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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Miss
Kirsty
McKendrick
+44 (0)114 222 4308
kirsty.mckendrick@sheffield.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
Stroke
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
You can take part if:
You may not be able to take part if:
1. Has significant other impairment of upper limb, e.g., frozen shoulder2. Has severe spasticity (Modified Ashworth score of ≥3)3. Has health conditions that prevent engagement with rehabilitation therapy, e.g., advanced dementia4. Has severe aphasia and either: a) informed consent unlikely based on consent support tool, b) engagement with RTT difficult, or c) inability to communicate adverse events from TVNS5. Currently participating in another stroke rehabilitation trial6. Pregnant or trying to get pregnant7. On a pacemaker or another implantable electrical device8. Has a cochlear implant or other similar device9. Currently receiving therapy or treatment to improve arm function and would not be willing to stop for the duration of the trial10. Has previously experienced a haemorrhagic stroke
For all participants entering the mechanistic sub-study only:1. Contraindications to Magnetic Resonance Imaging (MRI) (e.g., metal implant)2. Has previously experienced or is likely to suffer severe anxiety or claustrophobia in relation to MR imaging examination
Additional criteria for PET-MRI:1. Contraindications to Positron Emission Tomography (PET) (e.g., has a known allergy to FDG PET tracer)2. Has unstable diabetes
A full screening assessment will be conducted when the participant attends for the MRI to ensure the safety of the participant.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Miss
Kirsty
McKendrick
+44 (0)114 222 4308
kirsty.mckendrick@sheffield.ac.uk
More information about this study, what is involved and how to take part can be found on the study website.
The study is sponsored by Sheffield Teaching Hospitals NHS Foundation Trust and funded by National Institute for Health and Care Research; NIHR Evaluation, Trials and Studies Co-ordinating Centre (NETSCC); Grant Codes: NIHR133169.
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Or CPMS 53862
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
