RecruitingNot ApplicableInterventional

Vagus nerve stimulation for epilepsy in children and adults: assessment of longer term clinical and cost effectiveness in a randomised controlled trial

This important study is investigating Vagus Nerve Stimulation (VNS) for people with epilepsy that hasn't fully improved with medication. This type of epilepsy is sometimes called 'drug-resistant epilepsy.' Many people in the UK live with this, and treatments like brain surgery aren't always an option or effective in the long run. VNS involves a small device, similar to a pacemaker, that's placed under the skin and connected to a nerve in the neck. While VNS is already approved, we don't fully know how well it works over many years, or if it's especially helpful for certain groups, like children or adults with learning difficulties. This research aims to find out if VNS offers lasting benefits for these individuals.

At a glance

Status

Recruiting

Phase

Not Applicable

Sponsor

University of Liverpool

Enrolment target

300

Start

01 May 2026

Estimated completion

01 May 2030

Epilepsy

What is this study about?

Around 600,000 people in the UK have epilepsy. For about a third of these individuals, epilepsy medicines don't fully control their seizures. This is known as 'drug-resistant epilepsy' and it can significantly affect their daily lives and even reduce how long they live. While some people might be helped by brain surgery to remove the area causing seizures, this isn't always possible or effective for everyone in the long term.

Another treatment option available is Vagus Nerve Stimulation (VNS). This involves a minor surgical procedure to place a small battery device, similar to a heart pacemaker, under the skin in the upper chest. Thin wires then connect this device to a special nerve in the neck called the 'vagus nerve,' which sends signals to the brain to help control seizures. Even though VNS is already approved for drug-resistant epilepsy, we don't fully understand its long-term effects, or which people might benefit the most. For example, we aren't sure how well it works for children or adults who also have learning difficulties, who make up a large portion of people receiving VNS through the NHS.

This study has an important goal: to discover if VNS can provide both short-term and long-term benefits for people with drug-resistant epilepsy. This includes those with intellectual disabilities, helping us understand if VNS is a good and lasting choice for many more people.

Key takeaways

This study is for children (over 5) and adults with epilepsy that hasn't responded to medicines.
It aims to find out how well Vagus Nerve Stimulation (VNS) works in the long term.
Participants will be randomly assigned to have VNS activated at different times.
The study wants to know if VNS helps people with learning difficulties too.
It's about finding better ways to manage severe epilepsy for future patients.

Who may be eligible?

The study is looking for people who are aged 5 years or older and have epilepsy that hasn't responded well to usual medicines. This is often called 'drug-resistant epilepsy.'

Before inviting you, a team of epilepsy specialists at the hospital will need to agree that VNS is a suitable treatment option for your epilepsy. You (or your carer, if you're a child) should also be able to understand the study documents in English.

You cannot join the study if you have already had VNS treatment before, or if there's a medical reason why VNS wouldn't be safe or right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 5 years old or older?
Do you have epilepsy that isn't fully controlled by medication?
Has your epilepsy team discussed VNS as a possible treatment for you?
Can you understand information about the study in English?
Have you *not* had Vagus Nerve Stimulation (VNS) before?

Answer every question to see your result.

What does participation involve?

If you are identified as potentially suitable for VNS by your epilepsy team, you might be invited to join this study. If you agree, you would then be randomly assigned to one of three groups. This means it's decided by chance, like flipping a coin.

One group will have their VNS device switched on straight away. Another group will have their VNS device switched on after 6 months. The third group will have their VNS device switched on after 12 months. This allows us to compare the effects of VNS over time.

During the study, you would need to keep track of your seizures and answer questions about your health and how you're feeling. This helps the researchers understand the effects of the treatment. The study will follow participants for a minimum of two years after joining, with some involved for even longer.

Potential risks and benefits

The main benefit of taking part is that the information gathered will help future patients with epilepsy. You might personally benefit from VNS if it helps control your seizures. Possible downsides include having to wait for your VNS device to be switched on if you are in one of the delayed activation groups. You'll also need to regularly record your seizures and answer questionnaires, which takes time. VNS can sometimes cause mild side effects like a hoarse or croaky voice. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (11)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Walton Centre NHS Foundation Trust
Unverified
Liverpool, England
North Bristol NHS Trust
Unverified
Bristol, England
Nottingham University Hospitals NHS Trust
Unverified
Nottingham, England
Lothian
Unverified
City of Edinburgh, Scotland
Great Ormond Street Hospital for Children NHS Foundation Trust
Unverified
London, England
Greater Glasgow and Clyde
Unverified
Glasgow, Scotland
Northern Care Alliance NHS Foundation Trust
Unverified
Salford, England
Oxford University Hospitals NHS Foundation Trust
Unverified
Oxford, England
Leeds Teaching Hospitals NHS Trust
Unverified
Leeds, England
Cardiff & Vale University Lhb
Unverified
Cardiff, Wales
University Hospital Southampton NHS Foundation Trust
Unverified
Southampton, England

Common questions

What does 'randomised' mean?

It means you'll be assigned to a treatment group by chance, like drawing numbers from a hat. This ensures the study is fair.

What is 'Vagus Nerve Stimulation'?

It's a treatment where a small device, like a pacemaker, is placed under your skin and sends gentle pulses to a nerve in your neck to help control seizures.

Will I definitely get VNS straight away?

Not necessarily. If you join, you might be in a group that has the VNS switched on immediately, or after 6 months, or after 12 months.

Who is paying for this study?

The study is being funded by the NIHR Health Technology Assessment Programme, which is part of the UK National Institute for Health and Care Research.

How long will I be involved in the study?

If you take part, you will be followed for at least two years, with some participants involved for longer.

How to find out more

Stephanie Willshaw

vnstrial@liverpool.ac.uk +44 151 794 9766 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.