Prevention of Photoparoxysmal Abnormalities by Mozart K448

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prevention of Photoparoxysmal Abnormalities Through Patterned Auditory Stimulation

Conditions
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Photoparoxysmal Abnormalities, Epilepsy, Seizures

Intervention / Treatment
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* Other: Mozart K448
* Other: Beethoven's Für Elise
* Other: No music exposure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Mozart K448<br>Treatment: music exposure to Mozart K448 | Other: Mozart K448<br>* Subjects will receive auditory stimulation by exposure to Mozart's Sonata for Two Pianos in D Major, K448.<br>* Other names: Mozart's Sonata for Two Pianos in D Major, K448;|
| Placebo Comparator: Beethoven's Für Elise<br>Placebo: music exposure to Beethoven's Für Elise for piano | Other: Beethoven's Für Elise<br>* Subjects will receive auditory stimulation by exposure to Beethoven's Für Elise.<br>Other: No music exposure<br>* Subject's will not receive an intervention and will therefore, not receive auditory stimulation and/or exposure to music.<br>* Other names: Control: No music exposure.;|
| No Intervention: No music exposure<br>Control: no music exposure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Each participant will have a single one hour EEG for data aquistition. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Children's Health, Pediatrics, Epilepsy, Photoparoxysmal, Photosensitive, Music, Mozart, K-448