ABOUT The trial
What is our research about?
Every year over 15 million people have a stroke worldwide. Many stroke survivors are left with arm weakness which can make daily activities difficult. Although rehabilitation therapy does help after a stroke, the benefits are small.
However, research has shown that stimulating a nerve called the vagus nerve whilst moving the weak arm may help to improve arm recovery. In this research the stimulator was surgically implanted. Patients had to go into hospital for a therapist to trigger the stimulation of the vagus nerve.
In the TRICEPS study we will stimulate the vagus nerve through the ear using a small earpiece. This means that no surgery is needed. This is called Transcutaneous Vagus Nerve Stimulation or TVNS. Patients will be able to trigger the stimulation themselves, at home.
This study aims to find out whether TVNS paired with rehabilitation therapy can improve arm function in patients with arm weakness after a stroke.
In a sub-study, we will also assess if TVNS produces changes in the brain by doing MRI scans and, in some cases, PET scans.
Who is carrying out the research?
This study is being led and sponsored by the Sheffield Teaching Hospitals NHS Foundation Trust.
We will recruit 243 people from 15 stroke centres in the UK.
The study is being managed by the Clinical Trials Research Unit at the University of Sheffield.
The study is funded by the National Institute for Health Research (NIHR) Efficacy and Mechanism Evaluation (EME) Programme.
Who can take part?
Patients who are 18 years old and over.
Patients who have arm weakness following a stroke between 6 months to 10 years ago.
Patients who are no longer undergoing active rehabilitation therapy.
Take a look at the full eligibility criteria for further information.
What does taking part in the study involve?
Screening and enrolment
If you are interested in taking part in the study, you will be given a Participant Information Sheet. You will be invited to complete a telephone screening interview with a member of the research team. This is to ensure you meet the initial eligibility criteria.
If you meet the screening criteria and wish to continue, you will be invited to a face-to-face enrolment appointment. Here, you will be asked to sign a consent form and we will confirm eligibility by completing some tests with you.
This will involve going through some screening assessments (e.g., a review of your medical history and a physical examination). The research team will go through some questionnaires and a physical assessment of sensation, motor, and joint functioning. This is called the Upper Limb Fugl Meyer (ULFM) assessment.
This appointment will last approximately 2 hours.
If the assessments confirm you are eligible, you will be randomly allocated to receive either sham TVNS (very low stimulation) or active TVNS (a higher stimulation).
The research team will teach you how to use the TVNS device at your enrolment appointment.
Using the TVNS device
You 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 you. It will be completed at home, and includes repetitive tasks such as turning cards, moving objects, opening, and closing bottles.
Some patients will also be asked to wear the TVNS device whilst undertaking their daily activities, such as cooking.
A member of the clinical research team will organise phone or video calls with you throughout your 12-week treatment period.
These calls will focus on your rehabilitation therapy, if there are any issues with your TVNS device and to check if you are experiencing any side effects from the treatment.
If you would prefer, these may be completed face-to-face at the research facility.
Follow-up appointments
You will be followed up at a face-to-face appointment at 3 and 6 months after starting treatment.
During follow-up, you will be asked by a member of the research team to repeat similar physical assessments and questionnaires that were completed at your first appointment.
These appointments will last approximately 1-2 hours each.
At the end of the study, we will compare the tests at baseline, 3 months and 6 months to see if there are any differences in the results between timepoints.
What are the possible benefits of taking part?
By taking part in this study you will be:
Helping to inform the future evidence base of interventions for patients with arm weakness after stroke.
Given a specialised 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 patients who may not be receiving any other therapy for their arm weakness.
What are the possible risks of taking part?
The TVNS device is usually well tolerated but previous studies have found some side effects:
Less than 15 in 100 people have mild skin irritation from the ear clip.
Less than 5 in 100 people have headaches.
Less than 2 in 100 people have dizziness, sore throat and nausea.
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 patients.
Some patients may find taking part in the study time-consuming. You will need to attend at least 3 face-to-face appointments, in addition to the 12-week treatment period completed at home.