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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mozart K448 | Active Comparator | Treatment: music exposure to Mozart K448 |
|
| Beethoven's Für Elise | Placebo Comparator | Placebo: music exposure to Beethoven's Für Elise for piano |
|
| No music exposure | No Intervention | Control: no music exposure |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mozart K448 | Other | Subjects will receive auditory stimulation by exposure to Mozart's Sonata for Two Pianos in D Major, K448. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19369037 | Background | 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. | |
| 11680506 | 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. |
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| ID | Term |
|---|---|
| D004827 | Epilepsy |
| D012640 | Seizures |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
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| Beethoven's Für Elise | Other | Subjects will receive auditory stimulation by exposure to 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. |
|
|
| 1439341 | 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. |
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| 1396427 | 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. |
| 16146439 | 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. |
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| 11706087 | 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. |
| 17602882 | 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. |
| 12436086 | 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. |
| 10487178 | 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. |
| 14706037 | 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. |
| 9175137 | 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. |
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| 15380117 | 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. |
| 344840 | 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. |
| 19335019 | 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. |
| 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/>. |
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| 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/>. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |