The Effect of Music Periodicity on Interictal Epileptiform Discharges

Epilepsy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01515436
• Other study ID #: HR11247
• Status: Completed
• Phase: N/A
• First received: January 18, 2012
• Last updated: January 23, 2012
• Start date: February 2004
• Est. completion date: December 2007

Study information

• Verified date: January 2012
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2007
• Est. primary completion date: May 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 12 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Benign Childhood Epilepsy With Centrotemporal Spikes
• Epilepsy
• Epilepsy, Rolandic
• Rolandic Epilepsy
• Seizures

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States,