Effects of Recorded Music on Clinical and EEG Seizure Activity

NCT05289934 | Recruiting

• 1 other identifier: IRB00260509
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Keywords

Epilepsy; Electroencephalography (EEG); Music

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in heart rate variability (HRV)

  Epilepsy Monitoring Units Stay (up to Day 7)

• Change in blood pressure variability (BPV)

  Epilepsy Monitoring Units Stay (up to Day 7)

Study Arms (1)

Children with Epilepsy

EXPERIMENTAL

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

Interventions

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.

Children with Epilepsy

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• Non-English Speaking

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

RECRUITING

Related Publications (4)

• 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.

  PMID: 29034226 BACKGROUND

• 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.

  PMID: 29040398 BACKGROUND

• 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.

  PMID: 29696618 BACKGROUND

• 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.

  PMID: 31488774 BACKGROUND

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Sarah Kelley, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Kelley, MD

CONTACT

4109559100; saminof1@jhmi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 22, 2022
• Study Start: April 22, 2023
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)