Clinical trial NCT01363154: Prevention of Photoparoxysmal Abnormalities by Mozart K448
Official title: Prevention of Photoparoxysmal Abnormalities Through Patterned Auditory Stimulation
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Photoparoxysmal Abnormalities
Epilepsy
Seizures
Keywords: Children's Health
Pediatrics
Epilepsy
Photoparoxysmal
Photosensitive
Music
Mozart
K-448
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2011-06-01
Enrollment: 10
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Decreased duration (>25%) of photoparoxysmal response(s) during exposure to K-448
timeFrame: Each participant will have a single one hour EEG for data aquistition.
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Robert P Turner, MD, MSCR
role: PRINCIPAL_INVESTIGATOR
affiliation: MIND Institute
name: Mark Bodner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical University of South Carolina
name: Lee Anne Tetrick, BS
role: STUDY_DIRECTOR
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