Vagus Nerve Stimulation for epilepsy in children and adults: Assessment of Longer term clinical and cost Effectiveness in a Randomised controlled Trial
Epilepsy
Patients will be recruited in hospital a minimum of one month prior to their VNS implantation surgery to allow for initial seizure diary completion. To understand how effective VNS is, participants will be randomised to one of the following groups: 1. Immediate VNS activation 2. VNS activation after 6 months 3. VNS activation after 12 months Each delayed activation arm will be compared to the standard care immediate activation arm, with the null hypothesis that there is no difference in outcome between the treatments. A total of 150 participants will be allocated to immediate activation, with 75 participants allocated to each delayed activation arm. All participants in the trial will receive the best available standard care for any long-term symptoms they develop. A randomised controlled trial design has been chosen as it is the most reliable way to assess the effects of treatment. The design is pragmatic in order to allow treatment to be administered based on clinical need. The trial is not blinded as it is not feasible to blind site staff or patients to VNS device activation. Participants will mainly be recruited as part of standard epilepsy multi-disciplinary team MDT meetings where VNS implantation is discussed. Layered and proportionate participant information will be provided to allow an informed decision on participation. Once consent is obtained, demographic information and medical history will be collected, and participants will be provided with a seizure diary to collect seizure free days and seizure frequency for a minimum of one month prior to their VNS device implantation surgery. A randomisation visit will be arranged between 2 weeks and 24 hours prior to the participant’s VNS device implantation surgery. At this visit, details on anti-seizure medications will be collected and participants will complete questionnaires regarding their epilepsy, quality of life, and resource use. The site will randomise the participant to a trial arm, and partic
1. Aged greater than or equal to 5 years 2. Has treatment refractory focal, generalised, or unclassified epilepsy 3. Epilepsy surgery MDT agrees that VNS should be offered as a treatment for epilepsy 4. Patient (and/or carer) has a good enough understanding of the English language to read and understand study documents
1. Previous VNS 2. Contraindication to VNS