VNS-ALERT

• Research type

  Research Study

• Full title

  Vagus Nerve Stimulation for epilepsy in children and adults: Assessment of Longer term clinical and cost Effectiveness in a Randomised controlled Trial

• IRAS ID

  346186

• Contact name

  Anthony Marson

• Contact email

  A.G.Marson@liverpool.ac.uk

• Sponsor organisation

  University of Liverpool

• Duration of Study in the UK

  6 years, 11 months, 31 days

• Research summary

  Over 600,000 people in the UK have epilepsy. For a third, medication is ineffective,
  resulting in ‘drug-resistant epilepsy’, which can severely impact quality of life and reduce life expectancy.
  Brain surgery can help some with drug-resistant epilepsy by removing the problematic brain area, but identifying this area is not always possible, and surgery is only effective for 50-60% in the long term.
  Another possible treatment is vagus nerve stimulation (VNS). This involves implanting a battery under the skin on the upper chest (like a pace maker) and connecting it to the vagus nerve in the neck.
  Although VNS is approved for drug-resistant epilepsy, its long-term effectiveness and who it works for is not known. For example, we do not know how well it works for children or adults with epilepsy and intellectual disabilities, who make up half of NHS VNS recipients.
  Our project aims to find out if VNS provides long-term benefits for people with drug-resistant epilepsy, including those with intellectual disabilities.

  We will recruit 300 participants from epilepsy surgery centres over four years,
  following them for an additional two years. Participants will be over 5 years old with treatment-resistant epilepsy. Participants will all receive the VNS device as per usual treatment pathways. Participants will be randomised to either:
  - Immediate VNS activation
  - VNS activation after 6 months
  - VNS activation after 12 months

  Other than delayed VNS activation, participants will follow the normal care pathway and be followed up at regular six monthly clinics until the trial end to assess seizure frequency. Seizure severity and quality of life will be reviewed at all 6 monthly visits until 24 months, and then annually until the end of the trial.

  Study within a trial: We will interview participants and carers to understand their experience of taking part and of VNS in general.

• REC name

  Yorkshire & The Humber - Leeds West Research Ethics Committee

• REC reference

  26/YH/0012

• Date of REC Opinion

  30 Mar 2026

• REC opinion

  Further Information Favourable Opinion