A multi-center trial is underway in the UK to assess a novel device designed to improve arm strength in stroke survivors. The TRICEPS trial, led by the University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust, is evaluating a portable, non-invasive device that delivers electrical pulses to the brain via a connected earpiece, targeting the vagus nerve.
Addressing Post-Stroke Arm Weakness
Stroke is a significant health concern in the UK, with approximately 110,000 people experiencing a stroke each year. A substantial number of survivors, over 36,500 annually, are left with permanent arm weakness, impacting their ability to perform everyday tasks and significantly reducing their independence. The TRICEPS trial aims to address this unmet need by exploring a new approach to rehabilitation.
The TRICEPS Trial: Design and Intervention
The TRICEPS trial, funded by the Medical Research Council, the National Institute for Health and Care Research partnership, the Stroke Association, and the Association of British Neurologists, commenced in November 2023 and plans to enroll around 240 patients across 19 centers in England and Wales. Participants include individuals who experienced a stroke between six months and ten years prior to enrollment.
The intervention involves stimulating the vagus nerve using a wearable device connected to an earpiece. This earpiece delivers a gentle electrical current to the nerve in the ear, with the aim of improving the transmission of nerve signals from the brain to the arm, thereby facilitating movement. Patients are also prescribed exercises to perform at home, and their progress is monitored remotely via video calls every two weeks.
Early Patient Experiences
Phil Herbert, a participant in the TRICEPS trial who experienced a stroke three years ago, reported noticing a difference in his arm movement. He stated that he had "more movement" to open and close kitchen cupboards. While he still cannot use his fingers to hold a pen or type, he hopes that the trial will improve his finger function.
Expert Perspectives
Professor Arshad Majid, a Consultant Neurologist at the Royal Hallamshire Hospital and professor of neurology at the University of Sheffield, who is leading the trial, emphasized the impact of arm weakness on stroke survivors' lives. He highlighted the non-invasive nature of the treatment and the convenience of at-home therapy as key advantages of the approach.
Mechanism of Action and Previous Findings
Previous studies suggest that stimulating the vagus nerve while the patient attempts to move their affected arm can restore electrical signals and reduce arm weakness. The TRICEPS trial seeks to further validate these findings and establish the efficacy of this novel intervention in a larger patient population.
