The Effect of Music Periodicity on Interictal Epileptiform Discharges

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Randomized, Single-Blinded Clinical Trial: The Effect of Music Periodicity on Interictal Epileptiform Discharges

Conditions
-----------------
Rolandic Epilepsy, Benign Childhood Epilepsy With Centrotemporal Spikes, Epilepsy, Seizures

Intervention / Treatment
-----------------
* Other: Mozart alternating with Beethoven
* Other: Beethoven alternating with Mozart


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mozart alternating with Beethoven<br>Study participants will listen to Mozart's Sonata for Two Pianos in D Major, K. 448 alternating with Beethoven's Fur Elise. | Other: Mozart alternating with Beethoven<br>* Study participants will listen to Mozart's Sonata for Two Pianos in D Major, K. 448 alternating with Beethoven's Fur Elise.<br>|
| Active Comparator: Beethoven alternating with Mozart<br>Study participants will listen to Beethoven's Fur Elise alternating with Mozart's Sonata for Two Pianos in D Major, K. 448. | Other: Beethoven alternating with Mozart<br>* Study participants will listen to Beethoven's Fur Elise alternating with Mozart's Sonata for Two Pianos in D Major, K. 448.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rolandic Epilepsy, Benign Childhood Epilepsy with Centrotemporal Spikes (BCECTS), Epilepsy, Seizures, Music, Mozart, Beethoven