University of Sheffield (recruiting at 19 sites across the UK)
Keywords: Ischaemic stroke, Transcutaneous Vagus Nerve Stimulation (TVNS), arm weakness, rehabilitation exercises, stroke recovery
Open to: adult ischaemic stroke survivors
Deadline: 31 January 2025
How to Register: More information about the trial, including a short animated video is available on the trial website here www.triceps-trial.com
Further Details: If people have questions, want to find out more, or speak to a member of the team they can email us at triceps@sheffield.ac.uk
Research participation requests are sent to the Stroke Association from external research institutions (e.g. universities and hospitals).
We conduct checks on these before promoting but are not involved in their running. This means we cannot comment on trials and have no affiliation with them.
The TRICEPS trial is looking at whether Transcutaneous Vagus Nerve Stimulation (TVNS) whilst moving the weak arm, can improve arm recovery after a stroke. We are looking for people who;
- Had an ischaemic stroke between 6 months and 10 years ago and still have arm weakness
- Are aged 18+ years
- Are able and willing to take part in a research trial
- Do not have a pacemaker, cochlear implant or similar device
- Are not taking part in another stroke rehabilitation study
- Are not currently pregnant / trying to get pregnant
Participants will be put into a treatment group at random and either receive TVNS or sham TVNS (like a placebo).
Everyone will wear the device while doing rehabilitation therapy at home. Some participants will be asked to wear the TVNS device throughout the day, whilst doing usual daily activities.
Everyone will be invited to a follow up appointment after the 3 month treatment period and again a further 3 months later.
What is the opportunity about?
Many people have long term problems with their arm after stroke. It was recently shown that stimulating the vagus nerve during rehabilitation sessions led to better recovery of the arm than rehabilitation alone. That trial used an implanted stimulator, which required surgery, and the rehabilitation therapy was mostly delivered in hospital.
The TRICEPS trial aims to find out whether Transcutaneous Vagus Nerve Stimulation (TVNS) improves arm function after stroke when it is used alongside rehabilitation therapy over 12 weeks.
In this study we want to see if we can improve arm recovery by using a non-invasive stimulator which clips on to the ear and with the rehabilitation delivered at home. ‘Non-invasive’ means surgery is not needed. We want to assess this in the most thorough way so we will compare non-invasive vagus nerve stimulation with a sham that produces very low stimulation, like a placebo. Participants will not know which version they are receiving.
The results of this trial will provide important information about whether TVNS treatment whilst moving the weak arm can improve arm recovery after a stroke
More information, including and video explaining the trial is available on the trial website here www.triceps-trial.com.
What will it Involve?
Participation in the trial will last 6 months.
People interested in taking part will undergo an assessment of eligibility via a phone call (~10 minutes). Those potentially eligible will be invited to attend a face to face appointment in a clinical setting, such as a stroke centre or hospital, to take consent and fully assess eligibility. This will involve questionnaires and a physical assessment of their arm. Fully eligible participants will then be randomly assigned to a treatment group, be given a personalised therapy plan and be shown how to use the device. This appointment will last approximately 2½ hours.
The device will be taken home by the participant and used whilst carrying out the therapy exercises for 1-hour, 5 days a week, for 12 weeks. The therapy exercise plan will involve carrying out repetitive tasks such as turning cards, moving objects, opening, and closing bottles.
Some participants will, in addition, be asked to wear the device whilst doing their usual daily activities (between 1 and 8 hours, as chosen by the participant).
A member of the clinical research team will organise phone or video calls with participants throughout your 12-week treatment period.
Following the treatment period, participants will attend a face-to-face appointment where a member of the research team will repeat the questionnaires and assessments done at the first consent and eligibility appointment. These are repeated again 6 months after starting treatment.
Who can take part?
Participants are eligible if they;
- Are aged 18+ years
- Had an anterior circulation ischaemic stroke at least 6 months to10 years previously;
- Have moderate to severe arm weakness based on clinical assessment;
- Are able to participate in rehabilitation therapy and give informed consent
The following are exclusion criteria;
- Any other significant impairment of their affected arm e.g. frozen shoulder
- Severe spasticity
- Health conditions preventing engagement with rehabilitation exercises e.g. advanced dementia
- Severe aphasia
- Participating in other interventional stroke rehabilitation trial
- Pregnant or trying to become pregnant
- Have a pacemaker or other implantable device
- Has a cochlear implant or other similar device
- Currently receiving therapy or treatment to improve arm function and not willing to stop for durations of trial (6 months).
- Has previously had a haemorrhagic type of stroke.
What will you get from taking part?
Participants in the TRICEPS trial are contributing to improve medical knowledge and understanding about whether TVNS treatment, whilst moving the weak arm, can improve arm recovery following a stroke.
Participants in the active intervention arms will receive 12 weeks of TVNS therapy. All participants will receive a tailored therapy plan to self-deliver at home. This may be of value to some participants who may not be receiving any other therapy for their weak arm.
Participants can claim travel expenses for the initial consent and eligibility appointment and also the appointments carried out at 3 and 6 months after start of treatment.
How Can I Take Part?
More information about the trial, including a short animated video is available on the trial website here www.triceps-trial.com
If people have questions, want to find out more, or apeak to a member of the team they can email us at triceps@sheffield.ac.uk
_______________________________________________
Information on taking part in research
Research participation helps research teams to test new ideas and approaches by sharing information or trying new approaches in clinical trials.
Find out more about taking part in research
Taking part in clinical trials can support research to:
- Stop strokes from happening.
- Treat strokes.
- Support people to rebuild their lives.
By taking part in research, you can help us to learn more about stroke and make a difference in the lives of future stroke survivors.
Find out about how our research has made a difference in the lives of people affected by stroke.
We have produced the Clinical Trials and Stroke booklet to explain more about clinical trials and answer questions you might have about taking part. The booklet was produced with the NIHR Clinical Research Network.
_______________________________________________
Information on Research Involvement
Research Involvement is a different way of contributing to research that involves collaborating with researchers to design decisions about how research is shaped and conducted.
You do not need any research knowledge to do this, your lived experience is what would otherwise be missing. Involvement is about contributing this to shape projects in ways that create most potential to benefit people affected.