Restoring arm and hand function
In 2018 we funded a pilot clinical research trial in two research centres to explore neuromodulation - electrical stimulation of the spinal cord to modify and enhance the function of nerves. The Pathfinder study, the first of its kind in the UK, used a novel device designed to deliver the stimulation transcutaneously, or non-invasively across the surface of the skin.
The outcomes of this patient-based study were promising. Whilst the primary aim was to evaluate the safety and tolerability of this new treatment in a small group of patients, the study also looked for evidence of hoped-for improvements in a broad spectrum of function.
The study recruited patients with complete, chronic injuries at the cervical (neck) level. The treatment was well tolerated and found to be comfortable, with only minor pin-prick sensation experienced initially that quickly subsided.
As part of the trial, participants engaged in activity-based rehabilitation during and after treatment which was expected to reinforce changes in nerve function arising from the stimulation. Whilst the number of patients recruited to the study was too small to make any finding conclusive, some participants showed a number of positive effects as a result of the treatment:
• increased hand and arm function
• improvements in arm sensation
• lowering of high blood pressure at the end of each session
Importantly, the changes experienced in arm function and sensation persisted after treatment for some patients.
Further clinical trials
These positive results merit more detailed investigation in a larger group of patients to determine effectiveness, dose-response and persistence of effects. We also aim to recruit incomplete and paraplegic patients for a more inclusive set of trials.
We have now agreed funding of the next stage of the clinical research across three elements, significantly expanding the original study. The research will take place over two and a half years, starting in 2019, and will be carried out by researchers at centres in our growing neuromodulation research network here in the UK.
The total financial commitment is three quarters of a million pounds. An ambitious amount of money for the charity to raise.
Project 1: Increasing group size
Will build on the Pathfinder study by significantly increasing the number of chronic, cervical ASIA A patients recruited to prove effectiveness of the non-invasive treatment. The study will extend the treatment period from four to 16 weeks to give important information on dose response. This trial will also add an element not included in the Pathfinder trial. For six weeks prior to the start of spinal stimulation, the patients will undergo a programme of functional electrical stimulation to muscles to help build strength and conditioning.
Project 2: Hand and arm function
Will focus on improving hand and arm function in a group of patients with chronic, incomplete cervical injuries. Researchers will develop a standardised method for determining the electrical stimulation parameters to tune dosage which can be then used more widely in a range of clinical settings. The effects of combining the treatment at the optimum dose with task specific practice on hand and arm function will be examined.
Project 3: Arm, leg and autonomic function
Will look at the effects and benefits of very long duration treatment across a broad range of injury levels and severities. Treatment will be given for up to 12 months and over the course of a year to observe and describe any short term or long-lasting changes in sensory, motor or autonomic function that can be safely and comfortably derived from the treatment combination. Specifically, the researchers will monitor optimal stimulation dosage and frequency, identify best location of stimulation on the patient’s body, and investigate the best rehabilitation activities to drive change in motor, sensory or autonomic function.