Recorded Music for Epilepsy

Overseen By Sarah Kelley, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Disqualifiers: Non-English speaking

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: Up to 7 days

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether listening to Mozart or age-appropriate music can reduce seizures in children with epilepsy. Participants will listen to specific music tracks, known as "Music Stimuli," while in an Epilepsy Monitoring Unit (EMU) to observe any effects on seizure activity. The study targets children aged 4 to 17 who are in an EMU for up to 7 days. As an unphased trial, it offers participants a unique opportunity to contribute to innovative research that could enhance seizure management in children.

Do I need to stop my current medications for the music and epilepsy trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this music therapy is safe for children with epilepsy?

Research has shown that listening to Mozart's music, especially K.448, might be safe for people with epilepsy. Studies have found that many patients experience fewer seizures and reduced seizure-related brain activity after listening to this music. In one study, 84% of participants who listened to Mozart showed a decrease in seizure-related brain activity. Overall, music as a treatment has been well-tolerated, with no negative effects reported, suggesting that this approach is safe for people with epilepsy. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard epilepsy treatments that often involve medication or surgery, music stimuli offer a non-invasive and side-effect-free approach. Researchers are excited about this treatment because it uses Mozart's K.448 and age-appropriate instrumental songs to potentially reduce seizure activity. This method's unique feature is its delivery through music, which may provide therapeutic benefits simply by listening, making it an appealing option for children who might struggle with traditional treatment methods.

What evidence suggests that music stimuli might be an effective treatment for epilepsy?

Research has shown that listening to Mozart's music, especially the piece K448, can greatly reduce seizures in people with epilepsy. In some studies, participants experienced a 46.6% decrease in seizures after regularly listening to this music. One study found that children who listened to Mozart for two hours a day over fifteen days had more than a 50% reduction in seizures. This trial will explore the effects of music stimuli, including Mozart K.448, on children with epilepsy. Researchers believe the music affects brain activity, reducing the brief bursts of electrical activity that can lead to seizures. This suggests that music, particularly Mozart's, might serve as an effective and non-invasive treatment option for epilepsy. ^{2 3 4 6 7}

Who Is on the Research Team?

Sarah Kelley, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for English-speaking children aged 4 to 17 with epilepsy, who are staying in Epilepsy Monitoring Units for up to a week. Children who do not speak English cannot participate.

Inclusion Criteria

I am a child aged 4-17 staying in an Epilepsy Monitoring Unit for up to 7 days.

Exclusion Criteria

Non-English Speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants listen to Mozart K.448 and instrumental age-appropriate songs with washout periods in between during EMU stays

Up to 7 days

2 to 7 EMU stay days

Follow-up

Participants are monitored for changes in epileptiform discharges, heart rate variability, and blood pressure variability

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Music Stimuli

Trial Overview The study is testing whether listening to Mozart music or other age-appropriate music can help reduce the number of seizures and abnormal brain activity as seen on EEG in children with epilepsy.

How Is the Trial Designed?

Group I: Children with Epilepsy Experimental Treatment 1 Intervention

Children (age: 4- 17 years old) will participate in this study, and they will listen to Mozart K.448 (1st movement) and instrumental age-appropriate song with 10 minutes wash out in between, each lasting up to 9 minutes in the daytime (between 1-5 pm). The music stimuli will be randomly played in 2 to 7 days during the EMU stay (average 4 days). Music will be delivered via single-use earbuds.

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Published Research Related to This Trial

Listening to Mozart's Sonata for two pianos in D major, K.448, significantly reduced epileptiform discharges in 81% of the 58 Taiwanese children with seizure disorders, particularly benefiting those with generalized or central discharge types.

The reduction in discharges persisted in 76.1% of patients even after the music stopped, indicating a lasting effect, while a digitally computerized string version of the same piece did not produce similar benefits, highlighting the importance of the musical characteristics in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mozart K.448 and epileptiform discharges: effect of ratio of lower to higher harmonics. Lin, LC., Lee, WT., Wu, HC., et al.[2010]

In a study of 19 children and adolescents with refractory epileptic encephalopathies, music therapy using a set of Mozart's compositions resulted in a significant seizure reduction in 70% of participants, compared to only 22.2% in those listening to Mozart's sonata K448.

