The TRICEPS trial
The TRICEPS (TRanscutaneous lImb reCovEry Post-Stroke) trial investigates whether arm recovery after a stroke can be improved with a treatment called Transcutaneous Vagus Nerve Stimulation (TVNS).
Background
Over 15 million people experience a stroke worldwide annually. One-third are left with permanent weakness of their arm causing difficulties with daily activities. While rehabilitation does help post-stroke, the benefits are modest.
In a recent ground-breaking clinical trial, electrically stimulating a nerve called the vagus nerve (VN) while the participants moved their weak arm (in rehabilitation therapy) resulted in better arm recovery compared with rehabilitation therapy alone. However, the electrical stimulator was surgically implanted under a general anaesthetic and the VN stimulation was triggered by a therapist, and treatment was delivered in a hospital. Consequently, the uptake of this therapy may be limited.
The trial
TRICEPS is an innovative double-blinded, randomised, controlled, three-arm two-stage, adaptive trial.
The trial aims to determine whether the effects of rehabilitation therapy for arm recovery after stroke can be enhanced with a treatment called Transcutaneous Vagus Nerve Stimulation (TVNS). TVNS is a non-invasive way of stimulating the VN which does not involve either surgery or anaesthesia. The VN has a branch that goes to the ear which can be stimulated through the skin, using a small earpiece.
Participants will be randomised to receive self-delivered rehabilitation therapy and TVNS or self-delivered rehabilitation therapy and sham TVNS. In some cases, participants will also undertake activities of daily living (ADLs). Participants will be blinded to which treatment they receive.
Central study staff
| Name | Role | Organisation | Contact |
|---|---|---|---|
| Professor Arshad Majid | Chief Investigator | 91̽»¨ | arshad.majid@sheffield.ac.uk |
| Kirsty McKendrick | Trial Manager | 91̽»¨ | kirsty.mckendrick@sheffield.ac.uk |
| Shamila Ditta | Research Assistant | 91̽»¨ | s.ditta@sheffield.ac.uk |
| Kate Duffy | Research Assistant | 91̽»¨ | k.duffy@sheffield.ac.uk |
| Professor Cindy Cooper | CTRU Oversight | 91̽»¨ | c.l.cooper@sheffield.ac.uk |
| Katie Biggs | CTRU Oversight | 91̽»¨ | c.e.biggs@sheffield.ac.uk |
| Jasmine Allender | Trial Support Office | 91̽»¨ | j.allender@sheffield.ac.uk |
Co-applicants
| Name | Position | Organisation |
|---|---|---|
| Professor Cindy Cooper | Professor and Director of CTRU | 91̽»¨ |
| Dr Ali Ali | Academic Consultant Geriatrician | 91̽»¨ |
| Kaite Biggs | Assistant Director, CTRU | 91̽»¨ |
| Professor Jesse Dawson | Professor | University of Glasgow |
| Professor Avril Drummond | Professor | The University of Nottingham |
| Dr Munya Dimairo | Senior Research Fellow | 91̽»¨ |
| Dr Jessica Redgrave | Academic Consultant | 91̽»¨ |
| Mr Alex Roussel | PPI Representative | PPI representative based in England |
| Professor Li Su | Professor | 91̽»¨ |