Active not recruitingNAINTERVENTIONAL

Music as an Adjunctive Epileptic Seizure Treatment Option

This study is exploring if a particular Mozart sonata (K448) could be an extra way to help children aged 2 to 16 who have epilepsy that hasn't fully improved with standard medicines. Earlier research suggested this music might help reduce unusual brain activity in people with epilepsy. This trial wants to see if listening to this music daily for two months can actually reduce the number of seizures and improve how children think and learn. Children will be split into two groups: one listens to the Mozart K448, and the other listens to different music. Parents will keep a diary of seizures, and children will have tests to check their thinking skills at the start and end of the study. This helps researchers understand how feasible it is to conduct a larger study in the future.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Aberdeen

Enrolment target

Start

01 Jun 2023

Estimated completion

02 Dec 2026

Epilepsy Neurocognitive Disorders

What is this study about?

Imagine finding a way to help manage epilepsy that involves music! That's what this study is all about. We're looking into whether listening to a specific piece of classical music, Mozart's Sonata for two pianos in D major (known as K448), could be a helpful additional treatment for children with epilepsy.

Some early studies have shown that this particular Mozart piece might help calm unusual electrical activity in the brain, which is linked to seizures. This new study wants to build on that idea. We want to see if listening to the K448 sonata regularly can reduce how often children have seizures and if it can improve their thinking and memory skills. The children taking part have a type of epilepsy that hasn't fully responded to their current medication, which means their doctors are still looking for ways to help them more.

This trial is also important because it will help us understand the best way to design bigger studies in the future. We'll learn about any challenges in asking families to play music daily and how to ensure the study is fair and gives clear results. This way, we can make sure any future research is as effective as possible in finding new ways to help children with epilepsy.

Key takeaways

This study explores music (Mozart K448) as an additional treatment for childhood epilepsy.
It's for children aged 2-16 whose epilepsy hasn't responded well to standard medicines.
Children will listen to music daily for 8 minutes over two months.
Parents will keep a detailed seizure diary and complete questionnaires.
The study helps plan larger research to find new ways to help children with epilepsy.

Who may be eligible?

This study is designed for children between 2 and 16 years old who have been diagnosed with epilepsy. Specifically, it's for children whose epilepsy hasn't responded well to at least two different anti-seizure medicines, even when those medicines were taken correctly. This is sometimes called 'drug-resistant epilepsy'.

There are a few reasons why a child might not be able to join. For example, if they've recently changed their epilepsy medicine, or if their medicine is expected to change during the study. Children who have very few seizures (less than two per month) are also not eligible, as it would be hard to see if the music made a difference to their seizure frequency. Finally, if a child is already taking part in another medical study that involves new treatments, they wouldn't be able to join this one.

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 2 and 16 years?
Has your child tried at least two different epilepsy medicines, but still has seizures?
Has your child's epilepsy medicine been stable (no changes) for at least one month?
Does your child have at least two seizures per month?
Is your child not currently taking part in another treatment study?

Answer every question to see your result.

What does participation involve?

If your child takes part, their journey would start with recording some basic information about their health. For one month before the music starts, you'll be asked to keep a detailed diary of your child's seizures and when they happen. Then, for two months, your child will listen to music for about 8 minutes each day while they are awake. We'll provide an MP3 player and speaker with the music already on it.

Children will be randomly put into one of two groups: one group will listen to the Mozart K448 sonata, and the other will listen to a different piece of Mozart music that isn't expected to have the same effects. Neither you nor the researchers will know which music your child is listening to until after the study ends. During these two months, you'll continue to keep the seizure diary, noting when the music is played. Your child's epilepsy medicine will stay exactly the same throughout the study.

At the start and end of the study period, your child will complete some simple tests to check their thinking, memory, and learning skills. You will also continue to complete the seizure diary for one month after the music listening period ends. We'll also ask for your feedback through questionnaires and possibly a group discussion to understand how easy or difficult it was to include the music in your daily routine.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For your child, a potential benefit is that the music might help reduce their seizures or improve their thinking skills, though we can't promise this will happen. There are no known risks from listening to music, and your child's regular epilepsy medication will not change during the study. This means their usual care continues uninterrupted. The main commitment is the time involved in playing the music daily and keeping detailed diaries. Remember, joining a study is always voluntary, and you are free to withdraw your child at any time, for any reason, without it affecting their medical care.

Locations (2)

Royal Aberdeen Children's Hospital
Verified postcode
Aberdeen, United Kingdom
Royal Hospital for Children & Young People
Verified postcode
Edinburgh, United Kingdom

Common questions

What is 'drug-resistant epilepsy'?

It means your child's seizures haven't stopped or reduced enough after trying two different epilepsy medicines at the right doses.

Will my child's current medicine change during the study?

No, it's very important that your child's anti-seizure medicine stays exactly the same throughout the entire study period.

How long will my child listen to the music each day?

They will listen to the assigned music for about 8 minutes once a day, every day, for two months.

Will I know if my child is listening to the 'active' Mozart music or the control music?

No, this is a 'blinded' study, so neither you nor the research team will know which music your child is listening to until the study is over.

What kind of tests will my child have?

They will have tests that look at their thinking, memory, and learning skills, suitable for their age.