None listed
Conditions
Brief summary
Fifty five percent of all spinal cord injuries result in tetraplegia and with impaired motor and sensory function of arms, hands, legs and respiratory muscles. For people with tetraplegia, restoration of hand and arm function ranks highest of all functional recovery targets, closely followed by improved breathing and coughing. Exercise training is the main treatment for improving upper-limb and respiratory function after spinal cord injury. Emerging evidence from pre-clinical and clinical studies suggest transcutaneous spinal cord neuro-stimulation (TSS), increases spinal cord excitability through increased reflex input. The aim of this study is to explore the efficacy, safety, and acceptability of TSS combined with exercise training for chronic tetraplegia, targeting hand and respiratory function in a multi-centre community-based adaptive Bayesian Optimal Phase (BOP) II trial design across Australia and New Zealand. A BOP trial design allows for early analysis, identifying and ceasing trial arms that prove to be futile to continue. We hypothesise participants with complete SCI may improve in their strength and breathing outcome measures, however, it is not known whether the improvement will reach the pre-determined signal of benefit.
Interventions
All groups will receive three 30-minute exercise training sessions in combination with transcutaneous spinal stimulation per week for six weeks, in the presence of an experienced exercise physiologist, physio- or occupational therapist. Participants are allocated into groups in an alternating fashion. The targeted upper limb will be chosen by the participant. Tasks will include 3 sets of 8-10 handgrips, wrist contractions and breaths through an inspiratory muscle training device (such as a Phili
All groups will receive three 30-minute exercise training sessions in combination with transcutaneous spinal stimulation per week for six weeks, in the presence of an experienced exercise physiologist, physio- or occupational therapist. Participants are allocated into groups in an alternating fashion. The targeted upper limb will be chosen by the participant. Tasks will include 3 sets of 8-10 handgrips, wrist contractions and breaths through an inspiratory muscle training device (such as a Philips Threshold IMT) at 70% of the maximal voluntary contraction, which is likely to correspond to a Rating of Perceived Exertion of 7 out of 10, each session. Dexterity tasks using pegs, marbles, cups and other everyday objects will be practiced each session for 15 minutes. Task sets will be alternated in a random order to reduce the need to rest particular muscle groups and increase efficiency of the 30-minute exercise training session. Exercise intensity will be progressed as strength increases over the six weeks. Transcutaneous spinal stimulation will be applied with two anode electrodes (5x5 cm) placed over left and right acromion processes, and the cathode (2.5x10 cm) placed vertically over the C3-C7 level. A Digitimer Constant Current multi-modal stimulator (DS8R) will be used to deliver the spinal stimulation. The stimulus will be 1ms duration biphasic square-wave pulses, delivered in a train at 30 Hz. Participants allocated to receive kHz frequency stimulation will be presented the same stimulus parameters with an additional carrier frequency of 10kHz. The amplitude of the stimulation will be set at the level of reflex threshold in the wrist extensors (tested with a single pulse for each participant) or below if the participant finds the stimulation uncomfortable (but not below 70% reflex threshold. Delivery of the stimulation will be driven by a control box which the therapist will set to provide stimulation only during active training. The details of each training session provided to participants will be recorded by the therapist in a training diary. If a participant is unable to attend one of the weekly training sessions, a makeup session will be attempted to ensure they attend three sessions a week. Reasons if unable to attend will be documented in the training diary
Sponsors
Neuroscience Research Australia (NeuRA)
The University of Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Aged 18 years or older - Diagnosed with a motor complete spinal cord injury between the levels of C2 and C8 at least one year ago and able to breathe independently - Willing and able to participate in a training program three times a week for 6 weeks
Exclusion criteria
• Have a history of clinically significant autonomic dysreflexia in response to electrical stimulation • Unable to elicit reflexes whilst experiencing the stimulation • Cannot tolerate spinal stimulation at a therapeutic intensity • Have a progressive neurological disease or other major neurological condition other than the spinal cord injury (e.g., severe traumatic brain injury or stroke) • Open surgery within the last 3 months • Syrinx (fluid-filled cyst or cavity in spinal cord) on recent MRI • Severe upper limb spasticity or contractures • Any serious medical condition, cognitive impairment (i.e. trouble remembering or learning), drug dependency, psychiatric illness or behavioural problem preventing you from adhering to the protocol • Cardiac pacemaker or pregnant • Stem cell or olfactory ensheathing cell therapy within the last 5 years • Currently taking part, or in the follow-up period, of any other clinical trial
Outcome results
None listed