Prevention of Photoparoxysmal Abnormalities by Mozart K448

Epilepsy Clinical Trial

Official title:

Prevention of Photoparoxysmal Abnormalities Through Patterned Auditory Stimulation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01363154
• Other study ID #: 7683
• Status: Terminated
• Phase: N/A
• First received: May 27, 2011
• Last updated: June 2, 2013
• Start date: November 2010
• Est. completion date: February 2013

Study information

• Verified date: June 2013
• Source: Medical University of South Carolina
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 5 Years to 17 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Congenital Abnormalities
• Epilepsy
• Photoparoxysmal Abnormalities
• Seizures

Intervention

Other:
• Mozart K448
Subjects will receive auditory stimulation by exposure to Mozart's Sonata for Two Pianos in D Major, K448.
• Beethoven's Für Elise
Subjects will receive auditory stimulation by exposure to Beethoven's Für Elise.
• No music exposure
Subject's will not receive an intervention and will therefore, not receive auditory stimulation and/or exposure to music.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of South Carolina

Country where clinical trial is conducted

United States, 

References & Publications (27)

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Bodner M, Muftuler LT, Nalcioglu O, Shaw GL. FMRI study relevant to the Mozart effect: brain areas involved in spatial-temporal reasoning. Neurol Res. 2001 Oct;23(7):683-90. — View Citation

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>.

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Hughes JR, Daaboul Y, Fino JJ, Shaw GL. The "Mozart effect" on epileptiform activity. Clin Electroencephalogr. 1998 Jul;29(3):109-19. — View Citation

Hughes JR, Fino JJ, Melyn MA. Is there a chronic change of the "Mozart effect" on epileptiform activity? A case study. Clin Electroencephalogr. 1999 Apr;30(2):44-5. — View Citation

Hughes JR. The Mozart Effect. Epilepsy Behav. 2001 Oct;2(5):396-417. — View Citation

Hughes JR. The Mozart Effect: Additional Data. Epilepsy Behav. 2002 Apr;3(2):182-184. — View Citation

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Kasteleijn-Nolst Trenité DG, Binnie CD, Harding GF, Wilkins A. Photic stimulation: standardization of screening methods. Epilepsia. 1999;40 Suppl 4:75-9. Review. — View Citation

Kasteleijn-Nolst Trenité DG, van der Beld G, Heynderickx I, Groen P. Visual stimuli in daily life. Epilepsia. 2004;45 Suppl 1:2-6. Review. — View Citation

Lahiri N, Duncan JS. The Mozart effect: encore. Epilepsy Behav. 2007 Aug;11(1):152-3. Epub 2007 Jun 29. — View Citation

Macdonell RA, Curatolo JM, Berkovic SF. Transcranial magnetic stimulation and epilepsy. J Clin Neurophysiol. 2002 Aug;19(4):294-306. Review. — View Citation

Sarnthein J, vonStein A, Rappelsberger P, Petsche H, Rauscher FH, Shaw GL. Persistent patterns of brain activity: an EEG coherence study of the positive effect of music on spatial-temporal reasoning. Neurol Res. 1997 Apr;19(2):107-16. — View Citation

Temkin O. The falling sickness: A history of epilepsy from the Greeks to the beginnings of modern neurology. Baltimore: Johns Hopkins University Press, 1971.

Thornton-Wells TA, Cannistraci CJ, Anderson AW, Kim CY, Eapen M, Gore JC, Blake R, Dykens EM. Auditory attraction: activation of visual cortex by music and sound in Williams syndrome. Am J Intellect Dev Disabil. 2010 Mar;115(2):172-89. doi: 10.1352/1944-7588-115.172. — View Citation

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)

Turner RP. The acute effect of music on interictal epileptiform discharges. Epilepsy Behav. 2004 Oct;5(5):662-8. — View Citation

Van Buren JM, Wood JH, Oakley J, Hambrecht F. Preliminary evaluation of cerebellar stimulation by double-blind stimulation and biological criteria in the treatment of epilepsy. J Neurosurg. 1978 Mar;48(3):407-16. — View Citation

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* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreased duration (>25%) of photoparoxysmal response(s) during exposure to K-448	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.	Each participant will have a single one hour EEG for data aquistition.	No