ABOUT The trial

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.

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.

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. 

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.