinal cord injury research and implementation projects in Ontario.

The first two team grants were announced in 2017 and provide the research teams with $20,000 per year for two years.

Improving the Successful Translation of Promising Animal Therapies to Humans Through the Use of Viable Adult Human Spinal Cord Tissue

Principal Investigator: Dr. Tuan Bui, University of Ottawa

Many clinical trials based upon studies on animal models have failed to improve the treatment of symptoms associated with spinal cord injury (SCI). Clearly a better understanding of how best to translate animal-based studies to the treatment of human patients would be invaluable. We propose to bridge this translational divide by using cell cultures derived from human spinal cord (SC) tissue. As we collect healthy human tissue from organ donors within 1 to 4 hours post-mortem, our team is uniquely positioned to isolate viable cells from human adult spinal tissue. By successfully generating SC cell cultures including all cell types that are important for SC function and repair, we can test and validate promising therapies that have been developed in animal models. We will demonstrate this promising approach by validating two innovative animal-based models of SCI developed across Canada.

The first approach is based upon studying the treatment of SCI using pigs. This approach has already provided many important insights into the treatment of SCI but requires a better understanding of the intrinsic differences and similarities between pig and human SCs before the next steps towards potential therapeutic treatments can occur. We will address this critical issue of cross-species translatability through the study of cell cultures derived from the SCs of both pigs and human donors.

The second is an approach named intraspinal microstimulation (ISMS) that aims to electrically stimulate SC regions that can generate weight-bearing and walking in SC injured patients. Currently, this approach has yielded promising gains, but in animal models. Before being able to safely and effectively apply this approach in human patients, we propose to create three-dimensional models of human SCs using cell cultures that will allow ISMS to be fully tested and validated.

Co-investigators: Drs. Mike Hildebrand (Carleton University), Brian Kwon (University of British Columbia), Vivian Mushahwar (University of Alberta), and Eve Tsai (Ottawa Hospital Research Institute).

Development of the Spinal Cord Injury Rehabilitation Translational Continuum Team

Principal Investigator: Dr Cathy Craven, University Health Network, Toronto

This proposal assembles a multidisciplinary team of leading (SCI) researchers that span both basic and clinical research across Canada. The approaches will accelerate the translation of basic science into proven clinical treatments of SCI. The spinal cord injury Rehabilitation Translational Continuum Team (ReCon Team) was formed to address the major gaps between research produced in a laboratory and its clinical applications and the lack of consensus on methodologies and outcomes used in SCI rehabilitation research.

Our team is composed a unique interprovincial and international team of consumers, researchers and clinicians committed to understand how muscle, bone and the nervous system interact to influence the quality of rehabilitation and future service delivery models for individuals with SCI over the course of their lifetime.

The aim of the ReCon Team is to facilitate the development of new collaborations between consumers, leading muscle bone unit (MBU) and nervous system research scientists and rehabilitation experts to maximize the effectiveness and quality of rehabilitation interventions, functional health and well-being outcomes to improve the health and quality of life of people living with SCI.

The ReCon Team goals are to:

  • Develop recommendations for the use of common methodologies and outcomes (i.e. biomarkers, imaging and clinical assessments) across the translational continuum of SCI research;
  • Study the effects of promising rehabilitation modalities (i.e. electrical stimulation, hydro-intervention, whole-body vibration, stretching or gait training) on the muscle-bone unit and nervous system and their interactions across the rehab continuum; and
  • Promote development and adoption of promising rehabilitation interventions.

Achieving these goals will enable a shared understanding of the muscle-bone unit pathophysiological mechanisms and attempt to close the gap between basic research and clinical practice through a sustained dialogue and joint accountability. Successful implementation of the grant will advance research and substantively facilitate the abandonment of ineffective interventions, the optimization of existing interventions and development of new rehabilitation strategies.

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