Effects of Recorded Music on Clinical and EEG Seizure Activity

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05289934
• Other study ID #: IRB00260509
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2023
• Est. completion date: March 1, 2025

Study information

• Verified date: March 2024
• Source: Johns Hopkins University
• Contact: Sarah Kelley, MD
• Phone: 4109559100
• Email: saminof1[@]jhmi.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Seizures

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins School of Medicine	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Johns Hopkins University

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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	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)
Secondary	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)