Auditory Stimulation for Epilepsy

Overseen By Dara Manoach, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Intellectual disability, Motor problems, others

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

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether short bursts of noise during sleep can improve memory in people with epilepsy. Researchers aim to understand how these sounds interact with brain rhythms to support memory during sleep. The trial involves epilepsy patients already in the hospital with specialized brain monitoring equipment. Those undergoing continuous brain activity monitoring with electrodes may be suitable candidates. Participants should also be comfortable performing simple tasks and understand English. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance memory support for epilepsy patients.

Will I have to stop taking my current medications?

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

What prior data suggests that auditory stimulation is safe for epilepsy inpatients?

Research shows that listening to sounds, like music, can have both positive and negative effects on people with epilepsy. Some studies have found that certain types of music can help reduce seizures. For instance, one study discovered that listening to specific music lowered the number of seizures in various types of epilepsy. This suggests that sound therapy might benefit some individuals.

However, predicting the effects of sound remains challenging. While it might help, more research is needed to understand how different sounds affect epilepsy. This treatment uses non-invasive sounds, which are generally safe and easy to manage. Participants in the trial might experience few, if any, side effects from the sound-based treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Auditory stimulation is unique because it offers a non-invasive way to potentially manage epilepsy by targeting brain activity directly. Unlike traditional treatments like anti-seizure medications or surgical interventions, which can have significant side effects or require invasive procedures, auditory stimulation uses sound to influence brain patterns. Researchers are excited about this approach as it presents a novel mechanism of action, aiming to modulate neural activity through the auditory system, which could lead to fewer side effects and a more accessible treatment option.

What evidence suggests that auditory stimulation is effective for improving memory in epilepsy?

Research shows that listening to music can help people with epilepsy. Studies have found that certain sounds might reduce seizures. Music can change brain activity, which may help control seizures. Some evidence also suggests that sound can affect brain rhythms, possibly improving memory and thinking skills in people with epilepsy. While more research is needed, these findings offer hope that sound therapy, which participants in this trial will receive, could be a useful tool for managing epilepsy. ^{1 2 3 6 7}

Who Is on the Research Team?

Dara Manoach, PhD

Principal Investigator

Professor

Are You a Good Fit for This Trial?

This trial is for English-speaking epilepsy patients aged 12-65 who are inpatients with implanted hippocampal electrodes and can consent to the study. It's not suitable for those with intellectual disabilities affecting task performance, anticipated surgery that could affect sleep oscillations, or motor issues preventing finger tapping tasks.

Inclusion Criteria

Fluent in English

You are currently having continuous monitoring of brain activity with implanted electrodes.

Able to give informed consent/assent (for minors aged 12-17 or adults with an appointed guardian)

Exclusion Criteria

I have an intellectual disability that affects my daily tasks.

I had surgery that may have affected my sleep patterns.

I cannot perform tasks that require tapping my fingers due to motor issues.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Night

Participants undergo baseline sleep monitoring with implanted hippocampal electrodes and continuous scalp EEG

1 night

1 overnight stay (inpatient)

Memory Night

Participants are assessed for sleep-dependent memory consolidation with the finger tapping motor sequence task (MST) with training prior to sleep and testing the next morning

1 night

1 overnight stay (inpatient)

Stimulation Night

Participants receive auditory stimulation during sleep to enhance memory consolidation, with training on the MST before sleep and testing the next morning

1 night

1 overnight stay (inpatient)

Follow-up

Participants are monitored for changes in sleep and memory performance after the intervention

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Auditory Stimulation

Trial Overview The study tests if brief bursts of noise during sleep can enhance brain rhythms and improve memory in epilepsy patients. Participants will perform a motor procedural memory task with and without auditory stimulation while undergoing EEG monitoring.

How Is the Trial Designed?

Group I: Epilepsy inpatients Experimental Treatment 3 Interventions

Epilepsy inpatients with implanted hippocampal electrodes and continuous scalp EEG monitoring

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

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]

In a study of 97 patients with unilateral tinnitus and sensorineural hearing loss, sound therapy using hearing aids significantly reduced tinnitus severity, as shown by a marked decrease in Tinnitus Handicap Inventory scores after 3 months and 1 year of treatment.

