Prevention of Photoparoxysmal Abnormalities by Mozart K448

Sponsor

Medical University of South Carolina (Other)

Overall Status

Terminated

CT.gov ID

NCT01363154

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Photoparoxysmal Abnormalities Epilepsy Seizures	Other: Mozart K448 Other: Beethoven's Für Elise Other: No music exposure	N/A

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:

Treatment: music exposure to Mozart K448, vs.
Placebo: music exposure to Beethoven's Für Elise for piano, vs.
Control: no music exposure.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Prevention

Official Title:

Prevention of Photoparoxysmal Abnormalities Through Patterned Auditory Stimulation

Study Start Date :

Nov 1, 2010

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: Control: No music exposure.
No Intervention: No music exposure Control: no music exposure

Arm

Intervention/Treatment

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 Names:

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 Names:

Control: No music exposure.

No Intervention: No music exposure

Control: no music exposure

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 17 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical University of South Carolina	Charleston	South Carolina	United States	29425

Sponsors and Collaborators

Medical University of South Carolina

Investigators

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