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Winners announced in RHI’s Clinical Outcome Measures and Optimizing Neurorecovery funding competitions

In August, RHI announced two new funding opportunities – Clinical Outcome Measures (COM) and Pilot Studies – Optimizing Neurorecovery Following SCI (PSON). These competitions were developed to meet the objectives of RHI's 2013 – 2018 Business Plan, to align with the areas of focus of the Cure, Care and Commercialization Programs and ultimately, help RHI move closer towards achieving its vision of a world without paralysis after spinal cord injury. RHI is pleased to announce the results of both funding competitions.

Proposals submitted underwent a thorough review process to ensure alignment to RHI’s goals, relevancy and scientific merit. The Review Committees included people with SCI and external subject matter experts. Five projects from COM and two projects from PSON were selected for funding after undergoing the review process.

The COM competition sought projects that are developing and/or validating outcome measures for clinical studies.

“Through the five projects awarded in the COM competition, we will be able to validate and refine some of the data tools used by clinicians and test the effectiveness of interventions for issues that are important to people with SCI, such as bowel, bladder and upper limb function”, said Bill Barrable, CEO of RHI.

The PSON competition sought projects that will generate evidence on how specific therapies and/or technologies will improve neurological outcomes or physical function for people with SCI.

“The successful projects from the PSON competition are extremely innovative and will provide insight into electrical stimulation strategies that promote functional recovery in locomotion (walking) and cardiovascular health. All successful projects further strengthen RHI’s research portfolio and will help identify the most promising SCI research to be translated into treatments for people with SCI.”

“We received a number of high quality applications for both competitions. Unfortunately, the amount of funding we have available for these competitions is limited. As a result, there were strong applications that were not awarded funding. I would like to thank the reviewers who participated in the process and had the difficult task of scoring and ranking the applications.”

Congratulations to the funding recipients and best of luck in pursuing these exciting projects.

Continue reading to view summaries of the successful projects.

Clinical Outcome Measures

Project Title: Development of a patient reported outcome for bowel dysfunction following spinal cord injury
Principal Investigator: Anthony Burns
Lead Organization: UHN – Toronto Rehabilitation Institute

The impact of spinal cord injury (SCI) on bowel function is profound. Individuals with SCI and neurogenic bowel dysfunction (NBD) rate recovery of bowel function above walking as a priority for cure. The ramifications of NBD include impaired gastrointestinal motility, loss of continence, prolonged time to complete planned bowel evacuation, and a related loss of dignity. Despite its prevalence and importance, NBD has been understudied. Further, current outcome measures fail to capture the full impact of the condition on affected individuals (e.g., employment recreation, inter-personal relationships, etc.). To address this need, a patient reported outcome (PRO) measure will be developed. The proposed PRO measure builds upon our prior qualitative studies which identified issues and challenges of living with NBD. Rigorous methodology will be employed. The developed PRO measure will facilitate the future evaluation of clinical interventions intended to reduce the impact of NBD on individuals living with SCI.

Project Title: Establishing the Sensitivity, Specificity, and Clinical Utility of the SCI-QOL Common Data Elements (CDEs)
Principal Investigator: Pamela A. Kisala
Lead Organization: University of Delaware 

Objective: To further validate the Spinal Cord Injury – Quality of Life (SCI-QOL) common data elements
(CDEs) and to improve the interpretability and clinical utility of SCI-QOL scores. Design: Secondary data analysis and new consensus meetings of key stakeholders using modified “Bookmarking” standard-setting methodology. Setting: Existing data collected from 8 Model SCI systems sites across the US; consensus meetings at a top ranked rehabilitation hospital in the US. Participants: Existing data from over 300 individuals with SCI will be used to develop recovery trajectories (Aim 1) and calculate sensitivity and specificity values (Aim 2); existing data from over 700 individuals with SCI will be used to develop clinical vignettes for consensus meetings with 10 individuals with traumatic SCI and 10 SCI clinicians, respectively (Aim 3). Main Outcome: Validation data on the sensitivity, specificity, and responsiveness of the SCI-QOL item banks; meaningful clinical thresholds for SCI-QOL scores.

