Effects of Recorded Music on Clinical and EEG Seizure Activity

Not Applicable

Recruiting

• Conditions: Epilepsy
• Interventions: Behavioral: Music Stimuli

• Registration Number: NCT05289934
• Lead Sponsor: Johns Hopkins University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2022-03-10
• Study First Submitted QC: 2022-03-17
• Study First Posted: 2022-03-22
• Study Start: 2023-04-22
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-18
• Last Update Posted: 2024-03-19
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Children (age: 4 - 17 years old) who stay at Epilepsy Monitoring Units (EMU) up to 7 days may join.

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Exclusion Criteria

• Non-English Speaking

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Children with Epilepsy	Music Stimuli	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.

Primary Outcome Measures

Name	Time	Method
Change in the frequency of epileptiform discharges (number of seconds with spikes)	Epilepsy Monitoring Units Stay (up to Day 7)	The number of seconds with spikes will be measured.
Change in the frequency of epileptiform discharges (number of spikes)	Epilepsy Monitoring Units Stay (up to Day 7)	The number of spikes in 100 seconds will be counted.

Secondary Outcome Measures

Name	Time	Method
Change in heart rate variability (HRV)	Epilepsy Monitoring Units Stay (up to Day 7)	Heart rate variability (HRV) is the fluctuation in the time (ms) intervals between adjacent heartbeats.
Change in blood pressure variability (BPV)	Epilepsy Monitoring Units Stay (up to Day 7)	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.

Trial Locations

Locations (1)

Johns Hopkins School of Medicine; 🇺🇸 Baltimore, Maryland, United States