TRICEPS Trial Tests Home-Based Nerve Stimulation for Stroke Recovery

The TRICEPS trial is investigating whether a non-invasive nerve stimulation device, combined with rehabilitation, can improve arm and hand function in people who have experienced a stroke. The study is being conducted at multiple NHS centres in England and Wales and is led by research teams in Sheffield.

Participants use a device that delivers mild electrical pulses through a wired earpiece during home-based rehabilitation exercises. The device is worn for one hour, five days a week, over a 12-week period, with some participants also using it during daily activities.

The trial began enrolling participants in November 2023 and is structured as a multicentre, double-blinded, randomised, sham-controlled, multi-arm adaptive study. The original recruitment target was 243 participants, but this was increased to 270 after an interim independent analysis.

Eligibility criteria include adults aged 18 or older who have had an ischaemic stroke between six months and ten years ago, experience arm weakness, and are not currently receiving rehabilitation therapy. The study aims to assess whether the device, used alongside rehabilitation, can improve recovery outcomes for this group.

What the numbers show

• Recruitment began in November 2023
• Approximately 205 participants had joined by late October 2025
• The recruitment target was expanded from 243 to 270 participants

The trial is being carried out at 19 NHS sites, including locations in Sheffield, Leeds, Manchester, Liverpool, London, Bournemouth, and Sherborne. The main outcome being measured is the change in the Upper Limb Fugl-Meyer motor score at 91 days after the start of treatment. Secondary measures include the Wolf Motor Function Test, Modified Ashworth Scale, and the Stroke-Specific Quality of Life Scale.

A mechanistic substudy involving about 40 participants will examine changes in the brain using multimodal MRI and measure serum inflammatory cytokine levels. This substudy is designed to provide additional insights into the biological effects of the intervention.

The trial receives funding from a partnership between the Medical Research Council and the National Institute for Health and Care Research, with further support from the Stroke Association and the Association of British Neurologists. The University of Sheffield and Sheffield Teaching Hospitals NHS Foundation Trust are leading the research, with support from NIHR Sheffield Biomedical Research Centre and Clinical Research Facility.

According to a participant in Dorset, involvement in the study contributed to improved discipline with exercise and quality of life following a stroke. The trial continues to recruit participants across its network of NHS centres.

* This article is based on publicly available information at the time of writing.