There are three multi-centre clinical research studies that are currently supported or poised to be supported by the Rick Hansen SCI Registry: Minocycline, Cerebrospinal Fluid Pressure/Biomarker Validation, and Access to Care and Timing. These national collaborations are facilitated by RHI leadership and use the Registry as a shared data collection platform, enabling recruitment of study participants at multiple sites. The participation of multiple hospitals, researchers and clinicians across Canada is invaluable in maximizing the expertise applied to each study, and the speed at which advances can be made.

Cerebrospinal Fluid Pressure Monitoring and Biomarker Validation

Pioneered by Dr. Brian Kwon at Vancouver Hospital, the Cerebrospinal Fluid Pressure Monitoring and Biomarker Validation study uses a tiny catheter to continuously monitor the pressure of the cerebrospinal fluid (CSF) surrounding the spinal cord. Increases in CSF pressure can prevent the delivery of oxygen and nutrients via the blood supply to the injury site, thereby contributing to secondary damage to the spinal cord. CSF samples are analyzed for biomarkers which give a surprisingly accurate prediction (84%) of the extent of neurological damage and what functional outcomes are likely for a specific patient. These outcomes, which have been virtually impossible to predict in the past, are expected to be extremely useful in helping determine which treatments and clinical trials could be most beneficial for a specific patient.

Based on promising initial results, the Rick Hansen Institute has funded the first Canadian multi-centre clinical trial for acute SCI. The Cerebrospinal Fluid Pressure Monitoring and Biomarker Validation multi-centre trial will run through 2011 in 7 hospitals in Vancouver, Calgary, London, Ottawa, Montreal and Halifax.

Minocycline as a Neuroprotective Agent

Minocycline, an antibiotic that has been used as an acne treatment for over 30 years, has been demonstrated in animal models to have neuroprotective properties that minimize inflammation and secondary damage to the spinal cord. 24,25,26 As minocycline is an off-patent drug, pharmaceutical companies have little incentive to invest in developing new applications for its use. In 2004, Dr. Steve Casha and Dr. John Hurlbert, neurosurgeons at Dalhousie University and the University of Calgary, respectively, led an RHI-supported 52-patient trial, over 3 years, to evaluate the effectiveness of intravenous minocycline, administered less than 12 hours after injury. Results indicated positive impacts to both long-term physical motor recovery and sensory scores. Improvements were observed as early as 3 months post-injury and were maintained at 1 year.

The Rick Hansen Institute is sponsoring a multi-centre Canadian trial involving 6 research sites across Canada, and 100 patients over a 2 year period. Whereas new drug development typically requires 17-20 years and hundreds of millions of dollars, minocycline has been commonly used for over 30 years, and can therefore be translated into clinical practice in a fraction of the time and cost of new drug development.

Both Minocycline and Cerebrospinal fluid pressure monitoring will reduce the severity of SCI, reducing costs to the health care system, as a result of reduced hospital length of stay, reduced incidence of secondary complications, reduced hospital readmissions, and reduced need for home care support services.

Access to Care and Timing

The Access to Care and Timing study brings together an interdisciplinary team of health services researchers and professionals, and the UBC Sauder School of Business Centre for Operations Excellence, to study means of improving the timeliness and quality of acute and rehabilitation care for individuals with SCI. A simulation model will be created to describe the processes of care from the time of injury until discharge into the community – this model will then be used to optimize patient flow through the complex care system, with the goal of maximizing quality and efficiency of care. This study is currently underway in 12 acute and rehab hospitals in Vancouver, Calgary, Toronto, Hamilton, Quebec City and Montreal.