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Prevention of Photoparoxysmal Abnormalities by Mozart K448

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01363154
Recruitment Status : Terminated (terminated)
First Posted : June 1, 2011
Last Update Posted : June 4, 2013
Sponsor:
Information provided by (Responsible Party):
Robert P. Turner, 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.

Condition or disease Intervention/treatment Phase
Photoparoxysmal Abnormalities Epilepsy Seizures Other: Mozart K448 Other: Beethoven's Für Elise Other: No music exposure Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : November 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine


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 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



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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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
Publications:
Bodner M, Turner RP, Bowers C, Norment C (2009) Patterned auditory stimulus reduces seizure frequency in neurologically-impaired individuals. (submitted May 2010 to Epilepsia for publication)
CURE: Citizens United for Research in Epilepsy. Web. 04 Oct. 2010. <http://www.cureepilepsy.org/home.asp>.
Epilepsy Foundation of America. Web. 04 Oct. 2010. <https://efa.org/>.
Franaszczuk PJ, Kudela P, Bergey GK. External termination of recurrent bursting in a model of connected local neural sub-networks. Epilepsy Res. 2003;45(1-2):65-80.
Harding GF, Jeavons PM. Photosensitive Epilepsy. MacKeith Press, London, 1994.
Temkin O. The falling sickness: A history of epilepsy from the Greeks to the beginnings of modern neurology. Baltimore: Johns Hopkins University Press, 1971.
Turner RP, Bodner M, Wang L, Norment C, Bowers C, Zhou Y. The anti-epileptiform effect of acute auditory stimulation on Rolandic spikes: EEG spectral analysis and coherence in patients with Rolandic epilepsy. (2010 in preparation)
ILAE: International League Against Epilepsy. Web. 02 Oct. 2010. <http://www.ilae-epilepsy.org/>.
Zifkin BG and Andermann F. Visual Sensitive Epilepsies. International League Against Epilepsy. 28 Feb. 2005. Web. 04 Oct. 2010. <http://www.ilae-epilepsy.org/>.

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Responsible Party: Robert P. Turner, Assoc Prof Neurosciences, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT01363154    
Other Study ID Numbers: 7683
First Posted: June 1, 2011    Key Record Dates
Last Update Posted: June 4, 2013
Last Verified: June 2013
Keywords provided by Robert P. Turner, Medical University of South Carolina:
Children's Health
Pediatrics
Epilepsy
Photoparoxysmal
Photosensitive
Music
Mozart
K-448
Additional relevant MeSH terms:
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Epilepsy
Seizures
Congenital Abnormalities
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms