The Effect of Music Periodicity on Interictal Epileptiform Discharges

Sponsor
Medical University of South Carolina (Other)
Overall Status
Completed
CT.gov ID
NCT01515436
Collaborator
(none)
10
1
2
46
0.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Mozart alternating with Beethoven
  • Other: Beethoven alternating with Mozart
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
Randomized
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
A Randomized, Single-Blinded Clinical Trial: The Effect of Music Periodicity on Interictal Epileptiform Discharges
Study Start Date :
Feb 1, 2004
Actual Primary Completion Date :
May 1, 2004
Actual Study Completion Date :
Dec 1, 2007

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

Other: 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.

Active Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    5 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical University of South Carolina Charleston South Carolina United States 29425

    Sponsors and Collaborators

    • Medical University of South Carolina

    Investigators

    • Principal Investigator: Robert P Turner, MD, MSCR, Medical University of South Carolina

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Robert P. Turner, Dr. Robert Turner, Medical University of South Carolina
    ClinicalTrials.gov Identifier:
    NCT01515436
    Other Study ID Numbers:
    • HR11247
    First Posted:
    Jan 24, 2012
    Last Update Posted:
    Jan 24, 2012
    Last Verified:
    Jan 1, 2012
    Keywords provided by Robert P. Turner, Dr. Robert Turner, Medical University of South Carolina
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 24, 2012