Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE May 27, 2011
First Posted Date  ICMJE June 1, 2011
Last Update Posted Date June 4, 2013
Study Start Date  ICMJE November 2010
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 27, 2011)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Photoparoxysmal Abnormalities by Mozart K448
Official Title  ICMJE Prevention of Photoparoxysmal Abnormalities Through Patterned Auditory Stimulation
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Photoparoxysmal Abnormalities
  • Epilepsy
  • Seizures
Intervention  ICMJE
  • 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
  • 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.
Study Arms  ICMJE
  • Active Comparator: Mozart K448
    Treatment: music exposure to Mozart K448
    Intervention: Other: Mozart K448
  • Placebo Comparator: Beethoven's Für Elise
    Placebo: music exposure to Beethoven's Für Elise for piano
    Interventions:
    • Other: Beethoven's Für Elise
    • Other: No music exposure
  • No Intervention: No music exposure
    Control: no music exposure
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 2, 2013)
10
Original Estimated Enrollment  ICMJE
 (submitted: May 27, 2011)
30
Actual Study Completion Date  ICMJE February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 5 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01363154
Other Study ID Numbers  ICMJE 7683
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Robert P. Turner, Medical University of South Carolina
Study Sponsor  ICMJE Medical University of South Carolina
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Medical University of South Carolina
Verification Date June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP