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Clinical Trials/NCT05289934
NCT05289934RecruitingNot Applicable

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

Johns Hopkins University1 site in 1 country10 target enrollmentStarted: April 22, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
10
Locations
1
Primary Endpoint
Change in the frequency of epileptiform discharges (number of seconds with spikes)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
4 Years to 17 Years (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

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.

Intervention: Music Stimuli (Behavioral)

Outcomes

Primary Outcomes

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.

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.

Secondary Outcomes

  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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