RecruitingNAINTERVENTIONAL

The Children's Adaptive Deep Brain Stimulation for Epilepsy Trial

The CADET Trial is a study for children aged 5-14 who have a severe type of epilepsy called Lennox-Gastaut syndrome (LGS). It's trying to find out if a treatment called Deep Brain Stimulation (DBS) can help reduce how often these children have seizures. DBS involves gently stimulating certain parts of the brain using a small device. A new part of this research, called SMART-DBS, is looking at a more advanced way of using DBS. This part of the study involves children who have already received the DBS implant in a previous CADET study. They will be testing if this 'adaptive' DBS system, which adjusts itself, can work even better. The overall goal is to understand if this treatment is a safe and effective way to help children manage their epilepsy.

At a glance

Status

Recruiting

Phase

Sponsor

University College, London

Enrolment target

Start

24 Mar 2026

Estimated completion

31 Jan 2028

Lennox Gastaut Syndrome (LGS)

What is this study about?

The CADET Trial is a research study designed to help children aged 5 to 14 who live with a challenging type of epilepsy called Lennox-Gastaut syndrome (LGS). This condition often causes frequent and severe seizures. The study wants to see if a treatment called Deep Brain Stimulation (DBS) can help reduce the number of seizures these children experience. DBS involves a small device, placed during a surgical procedure, that sends gentle electrical pulses to specific areas of the brain to help control seizure activity.

This trial is looking at a specific DBS device that hasn't been widely used in the UK yet, to make sure it's safe and effective for children with LGS. All children taking part will have the device implanted. After a recovery period, some children will start receiving the stimulation right away, while others will have it switched off for a few weeks before it's turned on. This helps the researchers compare the results fairly and understand the treatment's true effect.

Linked to the main CADET Trial is a special additional study called SMART-DBS. This part of the research focuses on children who have already had the DBS device implanted through the CADET Trial or a previous phase of the study. SMART-DBS is investigating an advanced type of DBS that can 'adapt' itself, meaning it might learn and adjust to a child's specific seizure patterns. This could potentially lead to even better seizure control, and the researchers are keen to see if this newer approach is more effective.

Key takeaways

The CADET Trial is for children aged 5-14 with severe epilepsy (LGS).
It tests a brain implant (DBS) to see if it reduces seizures.
Children will have surgery for the implant, followed by a recovery phase.
Some children will have the device on sooner, others later, to compare results.
The SMART-DBS study checks a newer, adaptive version of the treatment for those who already have the implant.
Careful monitoring and stable medication are important throughout the study.

Who may be eligible?

This study is designed for children aged 5 to 14 years old who have been diagnosed with Lennox-Gastaut syndrome (LGS). To qualify, their LGS diagnosis needs to be confirmed by special brainwave tests (EEG) showing specific patterns, and they must have a history of 'drop seizures' (where they suddenly fall). They should also be experiencing at least 10 seizures every month and have tried at least two other epilepsy medications without them working well enough. It's important that they are currently taking stable doses of their usual epilepsy medications for at least four weeks before joining, and if they're on a special diet for epilepsy, that also needs to be stable.

There are also some reasons why a child might not be able to join. For example, if they have already had a different deep brain stimulation implant, or if they have another active device like a vagus nerve stimulator. Children with certain health issues that would make surgery risky, or with bleeding problems, or a nickel allergy, also can't take part. It's also important that their epilepsy medications or special diet haven't changed in the last few weeks or months. Finally, their brain scans must show that the DBS surgery can be done safely and effectively.

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.

Is your child between 5 and 14 years old?
Does your child have a diagnosis of Lennox-Gastaut syndrome (LGS) with drop seizures?
Does your child experience at least 10 seizures a month?
Have at least two epilepsy medicines not worked well for your child?
Are you able to keep your child's current medicines and special diet (if applicable) stable during the study?
Are you willing and able to help with study requirements, like seizure diaries and charging the device?

Answer every question to see your result.

What does participation involve?

If your child takes part, they will first go through a four-week period where their seizures are carefully monitored without any new treatment. Then, they will have surgery to place the small DBS device in their brain. After surgery, there will be another four-week recovery period. After this, your child will be randomly assigned to one of two groups: either their DBS device will be switched on straight away for 36 weeks, or it will be switched off for 12 weeks before being turned on for 24 weeks. This means the total time your child receives active treatment before the main results are looked at will be at least 24 weeks.

Throughout the study, you'll be asked to keep a diary of your child's seizures and ensure the device is charged if needed. Your child's usual epilepsy medications and any special diet (like a ketogenic diet) must remain stable throughout the study. There will be regular visits to the clinic for check-ups and assessments, where researchers will monitor your child's progress. The SMART-DBS part of the study is for children who have already gone through the main CADET Trial or a previous pilot study and already have an active DBS device; if eligible, you will be invited to consider this additional phase of the study.

Potential risks and benefits

Taking part in this study could potentially offer your child a new way to manage their seizures, especially if other treatments haven't worked well. While there are no guarantees, the hope is that the DBS device will help reduce how often your child has seizures and improve their quality of life. However, like any surgery, there are risks involved with placing the device, such as infection or bleeding. There's also the chance that the treatment might not work for your child. The study team will explain all potential risks in detail, and you will have the right to withdraw your child from the study at any time, for any reason, without it affecting their medical care.

Locations (1)

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

Great Ormond Street Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is Deep Brain Stimulation (DBS)?

DBS involves a small, implanted device that sends gentle electrical signals to specific areas of the brain to help control certain conditions, in this case, seizures.

What is Lennox-Gastaut syndrome (LGS)?

LGS is a severe type of epilepsy that typically begins in childhood and causes different kinds of seizures, often difficult to control with regular medication.

Will my child know if their device is switched on or off?

No, both you and the study doctors won't know if the device is active or not during the initial phase. This helps ensure the study results are fair and unbiased.

What is the Picostim DBS system?

This is the specific brand of DBS device being used in this study. It's an implantable device designed to deliver the electrical stimulation to the brain.

Can my child stop their current medications if they join the study?

No, it's very important that your child continues taking their existing epilepsy medications at stable doses throughout the study, as instructed by the study team and their doctor.

How to find out more

Rory J Piper, MRCS, PhD

rory.piper@ucl.ac.uk +44 20 7405 9200 Official trial record

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