Project Title: A wearable sensor for monitoring hand function at home
Principal Investigator: José Zariffa
Lead Organization: UHN – Toronto Rehabilitation Institute 

The recovery of upper limb function is rated as the number one priority for individuals with tetraplegia. In order to improve upper limb rehabilitation outcomes, it is essential to accurately measure the effectiveness of new approaches. There is currently no method that can provide reliable information about how much and how effectively an individual is using their hands once they leave the clinical environment and return home. To remedy this problem, we will develop a new sensor, based on unobtrusive wearable cameras and computer vision technology, which will monitor interactions of the hand with objects in the environment, and serve as the basis for a novel set of metrics reflecting independent hand use in the community.

Project Title: Pediatric Modifications to the International Spinal Cord Injury Data Sets
Principal Investigator: MJ Mulcahey
Lead Organization: Thomas Jefferson University 

Spinal Cord Injury (SCI) international data sets have been developed to establish a common language, assist in developing new SCI databases and, provide consistency for the design and publication of studies. While some of the workgroups included pediatric expertise, the data sets have not been evaluated for clinical relevance to pediatric SCI. Thus, the purpose of this study is to evaluate the relevance of the SCI international data sets to pediatric SCI (validity); and; to examine inter-rater reliability among pediatric clinicians. Using the same process that was established for endorsement of the original international data sets, recommendations for pediatric modifications will be presented to the International Data Set Steering Committee and exposed for public review.

Project Title: Quantitative Optical Measurement of Pelvic Floor Muscle Function in Women with Spinal Cord Injury (SCI) Using Near Infrared Spectroscopy (NIRS)
Principal Investigator: Lynn Stothers & Andrew J. Macnab
Lead Organization: University of British Columbia

Involuntary urinary leakage (incontinence) represents a considerable health care burden. Guidelines for incontinence treatment mandate pelvic floor muscle (PFM) strengthening in first line therapy. But currently caregivers cannot quantify PFM physiologic function, and patients have no defined physiologic endpoints that individualize/optimize their PFM training. We will develop quantitative measures for: (1) clinicians to objectively assess PFM physiologic function, and (2) patients with incomplete SCI to use to achieve optimal muscle ‘fitness’ during adaptive PFM training, using a transvaginal near infrared spectroscopy (NIRS) probe to monitor PFM oxygenation and hemodynamics during voluntary PFM contraction. NIRS is a ‘gold standard’ non-toxic optical method for measuring oxygenation/hemodynamics and optimizing training for elite athletes, where ‘fitness’ is defined by quantitative changes in oxygen supply and demand and rate of reoxygenation of muscle following contraction.

Pilot Studies – Optimizing Neurorecovery Following SCI 

Project Title: Deep Brain Stimulation of the Pedunculopontine Nucleus to Improve Walking After Spinal Cord Injury
Principal Investigator: Andres M. Lozano
Lead Organization: UHN – Toronto Western Hospital

Spinal cord injury (SCI) is a devastating condition affecting over 1 million individuals in North America. SCI often results in severe motor impairments with few available treatments options. Recent groundbreaking research has demonstrated that deep brain stimulation (DBS) of the mesencephalic locomotor region (MLR) greatly improves locomotion in a rat model with incomplete SCI. The pedunculopontine nucleus (PPN – a specific nucleus within the MLR) in humans has already been established as an auxillary DBS target in Parkinson Disease (PD), to improve motor control and locomotion. DBS of other targets has also been safely used in humans with SCI for chronic pain. These findings suggest that DBS of the PPN may have potential as a therapeutic intervention in the SCI population to improve locomotion. Our goal is to conduct a pioneering study in 5 selected incomplete SCI patients with severe gait impairment to examine if bilateral DBS of the PPN improves walking.

Project Title: Effect of epidural stimulation on vascular and cognitive health following spinal cord injury
Principal Investigator: Andrei V. Krassioukov
Lead Organization: University of British Columbia

Cardiovascular disease (CVD), including heart attacks and strokes, are primary killers of individuals with spinal cord injury (SCI). A number of factors after SCI predispose individuals to CVD including: damage to neurological control of blood vessels and the heart, physical inactivity, and extremely unstable blood pressure (BP: i.e., dramatic increases and decreases in arterial BP). Together, these factors triple the risk of heart attack and stroke among the SCI population, and also result in cognitive decline by limiting brain blood supply. Stabilizing BP improves brain blood vessel health and cognitive function in SCI, and may impact overall CVD risk. Epidural stimulation of the lumbar spinal cord may offer significant improvements in BP stability, by re‐establishing cardiovascular regulation in individuals with SCI. We propose to examine the effect of this novel intervention on BP stability, and the associated clinical consequences including brain blood vessel health, cognitive function and overall cardiovascular risk.