SeizureNCT01892605
The Clinical Application and Mechanism of Music Therapy (Mozart's Effect) on Epilepsy
A study testing music listening in people with Seizure, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Seizure
- What is being tested?
- music listening
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTaiwan
- Study dates
- Apr 2009to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- children who had epileptiform discharges with first unprovoked seizure
Who cannot join
- epileptic children without epileptiform discharges
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Seizure
- Being tested
- music listening
- Keywords
- Mozart K.448, first unprovoked seizure, epileptiform discharges, music therapy, children
- Medical subject headings
- Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
music listeningBehavioural
The treatment group listened to Mozart K.448 for eight minutes once daily before bedtime for at least six months.
| Study group | Role | What they receive |
|---|---|---|
| music listening, no music | Experimental | 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 Receives: Behavioral: music listening |
What is being measured
The primary outcome is the main question the study is designed to answer.
estimate seizure recurrence rate by Kaplan-Meier estimates
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2013 (estimated)
- Study startApr 2009
- Primary completionOct 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for SeizureStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lung-Chang Lin, PhD, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01892605
- Sponsor's protocol ID
- KMU-IRB-970391
- Status last verified
- Jul 2013
- First submitted
- 19 Jun 2013
- Last updated
- 4 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 21689988Lin 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.
PubMed 24410973
Study at a glance
From the registry record, last updated by the sponsor on 4 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Application and Mechanism of Music Therapy (Mozart's Effect) on Epilepsy
- ClinicalTrials.gov ID
- NCT01892605
- Acronym / sponsor ID
- KMU-IRB-970391
- Conditions
- Seizure
- Keywords
- Mozart K.448, first unprovoked seizure, epileptiform discharges, music therapy, children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 4 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| music listening, no music | Experimental | Behavioral: music listeningThe 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 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- children who had epileptiform discharges with first unprovoked seizure
Key exclusion criteria (1 listed)
- epileptic children without epileptiform discharges
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| music listeningThe treatment group listened to Mozart K.448 for eight minutes once daily before bedtime for at least six months. | Behavioural | music listening, no music |
Primary outcome
estimate seizure recurrence rate by Kaplan-Meier estimates
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jul 2013.
- Background: PubMed 21689988Lin 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.
- Derived from this study: PubMed 24410973Lin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lung-Chang Lin, PhD principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing music listening in people with Seizure, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
estimate seizure recurrence rate by Kaplan-Meier estimates (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01892605, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jul 2013.