Effects of Recorded Music on Clinical and EEG Seizure Activity
Primary Purpose
Epilepsy
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Music Stimuli
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Epilepsy, Electroencephalography (EEG), Music
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
Sites / Locations
- Johns Hopkins School of MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Children with Epilepsy
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in the frequency of epileptiform discharges (number of spikes)
The number of spikes in 100 seconds will be counted.
Change in the frequency of epileptiform discharges (number of seconds with spikes)
The number of seconds with spikes will be measured.
Secondary Outcome Measures
Change in heart rate variability (HRV)
Heart rate variability (HRV) is the fluctuation in the time (ms) intervals between adjacent heartbeats.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05289934
Brief Title
Effects of Recorded Music on Clinical and EEG Seizure Activity
Official Title
Effects of Recorded Music on Clinical and Electroencephalography (EEG) Seizure Activity
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2023 (Actual)
Primary Completion Date
March 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
Epilepsy, Electroencephalography (EEG), Music
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Children with Epilepsy
Arm Type
Experimental
Arm Description
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 Type
Behavioral
Intervention Name(s)
Music Stimuli
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in the frequency of epileptiform discharges (number of spikes)
Description
The number of spikes in 100 seconds will be counted.
Time Frame
Epilepsy Monitoring Units Stay (up to Day 7)
Title
Change in the frequency of epileptiform discharges (number of seconds with spikes)
Description
The number of seconds with spikes will be measured.
Time Frame
Epilepsy Monitoring Units Stay (up to Day 7)
Secondary Outcome Measure Information:
Title
Change in heart rate variability (HRV)
Description
Heart rate variability (HRV) is the fluctuation in the time (ms) intervals between adjacent heartbeats.
Time Frame
Epilepsy Monitoring Units Stay (up to Day 7)
Title
Change in blood pressure variability (BPV)
Description
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.
Time Frame
Epilepsy Monitoring Units Stay (up to Day 7)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Kelley, MD
Phone
4109559100
Email
saminof1@jhmi.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Kelley, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Kelley, MD
Phone
410-955-9100
Email
saminof1@jhmi.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29034226
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.
Results Reference
background
PubMed Identifier
29040398
Citation
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.
Results Reference
background
PubMed Identifier
29696618
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.
Results Reference
background
PubMed Identifier
31488774
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.
Results Reference
background
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Effects of Recorded Music on Clinical and EEG Seizure Activity
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