Effects of Recorded Music on Clinical and EEG Seizure Activity

Effects of Recorded Music on Clinical and Electroencephalography (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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy
• Intervention / Treatment: Behavioral: Music Stimuli

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Kelley, MD; Phone Number: 4109559100; Email: saminof1@jhmi.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Recruiting
      • Johns Hopkins School of Medicine
      • Contact: Sarah Kelley, MD; Phone Number: 410-955-9100; Email: saminof1@jhmi.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Children with Epilepsy; 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; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Investigators: Principal Investigator: Sarah Kelley, MD, Johns Hopkins University

Publications and helpful links

General Publications

• Shaffer F, Ginsberg JP. An Overview of Heart Rate Variability Metrics and Norms. Front Public Health. 2017 Sep 28;5:258. doi: 10.3389/fpubh.2017.00258. eCollection 2017.
• Abellan-Huerta J, Prieto-Valiente L, Montoro-Garcia S, Abellan-Aleman J, Soria-Arcos F. Correlation of Blood Pressure Variability as Measured By Clinic, Self-measurement at Home, and Ambulatory Blood Pressure Monitoring. Am J Hypertens. 2018 Feb 9;31(3):305-312. doi: 10.1093/ajh/hpx183.
• Bedetti C, Principi M, Di Renzo A, Muti M, Frondizi D, Piccirilli M, D'Alessandro P, Marchiafava M, Baglioni A, Menna M, Gubbiotti M, Elisei S. The Effect of Mozart's Music in Severe Epilepsy: Functional and Morphological Features. Psychiatr Danub. 2019 Sep;31(Suppl 3):467-474.
• Hernando-Requejo V. [Epilepsy, Mozart and his sonata K.448: is the <<Mozart effect>> therapeutic?]. Rev Neurol. 2018 May 1;66(9):308-314. Spanish.

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2023
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: March 10, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 22, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Epilepsy; Music; Electroencephalography (EEG)
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures
• Other Study ID Numbers: IRB00260509

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No