An innovative nerve stimulation therapy will be delivered to stroke survivors via a portable, pacemake device created by researchers at Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield.
The cost effective device works without the need for surgical implants and could play a major role in improving arm recovery after stroke.
The treatment delivers electrical pulses to the brain via a portable, pacemaker-like device while rehabilitation therapy is being carried out.
The trial is being 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).
The £2m trial, called Triceps, 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.
The group leading the trial claim that this is the first to investigate a treatment known as transcutaneous (through the skin) vagus nerve stimulation and that this 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.
In Triceps, the stimulation will be triggered via a lightweight, wearable pacemaker-like device which connects to a wired earpiece.
The stimulation will then be automatically activated as the arm is moved during therapy while the connected earpiece gently tickles the ear, meaning participants can access the treatment at home 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.
Participants will be asked to wear the device
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.
