eWALK v1
Research type
Research Study
Full title
Transcutaneous spinal cord stimulation combined with locomotor training to improve walking ability in people with chronic spinal cord injury. A randomised sham-controlled trial
IRAS ID
295935
Contact name
Margaret Purcell
Contact email
Sponsor organisation
Neuroscience Research Australia
Duration of Study in the UK
3 years, 3 months, 31 days
Research summary
A spinal cord injury (SCI) is a potentially debilitating and life changing event. Spinal cord injury leads to a wide range of deficits affecting a person’s motor, sensory and autonomic function. These deficits will limit a person’s functional capacity, most notably their ability to walk. Walking recovery is considered a high priority for individuals with SCI. Of those with an SCI, individuals with motor incomplete SCI are most likely to regain the ability to walk over ground. Therefore, the recovery of walking has become the focus of many drug and rehabilitative studies particularly considering an increasing prevalence of incomplete SCI. More recently there have been exciting new developments. Electrical stimulation to the spinal cord, both invasively and transcutaneously, is claimed to restore the ability to move previously paralysed limbs in some individuals. This voluntary movement was restored immediately in some, with others noting progressive improvements in paralysed limbs after combined spinal stimulation and intensive locomotor training. Mechanisms underlying this recovery are unknown, although even after the most severe SCI many connections in the spinal cord survive and can potentially be activated to cause movement. The combination of locomotor training and electrical spinal cord stimulation is thought to modulate spinal circuitry to optimise the use of available connections between the brain and the muscles below the lesion. Moreover, there is preliminary evidence that spinal stimulation can reduce the involuntary muscle activity present in some individuals following SCI that can limit their ability to walk, termed spasticity. Yet despite the increasing use of transcutaneous (surface) spinal cord stimulation to promote neural recovery, it remains unknown whether this is effective for people with SCI. The full translational potential of this treatment and a thorough assessment of how it works have not yet been explored. In order to rigorously assess the efficacy of spinal stimulation combined with locomotor training we will perform a multicentered randomised sham-controlled trial. This study will answer a pragmatic question about the effectiveness of this type of intervention, as well as further our understanding of neurophysiological mechanisms that may drive clinical changes.
The aim of this study is to determine the effectiveness of 12 weeks of surface spinal stimulation combined with locomotor training on the walking ability of people with incomplete SCI. Secondary outcomes will capture different aspects of recovery, strength, spasticity, bowel function, and quality of life.
REC name
London - City & East Research Ethics Committee
REC reference
21/LO/0685
Date of REC Opinion
21 Oct 2021
REC opinion
Favourable Opinion