Prevention of Photoparoxysmal Abnormalities by Mozart K448

Not Applicable

Terminated

• Conditions: Photoparoxysmal Abnormalities; Epilepsy; Seizures
• Interventions: Other: Mozart K448; Other: Beethoven's Für Elise; Other: No music exposure

• Registration Number: NCT01363154
• Lead Sponsor: Medical University of South Carolina

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:

1. Treatment: music exposure to Mozart K448, vs.

2. Placebo: music exposure to Beethoven's Für Elise for piano, vs.

3. Control: no music exposure.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-05-27
• Study First Submitted QC: 2011-05-27
• Study First Posted: 2011-06-01
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-02
• Last Update Posted: 2013-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mozart K448	Mozart K448	Treatment: music exposure to Mozart K448
Beethoven's Für Elise	Beethoven's Für Elise	Placebo: music exposure to Beethoven's Für Elise for piano
Beethoven's Für Elise	No music exposure	Placebo: music exposure to Beethoven's Für Elise for piano

Primary Outcome Measures

Name	Time	Method
Decreased duration (>25%) of photoparoxysmal response(s) during exposure to K-448	Each participant will have a single one hour EEG for data aquistition.	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.

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States