The Liverpool-ed trial will recruit 300 participants aged five and above from epilepsy surgery centres across the UK.
University of Liverpool researchers have begun work on a £2.7 million National Institute for Health and Care Research (NIHR)-funded trial looking at the long-term effectiveness of vagus nerve stimulation (VNS) in people with drug-resistant epilepsy.
VNS, a treatment involving a small implanted device that sends electrical impulses to the brain via the vagus nerve, offers an alternative for people for whom surgery is not appropriate or has failed. Though VNS is approved for use in the NHS, its long-term clinical and cost effectiveness remains uncertain, particularly for children and individuals with intellectual disabilities, who represent half of all VNS recipients.
The seven-year VNS-ALERT trial will recruit 300 participants aged five and above from epilepsy surgery centres across the UK. Participants will be randomly assigned to receive VNS activated immediately, after six months, or after twelve months. The trial’s primary outcome will be the number of seizure-free days experienced by participants, with other outcomes including quality of life, seizure severity, adverse effects, mortality, and cost-effectiveness.
“This landmark trial will provide much-needed evidence on whether VNS is a truly effective and cost-efficient treatment for people living with drug-resistant epilepsy,” said Tony Marson, professor of neurology at the University of Liverpool, who is leading the project.
Public contributors
Epilepsy affects more than 600,000 people in the UK. For around a third of these individuals, medication is not effective, leading to drug-resistant epilepsy, which is a condition that can significantly impair quality of life and increase the risk of premature death. While brain surgery is an option, it is only suitable for a limited number of people and has variable long-term outcomes.
Patient and public involvement has been central to the design and development of the trial. The project was co-designed with a public co-applicant with lived experience of epilepsy, alongside contributions from the Epilepsy Research Institute and the Shape Network – the UK’s largest community of people affected by epilepsy. Early feedback from surveys and workshops directly informed trial design, including the decision to use a staggered activation model to ensure all participants receive a VNS device.
Throughout the trial, public contributors will remain actively involved through advisory groups and representation on the project’s steering committee. A qualitative sub-study will also explore participants’ experiences, helping researchers ensure the trial remains inclusive and responsive to the needs of those taking part.
The trial will be delivered by Liverpool Clinical Trials Centre. Other collaborators include the Walton Centre NHS Foundation Trust, North Bristol NHS Trust, Bangor University, University Hospital of Wales, University of Plymouth, Oxford University Hospitals NHS Foundation Trust, the University of Sheffield and Newcastle University.
