9 months ago
53 A new stroke treatment which delivers electrical pulses to the brain via a portable, pacemaker-like device whilst rehabilitation therapy is being carried out is to be tested in a trial in a bid to improve arm recovery after stroke.
The new trial is led by researchers from Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield and funded by a partnership between the National Institute for Health and Care Research and the Medical Research Council and the Association of British Neurologists Fellowship (co-funded by the Stroke Association and Berkeley Foundation).
It will be the first to see if a treatment known as transcutaneous (through the skin) vagus nerve stimulation can improve hand and arm weakness in stroke survivors when given as a self-delivered treatment during stroke rehabilitation therapy.
Around 110,000 people suffer with a stroke in the UK every year and one third of stroke survivors are left with permanent arm weakness which can make daily activities difficult. Rehabilitation therapy is the main treatment for people recovering from a stroke. However, the benefits are modest and many stroke survivors have persisting arm weakness, limiting their ability to self-care.
The £2 million TRICEPS trial will build on the results of a recent clinical trial which showed that stimulating damaged areas of the brain using invasive vagus nerve stimulation improved arm recovery in stroke survivors when combined with stroke therapy more than if therapy alone was provided.
However, in this trial the electrical stimulator was surgically implanted in the chest to deliver the stimulation to damaged parts of the brain through a key nerve in the body known as the vagus nerve. As well as patients having a general anaesthetic to have the device implanted, the therapy in this trial had to be administered with hospital supervision as a therapist was required to trigger the stimulation.
In TRICEPS, the stimulation will instead be triggered via a wearable pacemaker-like device which connects to a wired earpiece. The stimulation will then be automatically activated as the arm is moved during therapy whilst the connected earpiece tickles the ear, meaning participants can access the treatment at home and without the need for a surgical implant.
Researchers hope that the portable, stimulation device will allow the revolutionary treatment to be provided to larger numbers of stroke patients, at cost and at scale.
Professor Arshad Majid, consultant neurologist at Sheffield Teaching Hospitals NHS Foundation Trust and professor of Cerebrovascular Neurology at the University of Sheffield and chief investigator of the trial said: “We are really excited to be launching this new study. In a very small preliminary trial, we showed that gently ‘tickling’ a nerve at the ear using mild electrical pulses improved arm and hand weakness after stroke when used in conjunction with stroke rehabilitation therapy.
“In our new trial we hope to establish if these findings can be replicated in larger numbers of patients, without the need for surgery, so that stroke survivors can access transcutaneous vagus nerve stimulation as part of their at-home rehabilitative therapy and care. By conducting this trial, we also hope to provide definitive answers as to whether this is an effective approach in improving recovery after stroke that can be rolled out at scale to large numbers of patients on the NHS.”
Up to 243 patients from 15 UK stroke centres are set to be enrolled into the trial over the next two years, which will also involve researchers from the University of Nottingham and the University of Glasgow, alongside the University of Sheffield’s Clinical Trial Research Unit.
The team of researchers will also be asking some participants to have an MRI scan so they can seek to understand the exact mechanisms behind the transcutaneous vagus nerve stimulation to work.
Participants will be asked to wear the device for an hour, five times a week as they carry out their stroke rehabilitation exercises at home with the support with the support of community physiotherapists and occupational therapists. Some participants will also be asked to wear the device while performing their usual daily activities for a period of 12 weeks.
The trial design and set up has been supported by the Sheffield Stroke and Aphasia Interest Group, who will continue to be involved throughout the running of the trial. It is also being supported by the NIHR Sheffield Biomedical Research Centre.
