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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different types of music might affect people with epilepsy, especially those whose seizures resist medication. Participants will listen to one of three types of music, including a special piece known to reduce epileptic activity in the brain. The goal is to determine if listening to music at home can help manage seizures. Suitable candidates for this trial have focal epilepsy, follow a stable treatment plan with an implanted responsive neurostimulation (RNS) device, and have access to a mobile device and wireless data.

As an unphased trial, this study provides a unique opportunity to explore innovative, non-invasive seizure management techniques.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that music therapy is generally safe for people with epilepsy. Studies, particularly those using Mozart's music, have found it can help reduce seizures and calm the brain. This suggests that listening to music might be a useful addition to regular epilepsy treatments.

For Music Piece A, past research has demonstrated that certain music can positively affect brain activity related to epilepsy. Listening daily to specific pieces like Mozart K.448 has been linked to fewer seizures in some studies.

Music Pieces B and C, although similar to the experimental music, have not shown the same positive effects on epilepsy. However, research has confirmed the safety of music therapy, with no reports of harm in these studies.

Overall, music therapy is a gentle and well-accepted approach. It shows promise as an additional treatment for epilepsy, with no major safety concerns reported in the studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the potential of music therapy as a novel approach to managing epilepsy. Unlike traditional treatments like anti-seizure medications, which work by stabilizing electrical activity in the brain, this trial investigates whether specific music pieces can positively influence brain activity associated with epilepsy. Music Piece A has been shown to potentially have a positive effect on epileptic activity, offering a non-invasive and potentially side-effect-free alternative. By comparing various types of music, the trial aims to understand if and how different musical compositions can benefit those with epilepsy, potentially paving the way for new, complementary therapies.

What evidence suggests that this trial's music interventions could be effective for epilepsy?

Research shows that listening to certain music can help people with epilepsy. In this trial, participants will receive different music interventions. For Music Piece A, studies found that 84% of patients experienced a significant reduction in brain signals linked to seizures. Music Piece B, another intervention in this trial, lacks the extensive research of Music Piece A, but it still supports the idea that music can reduce seizures. Music Piece C involves personalized music, which some studies also suggest can lower seizure activity. Overall, music therapy, especially with pieces like Mozart’s, has been shown to help reduce the frequency of seizures and related brain activity. ^{1 2 3 6 7}

Who Is on the Research Team?

Brian C Fidali, MD

Principal Investigator

Dartmouth-Hitchcock Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24272274/

The effects of Mozart's music on interictal activity in ... Data analysis indicated that 84% of patients listening to Mozart's music showed a significant decrease in IEDs. In addition, IEDs were decreased during (31.24%) ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11633764/

The bidirectional role of music effect in epilepsy: Friend or foe? Music, a ubiquitous art form throughout human history, has been confirmed as therapeutically effective in various neurological conditions, including epilepsy.

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/S1525505021004248

Music in epilepsy: Predicting the effects of the unpredictable Promising effects of daily listening to Mozart K.448 on reducing seizure frequency in individuals with epilepsy have been demonstrated.

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

Musical components important for the Mozart K448 effect ... An IED-related intervention with accumulating evidence is the use of music as a noninvasive, non-pharmacologic form of neuromodulation.

6. withpower.com withpower.com/trial/phase-refractory-epilepsy-6-2024-9fec6

Music Therapy for Epilepsy (SONATA Trial) 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10507627/

Calming effect of Clinically Designed Improvisatory Music for ... When used correctly, music has the potential to emotionally calm a person with epilepsy (PWEs). On the other hand, when used incorrectly, music ...