About the sub-study
What is the sub-study about?
We are conducting a mechanistic sub-study that explores whether TVNS alongside rehabilitation therapy produces changes in the brain. We will measure this using Magnetic Resonance Imaging (MRI).
The changes being investigated are:
brain plasticity
brain blood flow
energy use
A comparison will be made between participants using the TVNS device and participants using the sham TVNS device. We will look at whether changes in brain activity are linked to improvements in arm weakness in people who have had a stroke.
Who can take part in the sub-study?
The sub-study will only take place at Sheffield Teaching Hospitals. Therefore, only patients from Sheffield and nearby centres will be able to take part.
The sub-study will not be suitable for everyone so the trial team will discuss if it might be suitable for you when you attend your enrolment appointment for the main trial.
What does taking part in the sub-study involve?
The sub-study involves having two MRI scans. You will have an MRI scan at baseline and a follow-up scan about 3 months later, once you have finished your TVNS and therapy treatment.
Some participants may be asked if they would be happy to have a Positron Emission Tomography (PET) scan at the same time - this is called a PET-MRI scan. If you are invited to have a PET scan you can choose to have both the MRI and PET scan or just the MRI scan. If you had a PET scan at your first appointment, you will also have one at your follow-up appointment.
MRI and PET-MRI scans will last approximately 1 hour.
What will happen if I decide to take part in the sub-study?
If you are interested and potentially eligible, you will be given a sub-study Participant Information Sheet.
Eligibility will be confirmed and informed consent will be taken, which will confirm the scans that you agree to have.
We will then make an appointment for you to attend the MRI department at the Royal Hallamshire Hospital in Sheffield. Your MRI (and PET, if applicable) appointment must take place before you start your TVNS and therapy treatment.