Not yet recruitingNAINTERVENTIONAL

Deep Brain Stimulation vs. Vagus Nerve Stimulation for Epileptic Spasms

This study is looking at two different treatments, Deep Brain Stimulation (DBS) and Vagus Nerve Stimulation (VNS), for children aged 5 to 17 who have a type of epilepsy that hasn't improved with typical medications. The main goal is to find out which of these treatments is more effective and safer for reducing seizures, especially a specific type called epileptic spasms. Researchers will invite 20 children to take part from SickKids hospital in Canada. The study will last for about three to four years and will involve comparing the effects of these two different types of nerve stimulation. If you or someone you know has severe epilepsy and might fit these criteria, this study could offer valuable insights into potential treatment options.

At a glance

Status

Not yet recruiting

Phase

Sponsor

The Hospital for Sick Children

Enrolment target

Start

24 Nov 2025

Estimated completion

31 Dec 2027

Epilepsy; Seizure

What is this study about?

This research study is focused on helping children aged 5 to 17 who live with a very challenging form of epilepsy. This is for children whose seizures, especially those known as epileptic spasms, haven't been controlled by at least two different anti-epilepsy medicines – what doctors call 'drug-resistant epilepsy'. The study aims to directly compare two advanced treatments: Deep Brain Stimulation (DBS) and Vagus Nerve Stimulation (VNS). Both are types of treatment that involve sending small electrical signals to nerves or parts of the brain.

The main purpose is to understand which of these two treatments works better to reduce seizures and improve the child's quality of life, while also looking at how safe each treatment is. By carefully comparing DBS and VNS, doctors hope to gather important information that can help guide future treatment decisions for children with severe epilepsy.

This is a 'pilot study', which means it's a smaller, initial study involving 20 children. It's being carried out at SickKids hospital. The findings from this research could be very important in developing better ways to treat drug-resistant epilepsy and epileptic spasms in young people.

Key takeaways

This study compares two advanced treatments, DBS and VNS, for severe childhood epilepsy.
It's for children aged 5-17 whose seizures haven't responded to standard medicines.
The goal is to see which treatment is safer and more effective for reducing seizures.
20 children will be involved, and the study will last about 3 to 4 years.
Participation involves surgery for the device and regular follow-up visits at SickKids.

Who may be eligible?

This study is looking for children aged 5 to 17 years old, both boys and girls. To be considered, a child must have epilepsy that doctors have confirmed as 'drug-resistant'. This means their seizures haven't been controlled by at least two different anti-epilepsy medications. Also, their main type of seizure must include epileptic spasms or tonic spasms, which would be confirmed by brain wave tests (EEG).

Parents or legal guardians must be able to understand the study and give their written permission for their child to take part. The child and their family also need to be able to come to all the required appointments and follow the study instructions for up to 12 months after the main study period finishes.

Some important reasons why a child might not be able to join include: having needed treatment for drug or alcohol problems in the last six months (excluding caffeine and nicotine), having any condition that makes MRI scans unsafe, being unable to travel to SickKids for follow-up visits, having serious heart, breathing, kidney, or hormone conditions that would make surgery risky, being pregnant, or not being able to communicate well enough in English to fill out questionnaires. Also, if a child needs frequent MRI scans as part of their regular care, they might not be suitable.

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 aged between 5 and 17 years old?
Has your child's epilepsy not improved after trying at least two different seizure medications?
Does your child mainly experience epileptic spasms or tonic spasms?
Are you able to bring your child to SickKids for all study visits and follow the instructions?
Does your child or family speak English well enough for questionnaires?

Answer every question to see your result.

What does participation involve?

If your child takes part in this study, they will either receive Deep Brain Stimulation (DBS) or Vagus Nerve Stimulation (VNS). The study will involve a number of visits to SickKids hospital for assessments before and after the treatment. This will include careful checks by a neurologist to confirm the diagnosis and monitor progress.

You and your child will need to be able to attend all these appointments and follow the study doctors' instructions for up to 12 months after the main treatment phase. The estimated total time for the study, from start to finish, is between three and four years. Throughout this time, researchers will be carefully collecting information about your child's seizures and overall health. The study does not involve new medications, but rather two different types of implanted devices for nerve stimulation.

Potential risks and benefits

Participating in this study might offer your child the potential benefit of improved seizure control, even if other treatments haven't worked. It could lead to a better understanding of how to treat severe epilepsy in children. However, as with any medical procedure, there are potential risks associated with surgery and the devices themselves, such as infection or complications from the electrical stimulation. The research team will explain all potential risks in detail. It's important to remember that your child's participation is completely voluntary, and you have the right to withdraw them from the study at any time without affecting their medical care.

Locations (1)

The Hospital for Sick Children
Verified postcode
Toronto, Canada

Common questions

What is Deep Brain Stimulation (DBS)?

DBS involves placing small wires (electrodes) into specific areas of the brain to send tiny electrical signals, helping to control seizures.

What is Vagus Nerve Stimulation (VNS)?

VNS involves a small device, like a pacemaker, implanted under the skin in the chest that sends electrical pulses to a nerve in the neck called the vagus nerve, which can reduce seizures.

Will my child know which treatment they are receiving?

Yes, this is an 'open' study, meaning you and the doctors will know whether your child is receiving DBS or VNS.

How long will the total study last for my child?

The entire study is expected to run for about three to four years, including follow-up visits.

Where will the study take place?

All parts of the study, including assessments and follow-up, will take place at SickKids hospital.

How to find out more

George M Ibrahim, MD, PhD

george.ibrahim@sickkids.ca 416-813-6125 Official trial record

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