The Clinical Application and Mechanism of Music Therapy (Mozart's Effect) on Epilepsy
Primary Purpose
Seizure
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
music listening
Sponsored by
About this trial
This is an interventional treatment trial for Seizure focused on measuring Mozart K.448, first unprovoked seizure, epileptiform discharges, music therapy, children
Eligibility Criteria
Inclusion Criteria:
- children who had epileptiform discharges with first unprovoked seizure
Exclusion Criteria:
- epileptic children without epileptiform discharges
Sites / Locations
- Kaohsiung Medical University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
music listening, no music
Arm Description
The clinical application and mechanism of music therapy The clinical application and mechanism of music therapy (Mozart's effect) on epilepsy (Mozart's effect) on epilepsy
Outcomes
Primary Outcome Measures
estimate seizure recurrence rate by Kaplan-Meier estimates
Secondary Outcome Measures
Full Information
NCT ID
NCT01892605
First Posted
June 19, 2013
Last Updated
July 1, 2013
Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01892605
Brief Title
The Clinical Application and Mechanism of Music Therapy (Mozart's Effect) on Epilepsy
Official Title
The Clinical Application and Mechanism of Music Therapy (Mozart's Effect) on Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kaohsiung Medical University Chung-Ho Memorial Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Music has a long history in healing physical and mental illness. The Mozart effect was initially reported by Rauscher, Shaw, and Ky in the journal of "Nature" in the year of 1993. They examined performance on Stanford-Binet spatial tasks immediately following either 10 minutes of listening to Mozart's sonata K.448, silence, or instruction to relax. They found the performance scores were 9 point higher in Mozart-listening group than other two groups. Later, the beneficial influence of Mozart music on parkinson's disease, epilepsy, senile dementia, and attention-deficit/hyperactivity disorder was reported. However, the real neurophysiological mechanism of the influence remains unclear.
Epilepsy is a common disorder in the field of pediatric neurology. Although we had greatly advanced in develop of new anticonvulsant, thirty percent of patients with epilepsy have drug-resistance, which is associated with an increased risk of debilitating psychosocial consequences. In addition, the adverse effects of anticonvulsants are not uncommon. Few reports demonstrated that patients exposed to Mozart's music can significantly decrease in seizure frequencies and interictal epileptiform discharge. However, the case number of these studies was limited and the mechanisms of music therapy on epilepsy were not well known. In our recent studies, Mozart's music indeed decreased the epileptifrom discharge in the patients with epilepsy, particularly in the patients with generalized discharge and central discharge. On the basis of these encouraging results, we will try to investigate the neural mechanisms and clinical applications of music therapy in the following three years.
In the first year of our study, we use animal model to examine the possible mechanism of Mozart's effect. The aim of the second year study is investigation the effect of music on the cortical functions in the epileptic rat model. According to our previous study, Mozart's sonata K.448 was effective in reducing epileptiform discharge. On the basis of previous two-year results, the patients with epilepsy will be enrolled in the third year project to perform an individualized music therapy. In this study, we can provide an alternative therapy in the patients of epilepsy and investigate the possible biological mechanism of music effect.
Detailed Description
Children with first unprovoked seizure were investigated.Patients were randomly classified into treatment and control groups. They did not receive AED after their first unprovoked seizure. The treatment group listened to Mozart K.448 for eight minutes once daily before bedtime for at least six months.All of the patients received follow-up telephone calls monthly. Patients who experienced seizure recurrence were advised to begin AED treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seizure
Keywords
Mozart K.448, first unprovoked seizure, epileptiform discharges, music therapy, children
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
music listening, no music
Arm Type
Experimental
Arm Description
The clinical application and mechanism of music therapy The clinical application and mechanism of music therapy (Mozart's effect) on epilepsy (Mozart's effect) on epilepsy
Intervention Type
Behavioral
Intervention Name(s)
music listening
Intervention Description
The treatment group listened to Mozart K.448 for eight minutes once daily before bedtime for at least six months.
Primary Outcome Measure Information:
Title
estimate seizure recurrence rate by Kaplan-Meier estimates
Time Frame
up to 24 months
10. Eligibility
Sex
All
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
children who had epileptiform discharges with first unprovoked seizure
Exclusion Criteria:
epileptic children without epileptiform discharges
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lung-Chang Lin, PhD
Organizational Affiliation
Kaohsiung Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaohsiung Medical University Hospital
City
Kaohsiung
ZIP/Postal Code
807
Country
Taiwan
12. IPD Sharing Statement
Citations:
PubMed Identifier
21689988
Citation
Lin LC, Lee WT, Wu HC, Tsai CL, Wei RC, Mok HK, Weng CF, Lee MW, Yang RC. The long-term effect of listening to Mozart K.448 decreases epileptiform discharges in children with epilepsy. Epilepsy Behav. 2011 Aug;21(4):420-4. doi: 10.1016/j.yebeh.2011.05.015.
Results Reference
background
PubMed Identifier
24410973
Citation
Lin LC, Lee MW, Wei RC, Mok HK, Yang RC. Mozart K.448 listening decreased seizure recurrence and epileptiform discharges in children with first unprovoked seizures: a randomized controlled study. BMC Complement Altern Med. 2014 Jan 13;14:17. doi: 10.1186/1472-6882-14-17.
Results Reference
derived
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The Clinical Application and Mechanism of Music Therapy (Mozart's Effect) on Epilepsy
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