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The Effect of Music Periodicity on Interictal Epileptiform Discharges

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Robert P. Turner, Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT01515436
First received: January 18, 2012
Last updated: January 23, 2012
Last verified: January 2012
  Purpose

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 Intervention
Rolandic Epilepsy
Benign Childhood Epilepsy With Centrotemporal Spikes
Epilepsy
Seizures
Other: Mozart alternating with Beethoven
Other: Beethoven alternating with Mozart

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Single-Blinded Clinical Trial: The Effect of Music Periodicity on Interictal Epileptiform Discharges

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Enrollment: 10
Study Start Date: February 2004
Study Completion Date: December 2007
Primary Completion Date: May 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   5 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01515436

Locations
United States, South Carolina
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
  More Information

No publications provided

Responsible Party: Robert P. Turner, Dr. Robert Turner, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01515436     History of Changes
Other Study ID Numbers: HR11247
Study First Received: January 18, 2012
Last Updated: January 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
Rolandic Epilepsy
Benign Childhood Epilepsy with Centrotemporal Spikes (BCECTS)
Epilepsy
Seizures
Music
Mozart
Beethoven

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Rolandic
Seizures
Brain Diseases
Central Nervous System Diseases
Epilepsies, Partial
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on November 25, 2014