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

Plain English Summary

Background and study aims
Over 15 million people suffer a stroke worldwide annually. One third are left with arm weakness causing difficulties with daily activities. Whilst rehabilitation therapy does help after stroke, the benefits are modest. In a recent trial, stimulating the vagus nerve (VN) while the participant moved their weak arm resulted in better arm recovery compared with therapy alone. However, the stimulator was surgically implanted, and the VNS was triggered by a therapist in hospital. In this study the VN will be stimulated in a non-invasive way at home. The VN will be stimulated through the skin via an earpiece using a TVNS device. This study aims to determine whether transcutaneous vagus nerve stimulation (TVNS) paired with rehabilitation therapy of the affected arm after stroke improves motor function in participants with arm weakness following a stroke. In a sub-study, the researchers will also assess if TVNS produces changes in the brain via fMRI and, in some cases, PET scans.

Who can participate?
Patients aged 18 years and over who have arm weakness following a stroke between 6 months to 10 years ago and are no longer undergoing active rehabilitation therapy

What does the study involve?
Participants will be randomly allocated to receive either sham TVNS (very low stimulation) or active TVNS. Some participants will also be asked to wear the TVNS device whilst undertaking activities of daily living. Participants will wear the TVNS device when completing the self-delivered rehabilitation therapy for 1 hour per day, 5 days per week for 12 weeks. The rehabilitation therapy plan will be tailored to each participant, completed at home, and includes repetitive tasks such as turning cards, moving objects, opening, and closing bottles. Participants will be followed up at a face-to-face appointment at 3 and 6 months after starting treatment. The follow-up appointments enable outcome assessments of the intervention.

What are the possible benefits and risks of participating?
By taking part in this study, participants will be directly helping to inform the future evidence base of interventions for people with arm weakness after stroke. Participants will be given a tailored 12-week rehabilitation therapy programme to do at home and a TVNS device to use for the duration. This may be of benefit to some participants who may not be receiving any other therapy for their arm weakness. The TVNS device is usually well tolerated but previous studies have found some side effects. These are mild skin irritation (in 15% of cases), headaches (less than 5% of cases), dizziness, sore throat and nausea (all in less than 2% of cases). The nerve that is stimulated in this study can affect the heart rhythm but there has been lots of research using this device in humans with no concerns about the safety of the participants. Some participants may find participation in the trial time-consuming as it will require attendance at a minimum of three face-to-face appointments, in addition to the 12-week treatment period completed at home.

Where is the study run from?
About 15 stroke centres across the UK will be taking part in the study and it will be managed by the Clinical Trials Research Unit at the University of Sheffield (UK)

When is the study starting and how long is it expected to run for?
February 2022 to January 2026

Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)

Who is the main contact?
Kirsty McKendrick, kirsty.mckendrick@sheffield.ac.uk, triceps@sheffield.ac.uk

Study website

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom
• Wales

Study participating centres

Sponsor information

Sheffield Teaching Hospitals NHS Foundation Trust
Hospital/treatment centre

Northern General Hospital
Herries Road
Sheffield
S5 7AU
England
United Kingdom

Phone	+44 (0)114 226 5941
Email	dipak.patel12@nhs.net
Website	http://www.sth.nhs.uk/
"ROR"	https://ror.org/018hjpz25

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

07/03/2025: The participant level data sharing statement was added.
22/01/2025: The following changes were made to the trial record:
1. The recruitment end date was changed from 31/01/2025 to 31/07/2025.
2. The overall end date was changed from 31/07/2025 to 31/01/2026.
3. The plain English summary was updated to reflect these changes.
03/10/2024: The following study participating centres were added: Pulross Centre, Brownley Green Health Centre, Northenden Health Centre, Swithland House, Doncaster Royal Infirmary, Montagu Hospital, Bodmin Hospital, Heart of Hounslow, Centre for Health, Community Neurological Rehabilitation Service, Aintree Hospital, Moseley Hall Hospital, St Luke’s Hospital, West Pottergate Medical Centre, Sunderland Royal Hospital, University Hospital Llandough, Royal London Hospital, Royal Bournemouth Hospital, Yeatman Hospital, King’s College Hospital, South Petherton Community Hospital, Royal Hallamshire Hospital.
05/09/2023: The following changes were made to the trial record:
1. The recruitment start date was changed from 01/09/2023 to 01/10/2023.
2. The contact was changed.
18/04/2023: The recruitment start date was changed from 01/04/2023 to 01/09/2023.
14/02/2023: The recruitment start date was changed from 01/02/2023 to 01/04/2023.
03/11/2022: Trial's existence confirmed by the NIHR.