Prevention of Photoparoxysmal Abnormalities by Mozart K448

Medical University of South Carolina (MUSC)

Status: Terminated

Conditions: Seizures; Epilepsy; Photoparoxysmal Abnormalities

Treatments: Other: Beethoven's Für Elise; Other: No music exposure; Other: Mozart K448

Study type: Interventional

Funder types: Other

Identifiers

NCT01363154

7683

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 5 to 17 years old

Volunteers: No 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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10 participants in 3 patient groups, including a placebo group

Mozart K448

Active Comparator group

Description:

Treatment: music exposure to Mozart K448

Treatment:

Other: Mozart K448

Beethoven's Für Elise

Placebo Comparator group

Description:

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

Treatment:

Other: No music exposure

Other: Beethoven's Für Elise

No music exposure

No Intervention group

Description:

Control: no music exposure