29 October 2024
People who had a stroke less than ten years ago are being invited to take part in a groundbreaking trial investigating if a portable, pacemaker-like device could help them regain arm strength.
Researchers from Sheffield Teaching Hospitals NHS Foundation Trust and the University of Sheffield say the innovative TRICEPS trial, funded by the National Institute for Health and Care Research and the Medical Research Council, could transform the lives of those left with permanent arm weakness after a stroke.
Around 110,000 people suffer a stroke in the UK every year – with a third of survivors left with persisting arm weakness. This limits their ability to look after themselves. This can severely impact on quality of life, making it difficult for them to do simple tasks such as brushing their teeth, wheeling a supermarket trolley, cooking a meal or reaching shelves.
To mark World Stroke Day on Tuesday 29th October, the team are now urging local people to come forward and join the trial, which is running in NHS centres across the country, including in Sheffield, Bradford, Dorset, Doncaster, Leeds, Liverpool, London, and Manchester, and launched earlier this year.
The £2m trial uses a new treatment called transcutaneous (through the skin) vagus nerve stimulation (TVNS) to deliver mild electrical pulses to the brain to stimulate stroke-damaged areas of the brain.
Unlike a previous preliminary trial where the treatment was delivered through a surgical implant, in TRICEPS brain stimulation will instead be triggered via a lightweight, wearable pacemaker-like device which connects to a wired earpiece.
The stimulation will be automatically activated as the arm is moved during rehabilitation therapy as the connected earpiece gently tickles the ear, meaning people can access the treatment at home.
Professor Arshad Majid, Consultant Neurologist at Sheffield Teaching Hospitals NHS Foundation Trust and Professor of Cerebrovascular Neurology at the University of Sheffield, said:
“We're really excited to be leading this revolutionary trial, which could transform the lives of those left with permanent arm weakness after a stroke. TVNS has shown huge promise in a preliminary trial where the device was surgically implanted, but through this trial larger numbers of stroke survivors are set to benefit.
“Although strokes are more common in people aged 65 or over, they can happen to anyone, at any time. Human nervous tissue is rapidly lost as a stroke progresses, so if a stroke does happen, it’s important to ring 999 straight away to limit the damage to the brain and ensure life-saving treatments are given.
“This trial is open to people who had a stroke from 6 months up to 10 years ago, which is an incredible opportunity as there are not many rehabilitation studies so broad in their criteria.”
Patients will be randomly assigned to receive the TVNS treatment device or a dummy device. This will be given to them to wear at home for an hour, five times a week as they carry out their stroke rehabilitation exercises 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.
To find out more about the trial contact triceps@sheffield.ac.uk or visit the website at www.triceps-trial.com
The easiest way to recognise a stroke is the word FAST. This stands for: F = Face Drooping A = Arm Weakness S = Speech Difficulty T = Time to call 911.
ENDS