Innovative research in Greater Manchester is investigating if a portable, pacemaker-like device could significantly improve life for the more than 36,500 people in the UK every year left with permanent arm weakness after a stroke.

In Manchester, the TRICEPS study is being led by researchers from Manchester Local Care Organisation’s South Manchester Community Stroke Team, part of Manchester University NHS Foundation Trust (MFT).

Annually around 110,000 people in the UK will have a stroke – a serious life-threatening medical condition that happens when the blood supply to part of the brain is cut off. One third of stroke survivors are left with permanent arm weakness which can make daily activities difficult.

The TRICEPS study is funded by a partnership between the Medical Research Council (MRC) and the National Institute for Health and Care Research (NIHR). It will build on the results of an earlier clinical trial. Previous research showed that stimulating damaged areas of the brain through a key nerve in the body, known as the vagus nerve, improved arm recovery in stroke survivors when combined with stroke therapy – more than through therapy alone. Researchers hope that the portable, transcutaneous vagus nerve stimulation (TVNS) device, which stimulates the vagus nerve through the skin – avoiding the need for surgery, will mean larger numbers of stroke patients could benefit from this treatment.

Stephen’s Story

Stephen Hewitt, 54, is the first participant in the North West recruited to the TRICEPS study. After having a stroke in April 2022, Stephen was unable to walk for approximately eight months. The left side of his body was paralysed for weeks, and two years later he still has limited control of his left arm. Other after-effects of the stroke have meant that Stephen has speech therapy, which is how he learnt about the TRICEPS study. Although he is currently unable to work, he hopes to be able to do so in the future.

Stephen, a former telecommunications Strategy Manager in who lives in Baguley, South Manchester said: “It’s easy to take for granted just how much we use both arms in everyday life. I had more than 50 years of passing things to my left hand without a second thought, but now when I do so things end up on the floor – I’ve lost a lot of cups and saucers that way. I have had to learn to adapt, just to carry out ordinary activities, so any improvement to mobility in my left arm will make a huge difference.

“I may have slightly selfish reasons for hoping this treatment works, but I believe any research that can help find new ways to treat or expand knowledge around stroke is important. If by taking part in this study I could be helping all stroke survivors now, or in the future, I want to do so.”

In the TRICEPS study, TVNS is triggered via a lightweight, wearable device which connects to a wired earpiece. The stimulation is automatically activated as the arm is moved during therapy and for the user, feels like a gentle tickle to the ear.

South Manchester Community Stroke Team’s, Leanne Calcutt, Specialist Stroke Physiotherapist, who is leading the study at MFT, and Fatema Mullamitha, Team Lead, visited Stephen at home to fit and explain how to use the device, with a follow-up visit three months later. Stephen will have a further follow-up appointment at six months.

The South Manchester Community Stroke Team is part of Manchester Local Care Organisation which provides NHS community services for adults and children across the city, with expert care and treatment for a wide range of conditions at home or close to home.

Leanne Calcutt said: “We are delighted to be bringing this exciting study to Manchester. Working with stroke survivors, we can see how much it means to them to regain any pre-stroke levels of strength and mobility and a sense of how that can have a significant impact on their quality of life.

“By conducting this research, we aim to learn if this is an effective approach in improving recovery after stroke that can be rolled out at scale to large numbers of patients.”

Participants will wear the device for an hour, five times a week as they carry out their stroke rehabilitation exercises at home with the support of community physiotherapists and occupational therapists.

Stephen added: “It’s great that this new treatment involves something mobile phone-sized that you just connect to your ear using a small earpiece, is very portable and is non-invasive. For me, being able to avoid surgery is a huge step and could make this treatment accessible to more stroke survivors.”

Participants will be randomised to receive self-delivered rehabilitation therapy and TVNS or self-delivered rehabilitation therapy and ‘sham’ TVNS (which produces only very low stimulation). Participants and researchers will not know which treatment they are receiving.

Up to 243 patients from 15 UK stroke centres are set to be enrolled into the “TRanscutaneous lImb reCovEry Post-Stroke (TRICEPS)*” study over the next two years. TRICEPS is led by Sheffield Teaching Hospitals NHS Foundation Trust.

More information about the study is available on the TRICEPS study website.