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NCT Number: NCT05289934

Effects of Recorded Music on Clinical and EEG Seizure Activity

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

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

4 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

Location status: Recruiting

Location contact

Sarah Kelley, MD

CONTACT

[email protected]

410-955-9100

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Music Stimuli

Behavioral

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.

Primary outcomes

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

    Time frame: Epilepsy Monitoring Units Stay (up to Day 7)

    The number of spikes in 100 seconds will be counted.

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

    Time frame: Epilepsy Monitoring Units Stay (up to Day 7)

    The number of seconds with spikes will be measured.

Secondary outcomes

  1. Change in heart rate variability (HRV)

    Time frame: Epilepsy Monitoring Units Stay (up to Day 7)

    Heart rate variability (HRV) is the fluctuation in the time (ms) intervals between adjacent heartbeats.

  2. Change in blood pressure variability (BPV)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sarah Kelley, MD

CONTACT

[email protected]

4109559100

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 22, 2022
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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