Ignite Creation Date:
2025-12-25 @ 3:20 AM
Ignite Modification Date:
2025-12-26 @ 1:58 AM
Study NCT ID:
NCT01892605
Status:
COMPLETED
Last Update Posted:
2013-07-04
First Post:
2013-06-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Clinical Application and Mechanism of Music Therapy (Mozart's Effect) on Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012640', 'term': 'Seizures'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-01', 'studyFirstSubmitDate': '2013-06-19', 'studyFirstSubmitQcDate': '2013-07-01', 'lastUpdatePostDateStruct': {'date': '2013-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'estimate seizure recurrence rate by Kaplan-Meier estimates', 'timeFrame': 'up to 24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Mozart K.448', 'first unprovoked seizure', 'epileptiform discharges', 'music therapy', 'children'], 'conditions': ['Seizure']}, 'referencesModule': {'references': [{'pmid': '21689988', 'type': 'BACKGROUND', '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.'}, {'pmid': '24410973', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nEpilepsy 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.\n\nIn 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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children who had epileptiform discharges with first unprovoked seizure\n\nExclusion Criteria:\n\n* epileptic children without epileptiform discharges'}, 'identificationModule': {'nctId': 'NCT01892605', 'briefTitle': "The Clinical Application and Mechanism of Music Therapy (Mozart's Effect) on Epilepsy", 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': "The Clinical Application and Mechanism of Music Therapy (Mozart's Effect) on Epilepsy", 'orgStudyIdInfo': {'id': 'KMU-IRB-970391'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'music listening, no music', '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", 'interventionNames': ['Behavioral: music listening']}], 'interventions': [{'name': 'music listening', 'type': 'BEHAVIORAL', 'description': 'The treatment group listened to Mozart K.448 for eight minutes once daily before bedtime for at least six months.', 'armGroupLabels': ['music listening, no music']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Lung-Chang Lin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaohsiung Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}