CompletedNot ApplicableInterventional

A trial investigating the effectiveness of vagus nerve stimulation during rehabilitation therapy in patients with a weak arm following a stroke

Many people have lasting arm weakness after a stroke, which can make everyday activities like dressing or making a cup of tea difficult. Physical therapy helps, but recovery can slow down once standard hospital treatment ends. This study is testing a treatment called transcutaneous vagus nerve stimulation (tVNS). The vagus nerve connects to areas of the brain involved in movement. Participants wear a small, gentle stimulation device on their outer ear while doing tailored arm exercises at home for an hour a day, five days a week, over 12 weeks. Half of the participants receive active stimulation and half receive very low stimulation (a dummy treatment) to compare the results fairly. The trial is open to UK adults who had an ischaemic stroke between six months and ten years ago, aiming to discover if this home-based device can help people regain arm independence.

At a glance

Status

Completed

Phase

Not Applicable

Sponsor

Sheffield Teaching Hospitals NHS Foundation Trust

Enrolment target

243

Start

01 Oct 2023

Estimated completion

31 Jul 2026

Stroke

What is this study about?

Every year, thousands of people in the UK have a stroke. Around one in three survivors are left with ongoing weakness in their arm or hand. Standard rehabilitation helps in the early stages, but improvements often reach a plateau once therapy finishes. Researchers are looking for safe, effective ways to help people continue regaining arm movement long after their stroke.

This trial investigates whether gentle nerve stimulation can boost the benefits of arm exercises. It targets the vagus nerve, which runs from the brain down through the body and has small branches in the outer ear. Scientists believe that stimulating this nerve while moving the weak arm encourages the brain to build new pathways—a process known as neuroplasticity. While past trials required a small surgical implant, this study tests a lightweight earpiece that works safely through the skin at home.

Taking place across around 15 stroke centres in the UK, the study aims to show whether pairing this wearable device with daily tasks can create real, lasting improvements in arm function. A smaller group of participants will also have brain scans to show how nerve stimulation changes brain activity. If successful, this approach could offer an accessible, home-based treatment to help stroke survivors regain independence.

Key takeaways

Tests a simple, non-invasive earpiece device paired with home arm exercises.
Open to adults who had an ischaemic stroke between 6 months and 10 years ago.
Involves 1 hour of tailored exercises per day, 5 days a week, for 12 weeks.
Requires attendance at a minimum of three hospital check-ups over 6 months.
Aims to help the brain build new connections and improve daily arm function.

Who may be eligible?

This trial is open to adults aged 18 and over who had an ischaemic stroke (a stroke caused by a blood clot) between six months and ten years ago. You must have moderate to severe arm weakness, but you still need a small amount of movement in your wrist and fingers—such as being able to lift your wrist and straighten your fingers slightly. You should not be currently having active therapy for your arm, as researchers need to see the clear effect of this specific programme.

The study is not suitable for everyone. People who have had a haemorrhagic stroke (caused by a bleed in the brain) cannot take part. You also cannot join if you have very severe muscle stiffness (spasticity), other severe arm issues like a frozen shoulder, or health conditions that make it difficult to follow an exercise programme.

Because the device uses mild electrical pulses, you cannot take part if you have a pacemaker, a cochlear implant, or any other implanted electrical device. The trial is also not suitable for anyone who is pregnant or planning to become pregnant.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I had a stroke caused by a blood clot between 6 months and 10 years ago.
I have weak arm movement but can still move my wrist and fingers a little.
I am not currently doing regular NHS physiotherapy or arm rehabilitation.
I do not have a pacemaker, cochlear implant, or other electrical implant.
I am not pregnant and not planning to become pregnant.

Answer every question to see your result.

What does participation involve?

Taking part in the study lasts around six months in total. You will first attend a hospital appointment to check that the trial is safe and suitable for you. If you take part, a therapist will design a 12-week home exercise programme tailored to your abilities, including simple tasks like turning cards, opening containers, or grasping objects.

You will be asked to wear the earpiece device while doing these exercises at home for one hour a day, five days a week, for 12 weeks. A computer randomly decides whether your device delivers active stimulation or a very low, inactive level (a 'sham' control). You will attend at least three face-to-face hospital visits: at the start, at 3 months, and at 6 months, so researchers can check your arm progress. A small number of volunteers will also be invited to have optional brain scans.

Potential risks and benefits

Potential benefits include receiving a structured 12-week arm exercise plan and helping researchers discover better treatments for stroke recovery, though direct improvements to your arm cannot be guaranteed. The stimulation device is considered very safe. Minor side effects may include mild skin redness or irritation where the earpiece touches the skin (in about 15% of people), mild headaches (fewer than 5%), or brief dizziness, sore throat, or feeling sick (fewer than 2%). The main commitment is the time required for daily home exercises and hospital check-ups. Taking part is completely voluntary, and you are free to stop at any time without it affecting your standard NHS care.

Locations (21)

Royal Hallamshire Hospital
Approximate
Sheffield, England
John Radcliffe Hospital
Approximate
Oxford, England
Pulross Community Centre
City only
London, England
Melbourne Centre Surgery
City only
Leicester, England
Doncaster Royal Infirmary
Approximate
Doncaster, England
Montagu Hospital
Unverified
Mexborough, England
Bodmin Hospital
Unverified
Bodmin, England
Heart of Hounslow Centre for Health
Unverified
Hounslow, England
St Mary's Hospital
Unverified
Leeds, England
Aintree Hospital
Unverified
Fazakerley, England
Moseley Hall Hospital
Unverified
Birmingham, England
St Lukes Hospital
Unverified
Bradford, England

Common questions

Does the earpiece hurt?

No, it should not be painful. Most people describe it as a gentle tingling or prickling sensation on the ear.

Do I need an operation to fit the device?

No. The device sits comfortably on the outside of your ear like a headphone and does not require any surgery.

Can I choose to have the active stimulation instead of the dummy version?

No. A computer randomly assigns participants to ensure the study remains fair, unbiased, and scientifically accurate.

What happens if I find the exercises too difficult?

The exercises are tailored by a therapist to match your current ability, and the study team will support you throughout.

Do I have to pay to take part in this trial?

No, taking part is free. Many NHS trial centres also provide help with travel expenses for your hospital appointments.

How to find out more

Kirsty McKendrick

kirsty.mckendrick@sheffield.ac.uk +44 (0)114 222 4308 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.