Prevention of Photoparoxysmal Abnormalities by Mozart K448

NCT01363154 | Terminated DMC

• 1 other identifier: 7683
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Photoparoxysmal Abnormalities; Epilepsy; Seizures

Keywords

Children's Health; Pediatrics; Epilepsy; Photoparoxysmal; Photosensitive; Music; Mozart; K-448

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (3)

Mozart K448

ACTIVE COMPARATOR

Treatment: music exposure to Mozart K448

Other: Mozart K448

Beethoven's Für Elise

PLACEBO COMPARATOR

Placebo: music exposure to Beethoven's Für Elise for piano

Other: Beethoven's Für Elise; Other: No music exposure

No music exposure

NO INTERVENTION

Control: no music exposure

Interventions

Mozart K448 OTHER

Subjects will receive auditory stimulation by exposure to Mozart's Sonata for Two Pianos in D Major, K448.

Also known as: Mozart's Sonata for Two Pianos in D Major, K448

Mozart K448

Beethoven's Für Elise OTHER

Subjects will receive auditory stimulation by exposure to Beethoven's Für Elise.

Beethoven's Für Elise

No music exposure OTHER

Subject's will not receive an intervention and will therefore, not receive auditory stimulation and/or exposure to music.

Also known as: Control: No music exposure.

Beethoven's Für Elise

Eligibility Criteria

• Age: 5 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 \[range 0-2 AEDs\]

You may not qualify if:

• History of a generalized convulsion provoked by photic stimulation;
• Inability to complete and/or comply with study protocol

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (29)

• Banerjee PN, Filippi D, Allen Hauser W. The descriptive epidemiology of epilepsy-a review. Epilepsy Res. 2009 Jul;85(1):31-45. doi: 10.1016/j.eplepsyres.2009.03.003. Epub 2009 Apr 15.

  PMID: 19369037 BACKGROUND

• 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. doi: 10.1179/016164101101199108.

  PMID: 11680506 BACKGROUND

• Davis R, Emmonds SE. Cerebellar stimulation for seizure control: 17-year study. Stereotact Funct Neurosurg. 1992;58(1-4):200-8. doi: 10.1159/000098996.

  PMID: 1439341 BACKGROUND

• Engel J Jr; International League Against Epilepsy (ILAE). A proposed diagnostic scheme for people with epileptic seizures and with epilepsy: report of the ILAE Task Force on Classification and Terminology. Epilepsia. 2001 Jun;42(6):796-803. doi: 10.1046/j.1528-1157.2001.10401.x. No abstract available.

  PMID: 11422340 BACKGROUND

• Fisher RS, Uematsu S, Krauss GL, Cysyk BJ, McPherson R, Lesser RP, Gordon B, Schwerdt P, Rise M. Placebo-controlled pilot study of centromedian thalamic stimulation in treatment of intractable seizures. Epilepsia. 1992 Sep-Oct;33(5):841-51. doi: 10.1111/j.1528-1157.1992.tb02192.x.

  PMID: 1396427 BACKGROUND

• Fisher RS, Harding G, Erba G, Barkley GL, Wilkins A; Epilepsy Foundation of America Working Group. Photic- and pattern-induced seizures: a review for the Epilepsy Foundation of America Working Group. Epilepsia. 2005 Sep;46(9):1426-41. doi: 10.1111/j.1528-1167.2005.31405.x.

  PMID: 16146439 BACKGROUND

• Hughes JR, Daaboul Y, Fino JJ, Shaw GL. The "Mozart effect" on epileptiform activity. Clin Electroencephalogr. 1998 Jul;29(3):109-19. doi: 10.1177/155005949802900301.

  PMID: 9660010 BACKGROUND

• 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. doi: 10.1177/155005949903000204.

  PMID: 10358782 BACKGROUND

• Hughes JR. The Mozart Effect. Epilepsy Behav. 2001 Oct;2(5):396-417. doi: 10.1006/ebeh.2001.0250.

  PMID: 12609277 BACKGROUND

• Hughes JR. The Mozart Effect: Additional Data. Epilepsy Behav. 2002 Apr;3(2):182-184. doi: 10.1006/ebeh.2002.0329.