The group listening to the set of Mozart's compositions also showed greater improvements in behavioral aspects, such as reduced irritability and better sleep quality, suggesting that this music therapy could be a valuable nonpharmacological treatment option for managing seizures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mozart's music in children with drug-refractory epileptic encephalopathies: Comparison of two protocols. Coppola, G., Operto, FF., Caprio, F., et al.[2018]

In a pilot study involving 4 children with benign childhood epilepsy, listening to Mozart's Sonata for Two Pianos (K448) significantly reduced the frequency of interictal epileptiform discharges (IEDs) in two subjects, with reductions of 33.7%, 50.6%, and 33.9% compared to baseline.

The study suggests that K448 may have a beneficial effect on reducing IEDs, as opposed to control music (Beethoven's Für Elise), indicating a potential therapeutic role for music in managing certain types of epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The acute effect of music on interictal epileptiform discharges. Turner, RP.[2007]

A meta-analysis of 12 studies found that music-based neurostimulation significantly reduces the frequency of seizures and interictal epileptiform discharges (IED) in individuals with epilepsy, suggesting its potential as an effective treatment.

The results indicate that music therapy is a promising complementary and non-invasive approach for managing epilepsy, although further research is needed to optimize treatment protocols and confirm its efficacy across different types of epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe and sound: Meta-analyzing the Mozart effect on epilepsy. Sesso, G., Sicca, F.[2021]

Listening to Mozart K.448 significantly reduced the seizure recurrence rate in children with first unprovoked seizures, with rates of 37.2% in the treatment group compared to 76.8% in the control group over a follow-up period of 24 months.

The study also found significant decreases in epileptiform discharges on EEGs after 1, 2, and 6 months of listening to the music, suggesting that Mozart K.448 may be an effective alternative treatment for managing seizures in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mozart K.448 listening decreased seizure recurrence and epileptiform discharges in children with first unprovoked seizures: a randomized controlled study. Lin, LC., Lee, MW., Wei, RC., et al.[2021]

Listening to Mozart's music significantly reduced epileptiform discharges in the brains of 18 epilepsy surgery candidates, confirming the 'Mozart effect' in this patient group.

The study found that specific acoustic properties of music, such as harmonic spectrum and tempo, play a crucial role in reducing epileptic activity, suggesting that carefully selected musical pieces could serve as a noninvasive treatment option for epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mozart effect in epilepsy: Why is Mozart better than Haydn? Acoustic qualities-based analysis of stereoelectroencephalography. Štillová, K., Kiska, T., Koriťáková, E., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7278546/

Daily listening to Mozart reduces seizures in individuals with ... Promising effects of daily listening to Mozart on reducing seizure frequency in individuals with epilepsy have been demonstrated over the last 20 years.

2. nature.com nature.com/articles/s41598-021-95922-7

Musical components important for the Mozart K448 effect in ... ... musical stimulation and reductions ... Daily listening to Mozart reduces seizures in individuals with epilepsy: A randomized control study.

3. epilepsybehavior.com epilepsybehavior.com/article/S1525-5050(24)00210-5/fulltext

Personalised music as a treatment for epilepsy In this paper we look at non-pharmaceutical treatments for intractable epilepsy based on neurophysiological methods especially with EEG analysis.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1525505024001240

A systematic review of the Mozart effect in adult and ... Significant decrease in IEDs after 6 months of daily listening to K448 compared to before music (160 vs 540) and a reduction of 46.6 % in seizure frequency.

5. tp.amegroups.org tp.amegroups.org/article/view/7859/8916

Mozart's music in children with epilepsy - Lin The results show that after listening a set of Mozart's compositions 2 h per day for fifteen days, over 50% of seizure reductions compared with baseline are ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32449680/

Meta-analyzing the Mozart effect on epilepsy The nine meta-analyses showed significant reductions in seizures and IED frequencies after long-term music treatment, and in IED frequency ...

7. neurology.org neurology.org/doi/10.1212/WNL.94.15_supplement.744

Music therapy as an adjunctive treatment for refractory ... In the meta-analysis, 84% of patients exposed to Mozart were found to have a decrease in interictal epileptiform activity.