The Clinical Application and Mechanism of Music Therapy (Mozart's Effect) on Epilepsy

NCT ID: NCT01892605

Last Updated: 2013-07-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Seizure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

music listening

Intervention Type BEHAVIORAL

The treatment group listened to Mozart K.448 for eight minutes once daily before bedtime for at least six months.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

music listening

The treatment group listened to Mozart K.448 for eight minutes once daily before bedtime for at least six months.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* children who had epileptiform discharges with first unprovoked seizure

Exclusion Criteria

* epileptic children without epileptiform discharges
Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Kaohsiung Medical University Chung-Ho Memorial Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lung-Chang Lin, PhD

Role: PRINCIPAL_INVESTIGATOR

Kaohsiung Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Kaohsiung Medical University Hospital

Kaohsiung City, , Taiwan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 21689988 (View on PubMed)

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.

Reference Type DERIVED
PMID: 24410973 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KMU-IRB-970391

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.