Approximately 80-90% of patients reported improvements in both the loudness and annoyance of their tinnitus, indicating that hearing aids are an effective intervention for managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of hearing aids in patients with unilateral tinnitus with acquired ipsilateral sensorineural hearing loss. Ueno, M., Shinden, S., Oishi, N., et al.[2022]

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]

Music therapy has been shown to be an effective treatment for various conditions, including chronic pain, migraines in children, and chronic tinnitus, supported by moderate to large effect sizes in multiple meta-analyses.

The growing body of evidence suggests that music therapy should be considered as a viable intervention in clinical settings, with future research needed to compare its effectiveness against standard treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outcome research in music therapy: a step on the long road to an evidence-based treatment. Nickel, AK., Hillecke, T., Argstatter, H., et al.[2011]

In a study of 80 children aged 3-17 with autism or Asperger syndrome, both auditory training and listening to unmodified music led to significant improvements in behavior and severity of autism, which were maintained for 12 months.

Both groups also showed increases in verbal and performance IQ 3 to 12 months after the interventions, suggesting that auditory experiences may positively influence cognitive and behavioral outcomes in children with sound sensitivity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The long-term effects of auditory training on children with autism. Bettison, S.[2019]

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'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]

Auditory stimulation targeted to the patient's epileptogenic activity significantly reduced both the duration and frequency of seizures, decreasing from 5.70 to 2.66 seizures per day over the course of the study.

In contrast, random auditory stimulation did not produce any beneficial effects on seizure duration or frequency, highlighting the importance of targeted intervention in managing epilepsy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of auditory stimulation on epileptogenic electroencephalographic activity. Götestam, KG., Melin, L., Sjödén, PO.[2019]

A three-year clinical trial involving patients with neurological impairments demonstrated that passive exposure to specific music significantly reduced seizure rates by 24% during treatment and 33% during follow-up, with some subjects experiencing complete seizure cessation.

The study suggests that auditory stimulation through music can serve as a non-invasive, non-pharmacologic treatment option for epilepsy, supporting previous findings of its anti-seizure effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reduction of seizure occurrence from exposure to auditory stimulation in individuals with neurological handicaps: a randomized controlled trial. Bodner, M., Turner, RP., Schwacke, J., et al.[2021]

A systematic review of six randomized controlled trials involving 171 participants with autism spectrum disorders found that auditory integration training (AIT) did not consistently show benefits over control conditions, with three studies reporting no improvements.

While some studies indicated short-term improvements in specific behavior measures, the overall evidence is insufficient to support the effectiveness of AIT, and no significant adverse effects were reported.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory integration training and other sound therapies for autism spectrum disorders: a systematic review. Sinha, Y., Silove, N., Wheeler, D., et al.[2018]

Patients with sudden sensorineural hearing loss who received constraint-induced sound therapy alongside standard corticosteroid treatment experienced significantly better hearing recovery than those who only received corticosteroids.

Brain activity analysis in some patients indicated that constraint-induced sound therapy may help prevent harmful changes in the auditory cortex, suggesting it is a safe and effective treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Constraint-induced sound therapy for sudden sensorineural hearing loss--behavioral and neurophysiological outcomes. Okamoto, H., Fukushima, M., Teismann, H., et al.[2021]

Citations

1. 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.

2. 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.

3. sciencedirect.com sciencedirect.com/science/article/pii/S105913112200214X

Wired for sound: The effect of sound on the epileptic brain Current evidence reports the potential of sound to affect changes on epileptiform discharges in both positive and negative ways.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23071510/

Reduction of seizure occurrence from exposure to auditory ... Exposure to specific auditory stimuli (ie music) can significantly reduce seizures in subjects with a range of epilepsy and seizure types.

5. sciencedirect.com sciencedirect.com/science/article/pii/S1525505021004248

Music in epilepsy: Predicting the effects of the unpredictable In this paper, we review the effects of auditory stimulation on brain dynamics, in addition to computational approaches to define the structural features of ...

6. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0045303

Reduction of Seizure Occurrence from Exposure to Auditory ... Exposure to specific auditory stimuli (ie music) can significantly reduce seizures in subjects with a range of epilepsy and seizure types.

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

Calming effect of Clinically Designed Improvisatory Music for ... Music therapy is less commonly used for adult individuals with epilepsy and further investigations in music therapy for epilepsy are needed.