Recorded Music for Epilepsy

Overseen by Sarah Kelley, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Johns Hopkins University

Disqualifiers: Non-English speaking

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

This trial tests if listening to Mozart's music and other suitable songs can reduce seizures in children with epilepsy. The idea is that music might calm brain activity, helping to lower seizure frequency. Promising effects of listening to Mozart on reducing seizure frequency in individuals with epilepsy have been demonstrated over time.

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 data supports the effectiveness of the treatment Music Stimuli, Mozart Music Therapy, Music Stimuli, Auditory Stimulation for epilepsy?

Research shows that listening to Mozart's music, particularly the Sonata for Two Pianos in D major, K.448, can reduce epileptiform discharges (abnormal brain activity) in people with epilepsy. Studies have found significant decreases in these discharges and improvements in seizure control and behavior in children with epilepsy when exposed to Mozart's compositions. ^{1 2 3 4 5}

Is listening to recorded music, like Mozart's compositions, safe for people with epilepsy?

Research on using Mozart's music for epilepsy shows it can reduce seizure-related brain activity without any reported safety concerns, suggesting it is generally safe for humans. ^{1 2 3 4 6}

How is the treatment of recorded music for epilepsy different from other treatments?

This treatment is unique because it uses specific music, like Mozart's Sonata K.448, to reduce seizure activity and epileptiform discharges, offering a non-drug, auditory approach that can be more easily integrated into daily life compared to traditional medication. ^{1 2 4 5 6}

Research Team

Sarah Kelley, MD

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Music Stimuli (Behavioral Intervention)

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.

Participant Groups

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+

Theodore DeWeese

Johns Hopkins University

Chief Executive Officer since 2023

MD from an unspecified institution

Allen Kachalia

Johns Hopkins University

Chief Medical Officer since 2023

MD from an unspecified institution

Findings from Research

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 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]

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Mozart K.448 and epileptiform discharges: effect of ratio of lower to higher harmonics. [2010]

2. United States pubmed.ncbi.nlm.nih.gov

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

3. England pubmed.ncbi.nlm.nih.gov

Mozart effect in epilepsy: Why is Mozart better than Haydn? Acoustic qualities-based analysis of stereoelectroencephalography. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Safe and sound: Meta-analyzing the Mozart effect on epilepsy. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Mozart's music in children with drug-refractory epileptic encephalopathies: Comparison of two protocols. [2018]

6. England 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. [2021]