The Epilepsy Research Institute’s Shape Network – the UK’s largest community of research-interested people affected by epilepsy – has played a pivotal role in shaping a major new £2.7 million trial investigating the long-term effectiveness of vagus nerve stimulation (VNS) for drug-resistant epilepsy.
Funded by the National Institute for Health and Care Research (NIHR), the seven-year project, Vagus Nerve Stimulation for epilepsy in children and adults: Assessment of Longer term clinical and cost Effectiveness in a Randomised controlled Trial (VNS-ALERT), is led by Institute trustee Tony Marson, who is also professor of neurology at the University of Liverpool.
Epilepsy affects over 600,000 people in the UK, and around a third live with drug-resistant epilepsy, where medication does not work. VNS – a treatment that involves implanting a device that sends mild electrical impulses to the brain – offers an alternative to brain surgery, but its long-term clinical and cost-effectiveness remains unclear, particularly for children and individuals with intellectual disabilities.
The trial will recruit 300 participants aged five and above from epilepsy surgery centres across the UK, with VNS activation staggered at immediate, six-month, or twelve-month intervals. The main outcome will be seizure-free days, alongside seizure severity, quality of life, adverse effects, mortality, and cost-effectiveness.
Professor Marson said:
“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. Crucially, we are including children and adults with intellectual disabilities – groups historically underrepresented in epilepsy research.”
The Shape Network directly influenced the trial design through surveys and workshops with people living with epilepsy. Their input shaped key decisions, including the staggered activation model ensuring all participants ultimately receive a VNS device. Public contributors, including a co-applicant with lived experience of epilepsy, will continue to play an active role through advisory groups and the project steering committee.
Professor Carrol Gamble added:
“We are excited to be collaborating with Professor Marson on this research which allows us to contribute our extensive expertise in neurological trials in adults and children. We look forward to answering this important clinical question to benefit patients and their families.”
The trial will be delivered by the Liverpool Clinical Trials Centre with partners across the UK, including 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.