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

24 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will investigate the role of coordinated brain rhythms during sleep in memory consolidation and determine whether playing precisely timed brief bursts of noise can enhance these rhythms and improve memory in epilepsy inpatients with implanted hippocampal electrodes.

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 data supports the effectiveness of the treatment Auditory Stimulation for Epilepsy?

Research shows that music therapy, a form of sound therapy, has been effective for conditions like chronic pain and tinnitus, suggesting it might also help with epilepsy. Additionally, auditory training has shown benefits in improving behavior and sensory responses in children with autism, indicating potential positive effects for other neurological conditions. ^{1 2 3 4 5}

Is auditory stimulation safe for humans?

Research on auditory stimulation, including music therapy like the Mozart effect, suggests it is generally safe for humans. Studies have shown it can reduce seizure activity in people with epilepsy without reporting any harmful side effects. ^{6 7 8 9 10}

How does auditory stimulation differ from other treatments for epilepsy?

Auditory stimulation for epilepsy is unique because it uses specific music to activate the brain and reduce seizures, unlike traditional treatments that often involve medication. This non-drug approach, known as the 'Mozart effect', has shown promise in reducing seizure frequency and improving quality of life in some patients. ^{6 7 8 9 11}

Research Team

Dara Manoach, PhD

Principal Investigator

Professor

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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 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 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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Auditory integration training and other sound therapies for autism spectrum disorders: a systematic review. [2018]

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

Outcome research in music therapy: a step on the long road to an evidence-based treatment. [2011]

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

Constraint-induced sound therapy for sudden sensorineural hearing loss--behavioral and neurophysiological outcomes. [2021]

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

Effects of hearing aids in patients with unilateral tinnitus with acquired ipsilateral sensorineural hearing loss. [2022]

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

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

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

The effect of auditory stimulation on epileptogenic electroencephalographic activity. [2019]

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

Reduction of seizure occurrence from exposure to auditory stimulation in individuals with neurological handicaps: a randomized controlled trial. [2021]

8. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

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

10. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

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