Effects of Recorded Music on Clinical and EEG Seizure Activity

Study Overview
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Brief Summary
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This research is being done to determine if Mozart music and/or age-appropriate music can reduce the frequency of seizures and epileptiform discharges.

Detailed Description
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Several prospective studies have demonstrated the impact of Mozart's sonata for Two Pianos (K.448) on interictal epileptiform discharges and/or clinical seizure recurrence in children with epilepsy. While the exact mechanisms by which Mozart music has this effect are not yet established, there continues to be growing evidence demonstrating the positive effects on Mozart music upon seizure frequency and epileptiform discharges. Additional studies are needed to further elucidate the effect of Mozart music on epilepsy given the heterogeneity of protocols used in diverse clinical settings, with the goal of using these findings to drive potential therapy in the clinical setting. Therefore, this study will explore if there are differences in epileptiform activity and clinical seizures between Mozart K.448, instrumental age-appropriate songs, and a patient's baseline activity during EMU stays. The children (age 4-17 yrs.) will listen to Mozart K.448 (1st movement) and instrumental age-appropriate songs with washout (10 minutes) in between, each lasting up to 9 minutes in the daytime. The music stimuli will be randomly played in 2 to 7 EMU stay days (average length of stay 4 days) and delivered via single-use earbuds. As per standard clinical care the investigators will monitor continuous video electroencephalography (EEG) in the epilepsy monitoring unit. The frequency of epileptiform discharges (e.g., the number of spikes per 100 seconds, the number of seconds with spikes, and clinical seizures) will be counted before, during, and after music procedures. Heart rate variability and blood pressure will also be measured before, during, and after music stimuli to understand associations between physiological responses and epileptiform discharges to musical stimuli. Participants' behavior changes will be recorded.

Official Title
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Effects of Recorded Music on Clinical and Electroencephalography (EEG) Seizure Activity

Conditions
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Epilepsy

Intervention / Treatment
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* Behavioral: Music Stimuli


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children (age: 4 - 17 years old) who stay at Epilepsy Monitoring Units (EMU) up to 7 days may join. Exclusion Criteria: Non-English Speaking

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The children will listen to Mozart K.448 (1st movement) and instrumental age-appropriate songs with 10 minutes wash out in between, each lasting up to 9 minutes in the daytime (between 1-5 pm). The order of music stimuli will be randomly played in 2 to 7 days during the Epilepsy Monitoring Units (EMU) stay. Standard clinical care recording continuous video electroencephalography (EEG) in the EMU will be completed, epileptiform discharges (e.g., the number of spikes per 100 seconds, the number of seconds with spikes, and clinical seizures) will be counted before, during, and after music procedures. Heart rate variability and blood pressure will also be measured before, during, and after music stimuli. Participants' behavior changes will be recorded as a standard of care.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Children with Epilepsy<br>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. | Behavioral: Music Stimuli<br>* Nine-minute-long Mozart K.448 (1st movement) and instrumental age-appropriate songs will be played via single-use earbuds with 10 minutes wash-out in between music stimuli.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the frequency of epileptiform discharges (number of spikes) | The number of spikes in 100 seconds will be counted. | Epilepsy Monitoring Units Stay (up to Day 7) | 
| Change in the frequency of epileptiform discharges (number of seconds with spikes) | The number of seconds with spikes will be measured. | Epilepsy Monitoring Units Stay (up to Day 7) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in heart rate variability (HRV) | Heart rate variability (HRV) is the fluctuation in the time (ms) intervals between adjacent heartbeats. | Epilepsy Monitoring Units Stay (up to Day 7) | 
| Change in blood pressure variability (BPV) | The determinants of BPV are calculated for both systolic and diastolic blood pressure using the indices standard deviation (SD), average real variability (ARV), and coefficient of variation (CV) of all 3 measurement methods. The CV is obtained by dividing the SD by the average Blood Pressure (BP) level. The ARV is calculated as the average of the differences between consecutive BP measurements. SD, ARV and CV will be combined to report BPV. The unit of BPV is mmHg. | Epilepsy Monitoring Units Stay (up to Day 7) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epilepsy, Electroencephalography (EEG), Music