What side effects are associated with this type of intervention?

Common treatments for epilepsy that are similar to music therapy or auditory stimulation include transcranial magnetic stimulation (TMS) and noninvasive vagus nerve stimulation (nVNS). TMS has been associated with mild side effects such as headache, scalp discomfort, and rarely, seizures. Noninvasive vagus nerve stimulation may cause mild adverse events like a warm sensation, numbness, redness, itching, tingling, muscle spasm, and pain in the arm, shoulder, or neck. Both treatments are generally well-tolerated with no serious adverse events reported.

What prior FDA approvals exist?

FDA-approved treatments for epilepsy primarily include a range of antiepileptic drugs such as carbamazepine, levetiracetam, and valproate, which are used as monotherapy or in combination. Neuromodulatory interventions like transcranial magnetic stimulation (TMS) have also been explored, showing efficacy in reducing seizure frequency in some patients. While music therapy or auditory stimulation is being studied for its potential benefits in modulating neural activity, it is not yet an FDA-approved treatment for epilepsy.

What other types of research exist?

Promising novel alternatives to Music Therapy for epilepsy patients include individualized Low Amplitude Seizure Therapy (iLAST), Magnetic Seizure Therapy (MST), glutamate receptor modulators, and cannabinoid treatments.

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Behavioral Intervention

Recorded Music for Epilepsy

N/A

Recruiting

Led By Sarah Kelley, MD

Research Sponsored by Johns Hopkins University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up epilepsy monitoring units stay (up to day 7)

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial involves listening to music, there are no direct medical side effects expected. However, individual responses to music may vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ epilepsy monitoring units stay (up to day 7)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~epilepsy monitoring units stay (up to day 7)

This trial's timeline: 3 weeks for screening, Varies for treatment, and epilepsy monitoring units stay (up to day 7) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in the frequency of epileptiform discharges (number of seconds with spikes)

Change in the frequency of epileptiform discharges (number of spikes)

Secondary study objectives

Change in blood pressure variability (BPV)

Change in heart rate variability (HRV)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Children with EpilepsyExperimental Treatment1 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.

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for epilepsy primarily include antiseizure medications, which work by stabilizing neuronal membranes and reducing excitability through various mechanisms such as enhancing inhibitory neurotransmission (e.g., GABAergic activity) or inhibiting excitatory neurotransmission (e.g., glutamatergic activity). Other treatments include neuromodulation techniques like vagus nerve stimulation and deep brain stimulation, which modulate neural circuits to prevent seizure activity. Understanding these mechanisms is crucial for epilepsy patients as it helps in tailoring treatments that can effectively reduce seizure frequency and improve quality of life. Similar to these treatments, music therapy is being studied for its potential to modulate neural activity and reduce seizure frequency, offering a non-invasive alternative that could complement existing therapies.