None listed
Conditions
Brief summary
This project addresses a significant unmet need: recovery of arm and hand function in people with tetraplegia (loss of use of the arms and legs). This issue is ranked by survivors as being of the highest importance, more important than the ability to walk. A novel non-invasive method of spinal cord stimulation (transcutaneous spinal cord neuromodulation – TESCoN) will be trialled for the first time in Australia, and in both subacute and chronic tetraplegia. Electrodes on the skin at the back of the neck will deliver a unique form of stimulation to the spinal cord without causing discomfort. This will modulate (alter the activity of) spared but non-functional pathways as well as the spinal circuitry below the injury level. When combined with intensive rehabilitation of the arm and hand, TESCoN leads to altered connections within the spinal cord, resulting in improved function. TESCoN enhances the effect of intensive rehabilitation and is not a replacement for it. This study will be an open-label trial using an adaptive design, with a combined efficacy and safety endpoint and clear rules for stopping the trial if the intervention is shown to be ineffective and/or unsafe. TESCoN is expected to lead to improvements in function that are superior to those obtained with current best practice rehabilitation. Such recovery of function may have a substantial impact on independence, potential for employment, and quality of life.
Interventions
Upper limb rehabilitation will be provided in combination with transcutaneous spinal cord neuromodulation (TESCoN) for at least 2 hours per day, 5 days per week for 4 weeks.
The rehabilitation will be provided by a physiotherapist experienced in the management of spinal cord injury (SCI) and will be tailored to the motor capacity of each participant. It may include:
- strengthening exercises (e.g. resisted movements using weights or manual resistance as in proprioceptive neuromuscular facilitati
Upper limb rehabilitation will be provided in combination with transcutaneous spinal cord neuromodulation (TESCoN) for at least 2 hours per day, 5 days per week for 4 weeks. The rehabilitation will be provided by a physiotherapist experienced in the management of spinal cord injury (SCI) and will be tailored to the motor capacity of each participant. It may include: - strengthening exercises (e.g. resisted movements using weights or manual resistance as in proprioceptive neuromuscular facilitation patterns) - intensive training of gross and fine motor skill tasks (e.g. reaching for and manipulating objects of different size, weight and texture) - playing computer games that encourage hand movements TESCoN, provided concurrently with upper limb rehabilitation will be delivered via electrodes placed midline between the spinous processes of the C3-C4 and C6-C7 vertebrae using a stimulator (SpineX Inc, Ca, USA). Biphasic rectangular 1ms impulses will be applied, with a frequency of 30Hz, filled with a carrier frequency of 10Hz. This stimulation permits currents of up to 80-120 mA to be delivered to the skin without discomfort. Stimulation will be introduced gradually and adjusted according to the participant's tolerance. TESCoN will be delivered throughout the rehabilitation sessions, but may be turned off for short periods to assess the participant's ability to perform voluntary movements. Adherence to the intervention will be monitored through daily attendance records.
Sponsors
The University of Melbourne
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
15 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Confrmed motor complete (American Spinal Injury Association Impairment Scale [AIS] grade A or B), or incomplete (AIS grade C or D) tetraplegia at the time of enrolment in the study with injury below C4 vertebral level. 2. Subacute (3-6 months post-SCI), or chronic (12 months or more post-SCI) 3. Aged between 15 and 75 years 4. Have medical clearance to participate 5. Able to comply with attendance requirements for the study
Exclusion criteria
1. Other neurological disorders: signicant head injury, brachial plexus, or peripheral nerve injury 2. Previous upper limb reconstructive surgery 3. Pre-existing conditions: diabetes, elevated blood pressure 4. Severe cognitive impairment that precludes consent or ability to follow instructions 5. Skeletal or joint injury signicantly limiting range of movement of upper limbs 6. Contraindications to stimulation (pacemaker, pregnancy, breast feeding, cancer).
Outcome results
None listed