Music Therapy for Epilepsy

(SONATA Trial)

Recruiting at 1 trial location

Overseen By Brian C Fidali, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Dartmouth-Hitchcock Medical Center

Disqualifiers: Musicogenic seizures, Inability to consent, others

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

Compensation: Varies

Number of Visits: Unknown

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a prospective, placebo-controlled, double-blinded randomized study of self-administered auditory intervention in a naturalistic home environment.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. However, since it involves participants with stable RNS (responsive neurostimulation) regimens, it seems likely that you can continue your existing epilepsy treatment.

What data supports the effectiveness of this treatment for epilepsy?

Research shows that listening to Mozart's music, especially Sonata K.448, can reduce seizures and improve behavior in children with epilepsy. Studies found that certain compositions of Mozart's music led to significant seizure reduction and better quality of life, suggesting music therapy could be a helpful non-drug treatment for epilepsy. ^{1 2 3 4 5}

Is music therapy safe for people with epilepsy?

Research on music therapy, particularly using Mozart's music, has shown it to be safe for people with epilepsy, with studies focusing on its effects on brain activity and seizure frequency without reporting any harmful side effects. ^{2 3 6 7 8}

How does music therapy differ from other treatments for epilepsy?

Music therapy for epilepsy, particularly using Mozart's compositions, is unique because it is a non-drug treatment that can reduce seizure frequency and improve quality of life in patients with drug-resistant epilepsy. Unlike traditional medications, this therapy involves listening to specific music pieces, which has been shown to decrease abnormal brain activity and seizures in some patients. ^{1 3 6 7 9}

Research Team

Brian C Fidali, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Eligibility Criteria

This trial is for adults with hard-to-treat focal epilepsy who have had an RNS device implanted at least six months ago and are on a stable RNS treatment. Participants must be able to attend study visits, complete procedures, and have regular access to Wi-Fi and a personal mobile device.

Inclusion Criteria

Access to private or public wireless data service at regular intervals

Access to personal mobile device

I have epilepsy not controlled by medication and had an RNS device implanted over six months ago.

Exclusion Criteria

I am unable to do the tasks required for the study as decided by the research team.

Inability to obtain informed consent from the patient or legally authorized representative

Documentation of a musicogenic or auditory-triggered focal seizure semiology

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Data Collection

Retrospective data collection for 4 weeks prior to enrollment to assess baseline seizure activity and quality of life

4 weeks

Music Intervention

Participants listen to specific music pieces daily to assess effects on epileptic activity and quality of life

4 1/2 months

Self-administered at home

Follow-up

Participants are monitored for the lasting effects of the music intervention on epileptic activity and quality of life

1 week

Treatment Details

Interventions

• Active Comparator Intervention (Music B)
• Active Comparator Intervention (Music C)
• Experimental Intervention (Music A)

Trial Overview The study tests three different music interventions (Music A, B, C) delivered through a web app for epilepsy therapy. It's designed to see if any of the music types can help manage seizures better than usual care in a home setting.

Participant Groups

Group I: Music Piece A Experimental Treatment 1 Intervention

Participants will be asked to listen to a musical excerpt previously shown to have a positive effect on epileptic activity in human brain.

Group II: Music Piece B Active Control 1 Intervention

Participants will be asked to listen to a musical except very similar to the experimental stimuli that has not been shown to have a positive effect on epileptic activity.

Group III: Music Piece C Active Control 1 Intervention

Participants will select a preferred excerpt from several popular musical genres. This piece is modified to have some similarities to the experimental musical excerpt.

Who Is Running the Clinical Trial?

Dartmouth-Hitchcock Medical Center

Lead Sponsor

Trials

548

Recruited

2,545,000+

Dartmouth College

Collaborator

Trials

93

Recruited

1,415,000+

University of Massachusetts, Worcester

Collaborator

Trials

372

Recruited

998,000+

Findings from Research

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'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 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]

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]

References

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

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

2. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

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

4. 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]

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

Complementary and Alternative Medicine: The Mozart Effect on Childhood Epilepsy-A Systematic Review. [2018]

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

A protocol of systematic review and meta-analysis of Mozart's Music for drug-resistant epilepsy. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Daily listening to Mozart reduces seizures in individuals with epilepsy: A randomized control study. [2022]

9. Croatia pubmed.ncbi.nlm.nih.gov

Mozart's music and multidrug-resistant epilepsy: a potential EEG index of therapeutic effectiveness. [2019]