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 | СŷÊÓƵ | arshad.majid@sheffield.ac.uk |
| Kirsty McKendrick | Trial Manager | СŷÊÓƵ | kirsty.mckendrick@sheffield.ac.uk |
| Shamila Ditta | Research Assistant | СŷÊÓƵ | s.ditta@sheffield.ac.uk |
| Kate Duffy | Research Assistant | СŷÊÓƵ | k.duffy@sheffield.ac.uk |
| Professor Cindy Cooper | CTRU Oversight | СŷÊÓƵ | c.l.cooper@sheffield.ac.uk |
| Katie Biggs | CTRU Oversight | СŷÊÓƵ | c.e.biggs@sheffield.ac.uk |
| Jasmine Allender | Trial Support Office | СŷÊÓƵ | j.allender@sheffield.ac.uk |
Co-applicants
| Name | Position | Organisation |
|---|---|---|
| Professor Cindy Cooper | Professor and Director of CTRU | СŷÊÓƵ |
| Dr Ali Ali | Academic Consultant Geriatrician | СŷÊÓƵ |
| Kaite Biggs | Assistant Director, CTRU | СŷÊÓƵ |
| Professor Jesse Dawson | Professor | СŷÊÓƵ of Glasgow |
| Professor Avril Drummond | Professor | The СŷÊÓƵ of Nottingham |
| Dr Munya Dimairo | Senior Research Fellow | СŷÊÓƵ |
| Dr Jessica Redgrave | Academic Consultant | СŷÊÓƵ |
| Mr Alex Roussel | PPI Representative | PPI representative based in England |
| Professor Li Su | Professor | СŷÊÓƵ |