Prevention of Photoparoxysmal Abnormalities by Mozart K448
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|ClinicalTrials.gov Identifier: NCT01363154|
Recruitment Status : Terminated (terminated)
First Posted : June 1, 2011
Last Update Posted : June 4, 2013
|Condition or disease||Intervention/treatment||Phase|
|Photoparoxysmal Abnormalities Epilepsy Seizures||Other: Mozart K448 Other: Beethoven's Für Elise Other: No music exposure||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prevention of Photoparoxysmal Abnormalities Through Patterned Auditory Stimulation|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
Active Comparator: Mozart K448
Treatment: music exposure to Mozart K448
Other: Mozart K448
Subjects will receive auditory stimulation by exposure to Mozart's Sonata for Two Pianos in D Major, K448.
Other Name: Mozart's Sonata for Two Pianos in D Major, K448
Placebo Comparator: Beethoven's Für Elise
Placebo: music exposure to Beethoven's Für Elise for piano
Other: Beethoven's Für Elise
Subjects will receive auditory stimulation by exposure to Beethoven's Für Elise.
Other: No music exposure
Subject's will not receive an intervention and will therefore, not receive auditory stimulation and/or exposure to music.
Other Name: Control: No music exposure.
No Intervention: No music exposure
Control: no music exposure
- Decreased duration (>25%) of photoparoxysmal response(s) during exposure to K-448 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01363154
|United States, South Carolina|
|Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Principal Investigator:||Robert P Turner, MD, MSCR||Medical University of South Carolina|
|Principal Investigator:||Mark Bodner, MD||MIND Institute|
|Study Director:||Lee Anne Tetrick, BS||Medical University of South Carolina|