  PMID: 12609420 BACKGROUND

• Jacobs MP, Fischbach GD, Davis MR, Dichter MA, Dingledine R, Lowenstein DH, Morrell MJ, Noebels JL, Rogawski MA, Spencer SS, Theodore WH. Future directions for epilepsy research. Neurology. 2001 Nov 13;57(9):1536-42. doi: 10.1212/wnl.57.9.1536.

  PMID: 11706087 BACKGROUND

• Lahiri N, Duncan JS. The Mozart effect: encore. Epilepsy Behav. 2007 Aug;11(1):152-3. doi: 10.1016/j.yebeh.2007.04.017. Epub 2007 Jun 29.

  PMID: 17602882 BACKGROUND

• Macdonell RA, Curatolo JM, Berkovic SF. Transcranial magnetic stimulation and epilepsy. J Clin Neurophysiol. 2002 Aug;19(4):294-306. doi: 10.1097/00004691-200208000-00004.

  PMID: 12436086 BACKGROUND

• Kasteleijn-Nolst Trenite DG, Binnie CD, Harding GF, Wilkins A. Photic stimulation: standardization of screening methods. Epilepsia. 1999;40 Suppl 4:75-9. doi: 10.1111/j.1528-1157.1999.tb00911.x.

  PMID: 10487178 BACKGROUND

• Kasteleijn-Nolst Trenite DG, van der Beld G, Heynderickx I, Groen P. Visual stimuli in daily life. Epilepsia. 2004;45 Suppl 1:2-6. doi: 10.1111/j.0013-9580.2004.451004.x.

  PMID: 14706037 BACKGROUND

• 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. doi: 10.1080/01616412.1997.11740782.

  PMID: 9175137 BACKGROUND

• 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.

  PMID: 20440382 BACKGROUND

• Turner RP. The acute effect of music on interictal epileptiform discharges. Epilepsy Behav. 2004 Oct;5(5):662-8. doi: 10.1016/j.yebeh.2004.07.003.

  PMID: 15380117 BACKGROUND

• 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. doi: 10.3171/jns.1978.48.3.0407. No abstract available.

  PMID: 344840 BACKGROUND

• Verduzco-Flores S, Ermentrout B, Bodner M. From working memory to epilepsy: dynamics of facilitation and inhibition in a cortical network. Chaos. 2009 Mar;19(1):015115. doi: 10.1063/1.3080663.

  PMID: 19335019 BACKGROUND

• 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)

  BACKGROUND

• CURE: Citizens United for Research in Epilepsy. Web. 04 Oct. 2010. <http://www.cureepilepsy.org/home.asp>.

  BACKGROUND

• Epilepsy Foundation of America. Web. 04 Oct. 2010. <https://efa.org/>.

  BACKGROUND

• Franaszczuk PJ, Kudela P, Bergey GK. External excitatory stimuli can terminate bursting in neural network models. Epilepsy Res. 2003 Feb;53(1-2):65-80. doi: 10.1016/s0920-1211(02)00248-6.

  PMID: 12576169 BACKGROUND

• Harding GF, Jeavons PM. Photosensitive Epilepsy. MacKeith Press, London, 1994.

  BACKGROUND

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

  BACKGROUND

• 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)

  BACKGROUND

• ILAE: International League Against Epilepsy. Web. 02 Oct. 2010. <http://www.ilae-epilepsy.org/>.

  BACKGROUND

• Zifkin BG and Andermann F. Visual Sensitive Epilepsies. International League Against Epilepsy. 28 Feb. 2005. Web. 04 Oct. 2010. <http://www.ilae-epilepsy.org/>.

  BACKGROUND

MeSH Terms

Conditions

Epilepsy; Seizures

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robert P Turner, MD, MSCR

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Mark Bodner, MD

  MIND Institute

  PRINCIPAL INVESTIGATOR

• Lee Anne Tetrick, BS

  Medical University of South Carolina

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof Neurosciences

Study Record Dates

• First Submitted: May 27, 2011
• First Posted: June 1, 2011
• Study Start: November 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: June 4, 2013

Record last verified: 2013-06

Locations

US (1)