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Prevention of Photoparoxysmal Abnormalities by Mozart K448

Primary Purpose

Photoparoxysmal Abnormalities, Epilepsy, Seizures

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mozart K448
Beethoven's Für Elise
No music exposure
Sponsored by
Medical University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Photoparoxysmal Abnormalities focused on measuring Children's Health, Pediatrics, Epilepsy, Photoparoxysmal, Photosensitive, Music, Mozart, K-448

Eligibility Criteria

5 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 5-17 years, inclusive
  • Female or male with photoparoxysmal epilepsy clinical history, and at least one seizure, as defined by the International League Against Epilepsy (International Classification of Epilepsies and Epileptic Syndromes; Commission on Classification and Terminology of the International League Against Epilepsy 1989)
  • Abnormal EEG consistent with features of photoparoxysmal epilepsy: occipital based epileptiform abnormalities with otherwise normal background interictal EEG;
  • On < or equal to 2 anti-seizure medications [range 0-2 AEDs]

Exclusion Criteria:

  • History of a generalized convulsion provoked by photic stimulation;
  • Inability to complete and/or comply with study protocol

Sites / Locations

  • Medical University of South Carolina

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

No Intervention

Arm Label

Mozart K448

Beethoven's Für Elise

No music exposure

Arm Description

Treatment: music exposure to Mozart K448

Placebo: music exposure to Beethoven's Für Elise for piano

Control: no music exposure

Outcomes

Primary Outcome Measures

Decreased duration (>25%) of photoparoxysmal response(s) during exposure to K-448
Each participant will have a single one hour EEG for data aquistition. The recorded EEG data will be analyzed to determine significant causal reductions or prevention of photoparoxysmal responses resulting from the auditory stimulation, along with determining all induced patterns of cortical activation.

Secondary Outcome Measures

Full Information

First Posted
May 27, 2011
Last Updated
June 2, 2013
Sponsor
Medical University of South Carolina
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1. Study Identification

Unique Protocol Identification Number
NCT01363154
Brief Title
Prevention of Photoparoxysmal Abnormalities by Mozart K448
Official Title
Prevention of Photoparoxysmal Abnormalities Through Patterned Auditory Stimulation
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Terminated
Why Stopped
terminated
Study Start Date
November 2010 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
February 2013 (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
Yes

5. Study Description

Brief Summary
The purpose of this clinical trial is to examine the effect of non-invasive cortical activation by specific patterned auditory stimulation (Mozart K448- Piano Sonata for Two Hands in D Major), in altering or eliminating photoparoxysmal abnormalities. Recent work has indicated that such evoked activity (i.e. by specific music) can result in significant reductions, or even complete termination of epileptiform activity and/or seizures across a broad range of individuals with epilepsy. A hypothesis is generated that specific music activation would beneficially effect photoparoxysmal based epileptiform abnormalities.
Detailed Description
Non-pharmacologic, non-surgical treatments for seizures and epilepsy are of increasing importance, given the potential side effects as well as lack of complete seizure control with such treatments. Based on previous studies demonstrating an anti-convulsant and anti-epileptiform effect achieved in subjects by music exposure, it is proposed that specific musical stimuli may causally result in widely distributed cortical activation in such a fashion as to effectively prevent or terminate epileptiform abnormalities in subjects with photosensitive epilepsy. We will investigate the effect of specific musical stimulation (Mozart K448) to reduce or prevent photoparoxysmal abnormalities in subjects. Primary outcome will be evaluated in 3 groups, assessing alteration/cessation of photic-induced abnormalities during: Treatment: music exposure to Mozart K448, vs. Placebo: music exposure to Beethoven's Für Elise for piano, vs. Control: no music exposure.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Photoparoxysmal Abnormalities, Epilepsy, Seizures
Keywords
Children's Health, Pediatrics, Epilepsy, Photoparoxysmal, Photosensitive, Music, Mozart, K-448

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mozart K448
Arm Type
Active Comparator
Arm Description
Treatment: music exposure to Mozart K448
Arm Title
Beethoven's Für Elise
Arm Type
Placebo Comparator
Arm Description
Placebo: music exposure to Beethoven's Für Elise for piano
Arm Title
No music exposure
Arm Type
No Intervention
Arm Description
Control: no music exposure
Intervention Type
Other
Intervention Name(s)
Mozart K448
Other Intervention Name(s)
Mozart's Sonata for Two Pianos in D Major, K448
Intervention Description
Subjects will receive auditory stimulation by exposure to Mozart's Sonata for Two Pianos in D Major, K448.
Intervention Type
Other
Intervention Name(s)
Beethoven's Für Elise
Intervention Description
Subjects will receive auditory stimulation by exposure to Beethoven's Für Elise.
Intervention Type
Other
Intervention Name(s)
No music exposure
Other Intervention Name(s)
Control: No music exposure.
Intervention Description
Subject's will not receive an intervention and will therefore, not receive auditory stimulation and/or exposure to music.
Primary Outcome Measure Information:
Title
Decreased duration (>25%) of photoparoxysmal response(s) during exposure to K-448
Description
Each participant will have a single one hour EEG for data aquistition. The recorded EEG data will be analyzed to determine significant causal reductions or prevention of photoparoxysmal responses resulting from the auditory stimulation, along with determining all induced patterns of cortical activation.
Time Frame
Each participant will have a single one hour EEG for data aquistition.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 5-17 years, inclusive Female or male with photoparoxysmal epilepsy clinical history, and at least one seizure, as defined by the International League Against Epilepsy (International Classification of Epilepsies and Epileptic Syndromes; Commission on Classification and Terminology of the International League Against Epilepsy 1989) Abnormal EEG consistent with features of photoparoxysmal epilepsy: occipital based epileptiform abnormalities with otherwise normal background interictal EEG; On < or equal to 2 anti-seizure medications [range 0-2 AEDs] Exclusion Criteria: History of a generalized convulsion provoked by photic stimulation; Inability to complete and/or comply with study protocol
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
First Name & Middle Initial & Last Name & Degree
Mark Bodner, MD
Organizational Affiliation
MIND Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lee Anne Tetrick, BS
Organizational Affiliation
Medical University of South Carolina
Official's Role
Study Director
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

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Prevention of Photoparoxysmal Abnormalities by Mozart K448

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