Effects of Recorded Music on Clinical and EEG Seizure Activity

NCT ID: NCT05289934

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-22
• Study Completion Date: 2026-03-01

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.

Conditions

Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Music Stimuli

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sarah Kelley, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Sarah Kelley, MD

Role: CONTACT

saminof1@jhmi.edu

4109559100

Facility Contacts

Sarah Kelley, MD

Role: primary

saminof1@jhmi.edu

410-955-9100

References

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.

Reference Type: BACKGROUND

PMID: 29034226 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29040398 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29696618 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31488774 (View on PubMed)

Other Identifiers

IRB00260509

Identifier Type: -

Identifier Source: org_study_id