Spinal Stimulation In Chronic Complete Tetraplegia (Version #1)
Research type
Research Study
Full title
Non-invasive spinal cord stimulation combined with activity-based therapy in chronic complete high level spinal cord injury
IRAS ID
238164
Contact name
Margaret A Purcell
Contact email
Sponsor organisation
NHS GGC Research &Development
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
Electrical spinal stimulation combined with activity-based therapy can improve motor and autonomic function in individuals suffering from varying degrees of paralysis. Spinal stimulation studies have included invasive implanted devices and non-invasive transcutaneous (via the skin) systems, using different combinations of spinal level targeted, stimulation current, waveform, amplitude and duration. Invasive and non-invasive systems have been demonstrated to permit chronic SCI individuals, previously considered to have complete injuries (ASIA A), to regain some degree of voluntary and autonomic function during periods of stimulation. The aim of this study is to evaluate the safety, tolerability and feasibility of a novel non-invasive transcutaneous electrical spinal cord stimulation system combined with activity-based therapy in patients who have paralysis of their arms and legs. We will also investigate any immediate and possibly lasting effects on their sensory, motor and autonomic function. Patients will be recruited from two UK spinal injuries centers. We will use a novel transcutaneous spinal stimulator that has been designed to deliver safe and pain-free bursts of low and high frequency pulsed current that minimise the capacitance effects of the skin surface and maximise conductance to target neural structures. We aim to investigate this form of neuromodulation in a small group of individuals with chronic complete high level (C4-C6) tetraplegia. Our goal is to observe and describe any immediate or lasting changes in function that can safely and comfortably be derived from this combination of spinal stimulation and activity-based therapy. If this therapy can cause any lasting improvements in sensory, motor or autonomic function, and hand function in particular, then this may lead to a greater degree of functional independence for these individuals.
REC name
West of Scotland REC 4
REC reference
18/WS/0004
Date of REC Opinion
29 Jan 2018
REC opinion
Further Information Favourable Opinion