- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01892605
The Clinical Application and Mechanism of Music Therapy (Mozart's Effect) on Epilepsy
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.
Study Overview
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kaohsiung, Taiwan, 807
- Kaohsiung Medical University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- children who had epileptiform discharges with first unprovoked seizure
Exclusion Criteria:
- epileptic children without epileptiform discharges
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: music listening, no music
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
|
The treatment group listened to Mozart K.448 for eight minutes once daily before bedtime for at least six months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
estimate seizure recurrence rate by Kaplan-Meier estimates
Time Frame: up to 24 months
|
up to 24 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lung-Chang Lin, PhD, Kaohsiung Medical University
Publications and helpful links
General Publications
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KMU-IRB-970391
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Seizure
-
Assiut UniversityNot yet recruitingNewly Diagnosed Epilepsy With Focus on Seizure Frequency at Onset and Long-term Seizure Control
-
Rapport Therapeutics Inc.RecruitingEpilepsy | Focal Epilepsy | Focal Onset Seizure | Seizure | Refractory Focal Epilepsy | Focal SeizureUnited States
-
Dartmouth-Hitchcock Medical CenterCompletedDepression | Non-Epileptic Seizure | Psychogenic Non-Epileptic Seizure | Psychogenic SeizureUnited States
-
First Affiliated Hospital of Wenzhou Medical UniversityNingbo Medical Center Lihuili Hospital; The Central Hospital of Lishui City; Ningbo... and other collaboratorsNot yet recruitingPost-stroke Seizure | Post-stroke EpilepsyChina
-
Michael A. Gelfand, MD, PhDEpilepsy FoundationCompletedGeneralized Tonic Clonic Seizure | Drug Resistant Epilepsy | Drop Seizures | Complex Partial Seizure | Fall Due to SeizureUnited States
-
Children's Hospital of Fudan UniversityRecruitingSeizures | Seizure Disorder | Seizure Newborn | Seizure GeneralizedChina
-
Vitaflo International, LtdChildren's Hospital of PhiladelphiaCompletedSeizure DisordersUnited States
-
Pakistan Air Force (PAF) Hospital IslamabadCompletedSeizure Disorder Generalized Tonic ClonicPakistan
-
Pfizer's Upjohn has merged with Mylan to form Viatris...CompletedEpilepsy | Epilepsies, Partial | Partial Seizure Disorder | Complex Partial Seizure DisorderCosta Rica, Peru, El Salvador, Guatemala
-
Brain SentinelUnknownEpilepsy | Non-Epileptic Seizure | Motor SeizureAustria
Clinical Trials on music listening
-
Anglia Ruskin UniversityCompletedDepression | Stress | Anxiety | Visual Impairment | Low Vision | Emotional AdjustmentUnited Kingdom
-
Inonu UniversityCompletedCancer | ChemotherapyTurkey
-
Cliniques universitaires Saint-Luc- Université...Completed
-
Selcuk UniversityCompletedPostoperative Pain | Cesarean Section; DehiscenceTurkey (Türkiye)
-
Aydin Adnan Menderes UniversityCompletedPain | Anxiety | Nurse's RoleTurkey
-
Erasmus Medical CenterCompleted
-
University of British ColumbiaNortheastern UniversityRecruiting
-
Turku University HospitalAcademy of FinlandCompleted
-
New York UniversityRecruiting
-
The Hong Kong Polytechnic UniversityCompleted