The Effect of Music Periodicity on Interictal Epileptiform Discharges

NCT ID: NCT01515436

Last Updated: 2012-01-24

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2007-12-31

Brief Summary

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The purpose of this study is to determine if having children listen to the music of Wolfgang Amadeus Mozart (Sonata for Two Pianos in D Major, K. 448) will lessen the amount of spike discharges on his/her Electroencephalography (EEG). These spike discharges often occur during a 24 hour period in the EEG of a child with Benign Childhood Epilepsy with Centrotemporal Spikes (BCECTS), or Rolandic Epilepsy. Should there be a decrease in the amount of spike discharges after listening to Mozart's music, this information may lead to new understanding and possible treatments for epilepsy.

Detailed Description

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Conditions

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Rolandic Epilepsy Benign Childhood Epilepsy With Centrotemporal Spikes Epilepsy Seizures

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Mozart alternating with Beethoven

Study participants will listen to Mozart's Sonata for Two Pianos in D Major, K. 448 alternating with Beethoven's Fur Elise.

Group Type ACTIVE_COMPARATOR

Mozart alternating with Beethoven

Intervention Type OTHER

Study participants will listen to Mozart's Sonata for Two Pianos in D Major, K. 448 alternating with Beethoven's Fur Elise.

Beethoven alternating with Mozart

Study participants will listen to Beethoven's Fur Elise alternating with Mozart's Sonata for Two Pianos in D Major, K. 448.

Group Type ACTIVE_COMPARATOR

Beethoven alternating with Mozart

Intervention Type OTHER

Study participants will listen to Beethoven's Fur Elise alternating with Mozart's Sonata for Two Pianos in D Major, K. 448.

Interventions

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Mozart alternating with Beethoven

Study participants will listen to Mozart's Sonata for Two Pianos in D Major, K. 448 alternating with Beethoven's Fur Elise.

Intervention Type OTHER

Beethoven alternating with Mozart

Study participants will listen to Beethoven's Fur Elise alternating with Mozart's Sonata for Two Pianos in D Major, K. 448.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Female or male with BCECTS clinical history, and at least one seizure, as defined by the International League Against Epilepsy.
* EEG consistent with features of BCECTS: centrotemporal (rolandic) interictal spike discharges (ISDs) with otherwise normal background interictal EEG
* Screening neurological examination normal (by PI or other pediatric neurologist in the Division of Pediatric Neurology at MUSC)
* Age 5-12 years, inclusive
* On less than or equal to 2 anti-epileptic drugs (AED) \[Range 0-2 AEDs\]

Exclusion Criteria

* Currently taking Clonazepam or other Benzodiazepines
* Inability to complete 12 hour admission and comply with study protocol
* Prohibited Therapy or Activities During Study Period: Use of computer or video games. Viewing of video tapes will be prohibited due to potential effect of music in videos on underlying process of study.
* Due to the confounding factor of probably suppression of IEDs after a clinical seizure, any subject experiencing a seizure of any duration 24 hours prior to beginning the study will be excluded from the study.
* For any subject experiencing a seizure during the study, data analysis will cease from that point onward.
Minimum Eligible Age

5 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical University of South Carolina

OTHER

Sponsor Role lead

Responsible Party

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Robert P. Turner

Dr. Robert Turner

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert P Turner, MD, MSCR

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Locations

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Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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HR11247

Identifier Type: -

Identifier Source: org_study_id

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