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The Effect of Music Periodicity on Interictal Epileptiform Discharges

Primary Purpose

Rolandic Epilepsy, Benign Childhood Epilepsy With Centrotemporal Spikes, Epilepsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mozart alternating with Beethoven
Beethoven alternating with Mozart
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rolandic Epilepsy focused on measuring Rolandic Epilepsy, Benign Childhood Epilepsy with Centrotemporal Spikes (BCECTS), Epilepsy, Seizures, Music, Mozart, Beethoven

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Mozart alternating with Beethoven

Beethoven alternating with Mozart

Arm Description

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

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
January 18, 2012
Last Updated
January 23, 2012
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT01515436
Brief Title
The Effect of Music Periodicity on Interictal Epileptiform Discharges
Official Title
A Randomized, Single-Blinded Clinical Trial: The Effect of Music Periodicity on Interictal Epileptiform Discharges
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
May 2004 (Actual)
Study Completion Date
December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of South Carolina

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rolandic Epilepsy, Benign Childhood Epilepsy With Centrotemporal Spikes, Epilepsy, Seizures
Keywords
Rolandic Epilepsy, Benign Childhood Epilepsy with Centrotemporal Spikes (BCECTS), Epilepsy, Seizures, Music, Mozart, Beethoven

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Masking
Investigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mozart alternating with Beethoven
Arm Type
Active Comparator
Arm Description
Study participants will listen to Mozart's Sonata for Two Pianos in D Major, K. 448 alternating with Beethoven's Fur Elise.
Arm Title
Beethoven alternating with Mozart
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Mozart alternating with Beethoven
Intervention Description
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
Intervention Name(s)
Beethoven alternating with Mozart
Intervention Description
Study participants will listen to Beethoven's Fur Elise alternating with Mozart's Sonata for Two Pianos in D Major, K. 448.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert P Turner, MD, MSCR
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States

12. IPD Sharing Statement

Learn more about this trial

The Effect of Music Periodicity on Interictal Epileptiform Discharges

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