None listed
Conditions
Brief summary
This study will specifically investigate whether functional electrical stimulation (FES) reverses myelin abnormalities in peripheral nerves of people with spinal cord injury. Participants who are scheduled to undergo nerve transfer surgery will be asked to undertake a program of FES using the ReGrasp device (Rehabtronics Inc, Edmonton Canada) for at least one hour dail, 5 days per week for 6 weeks prior to the surgery. This device enables a person to close and open the hand and can be operated independently by simple head motions detected by an earpiece. Biopsies of the relevant nerves and muscles will be obtained during the surgery, and these will be processed, analysed and compared with those obtained from previous nerve transfer surgery participants (historical controls). The primary outcome measure is the axon/nerve fibre ratio. Secondary outcomes include clinical assessments of hand function, independence, pain, well-being and quality of life, with participants being followed up for 24 months post-surgery. A cost-utility analysis will also be conducted.
Interventions
Functional electrical stimulation will be delivered using the ReGrasp device. Surface electrodes are embedded in a cuff worn on the forearm. The stimulator can be operated independently by simple head motions detected by an earpiece containing an accelerometer. The earpiece sends radio frequency signals to the stimulator, advancing it through a 3-state sequence: hand opening, grasp, no stimulation. Typical pulse parameters are: biphasic rectangular wave pulses, frequency 20 to 30 pulses/sec, pul
Functional electrical stimulation will be delivered using the ReGrasp device. Surface electrodes are embedded in a cuff worn on the forearm. The stimulator can be operated independently by simple head motions detected by an earpiece containing an accelerometer. The earpiece sends radio frequency signals to the stimulator, advancing it through a 3-state sequence: hand opening, grasp, no stimulation. Typical pulse parameters are: biphasic rectangular wave pulses, frequency 20 to 30 pulses/sec, pulse duration 100 to 200 microseconds, amplitude 25 to 35mA, However, clinicians will be able to adjust values for patient comfort. Participants and their carers will be trained in the use of the ReGrasp, and participants will be asked to use the device for at least one hour daily, 5 days per week for 6 weeks prior to nerve transfer surgery. They will be asked to record their daily use of the ReGrasp in a diary, and adherence will be monitored through weekly phone calls by the therapist to participants, who will also monitor any adverse events. Surgery will occur between 1 and 2 weeks after cessation of the stimulation. This surgery does not form part of the intervention.
Sponsors
Austin Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Complete or incomplete tetraplegia with C5 – C7 motor neurological level 2. Assessed as suitable for nerve transfer surgery by the surgical and occupational therapy team at the Upper Limb Program Multidisciplinary Clinic at Austin Health 3. Consent to nerve transfer surgery and intra-operative nerve and muscle biopsies after being fully informed about expected outcomes, potential risks, surgical procedure, recovery time, postoperative therapy commitments. 4. Able to comply with therapy protocols pre-operatively
Exclusion criteria
1. Accompanying head injury, brachial plexus or peripheral nerve injury at the time of, or preceding the spinal cord injury 2. Any other pre-existing neurological condition 3. Cognitive impairment limiting ability to consent to surgery or comply with postoperative rehabilitation 4. Skeletal or joint injury signifcantly limiting passive range of movement across a joint relevant to the proposed nerve transfer 5. Contraindications to functional electrical stimulation
Outcome results
None listed