NCT01515436

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2004

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2004

Completed
3.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 24, 2012

Completed
Last Updated

January 24, 2012

Status Verified

January 1, 2012

Enrollment Period

3 months

First QC Date

January 18, 2012

Last Update Submit

January 23, 2012

Conditions

Rolandic EpilepsyBenign Childhood Epilepsy With Centrotemporal SpikesEpilepsySeizures

Keywords

Rolandic EpilepsyBenign Childhood Epilepsy with Centrotemporal Spikes (BCECTS)EpilepsySeizuresMusicMozartBeethoven

Study Arms (2)

Mozart alternating with Beethoven

ACTIVE COMPARATOR

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

Beethoven alternating with Mozart

ACTIVE COMPARATOR

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

Interventions

Mozart alternating with BeethovenOTHER

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

Mozart alternating with Beethoven
Beethoven alternating with MozartOTHER

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

Beethoven alternating with Mozart

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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) \[Range 0-2 AEDs\]

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Epilepsy, RolandicEpilepsySeizures

Condition Hierarchy (Ancestors)

Epilepsies, PartialBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic SyndromesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Robert P Turner, MD, MSCR

    Medical University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Robert Turner

Study Record Dates

First Submitted

January 18, 2012

First Posted

January 24, 2012

Study Start

February 1, 2004

Primary Completion

May 1, 2004

Study Completion

December 1, 2007

Last Updated

January 24, 2012

Record last verified: 2012-01

Locations

US(1)