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. ONF is strategically supporting research, clinical interventions and many other strategies that minimize further damage, improve care and accelerate functional improvements.

ONF supported SCI projects

A few major activities that ONF has supported in this area include:

Riluzole Trial

Riluzole as a drug has already been approved by the FDA, 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. By doing this it has a protective effect. It also helps to modulate the neurotransmitter glutamate. (see figure)

Its use in acute Spinal Cord Injury has shown some promising results. Therefore our phase IIB/III trial of Riluzole in Spinal Cord Injury Study (RISCIS) is under way to evaluate the superior benefits of this drug in acute cervical spinal cord injury.  It is exciting in that its neuroprotective properties also 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 Ontario Neurotrauma Foundation (ONF), Canadian Spinal Research Organization (CSRO) and Ontario Spinal Cord Injury Research Network (OSIRN) are providing support for the three Toronto-based academic hospitals (Toronto Western Hospital, St. Michael’s Hospital and Sunnybrook Hospital) to participate in this trial. In August 2016 53 people had been recruited at 22 study sites in Canada, the U.S., Australia. The number of study sites is expected to increase to 27 by January 2017.

Publications:

Riluzole for acute traumatic spinal cord injury: a promising neuroprotective treatment strategy. http://www.ncbi.nlm.nih.gov/pubmed/23295632 (2014)

Riluzole as a neuroprotective drug for spinal cord injury: from bench to bedside http://www.ncbi.nlm.nih.gov/pubmed/25939067 (2016)

Figure 1:

Riluzole

 

 

 

 

 

 

 


Limiting secondary damage to spinal cord - CAMPER Trial

A current key clinical research projects is CAMPER (Cerebrospinal Fluid Pressure Monitoring and Biomarker Validation Study), which is jointly funded by ONF and the Rick Hansen Institute (RHI). It is designed to limit secondary damage to the spinal cord by developing a procedure to help drain the cerebral spinal cord fluid (CSF) and reduce swelling and pressure build-up at the injury site.

CAMPER is a multi-center clinical trial led by Dr. B. Kwon, in Vancouver. The three participating sites in Ontario are London Health Sciences in London, Hamilton General Hospital in Hamilton and St. Michael's Hospital in Toronto.


Personalized Adapted Locomotor Training at the Lyndhurst Centre, Toronto Rehabilitation Institute-University Health Network

Personalized Adapted Locomotor Training (PALT) is an intensive, walking-focused rehabilitation program that aims to help individuals with incomplete spinal cord injury increase their independence and level of function. PALT involves a combination of body weight-supported treadmill training, and over-ground walking and balance training that is directed by each individual’s rehabilitation goals.

The primary objectives of this study are to evaluate the feasibility and cost-effectiveness of PALT for individuals with sub-acute SCI in an outpatient SCI rehabilitation setting in Canada. Participants of PALT attend 40 or more training sessions. Measures of walking, balance, quality of life, respiratory function, and strength are performed every five weeks during PALT, and at six and twelve months after the completion of training. Utilization of health care resources is recorded for the year following PALT. The findings will direct the structure and delivery of future locomotor training programs for individuals with SCI.

Publications to-date:

Chan K, Guy K, Shah G, Golla J, Flett H, Williams J, Musselman KE. Measuring balance in high-functioning individuals with incomplete spinal cord injury: The community balance and mobility scale. Spinal Cord, August 2016.

WAVE Project

ONF is supporting a pilot study of whole body vibration (WBV) for the treatment of osteoporosis in men with incomplete spinal cord injury.

It has been suggested that whole body vibration has beneficial effects on bone mass, muscle strength and endurance among able‐bodied persons including postmenopausal women, elite athletes and bariatric clients. This pilot study seeks to confirm the therapeutic potential of WBV on similar bone, body composition and muscle parameters among men with motor incomplete spinal cord injury.

The primary aim of the study is to determine the efficacy of passive standing and intermittent whole body vibration on biochemical markers of bone turnover, mineral density, and bone architecture and to describe the effects of WBV on body composition. The study is currently focused on a convenience sample of 10 men with similar body mass index, aged 20‐60 years, with chronic, incomplete, paraplegia.

Results from a Lyndhurst study re complete spinal cord injury and WBV published in 2014 http://www.toronto-fes.ca/publications/2014_Masani_J_Spinal_Cord_Med_37_pp-575_581.pdf

Other Publications:

Totosy de Zepetnek JO, Miyatani M, Szeto M, Giangregorio LM, Craven BC. (2017). The effects of whole body vibration on pulse wave velocity in men with chronic spinal cord injury. J Spinal Cord Med. Accepted

Masani K, Alizadeh-Meghrazi M, Sayenko DG, Zariffa J, Moore C, Giangregorio L, Popovic MR, Craven BC.(2014). Muscle Activity, Cross-Sectional Area and Density Following Passive Standing and Whole Body Vibration: A Case Series. J Spinal Cord Med. 37(5): 575-581.

Alizadeh-Meghrazi M, Masani K, Zariffa J, Sayenko DG, Popovic MR, Craven BC.(2014). Effect of wholebody vibration on lower-limb EMG activity in subjects with and without spinal cord injury. J Spinal Cord Med. 37(5): 525-536.

Alizadeh-Meghrazi M, Zariffa J, Masani K, Popovic MR, Craven BC.(2014). Variability of vibrations produced by commercial whole-body vibration platforms. J Rehabil Med. 46(9): 937-940.

Hadi SC, Delparte JJ, Hitzig SL, Craven BC.(2012). Subjective experiences of men with and without spinal cord injury: Tolerability of the Juvent and WAVE whole body vibration plates. PM&R. 4(12): 954-62.

Alizadeh-Meghrazi M, Masani K, Popovic MR, Craven BC.(2012). Whole-Body Vibration during Passive Standing in Individuals with Spinal Cord Injury: Effects of Plate Choice, Frequency, Amplitude and Subject's Posture on Vibration Propagation. PM&R. 4(12): 963-75.