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RecruitingNCT05289934

Effects of Recorded Music on Clinical and EEG Seizure Activity

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
10 (estimated)
Sponsor
Johns Hopkins University · Academic / Other
Sex
All
Age
4 Years – 17 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALMusic StimuliNine-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.

Timeline

Start date
2023-04-22
Primary completion
2027-03-01
Completion
2027-03-01
First posted
2022-03-22
Last updated
2026-03-06

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT05289934. Inclusion in this directory is not an endorsement.